[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Notices]
[Pages 8919-8920]
[FR Doc No: 2018-04122]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2018-0016]

Public Meeting Regarding NHTSA's Research Portfolio

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation (DOT).

ACTION: Notice of public meeting.

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SUMMARY: NHTSA is announcing a public meeting where the agency's
Vehicle Safety Research and Behavioral Safety Research offices will
present information on activities related to priority research programs
in vehicle and behavioral safety, including a focused overview session
on NHTSA's research in Automated Driving Systems (ADSs).
Representatives from multiple research offices will present the
research program area activities, near-term expected deliverables, and
accept questions from the audience at the end.

DATES: NHTSA will hold the public meeting on March 16, 2018 from 8:30
a.m. to 4:30 p.m., Eastern Standard Time. Check-in (through security)
will begin at 7:30 a.m. Attendees should arrive early enough to enable
them to go through security by 8:30 a.m. The public docket will remain
open until April 2, 2018.

ADDRESSES: The public meeting will be held at the DOT headquarters
building located at 1200 New Jersey Avenue SE, Washington, DC 20590
(Green Line Metro Station at Navy Yard) in the [West Building Atrium].
This facility is accessible to individuals with disabilities. The
meeting will also be webcast live, and a link to the webcast will be
made available to registrants prior to the event.

FOR FURTHER INFORMATION CONTACT: If you have questions about the public
meeting, please contact Lisa Floyd at<PHONE_NUMBER>, by email at
[email protected], or by U.S. Mail at U.S. Department of
Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590.

SUPPLEMENTARY INFORMATION: Registration is necessary for all attendees.
Attendees should register at https://www.surveymonkey.com/r/NHTSAPUBLICMEETING by March 9, 2018. Please provide name, affiliation,
email, and indicate whether you will be attending in person and whether
you require special accommodations. Space is limited, so advanced
registration is highly encouraged.
    NHTSA DOT is committed to providing equal access to this meeting
for all participants. If you need an accommodation because of a
disability, please contact Lisa Floyd at<PHONE_NUMBER>, or via email at
[email protected], with your request by close of business March 9,
2018. Should it be necessary to cancel or reschedule the meeting due to
inclement weather or other emergency, NHTSA will take all available
measures to notify registered participants.
    NHTSA will conduct the public meeting informally, and technical
rules of evidence will not apply. We will arrange for a written
transcript of the meeting and keep the official record open for 30 days
after the meeting to allow submission of supplemental information. You
may make arrangements to obtain copies of the transcript directly with
the court reporter, and the transcript will also be posted in the
docket when it becomes available.
    Written Comments: Written comments on the presented information can
be submitted during the 30-day comment period. Please submit all
written comments no later than April 2, 2018 by any of the following
methods:
     Federal Rulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001, between
9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: All submissions must include the agency name and
docket number. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided. Please see the Privacy Act discussion below.

    Docket: For access to the docket, go to http://www.regulations.gov
at any time, or to 1200 New Jersey Avenue SE, West Building, Ground
Floor, Room W12-140, Washington, DC 20590 between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. Telephone: 202-366-
9826.
    Privacy Act: Anyone can search the electronic form for comments
published in the docket by the name of the individual submitting the
comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; pages 19477-78) or you may visit
https://www.regulations.gov/privacyNotice.
    Confidential Business Information: If you wish to submit any
information under a claim of confidentiality, you should submit three
copies of your complete submission, including the information you claim
to be confidential business information to the Chief Counsel, NHTSA, at
1200 New Jersey Avenue SE, Washington, DC 20590. In addition, you
should submit two copies, from which you have deleted the claimed
confidential business information, to Docket Management at the address
given above. When you send a comment containing information claimed to
be confidential business information, you should submit a cover letter
setting forth the information specified in our confidential business
information regulation (49 CFR part 512).
    Background: Each year, NHTSA executes a broad array of research
programs in support of agency priorities. The agency's research
portfolio covers program areas pertaining to vehicle safety, including
safety countermeasures implemented through the vehicle, components,
operation and use, among others, and behavioral safety, which includes
safety countermeasures that pertain to the behavior and actions of the
driver, occupant, and other road users.
    The public meeting is intended to provide public outreach regarding
the priority research activities at NHTSA for both vehicle and
behavioral safety, including expected near-term deliverables. One of
the key priority program areas for NHTSA's Vehicle Safety Research is
Automated Driving Systems; thus, the public meeting will allocate
dedicated time to discuss research in this program area.
    For each of the areas of discussion at this public meeting, NHTSA
will briefly discuss the work underway and allow time to answer
questions from participants.
    The agency invites comments on the information presented regarding
research priorities, research goals, and additional research gaps/needs
the public may believe NHTSA should be addressing. Slides presented at
the public meeting will be posted to the docket subsequently. The
webcast will also be made available for off-line viewing after the
public meeting.

