[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Notices]
[Page 50275]
[FR Doc No: 2023-16254]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration (FAA)

Notice of Opportunity for Public Comment on Release of Federally
Obligated Land at the Brunswick Golden Isles Airport (BQK), Brunswick,
GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA proposes to rule and invites public comment on the
release of land at the Brunswick Golden Isles Airport(BQK), Brunswick,
Georgia.

DATES: Comments must be received on or before August 31, 2023.

ADDRESSES: Documents are available for review by prior appointment at
the following location: Atlanta Airports District Office, Attn: Joseph
Robinson, Planner, 1701 Columbia Ave., Suite 220, College Park, Georgia
30337-2747, Telephone:<PHONE_NUMBER>.
    Comments on this notice may be mailed or delivered in triplicate to
the FAA at the following address: Atlanta Airports District Office,
Attn: Joseph Robinson, Planner, 1701 Columbia Ave., Suite 220, College
Park, Georgia 30337-2747.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Robert Burr, Executive Director, Glynn County
Airport Comission at the following address: 295 Aviation Parkway, Suite
205, Brunswick, GA 31525.

FOR FURTHER INFORMATION CONTACT: Joseph Robinson, Airport Planner,
Atlanta Airports District Office, 1701 Columbia Ave., Suite 220,
College Park, Georgia 30337-2747,<PHONE_NUMBER>. The application may
be reviewed in person at this same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the Glynn
County Airport Comission request to release and sell five tracts of
land consisting of approximately 51.492 acres of airport property at
the Brunswick Golden Isles Airport (BQK) under the provisions of 49
U.S.C. 47107(h)(2). On June 27, 2023, the FAA determined the request to
release property at the Brunswick Golden Isles Airport (BQK) submitted
by the Sponsor meets the procedural requirements of the Federal
Aviation Administration and the release of the property does not and
will not impact future aviation needs at the airport. The FAA may
approve the request, in whole or in part, no sooner than thirty days
after the publication of this notice.
    The following is a brief overview of the request:
    The Brunswick Golden Isles Airport (BQK) is proposing the release
of airport property containing 51.492 acres, more or less. The property
was aquired via surplus property transfer on April 18, 1977. The
purpose of this request is to permanently release the federal
obligations on the property given there is no potential for future
aviation use, as demonstrated by the Airport Layout Plan. In accordance
with 49 U.S.C. 47107(c)(2)(B)(i) and (iii), the airport will receive
fair market value for the property, which will be subsequently
reinvested in another eligible airport improvement project for aviation
use.
    Any person may inspect, by appointment, the request in person at
the FAA office listed above under FOR FURTHER INFORMATION CONTACT.
Issued in College Park, Georgia on July 27, 2023.

Joseph Parks Preston,
Manager, Atlanta Airports District Office, Southern Region.
[FR Doc. 2023-16254 Filed 7-31-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Rules and Regulations]
[Page 36399]
[FR Doc No: 2014-15122]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2013-0327]

Regattas and Marine Parades in the COTP Lake Michigan Zone--
Chinatown Chamber of Commerce Dragon Boat Race, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the special local regulation on
the South Branch of the Chicago River for the Chinatown Chamber of
Commerce Dragon boat Race in Chicago, Illinois. This regulated area
will be enforced from 7 a.m. until 5 p.m. on June 28, 2014. This action
is necessary and intended to ensure safety of life and property on
navigable waters immediately prior to, during, and immediately after
the Dragon Boat race. During the aforementioned period, the Coast Guard
will enforce restrictions upon, and control movement of, vessels in a
portion of the Captain of the Port Lake Michigan Zone.

DATES: The regulations in 33 CFR 100.909 will be enforced from 7 a.m.
until 5 p.m. on June 28, 2014.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email MST1 John Ng, Waterways Management Division,
Marine Safety Unit Chicago, Chicago, IL at<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulation listed in 33 CFR 100.909, Chinatown Chamber of
Commerce Dragon Boat Race; Chicago, IL. This special local regulation
will encompass all waters of the South Branch of the Chicago River from
the West 18th Street Bridge at position 41[deg]51'28'' N,
087[deg]38'06'' W to the Amtrak Bridge at position 41[deg]51'20'' N,
087[deg]38'13'' W (NAD 83). This year, this special local regulation
will be enforced from 7 a.m. until 5 p.m. on June 28, 2014.
    Vessels desiring to transit the regulated area may do so only with
prior approval of the Patrol Commander and when so directed by that
officer. Vessels will be operated at a no wake speed to reduce the wake
to a minimum, and in a manner which will not endanger participants in
the event or any other craft. The rules contained in the above two
sentences shall not apply to participants in the event or vessels of
the patrol operating in the performance of their assigned duties. The
Patrol Commander may direct the anchoring, mooring, or movement of any
boat or vessel within the regatta area.
    This document is issued under authority of 33 CFR 100.909,
Chinatown Chamber of Commerce Dragon Boat Race; Chicago, IL, and 5
U.S.C. 552(a). In addition to this publication in the Federal Register,
the Coast Guard will provide the maritime community with advance
notification of the enforcement of this special local regulation via
Broadcast Notice to Mariners or Local Notice to Mariners. The Captain
of the Port, Lake Michigan, or his or her on-scene representative may
be contacted via Channel 16, VHF-FM.

    Dated: June 16, 2014.
M.W. Sibley,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2014-15122 Filed 6-26-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 145 (Wednesday, July 29, 2015)]
[Rules and Regulations]
[Pages 45079-45085]
[FR Doc No: 2015-18610]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0325; FRL-9930-22]

Ethanesulfonic Acid, 2-hydroxy and the Corresponding Ammonium,
Sodium, Potassium, Calcium, Magnesium, and Zinc Salts; Exemption from
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of ethanesulfonic acid, 2-hydroxy- (CAS
Reg. No. 107-36-8); ethanesulfonic acid, 2-hydroxy-, ammonium salt (CAS
Reg. No. 57267-78-4); ethanesulfonic acid, 2-hydroxy-, sodium salt (CAS
Reg. No. 1562-00-1); ethanesulfonic acid, 2-hydroxy-, potassium salt
(CAS Reg. No. 1561-99-5); ethanesulfonic acid, 2-hydroxy-, calcium salt
(CAS Reg. No. 10550-47-7); ethanesulfonic acid, 2-hydroxy-, magnesium
salt (CAS Reg. No. 17345-56-1), and ethanesulfonic acid, 2-hydroxy-,
zinc salt (CAS Reg. No. 129756-32-7) when used as inert ingredients
(chelator, sequestrant and conditioning agent) in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest and applied to animals. Technology Sciences Group Inc.
(1150 18th St. NW., Suite 1000 Washington, DC 20036) on behalf of
Huntsman Corporation (8600 Gosling Rd., The Woodlands, TX 77381)
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting establishment of an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of ethanesulfonic
acid, 2-hydroxy- and its corresponding ammonium, sodium, potassium,
calcium, magnesium, and zinc salts.