Draft Agenda

Friday, March 16, 2018

7:30 a.m.-8:45 p.m. Arrival/Check-In
8:45 a.m.-9 a.m. Housekeeping
9 a.m.-9:30 a.m. Overview
9:30 a.m.-10:45 a.m. Public Meeting Session--Crash Avoidance and
Electronic Systems Safety Research
10:45 a.m.-11 a.m. Break
11 a.m.-12:15 p.m. Public Meeting Session--Biomechanics and
Crashworthiness
12:15 p.m.-1:15 p.m. Lunch Break
1:15 p.m.-2:15 p.m. Automated Driving Systems Research
2:15 p.m.-2:30 p.m. Break
2:30 p.m.-4 p.m. Behavioral Safety Research
Closing

    Issued in Washington, DC, under authority delegated by 49 CFR
1.95.
Nathaniel Beuse,
Associate Administrator for Vehicle Safety Research.
[FR Doc. 2018-04122 Filed 2-28-18; 8:45 am]
BILLING CODE 4910-59-P


43465 Federal Register / Vol. 68, No. 141 / Wednesday, July 23, 2003 / Rules and Regulations Implementation Plan revision have been approved. ( 4) The revised commitment to perform a mid course review and submit the results by December 31, 2004 included in the April 8, 2003 SIP revision is approved. [ FR Doc. 03   18853 Filed 7   22   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0242; FRL   7317   5]

Thiophanate Methyl; Pesticide Tolerance for Emergency Exemptions AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a time limited tolerance for residues of thiophanate methyl and its metabolite methyl 2 benzimidazoyl carbamate ( MBC) in or on fruiting vegetables. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) authorizing use of the pesticide on fruiting vegetables. This regulation establishes a maximum permissible level for residues of thiophanate methyl in this food commodity. The tolerance will expire and is revoked on December 31, 2005. DATES: This regulation is effective July 23, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0242, must be received on or before September 22, 2003.

ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VII. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   9356; e mail address: conrath. andrea@ epa. gov.

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 potentially affected entities may include, but are not limited to:   Crop producers ( NAICS 111)   Animal producers ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ID number OPP   2003   0242. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title _ 40/ 40cfr180_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408( e) and 408 ( l)( 6) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a, is establishing a tolerance for residues of the fungicide thiophanate methyl and its metabolite methyl 2 benzimidazoyl carbamate, in or on vegetables, fruiting, group 8 at 0.5 parts per million ( ppm). This tolerance will expire and is revoked on December 31, 2005. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations. Section 408( l)( 6) of the FFDCA requires EPA to establish a time limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408( e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i. e., without having received any petition from an outside party. Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish 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 the 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 the 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 VerDate Jan< 31> 2003 14: 37 Jul 22, 2003 Jkt 200001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 23JYR1. SGM 23JYR1 43466 Federal Register / Vol. 68, No. 141 / Wednesday, July 23, 2003 / Rules and Regulations no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Section 18 of the FIFRA authorizes EPA to exempt any Federal or State Agency from any provision of FIFRA, if EPA determines that `` emergency conditions exist which require such exemption.'' This provision was not amended by the Food Quality Protection Act of 1996 ( FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Thiophanate Methyl on Fruiting Vegetables and FFDCA Tolerances Benomyl has historically been used to control the disease caused by sclerotinia sclerotiorum, more commonly known as white mold, timber rot, or sclerotinia stem rot, in fruiting vegetables, including tomatoes. The recent cancellation of benomyl has left fruiting vegetable producers in Florida, and tomato producers in New Jersey and Virginia without sufficient means to control this disease, and the applicants claim that there are no other registered fungicides or alternative control practices which are effective to control this disease. Thiophanate methyl is related to benomyl, and degrades to the same active compound as benomyl. Field trial data also shows thiophanate methyl to be significantly effective at controlling white mold. It is expected that a similar level of control would be achieved with thiophanate methyl as that achieved in the past with benomyl. Significant economic losses are expected without the requested use of thiophanate methyl. EPA has authorized under FIFRA section 18 the use of thiophanate methyl on fruiting vegetables in Florida, and tomatoes only in New Jersey and Virginia, for control of white mold, also known as timber rot, or sclerotinia stem rot ( sclerotinia sclerotiorum). After having reviewed the submissions, EPA concurs that emergency conditions exist for these States. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of thiophanate methyl in or on fruiting vegetables. In doing so, EPA considered the safety standard in section 408( b)( 2) of the FFDCA, and EPA decided that the necessary tolerance under section 408( l)( 6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408( l)( 6) of the FFDCA. Although this tolerance will expire and is revoked on December 31, 2005, under section 408( l)( 5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on fruiting vegetables after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether thiophanate methyl meets EPA's registration requirements for use on fruiting vegetables or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of thiophanate methyl by a State for special local needs under FIFRA section 24( c). Nor does this tolerance serve as the basis for any States other than Florida, New Jersey, or Virginia to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for thiophanate methyl, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances November 26, 1997 ( 62 FR 62961) ( FRL   5754   7). Consistent with section 408( b)( 2)( d) of the FFDCA , 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 thiophanate methyl and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for a timelimited tolerance for residues of thiophanate methyl in or on fruiting vegetables at 0.5 ppm. The most recent estimated aggregate risks resulting from the use of thiophanate methyl, are discussed in the Federal Register ofAugust 28, 2002 ( 67 FR 55137) ( FRL   7192   1), final rule establishing tolerances for residues of thiophanate methyl in/ on grapes, pears, potatoes, canola, and pistachios. In that prior action, risk was estimated assuming tolerance level residues in all commodities for established and proposed tolerances. Available residue data indicate that the use pattern for these emergency exemptions will not result in residues of thiophanate methyl in fruiting vegetables over 0.5 ppm. Therefore, a tolerance is being established for this crop group at this