DATES: This regulation is effective July 29, 2015. Objections and
requests for hearings must be received on or before September 28, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0325, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. 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 OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this
document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0325 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 28, 2015. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0325, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10684) by
Technology Sciences Group Inc. (1150 18th St. NW., Suite 1000,
Washington, DC 20036) on behalf of Huntsman Corporation (8600 Gosling
Rd., The Woodlands, TX 77381). The petition requested that 40 CFR
180.910 and 40 CFR 180.930 be amended by establishing an exemption from
the requirement of a tolerance for residues of ethanesulfonic acid, 2-
hydroxy- (CAS Reg. No. 107-36-8); ethanesulfonic acid, 2-hydroxy-,
ammonium salt (CAS Reg. No. 57267-78-4); ethanesulfonic acid, 2-
hydroxy-, sodium salt (CAS Reg. No. 1562-00-1);

ethanesulfonic acid, 2-hydroxy-, potassium salt (CAS Reg. No. 1561-99-
5); ethanesulfonic acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550-
47-7); ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No.
17345-56-1), and ethanesulfonic acid, 2-hydroxy-, zinc salt (CAS Reg.
No. 129756-32-7) when used as inert ingredients (chelator, sequestrant,
and conditioning agent) in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest and applied to
animals in accordance with 40 CFR 180.910 and 180.930, respectively.
That document referenced a summary of the petition prepared by
Technology Sciences Group Inc., the petitioner, which is available in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue . . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for ethanesulfonic acid, 2-hydroxy
and the corresponding ammonium, sodium, potassium, calcium, magnesium,
and zinc salts (also referred to as isethionic acid and its salts)
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with
isethionic acid and its salts follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by isethionic acid and its salts as well
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are
discussed in this unit.
    Isethionate salts are expected to metabolize and dissociate into
isethionic acid in the body. Therefore, toxicity for each of the
isethionate salt forms are expected to have equal toxicity and share
similar physical and chemical characteristics. Studies on isethionic
acid or any one of its salt can be considered relevant for the entire
group.
    The acute oral toxicity of isethionic acid ammonium salt is low.
The acute oral lethal dose (LD)50 in rats were > 1,000
milligram/kilogram/body weight (mg/kg-bw). The acute dermal toxicity in
rats was > 1,000 mg/kg-bw. Ammonium isethionate is a minimal eye
irritant based on a primary eye irritation study in rabbits. Ammonium
isethionate is not dermally irritating based on a primary skin
irritation study in rabbits. Ammonium isethionate has an acute
inhalation lethal concentration (LC)50 > 6.295 milligram/
liter (mg/L) and is not a dermal sensitizer.
    In a 90-day oral toxicity study on rats via gavage with sodium
isethionate, decreased mean corpuscular hemoglobin concentration,
increased mean absolute and relative reticulocyte counts, increased
spleen weights and microscopic changes in the liver, bile duct, and
spleen were observed at 1,000 milligram/kilogram/day (mg/kg/day)
(LOAEL). Effects showed complete reversal after exposure was
discontinued. The NOAEL for sodium isethionate was identified in this
study as 200 mg/kg/day.
    In an OSCPP Harmonized Test Guideline 870.3650 combined repeated
dose toxicity study with the reproduction/developmental toxicity
screening test, ammonium isethionate was administered to rats by
gavage. The parental systemic LOAEL for ammonium isethionate is 500 mg/
kg/day based on absolute and relative kidney weights and relative
adrenal weights, and the parental systemic NOAEL is 250 mg/kg/day. The
reproductive/developmental LOAEL for ammonium isethionate in rats was
not identified, and the reproductive/developmental NOAEL is greater
than or equal to 500 mg/kg/day.
    Ammonium isethionate was negative for mutagenicity or chromosomal
aberrations in a battery of tests of genotoxicity including a reverse
gene mutation assay in bacteria, an in vitro mammalian cell gene
mutation test using mouse lymphoma cells and an in vitro mammalian cell
micronucleus test.
    The OncoLogicTM structure-activity model was used to
evaluate the likelihood that isethionic acid and its salts may cause
cancer. Structure-activity modeling using Oncologic

indicates that isethionic acid does not contain structural alerts of
potential concern for carcinogenicity. Based on the negative results
for genotoxicity as well as the structure-activity model for
carcinogenicity there is a low concern for isethionic acid and its
salts as potential carcinogens.
    No neurotoxicity studies were available in the database for
isethionic acid and its salts. However, a functional observational
battery (FOB) and locomotor activity patterns were evaluated in the
combined reproduction/developmental toxicity screening test and 90-day
oral toxicity study. No alterations in the FOB or locomotor activity
patterns were observed.
    No Immunotoxicity studies on isethionic acid and its salts were
available in the database. Increased spleen weights and microscopic
changes in the spleen were observed in the 90-day toxicity study in
rats; however, the chronic reference dose (cRfD) is based on this study
and is protective of these effects.
    No metabolism studies were available in the database for isethionic
acid and its salts.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for isethionic acid and
its salts used for human risk assessment is shown in Table 1 of this
unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Isethionic Acid and Its Salts for Use in Human Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50          An acute effect was not found in the database therefore an acute dietary
 years of age).                                             assessment is not necessary.
                                  ------------------------------------------------------------------------------
Acute dietary (General population     An acute effect was not found in the database therefore an acute dietary
 including infants and children).                           assessment is not necessary.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 200 mg/kg/    Chronic RfD = 200    90-day oral toxicity-rat LOAEL =
                                    day.                  mg/kg/day.           1,000 mg/kg/day based on
                                   UFA = 10x...........  cPAD = 2.0 mg/kg/     decreased body weight, changes in
                                   UFH = 10x...........   day.                 hematology parameters, increased
                                   FQPA SF = 1x........                        spleen weights, macroscopic
                                                                               changes in the liver and
                                                                               microscopic changes in the liver,
                                                                               bile duct and spleen.
Incidental oral short-term (1 to   NOAEL = 200 mg/kg/    LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
 30 days).                          day.                                       1,000 mg/kg/day based on
                                   UFA = 10x...........                        decreased body weight, changes in
                                   UFH = 10x...........                        hematology parameters, increased
                                   FQPA SF = 1x........                        spleen weights, macroscopic
                                                                               changes in the liver and
                                                                               microscopic changes in the liver,
                                                                               bile duct and spleen.
Incidental oral intermediate-term  NOAEL = 200 mg/kg/    LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
 (1 to 6 months).                   day.                                       1,000 mg/kg/day based on
                                   UFA = 10x...........                        decreased body weight, changes in
                                   UFH = 10x...........                        hematology parameters, increased
                                   FQPA SF = 1x........                        spleen weights, macroscopic
                                                                               changes in the liver and
                                                                               microscopic changes in the liver,
                                                                               bile duct and spleen.
Dermal short-term (1 to 30 days).  Dermal (or oral)      LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
                                    study NOAEL = 200                          1,000 mg/kg/day based on
                                    mg/kg/day (dermal                          decreased body weight, changes in
                                    absorption rate =                          hematology parameters, increased
                                    100%.                                      spleen weights, macroscopic
                                   UFA = 10x...........                        changes in the liver and
                                   UFH = 10x...........                        microscopic changes in the liver,
                                   FQPA SF = 1x........                        bile duct and spleen.
Dermal intermediate-term (1 to 6   Dermal (or oral)      LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
 months).                           study NOAEL = 200                          1,000 mg/kg/day based on
                                    mg/kg/day (dermal                          decreased body weight, changes in
                                    absorption rate =                          hematology parameters, increased
                                    100%.                                      spleen weights, macroscopic
                                   UFA = 10x...........                        changes in the liver and
                                   UFH = 10x...........                        microscopic changes in the liver,
                                   FQPA SF = 1x........                        bile duct and spleen.

Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
 days).                             study NOAEL = 200                          1,000 mg/kg/day based on
                                    mg/kg/day                                  decreased body weight, changes in
                                    (inhalation                                hematology parameters, increased
                                    absorption rate =                          spleen weights, macroscopic
                                    100%).                                     changes in the liver and
                                   UFA = 10x...........                        microscopic changes in the liver,
                                   UFH = 10x...........                        bile duct and spleen.
                                   FQPA SF = 1x........
Inhalation (1 to 6 months).......  Inhalation (or oral)  LOC for MOE = 100..  90-day oral toxicity-rat LOAEL =
                                    study NOAEL = 200                          1,000 mg/kg/day based on
                                    mg/kg/day                                  decreased body weight, changes in
                                    (inhalation                                hematology parameters, increased
                                    absorption rate =                          spleen weights, macroscopic
                                    100%).                                     changes in the liver and
                                   UFA = 10x...........                        microscopic changes in the liver,
                                   UFH = 10x...........                        bile duct and spleen.
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)       Based on structural activity analysis, lack of effects suggestive of
                                      potential carcinogenicity in subchronic studies and negative results for
                                     genotoxicity in bacterial and mammalian cell assays, there is a low concern
                                     for the salts of isethionate and isethionic acid as potential carcinogens.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to isethionic acid and its salts, EPA considered exposure
under the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from isethionic acid and its salts in food
as follows:
    An acute dietary risk assessment was not conducted because no
endpoint of concern following a single exposure was identified in the
available studies. A chronic dietary exposure assessment was completed
and performed using the Dietary Exposure Evaluation Model DEEM-
FCID\TM\, Version 3.16 which includes food consumption information from
the U.S. Department of Agriculture's National Health and Nutrition
Examination Survey, ``What We Eat In America'', (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008. In the absence of
actual residue data, the inert ingredient evaluation is based on a
highly conservative model that assumes that the residue level of the
inert ingredient would be no higher than the highest established
tolerance for an active ingredient on a given commodity. Implicit in
this assumption is that there would be similar rates of degradation
between the active and inert ingredient (if any) and that the
concentration of inert ingredient in the scenarios leading to these
highest of tolerances would be no higher than the concentration of the
active ingredient. The model assumes 100 percent crop treated (PCT) for
all crops and that every food eaten by a person each day has tolerance-
level residues. A complete description of the general approach taken to
assess inert ingredient risks in the absence of residue data is
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water)
Dietary Exposure and Risk Assessments for the Inerts'' (D361707, S.
Piper, 2/25/09) and can be found at http://www.regulations.gov in
docket ID number EPA-HQ-OPP-2008-0738.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for isethionic acid and
its salts, a conservative drinking water concentration value of 100
parts per billion (ppb) based on screening level modeling was used to
assess the contribution to drinking water for the chronic dietary risk
assessments for parent compound. These values were directly entered
into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Isethionic acid and its salts may be used as inert ingredients in
pesticide products that are registered for specific uses that may
result in indoor or outdoor residential inhalation and dermal
exposures. A screening level residential exposure and risk assessment
was completed utilizing conservative residential exposure assumptions.
The Agency assessed short- and intermediate-term dermal and inhalation
exposures for residential handlers that would result from low pressure
hand wand, hose end sprayer and trigger sprayer for each pesticide
type, herbicide, insecticide, and fungicide. The Agency assessed post-
application short-term dermal exposure for children short-term hand-to-
mouth and dermal exposure for children and adults from contact with
treated lawns.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found isethionic acid and its salts to share a common
mechanism

of toxicity with any other substances, and isethionic acid and its
salts does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that isethionic acid and its salts does not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Fetal susceptibility was not
observed in the combined developmental/reproduction toxicity screening
test in rats. Neither offspring nor reproduction toxicity was observed
in this study at dose levels up to 500 mg/kg/day in rats, the highest
dose tested.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for isethionic acid and its salts contains
the following acceptable studies: Subchronic, reproduction/
developmental screening study, and a mutagenicity study. The database
is considered to be adequate to assess prenatal and postnatal toxicity.
    ii. There is no indication that isethionic acid and its salts are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional uncertainty factors (UF) to account
for neurotoxicity.
    iii. There is no indication that isethionic acid and its salts are
immunotoxic chemicals. Although increased spleen weights and
microscopic changes in the spleen were observed in the 90-day toxicity
study in rats those effects were due to red blood cell destruction and
therefore not considered an immuno toxic effect. In any event, the cRfD
is based on this study and is protective of these effects. Therefore,
there is no need for an Immunotoxicity study or additional UFs to
account for Immunotoxicity.
    iv. There is no evidence that isethionic acid and its salts result
in increased susceptibility for infants and children.
    v. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to isethionic acid and its salts in drinking water.
EPA used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by isethionic acid and its salts.

E. Aggregate Risks and Determination of Safety

    1. Determination of safety section. EPA determines whether acute
and chronic dietary pesticide exposures are safe by comparing aggregate
exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For
linear cancer risks, EPA calculates the lifetime probability of
acquiring cancer given the estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate PODs to ensure that an adequate MOE exists.
    2. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
isethionic acid and its salts is not expected to pose an acute risk.
    3. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
isethionic acid and its salts from food and water will utilize 9.5% of
the cPAD for the U.S. population and 35.3% of the cPAD for children 1-2
yrs. old, the population group receiving the greatest exposure.
    4. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Isethionic
acid and its salts may be used as an inert ingredient in pesticide
products that are registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to isethionic acid and its salts.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 187 for adults
and 123 for children. Because EPA's level of concern for isethionic
acid and its salts are MOEs of 100 or below, these MOEs are not of
concern.
    5. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Isethionic acid and its salts are currently used as an inert
ingredient in pesticide products that are registered for uses that
could result in intermediate-term residential exposure. The endpoint of
concern selected for short- and intermediate-term exposure assessment
is the same NOAEL, therefore intermediate term exposure is not expected
to exceed short term aggregate exposure and therefore there are no
concerns for intermediate-term aggregate exposure.
    6. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to isethionic acid
and its salts; therefore, a cancer dietary exposure assessment was not
performed and an aggregate risk and aggregate cancer risk assessment is
not a concern.
    7. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to isethionic acid and its salt residues.