level. The risk assessment related to incremental addition of these items at this level to dietary exposure is discussed below. Refer also to the August 28, 2002 Federal Register document for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies in part upon that risk assessment and the findings made in the Federal Register document in support of this action. Below is a brief summary of the aggregate risk assessment. EPA has evaluated the available toxicity data and considered its 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. A summary of the toxicological dose and endpoints for thiophanate methyl for use in human risk assessment is discussed in the final rule published in the Federal Register of August 28, 2002 ( 67 FR 55137) ( FRL   7192   1). For thiophanate methyl, the Agency recently modified the tolerance expression, so that the residues to be regulated in plant and animal commodities for purposes of tolerance enforcement will consist of the residues of thiophanate methyl and its metabolite methyl 2 benzimidazolyl carbamate, expressed as thiophanate methyl. Exposure from the use of benomyl, another pesticide which degrades under environmental conditions to MBC was not included in this assessment because the only basic registrant of benomyl requested voluntary cancellation of all benomyl containing products in April 2001. Product cancellations were effective in early 2001 with sales and distribution of benomyl containing VerDate Jan< 31> 2003 14: 37 Jul 22, 2003 Jkt 200001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 23JYR1. SGM 23JYR1 43467 Federal Register / Vol. 68, No. 141 / Wednesday, July 23, 2003 / Rules and Regulations products ending by December 31, 2001. However, the Agency conducted a dietary assessment using United States Department of Agriculture ( USDA) Pesticide Data Program ( PDP) monitoring data for benomyl, measured as MBC to estimate residues of thiophanate methyl because MBC is a common metabolite of both benomyl and thiophanate methyl. PDP data were available for apples, bananas, beans, cucurbits, peaches and strawberries. The PDP analytical method employs a hydrolysis step that converts any benomyl present to MBC. MBC is then quantitated and corrected for molecular weight, and results are measured as the sum of benomyl and MBC. Therefore, using MBC data to estimate thiophanate methyl residues may be a conservative approach in that it may overestimate thiophanate methyl residues. Monitoring data on benomyl from the PDP were used to estimate dietary exposure to MBC, for apples, apple juice, bananas, succulent beans, cantaloupes, cucumbers, peaches, strawberries, citrus, and fruiting vegetables. EPA assessed risk scenarios for thiophanate methyl under acute, chronic, and short term and intermediate term exposures. Risk estimates were calculated for the residues of toxicological concern, the parent compound thiophanate methyl, and its metabolites methyl 2 benzimidazolyl carbamate plus 2 amine 1 H benzimidazole ( MBC+ 2 AB). To update the previous risk assessment, thiophanate methyl acute and chronic dietary exposure assessments were conducted using the most current version of the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEMTM FCID), Version 1.3), which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII), 1994   1996/ 98. The 1998 CSFII survey focused on children from birth to 9 years old and greatly expanded ( by several fold) the number of children aged birth to 4 years. Importantly, the supplemental survey was designed in a manner such that the results from the 1998 CSFII survey could be combined with the 1994   96 survey. The data in this newer CSFII survey ( termed the 1994   1996/ 98 CSFII) are based on the reported consumption of more than 20,000 individuals over two nonconsecutive survey days and is considered to be a more appropriate and more robust data set than the 1989   91 CSFII survey, which was used in the previous assessment. The most current version of DEEMTMFCID was used for all dietary risk estimates calculated, and existing uses, as well as the proposed section 18 uses ( blackberries, tomatoes and fruiting vegetables) were included. When calculating risk estimates from MBC+ 2 AB, an FQPA safety factor of 10 was applied for all infant and children population subgroups. Percent of crop treated information was also incorporated for most established uses and for all of the section 18 uses. The acute and chronic dietary risk estimates for thiophanate methyl were < 100% of the acute and chronic Population Adjusted Doses ( aPAD and cPAD) at the 99.9th exposure percentile for the general U. S. population and all population subgroups. The acute and chronic dietary risk estimates for MBC + 2 AB were also < 100% of the aPAD and cPAD at the 99.9th exposure percentile for the general U. S. population and all population subgroups. EPA generally has no concern for exposures below 100% of the PADs, because the PADs represent the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. The most highly exposed subgroup for all risk estimates calculated was children 1   2 years. Table 1 summarizes the percentages of aPADs and cPADs for all scenarios for the overall U. S. population and for the most highly exposed population subgroup ( children 1   2 years).