V. Analytical Enforcement Methodology

    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.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are

established under 40 CFR 180.910 and 40 CFR 180.930 for ethanesulfonic
acid, 2-hydroxy- (CAS Reg. No. 107-36-8); ethanesulfonic acid, 2-
hydroxy-, ammonium salt (CAS Reg. No. 57267-78-4); ethanesulfonic acid,
2-hydroxy-, sodium salt (CAS Reg. No. 1562-00-1); ethanesulfonic acid,
2-hydroxy-, potassium salt (CAS Reg. No. 1561-99-5); ethanesulfonic
acid, 2-hydroxy-, calcium salt (CAS Reg. No. 10550-47-7);
ethanesulfonic acid, 2-hydroxy-, magnesium salt (CAS Reg. No. 17345-56-
1), and ethanesulfonic acid, 2-hydroxy-, zinc salt (CAS Reg. No.
129756-32-7) when used as inert ingredients (chelators, sequestrants,
and conditioning agents) in pesticide formulations applied to growing
crops and raw agricultural commodities after harvest and applied to
animals.

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 21, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.910, add alphabetically the inert ingredients to the
table to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
      Inert ingredients              Limits                 Uses
------------------------------------------------------------------------

                              * * * * * * *
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy- (CAS Reg. No. 107-                         sequestrant, or
 36-8).                                              conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, ammonium salts                            sequestrant, or
 (CAS Reg. No. 57267-78-4).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, calcium salts                             sequestrant, or
 (CAS Reg. No. 10550-47-7).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, magnesium salts                           sequestrant, or
 (CAS Reg. No. 17345-56-1).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, potassium salts                           sequestrant, or
 (CAS Reg. No. 1561-99-5).                           conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, sodium salts (CAS                         sequestrant, or
 Reg. No. 1562-00-1).                                conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, zinc salts (CAS                           sequestrant, or
 Reg. No. 129756-32-7).                              conditioning agent.

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

0
3. In Sec.  180.930, add alphabetically the inert ingredients to the
table to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
      Inert ingredients              Limits                 Uses
------------------------------------------------------------------------

                              * * * * * * *
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy- (CAS Reg. No. 107-                         sequestrant, or
 36-8).                                              conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, ammonium salts                            sequestrant, or
 (CAS Reg. No. 57267-78-4).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, calcium salts                             sequestrant, or
 (CAS Reg. No. 10550-47-7).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, magnesium salts                           sequestrant, or
 (CAS Reg. No. 17345-56-1).                          conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, potassium salts                           sequestrant, or
 (CAS Reg. No. 1561-99-5).                           conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, sodium salts (CAS                         sequestrant, or
 Reg. No. 1562-00-1).                                conditioning agent.
Ethanesulfonic acid, 2-       ....................  Chelator,
 hydroxy-, zinc salts (CAS                           sequestrant, or
 Reg. No. 129756-32-7).                              conditioning agent.

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

[FR Doc. 2015-18610 Filed 7-28-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 201 (Friday, October 17, 2014)]
[Proposed Rules]
[Pages 62366-62368]
[FR Doc No: 2014-24616]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-0293; Airspace Docket No. 14-ANE-5]

Proposed Establishment of Class E Airspace; Plainville, CT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E Airspace at
Plainville, CT, to accommodate new Area Navigation (RNAV) Global
Positioning System (GPS) Standard Instrument Approach Procedures
(SIAPs) serving Robertson Field Airport. This action would enhance the
safety and airspace management of Instrument Flight Rules (IFR)
operations within the National Airspace System.

DATES: Comments must be received on or before December 1, 2014.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey SE., Washington, DC 20590-

0001; Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify
the Docket Number FAA-2014-0293; Airspace Docket No. 14-ANE-5, at the
beginning of your comments. You may also submit and review received
comments through the Internet at  http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2014-0293; Airspace Docket No. 14-ANE-5) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at  http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2014-0293; Airspace Docket No. 14-ANE-5.'' The postcard will be
date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except Federal Holidays, at the
office of the Eastern Service Center, Federal Aviation Administration,
Room 350, 1701 Columbia Avenue, College Park, Georgia 30337.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>, to
request a copy of Advisory circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace at
Plainville, CT, providing the controlled airspace required to support
the new RNAV (GPS) standard instrument approach procedures for
Robertson Field Airport. Controlled airspace extending upward from 700
feet above the surface within a 9.5-mile radius of the airport would be
established for IFR operations.
    Class E airspace designations are published in Paragraph 6005 of
FAA order 7400.9Y, dated August 8, 2014, and effective September 15,
2014, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would establish Class E airspace at Robertson
Field Airport, Plainville, CT.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9Y, Airspace Designations and Reporting
Points, dated August 8, 2014, effective September 15, 2014, is amended
as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward from 700
Feet or More Above the Surface of the Earth.

* * * * *

ANE CT E5 Plainville, CT [New]

Robertson Field Airport, CT
    (Lat. 41[deg]41'22'' N., long. 72[deg]51'53'' W.)

    That airspace extending upward from 700 feet above the surface
within a 9.5-mile radius of Robertson Field Airport.

    Issued in College Park, Georgia, on October 7, 2014.
Myron A. Jenkins,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2014-24616 Filed 10-16-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 17, 2008 (Volume 73, Number 117)]
[Notices]
[Page 34285-34288]
[DOCID:fr17jn08-41]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

June 10, 2008.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC08-86-000.
    Applicants: Wabash Valley Power Association, Inc., TPF Generation
Holdings, LLC, Holland Energy, LLC.
    Description: Wabash Valley Power Association (Inc), et al. submits
an Addendum to its Application for Authorization Disposition of
Jurisdictional Assets under section 203.
    Filed Date: 06/09/2008.
    Accession Number: 20080609-5050.
    Comment Date: 5 p.m. Eastern Time on Monday, June 30, 2008.

    Docket Numbers: EC08-99-000.
    Applicants: Noble Environmental Power.
    Description: Joint Application of Noble Environmental Power, LLC
for Authorization of Proposed Transaction under Section 203, and
Request for Expedited Consideration, Waiver of Certain Filing
Requirements.
    Filed Date: 06/05/2008.
    Accession Number: 20080605-5046.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 26, 2008.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG08-75-000.
    Applicants: Notrees Windpower, LP.
    Description: Self Certification Notice of Exempt Wholesale
Generator of Notrees Windpower, LP.
    Filed Date: 06/04/2008.
    Accession Number: 20080604-5073.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER98-1767-011; ER07-501-007; ER99-1695-011; ER99-
2984-010.
    Applicants: Tenaska Frontier Partners, Ltd.; Birchwood Power
Partners, L.P.; Elwood Energy, LLC; Green Country Energy, LLC.
    Description: Notification of Non-Material Change in Status of J-
Power North America Holdings, Ltd.
    Filed Date: 06/06/2008.
    Accession Number: 20080606-5136.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER96-719-019; ER97-2801-020; ER99-2156-013.
    Applicants: Cordova Energy Company LLC, MidAmerican Energy Company.
    Description: Cordova Energy Company LLC et al. submits information
regarding PaCificCorp's Blundell Geothermal II Generating Facility.
    Filed Date: 06/03/2008.
    Accession Number: 20080605-0122.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 24, 2008.