TABLE 1.   ACUTE AND CHRONIC DIETARY RISK ESTIMATES FOR THIOPHANATE METHYL EXISTING AND PROPOSED USES Population Subgroup aPAD Utilized cPAD Utilized TM MBC + 2 AB TM MBC + 2 AB U. S. population 6% 2% < 1% < 1%

Children ( 1   2 years) 22% 58% 2% 10%

The acute drinking water assessment, based on simultaneous dietary exposure to both MBC and thiophanate methyl ( which was converted to MBC equivalents) resulted in Drinking Water Levels of Comparison ( DWLOCs) for the overall U. S. population of 5,833 parts per billion ( ppb), and for children ( 1   2 years) of 72 ppb ( the population subgroup with the lowest DWLOC). All acute DWLOCs were well above the acute Estimated Environmental Concentrations ( EECs) for ground water and surface water, at 3 and 44 ppb, respectively The chronic drinking water assessment, based on simultaneous dietary exposure to both MBC and thiophanate methyl ( which was converted to MBC equivalents) resulted in chronic DWLOCs for the overall U. S. population of 870 ppb, and for children ( 1   2 years) of 22 ppb ( the population subgroup with the lowest DWLOC). All chronic DWLOCs were well above the chronic EEC for ground water of 3 ppb. The chronic DWLOCs were also above the chronic EEC for surface water of 23   24 ppb, except for that of the most highly exposed subgroup, children ( 1   2 years), which is slightly below the EEC with a chronic DWLOC of 22 ppb. However, given the conservative nature of the screening level approach to estimated drinking water risks, and the equivalent levels of the chronic DWLOC and EEC ( 22   23   24 ppb), the Agency does not believe this represents a significant risk or concern for chronic aggregate exposures. Short term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Thiophanate methyl and MBC are currently registered for uses that could result in short term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short term exposures for thiophanate methyl and MBC. All residential exposures are considered to be short term. The Margins of Exposure ( MOEs) ( converted to MBC equivalents) for aggregate shortterm exposure to thiophanate methyl are as follows: Oral exposure of children ( 1   6 years) is 670; dermal exposure of children ( 1   6 years) is 1,000; and VerDate Jan< 31> 2003 14: 37 Jul 22, 2003 Jkt 200001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 23JYR1. SGM 23JYR1 43468 Federal Register / Vol. 68, No. 141 / Wednesday, July 23, 2003 / Rules and Regulations dermal exposure of females ( 13   50 years) is 1,315. Prior to the application rate change agreed to by the registrants in connection with the Agency's reregistration process evaluation of thiophanate methyl, MOEs for aggregate exposure to MBC from the use of MBC as an in can paint preservative were 670 for dermal exposure and 770 for exposure via inhalation. As a result of negotiated mitigation measures related to the reregistration review of this chemical, the registrant has now lowered the application rate for the incan paint uses to the extent that the MOEs are now acceptable (> 1,000). The MOEs ( converted to MBC equivalents) for the total thiophanate methyl and MBC aggregate exposure are as follows: 630 for oral and dermal exposure of children ( 1   6 years); 770 for exposure via inhalation for females ( 13   50 years); and 620 for oral and dermal exposure for females ( 13   50 years). The aggregate short term exposure to MBC and thiophanate methyl resulting from food, water and residential use exceeds the Agency's level of concern for children ( infants, and 1   6 years), and females 13   50 years, due primarily to postapplication exposures on turf. Registrants are performing a hand press study and have submitted a 5   day inhalation study to help refine this assessment. Based on these mitigation measures, and the conservative method of exposure estimation, the risks do not exceed the Agency's level of concern. Aggregate cancer risk for U. S. population. The total thiophanate methyl and MBC+ 2 AB dietary cancer risk is 1.1 x 10 6 for existing and proposed new uses ( incorporating the refinements and amortizations as previously described). The cancer risk from non occupational residential exposure is 1.1 x 10 6. Therefore, aggregate cancer risk is 2.2 x 10 6. This risk estimate includes cancer risk from both thiophanate methyl and MBC+ 2 AB on food including all pending uses and section 18 uses, thiophanate methyl exposure from treating ornamentals, thiophanate methyl exposure from performing post application lawn activities, and exposure from applying paint containing MBC. This is considered to be a high end risk scenario since it is not expected that someone would treat ornamentals, perform high exposure post application activities, and apply paint containing MBC every year for 70 years. Therefore, this estimate is considered to be a conservative estimate. Additionally, the cancer risk estimate for drinking water is based on the highest EEC, which is also a very high end risk estimate since it is based on the maximum rate being applied every season for 70 years. The risk estimate calculations also assumed that the modeled surface water EEC is equivalent to concentrations in finished drinking water. Thus, food plus water plus non occupational residential cancer risk is 2.2 x 10 6 which is within the range considered as negligible. Therefore, the risks do not exceed the Agency's level of concern. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to thiophanate methyl and MBC+ 2 AB residues.

V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755   5350; telephone number: ( 410) 305   2905; e mail address: residuemethods@ epa. gov.