    Docket Numbers: ER01-2830-003.
    Applicants: Davison Van Cleve, PC.
    Description: Application of Roseburg Forest Products for Finding as
a Category 1 Seller of Davison Van Cleve, PC.

    Filed Date: 06/09/2008.
    Accession Number: 20080609-5124.
    Comment Date: 5 p.m. Eastern Time on Monday, June 30, 2008.

    Docket Numbers: ER02-1903-008.
    Applicants: FPL Energy Marcus Hook, L.P.
    Description: FPL Energy Marcus Hook LP submits a notice of change
in status.
    Filed Date: 06/06/2008.
    Accession Number: 20080610-0219.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER02-1903-008.
    Applicants: FPL Energy Marcus Hook, L.P.
    Description: FPL Energy Marcus Hook LP submits a notice of change
in status.
    Filed Date: 06/06/2008.
    Accession Number: 20080610-0219.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER03-9-013; ER98-2157-014.
    Applicants: Westar Energy, Inc.; Kansas Gas and Electric Company
    Description: Westar Energy, Inc submits Sixth Revised Sheet 1 et
al. to its FERC Tariff, Third Revised Volume 6, effective 9/18/07.
    Filed Date: 06/04/2008.
    Accession Number: 20080606-0056.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: ER07-45-002.
    Applicants: Horizon Power & Light LLC.
    Description: Horizon Power & Light LLC submits the Amended Updated
Market Power Analysis.
    Filed Date: 06/04/2008.
    Accession Number: 20080609-0070.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: ER08-781-001.
    Applicants: Central Illinois Light Company, Central Illinois Public
Service Company, Illinois Power Company.
    Description: The Ameren Illinois Utilities jointly submit a
compliance filing of an executed Electric Resource Sharing Agreement
for Capacity.
    Filed Date: 06/04/2008.
    Accession Number: 20080606-0006.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: ER08-832-001.
    Applicants: ISO New England Inc.
    Description: Notice of Withdrawal of Tariff Sheets re ISO New
England.
    Filed Date: 06/06/2008.
    Accession Number: 20080606-5112.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER08-848-001.
    Applicants: GearyEnergy, LLC.
    Description: GearyEnergy, LLC submits a revised application for
market-based rate authority.
    Filed Date: 06/05/2008.
    Accession Number: 20080610-0225.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 26, 2008.

    Docket Numbers: ER08-1025-001.
    Applicants: The Connecticut Light and Power Company
    Description: The Connecticut Light and Power Co. submits Amendment
No. 2 to the Interconnection and Operation Agreement.
    Filed Date: 06/05/2008.
    Accession Number: 20080610-0224.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 26, 2008.

    Docket Numbers: ER08-1028-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits Second Revised Sheet 11 and
1 to the Wholesale Electric Service Agreement commencing 2/1/88,
designated First Revised Rate Schedule FERC 170 between Kansas Gas and
Electric Company etc.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0097.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1030-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc & Kansas Gas & Electric Co submits
Second Revised Sheets 9 & 1 to the Wholesale Electric Service Agreement
commencing 2/1/88, designated First Revised Rate Schedule FERC 169 w/
City of La Harpe, KS.
    Filed Date: 05/30/2008.
    Accession Number: 20080603-0096.
    Comment Date: 5 p.m. Eastern Time on Friday, June 20, 2008.

    Docket Numbers: ER08-1057-001.
    Applicants: Entergy Services, Inc.
    Description: Entergy Operating Companies submits corrected pages
B.1 and B.1.1 and requests that the corrected pages replace those
included in the original filing made on 5/30/08.
    Filed Date: 06/06/2008.
    Accession Number: 20080610-0220.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER08-1065-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits amendments to
Schedule 12 Appendix of the PJM Tariff to include cost responsibility
assignments for four baseline upgrades that will operate at or above
500 kV, etc.
    Filed Date: 06/03/2008.
    Accession Number: 20080605-0044.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 24, 2008.

    Docket Numbers: ER08-1066-000.
    Applicants: ISO New England Inc. and New England Power Pool
Participants Committee.
    Description: ISO New England, Inc and New England Power Pool
Participants Committee submits First Revised Sheet 7307D et al and
supporting testimony of Peter K Wong.
    Filed Date: 06/03/2008.
    Accession Number: 20080605-0045.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 24, 2008.

    Docket Numbers: ER08-1067-000.
    Applicants: American Electric Power Service Corporation.
    Description: The American Electric Power Service Corp on behalf of
the AEP Operating Companies submits the Third Revision to the
Interconnection and Local Delivery Service Agreement 1425 with the
Village of Plymouth.
    Filed Date: 06/04/2008.
    Accession Number: 20080605-0046.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: ER08-1068-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits an executed
interconnection service agreement with Providence Heights Wind, LLC et
al.
    Filed Date: 06/04/2008.
    Accession Number: 20080605-0047.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: ER08-1070-000.
    Applicants: Coral Power, L.L.C.
    Description: Coral Power, LLC submits a Notice of Cancellation of
Fourth Revised Rate Schedule FERC 1, effective 6/1/08.
    Filed Date: 06/04/2008.
    Accession Number: 20080606-0005.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: ER08-1071-000.
    Applicants: Coral Energy Management, LLC.
    Description: Coral Energy Management, LLC submits a Notice of
Cancellation of First Revised Rate Schedule FERC 1.
    Filed Date: 06/04/2008.
    Accession Number: 20080606-0004.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: ER08-1072-000.
    Applicants: Nevada Power Company.
    Description: Nevada Power Co. submits a Notice of Termination of
the Service Agreement for Long-Term Firm Point-to-Point Transmission
Service.
    Filed Date: 06/04/2008.
    Accession Number: 20080606-0003.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: ER08-1073-000.
    Applicants: Deseret Generation & Transmission Co-op.
    Description: Deseret Generation & Transmission Co-operative, Inc
submits its annual Informational Filing setting forth updated approved
costs for member-owned generation resources for 2008.
    Filed Date: 06/04/2008.
    Accession Number: 20080606-0002.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: ER08-1074-000.
    Applicants: The Midwest Independent Transmission Sys.
    Description: Midwest Independent Transmission System Operator, Inc
submits an executed Small Generator Interconnection Agreement.
    Filed Date: 06/04/2008.
    Accession Number: 20080606-0001.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Docket Numbers: ER08-1075-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Operating Companies submits proposed
amendments to the agreement first executed on 11/17/06 with Southwest
Power Pool, Inc.
    Filed Date: 06/05/2008.
    Accession Number: 20080609-0115.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 26, 2008.

    Docket Numbers: ER08-1076-000.
    Applicants: The American Electric Power Service Corp.
    Description: AEP Operating Companies submits a second revision to
the Interconnection and Local Delivery Service Agreement 1429 with
Village of Sycamore.
    Filed Date: 06/05/2008.
    Accession Number: 20080609-0112.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 26, 2008.

    Docket Numbers: ER08-1077-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Co. submits a Large
Generator Interconnection Agreement with CPV Sentinel, LLC et al.
    Filed Date: 06/05/2008.
    Accession Number: 20080609-0114.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 26, 2008.

    Docket Numbers: ER08-1078-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Gulf States Louisiana, LLC submits an amended
Interconnection and Operating Agreement between RSC Cogen, LLC and EGS.
    Filed Date: 06/06/2008.
    Accession Number: 20080610-0204.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER08-1079-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Services, Inc submits an amended
Interconnection and Operating Agreement between LSP Energy Limited
Partnership and EMI.
    Filed Date: 06/06/2008.
    Accession Number: 20080610-0205.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER08-1086-000.
    Applicants: Saracen Energy MB L.P.
    Description: Saracen Energy MB LP submits its Cancellation of Rate
Schedule and gives notice that Rate Schedule FERC 1 effective 7/1/07,
is being cancelled.
    Filed Date: 06/05/2008.
    Accession Number: 20080610-0213.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 26, 2008.

    Docket Numbers: ER08-1088-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits a revised
interconnection service agreement and revised construction service
agreement.
    Filed Date: 06/06/2008.
    Accession Number: 20080610-0203.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER08-1089-000.
    Applicants: Port Washington Generating Station LLC.
    Description: Port Washington Generating Station LLC notifies FERC
of the termination of Rate Schedule FERC 1 under which PWGS was
authorized to sell test power to Wisconsin Electric Power Company etc.
    Filed Date: 06/06/2008.
    Accession Number: 20080610-0214.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER08-1089-000.
    Applicants: Port Washington Generating Station LLC.
    Description: Port Washington Generating Station LLC notifies FERC
of the termination of Rate Schedule FERC 1 under which PWGS was
authorized to sell test power to Wisconsin Electric Power Company etc.
    Filed Date: 06/06/2008.
    Accession Number: 20080610-0214.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER08-1090-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
revisions to its Open Access Transmission Tariff and Market
Administration and Control Area Services Tariff.
    Filed Date: 06/06/2008.
    Accession Number: 20080610-0215.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: ER08-1091-000.
    Applicants: West Valley Leasing Company, LLC.
    Description: West Valley Leasing Company, LLC submits Notice of
Cancellation of its market-based rate tariff, FERC Electric Tariff,
Original Volume 1, to become effective 6/10/08.
    Filed Date: 06/09/2008.
    Accession Number: 20080610-0216.
    Comment Date: 5 p.m. Eastern Time on Monday, June 30, 2008.

    Docket Numbers: ER08-1092-000.
    Applicants: The American Electric Power Service Corp.
    Description: AEP Operating Companies submits a second revision to
the Interconnection and Local Delivery Service agreement 1421 with
Village of Cygnet.
    Filed Date: 06/09/2008.
    Accession Number: 20080610-0218.
    Comment Date: 5 p.m. Eastern Time on Monday, June 30, 2008.

    Docket Numbers: ER08-1093-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Co. submits notices of
termination for two Special Facilities Agreements with City and County
of San Francisco.
    Filed Date: 06/09/2008.
    Accession Number: 20080610-0217.
    Comment Date: 5 p.m. Eastern Time on Monday, June 30, 2008.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES08-52-000.
    Applicants: Monongahela Power Company.
    Description: Application of Monongahela Power Company under Section
204 of the Federal Power Act for Authorization under Section 204(a) to
issue up to $410 Million in First Mortgage Bonds or Other Long-Term
Debt Instruments.
    Filed Date: 06/09/2008.
    Accession Number: 20080609-5117.
    Comment Date: 5 p.m. Eastern Time on Monday, June 30, 2008.

    Take notice that the Commission received the following foreign
utility company status filings:

    Docket Numbers: FC08-6-000.
    Applicants: SunEdison International, LLC.
    Description: Notice of Self Certification of Foreign Utility
Company, Status of SunEdison International, LLC.
    Filed Date: 06/06/2008.
    Accession Number: 20080606-5121.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA08-13-003.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits
tariff revisions in compliance to FERC's 5/7/08 Order.
    Filed Date: 06/06/2008.
    Accession Number: 20080610-0223.
    Comment Date: 5 p.m. Eastern Time on Friday, June 27, 2008.

    Docket Numbers: OA07-88-002.
    Applicants: Carolina Power & Light Company d/b/a Pro, Florida Power
Corp. d/b/a Progress Energy, Progress Energy, Inc.
    Description: Order No. 890 OATT Filing of Carolina Power & Light
Company and Florida Power Corporation.
    Filed Date: 06/04/2008.
    Accession Number: 20080604-5069.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 25, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings 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) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov.
    To facilitate electronic service, persons with Internet access who
will eFile a document and/or be listed as a contact for an intervenor
must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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>.

 Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-13559 Filed 6-16-08; 8:45 am]

BILLING CODE 6717-01-P


NCS Herald Cohort Study Instrument # 4 Partner Questionnaire Preconception Initial Visit Eligibility: All partners enrolled while woman was not pregnant Mode of administration: Interviewer, home visit 8/ 4/ 2005 Public reporting burden for this collection of information is estimated to average 40 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Dr. Pauline Mendola, US EPA, MD 58A, Research Triangle Park, NC 27711. E mail: mendola. pauline@ epa. gov. Partner Preconception 1 ( Instrument # 4)

1 PRELOADED DATA:

Today's date Language of interview ( English/ Spanish)

Female Name Female Address and Phone Spouse/ Partner's Name ( Preload from screener)

Spouse/ Partner's Address and Phone ( Preload from screener)

QUESTIONNAIRE: Partner Preconception 1 ( Instrument # 4)

2 Occupation ( Full)

Next, I'm going to ask you about your education and employment.

1. Are you currently a full or part time student?

1 NO, NOT A STUDENT

SKIP TO Q3 2 YES, FULL TIME STUDENT 3 YES, PART TIME STUDENT 2. What type of school are you currently attending?

1 HIGH SCHOOL 2 TECHNICAL SCHOOL 3 COLLEGE OR UNIVERSITY 4 GRADUATE SCHOOL 5 PROFESSIONAL SCHOOL ( FOR EXAMPLE, MEDICAL SCHOOL) 6 OTHER ( SPECIFY)_________________

3. Are you currently

1 Working at a job or business,

SKIP TO PARAGRAPH BEFORE Q5 2 Looking for work, or 3 Not working at a job or business?

4. Were you working at a job or business at any time during the last 12 months?

1 YES 2 NO

GO TO NEXT MODULE Now, I'd like to ask you a few questions about jobs you held in the last year. I will collect information on your last 3 jobs, if they occurred in the last 12 months. Let's start with your ( FILL: current/ most recent/ next) job.

5. On what date did you start this job?

MM/ DD/ YYYY 6. [ SKIP AND PREFILL WITH ` 1' IF CURRENT JOB] On what date did you stop working at this job?

MM/ DD/ YYYY 1 = STILL EMPLOYED 7. What kind of business or industry ( FILL: is/ was) this? ( For example: TV and radio management, retail shoe store, state labor department, farm.)

_________________________________ ENTER NAME OF BUSINESS, JOB, OR INDUSTRY Partner Preconception 1 ( Instrument # 4)

3 8. What kind of work ( FILL: are/ were) you doing? ( For example: farming, mail clerk, computer specialist.)

_________________________________ ENTER NAME OF OCCUPATION 9. How many hours a week ( FILL: do/ did) you usually work at this job?

____ HOURS 10. ( FILL: Do/ Did) you do shift work for this job?

1 YES 2 NO

SKIP TO Q12 11. ( FILL: Does/ Did) this include the night shift?

1 YES 2 NO 12. Did you have any other jobs in the last 12 months?

1 YES [ REPEAT Q5 Q11 FOR UP TO 3 JOBS] 2 NO

GO TO NEXT MODULE { END OF OCCUPATION MODULE} Partner Preconception 1 ( Instrument # 4)

4 Chemical Exposures Module Now I'm going to ask you about chemicals you may have used at work, at home, or for any hobbies.

A. Have you been exposed to [ HAND SHOW CARD TO PARTICIPANT FOR EACH EXPOSURE FROM TABLE BELOW] in the last 12 months?

If Yes, ASK:

B. Are you currently exposed to [ INSERT EXPOSURE] YES NO

SKIP TO NEXT EXPOSURE C. How often are you exposed to [ INSERT EXPOSURE] ? Would you say. . .

D. Did the exposure occur while you were at work?

A. Exposed in last 12 months Yes= 01 No = 02 B. Currently Exposed Yes = 01 No = 02 C. Frequency 1 = Daily 2 = 2 3/ week 3 = 1/ week 4 = 1/ month 5 = < 1/ month D. At work Yes = 01 No = 02 1. Fuels, solvents, dry cleaning fluids, degreasers, or adhesives 2. Lead, including paints with lead in them 3. Fumes or gases ( e. g., nitrous oxide, ethylene oxide, anesthetic gases) 4. Radiation ( e. g., fluoroscopy, radioisotopes, highintensity microwaves, x rays) 5. Mercury 6. Metal fumes or particles 7. Pesticides that you've mixed or applied 8. Paints, strippers, or varnishes 9. Hair and nail products ( e. g, hair dye, bleach, hair relaxer, nail polish and remover) 10. Cleaning products ( e. g., oven cleaner, disinfectant, carpet cleaner, bleach) 11. Carbon black from copying machines 12. Coal or coal products from hot asphalt, tar, or roofing material { END OF CHEMICAL EXPOSURES MODULE} Partner Preconception 1 ( Instrument # 4)

5 Personal and Family Medical History ( full)

Now I'd like to ask you some questions about your general health.

1. Are you allergic to  ( CODE ALL THAT APPLY)

1 cats? 2 pollen? 3 dust? 4 insect bites or stings? 5 any foods? ( SPECIFY) ___________________ 6 anything else? ( SPECIFY) __________________

2. Have you ever had a condition called " hayfever" or an allergy that makes your nose runny or stuffy or your eyes itchy when you do not have a cold?

1 YES 2 NO

SKIP TO Q4 3. Did a doctor or other medical provider ever say that this was hayfever or allergy?

1 YES 2 NO 4. Did a doctor or other medical provider ever tell you that you had a skin allergy or eczema?

1 YES 2 NO 5. Did a doctor or other medical provider ever tell you that you had asthma?

1 YES 2 NO

SKIP TO Q8 6. In the past 6 months, have you used any inhalers or taken any pills for asthma or wheezing or whistling in your chest?

1 YES 2 NO 7. Have you ever gone to an emergency room or stayed overnight in a hospital for your asthma?

1 YES 2 NO 8. Do you have any of the following health problems? ( CODE ALL THAT APPLY)

1 High blood pressure or hypertension 2 High blood sugar or diabetes 3 High cholesterol 4 Anemia ( poor blood, low iron) 5 Heart problems Partner Preconception 1 ( Instrument # 4)

6 9. Have you ever been diagnosed with any other serious illnesses that I haven't asked about?

1 YES 2 NO

SKIP TO Q10 9a. What were those illnesses? ( ENTER VERBATIM)

_______________________

10. During the past 6 months, have you been hospitalized for any reason?

1 YES 2 NO

SKIP TO Q11 10a. Why were you hospitalized? ( ENTER VERBATIM)

_______________________

11. Have any of your blood relatives   your mother, father, sisters or brothers   ever had  ( CODE ALL THAT APPLY)

1 High blood pressure or hypertension? 2 High blood sugar or diabetes? 3 High cholesterol? 4 Heart problems?

{ END OF PERSONAL AND FAMILY MEDICAL HISTORY MODULE} Partner Preconception 1 ( Instrument # 4)

7 Demographics ( Full)

1. What is your date of birth?

MM/ DD/ YYYY

( calculate age; Ineligible if less than 18 years of age)

2. Are you of Hispanic or Spanish origin?

1 YES 2 NO

SKIP TO Q3 2a. Are you  ( Interviewer, read responses. Code all that apply.)

1 Mexican, Mexican American, or Chicano 2 Puerto Rican 3 Cuban 4 Other ( specify)

3. What is your race? ( Code all that apply)

1 WHITE 2 BLACK OR AFRICAN AMERICAN 3 AMERICAN INDIAN OR ALASKA NATIVE 4 NATIVE HAWAIIAN 5 GUAMANIAN OR CHAMORRO 6 SAMOAN 7 OTHER PACIFIC ISLANDER ( SPECIFY) _______________ 8 ASIAN INDIAN 9 CHINESE 10 FILIPINO 11 JAPANESE 12 KOREAN 13 VIETNAMESE 14 OTHER ASIAN ( SPECIFY) _______________ 15 OTHER RACE ( SPECIFY) ________________

4. In what country were you born?

1 USA 2 OTHER ( SPECIFY) __________

5. What is the highest grade or level of school that you have completed or the highest degree you have received?

1 NO HGH SCHOOL DEGREE

What is the highest grade of school you completed? ( Enter grade) _______ 2 HIGH SCHOOL DIPLOMA 3 GED OR EQUIVALENT 4 SOME COLLEGE 5 ASSOCIATE ( 2 YEAR) DEGREE 6 BACHELOR'S DEGREE 7 MASTER'S DEGREE 8 PROFESSIONAL DEGREE 9 DOCTORAL DEGREE Partner Preconception 1 ( Instrument # 4)

8 Partner Preconception 1 ( Instrument # 4)

9 6. What is the approximate gross annual income for all members in this household? ( INTERVIEWER: USE SHOW CARD)

1 Less than $ 9,999, 2 $ 10,000  $ 19,999, 3 $ 20,000  $ 29,999, 4 $ 30,000  $ 39,999, 5 $ 40,000  $ 49,999, 6 $ 50,000  $ 74,999, 7 $ 75,000  $ 99,999, or 8 $ 100,000 or more?

{ END OF DEMOGRAPHICS MODULE} Partner Preconception 1 ( Instrument # 4)

10 Alcohol ( Full)

The next few questions are about alcohol consumption. A " drink" is a can or bottle of beer, a glass of wine or a wine cooler, a shot of liquor, or a mixed drink with liquor in it. We are not asking about times when you only had a sip or two from a drink.

1. Have you had any alcoholic drinks in the past 2 years?

1 YES 2 NO

SKIP TO NEXT MODULE 2. Have you had any alcoholic drinks in the past 3 months?

1 YES 2 NO

SKIP TO NEXT MODULE 3. During the past 3 months, how many alcoholic drinks did you have in an average week? Would you say

1 Less than 1 drink a week, 2 1 to 3 drinks a week, 3 4 to 6 drinks a week, 4 7 to 13 drinks a week, or 5 14 drinks or more a week?

4. During the past 3 months, how many times did you drink 5 alcoholic drinks or more in one sitting? Would you say

1 Never, 2 1 time, 3 2 or 3 times, 4 4 or 5 times, or 5 6 or more times?

5. During the past 3 months, what one type of alcohol did you drink most often?

1 BEER 2 LIQUOR 3 WINE 4 OTHER ( SPECIFY)_________________

{ END OF ALCOHOL MODULE} Partner Preconception 1 ( Instrument # 4)

11 Tobacco ( Full)

These next questions are about your use of tobacco products. This includes cigarettes, chewing tobacco, snuff, cigars, and pipe tobacco.

1. During the past 30 days, have you used snuff, dip, or chewing tobacco, even once?

1 YES 2 NO 2. During the past 30 days, have you smoked a cigar or tobacco pipe, even once?

1 YES 2 NO

SKIP TO Q3 2a. How often do you smoke cigars or tobacco pipes?

_____ NUMBER OF TIMES ENTER UNIT 1 DAY 2 WEEK 3 MONTH 3. Have you smoked at least 100 cigarettes in the past 2 years?

1 YES 2 NO

SKIP TO Q7 4. Do you currently smoke cigarettes?

1 YES

SKIP TO Q6 2 NO 5. When did you last stop smoking?

___ MONTH ___ YEAR SKIP TO Q7 6. How many cigarettes do you smoke on an average day now? Would you say  [ INTERVIEWER PROBE: ONE PACK IS 20 CIGARETTES]

1 Less than 1 cigarette per day, 2 1 to 5 cigarettes, 3 6 to 10 cigarettes, 4 11 to 20 cigarettes, 5 21 to 40 cigarettes, or 6 41 cigarettes or more? Partner Preconception 1 ( Instrument # 4)

12 7. Does your wife or partner currently smoke cigarettes?

1 YES 2 NO 8. Not including yourself, how many cigarette smokers live in your home now?

_____

9. About how many hours per day are you in the same room with someone who is smoking cigarettes, cigars, or tobacco pipes?

_____ Hours 999 Less than 1 hour a day 10. Which of the following statements describes the rules about smoking inside your home now?

1 No one is allowed to smoke anywhere inside my home. 2 Smoking is allowed in some rooms or at some times. 3 Smoking is permitted anywhere inside my home.

{ END OF TOBACCO MODULE} Partner Preconception 1 ( Instrument # 4)

13 Acceptability ( To be administered at the end of the home visit)

This study will be able to answer health questions best if we are able to keep people involved in the study. To do this, we would like to get some feedback from you about the study overall and this visit today to help improve the study in the future.

1. Was participating in the visit today convenient for you?

1 YES

SKIP TO Q6 2 NO 2. Did you have to take time off from work to have this interview today?

1 YES 2 NO 3. Did you need to find childcare to have this interview today?

1 YES 2 NO 4. Were there any other major obstacles for you to have this interview today?

1 YES 2 NO

SKIP TO Q6 5. What were they? ( ENTER VERBATIM)

____________________________

6. Why did you decide to participate in this study? ( CODE ALL THAT APPLY)

1 THE STUDY WOULD BENEFIT MYSELF OR MY CHILD 2 CONTRIBUTE TO IMPROVE HEALTH OF CHILDREN AND PREGNANT WOMEN IN THE FUTURE 3 INTERESTING PROJECT TO BE INVOLVED IN 4 CURIOSITY 5 DESIRE TO BELONG TO A GROUP OR COMMUNITY OF SIMILAR PEOPLE 6 DIDN'T FEEL COMFORTABLE SAYING NO 7 OTHER REASON ( SPECIFY) __________________________

7. Is there anything that you especially like about participating in this study? ( ENTER VERBATIM)

____________________________

8. Is there anything you especially dislike about participating in this study? ( ENTER VERBATIM)

____________________________ Partner Preconception 1 ( Instrument # 4)

14 9. Finally, do you have any recommendations as to what we could do differently in the overall study or in these interviews? ( ENTER VERBATIM)

____________________________

{ END OF ACCEPTABILITY MODULE}


[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Page 17047]
[FR Doc No: 2015-07269]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0815]

Electronic Study Data Submission; Data Standards; Recommending
the Use of the World Health Organization Drug Dictionary

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
support for the World Health Organization (WHO) Drug Dictionary
(available at http://www.who-umc.org/), which is maintained and updated
by the Uppsala Monitoring Centre. FDA is encouraging sponsors and
applicants to use WHO Drug Dictionary codes in investigational study
data provided in regulatory submissions to the Center for Drug
Evaluation and Research and to the Center for Biologics Evaluation and
Research. The WHO Drug Dictionary contains unique codes for identifying
drug names and evaluating medicinal product information, including
active ingredients and therapeutic uses. Typically, WHO Drug Dictionary
is used to code concomitant medications used by subjects during the
course of a clinical trial. WHO Drug Dictionary will be listed in the
FDA Data Standards Catalog posted to FDA's Study Data Standards
Resources Web site at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm

DATES: Although you can comment on this notice at any time, to ensure
that the Agency considers your comments submit either electronic or
written comments by May 5, 2015.

ADDRESSES: Submit written requests for single copies of the documents
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, rm. 1192, Silver Spring, MD 20993-002,
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The use of a common dictionary to code concomitant medications is
an important component of study data standardization. Generally,
controlled terminology standards specify the key concepts that are
represented as definitions, preferred terms, synonyms, codes, and code
system. The analysis of study data is greatly facilitated by the use of
controlled terms for clinical or scientific concepts that have
standard, predefined meanings and representations. WHO Drug Dictionary
contains unique codes as drug names and corresponding medicinal product
information, including active ingredients and the Anatomical
Therapeutic Chemical (ATC) classification system for the therapeutic
uses. Typically, sponsors and applicants use WHO Drug Dictionary to
code and analyze concomitant medications taken by subjects during the
course of clinical trials.
    Although use of WHO Drug Dictionary codes are not required at this
time, FDA now supports and encourages the use of WHO Drug Dictionary
coded concomitant medications used in clinical trials. For purposes of
this notice, ``supported'' means the receiving Center has established
processes and technology to support receiving, processing, reviewing,
and archiving files in the specified standard.
    FDA is now encouraging sponsors and applicants to provide WHO Drug
Dictionary codes for concomitant medication data in investigational
studies provided in regulatory submissions (e.g., investigational new
drug applications, new drug applications, abbreviated new drug
applications, and biologics license applications). The codes should
include the drug product trade name where available, the active
ingredient(s) and the ATC class.

II. Comments

    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this notice to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07269 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P