B. International Residue Limits The Codex Alimentarius Commission has established maximum residue limits ( MRLs) for thiophanate methyl residues in/ on various plant and animal commodities. Codex MRLs for thiophanate methyl are currently expressed as MBC. The Codex MRL residue definition and the U. S. tolerance definition, previously expressed as only thiophanate methyl, have been incompatible and will remain incompatible even with the recent revision of the U. S. tolerance definition, since the revised tolerance definition includes both thiophanate methyl and MBC. Additionally, there is a 5.0 ppm Codex MRL for thiophanate methyl on tomatoes. The 0.5 ppm tolerance for fruiting vegetables, including tomatoes, being established by this document will not harmonize with Codex.

C. Conditions The pesticide, thiophanate methyl may be applied using ground equipment, at a rate of 1 lb. of formulated product ( 0.7 lb. active ingredient ( a. i.)) per acre, not to exceed 4 lbs. ( 2.8 lbs. a. i.) per acre per crop. A maximum of four applications per crop may be made at 7 to 14 day intervals, and a 2   day pre harvest interval must be observed. Applications may not be made through any type of irrigation system. VI. Conclusion Therefore, the tolerance is established for residues of thiophanate methyl and its metabolite, MBC, expressed as thiophanate methyl, in or on vegetables, fruiting, group 8 at 0.5 ppm.

VII. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2003   0242 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 22, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked VerDate Jan< 31> 2003 14: 37 Jul 22, 2003 Jkt 200001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 23JYR1. SGM 23JYR1 43469 Federal Register / Vol. 68, No. 141 / Wednesday, July 23, 2003 / Rules and Regulations confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by the docket ID number OPP   2003   0242, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: opp docket@ epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

VIII. Statutory and Executive Order Reviews This final rule establishes a timelimited tolerance under section 408 of the FFDCA. 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 rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). 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 of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under section 408 of the FFDCA, such as the tolerance 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This VerDate Jan< 31> 2003 14: 37 Jul 22, 2003 Jkt 200001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 23JYR1. SGM 23JYR1 43470 Federal Register / Vol. 68, No. 141 / Wednesday, July 23, 2003 / Rules and Regulations rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal Register. This final rule 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 10, 2003. Deborah McCall, Acting Director, Registration Division, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows: PART 180   [ AMENDED]

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

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

 2. Section 180.371 is amended by alphabetically adding the following commodity to the table in paragraph ( b) to read as follows:

§ 180.371 Thiophanate methyl; tolerances for residues.

* * * * * ( b) * * *

Commodity Parts per million Expiration/ revocation date * * * * * * * Vegetable, fruiting, group 8 ......................................................................................................................... 0.5 12/ 31/ 05 * * * * * [ FR Doc. 03   18499 Filed 7   22   03; 8: 45 am]

BILLING CODE 6560   50   S DEPARTMENT OF HOMELAND SECURITY Coast Guard 46 CFR Part 401 [ USCG   2002   12840]

RIN 1625   AA74 ( Formerly 2115   AG46)

Basic Rates and Charges on Lake Erie and the Navigable Waters From Southwest Shoal to Port Huron, MI AGENCY: Coast Guard, DHS. ACTION: Temporary final rule; change of effective period.

SUMMARY: The Coast Guard is extending the effective period for the temporary final rule on basic rates and charges on Lake Erie and the navigable waters from Southwest Shoal to Port Huron, MI ( District Two, Area 5), to December 24, 2003. Extension of the effective period ensures that the pilotage rates in District Two, Area 5, remain at the current rate while the Coast Guard completes its pending ratemaking project. DATES: Effective July 18, 2003, § 401.407( b), suspended at 67 FR 47466, July 19, 2002, effective July 19, 2002, until July 21, 2003, will continue to be suspended through December 24, 2003; and § 401.407( c), temporarily added at 67 FR 47466, July 19, 2002, effective July 19, 2002, until July 21, 2003, will continue to be extended through December 24, 2003. ADDRESSES: The Docket Management Facility maintains the public docket for this rulemaking. Comments and material received from the public, as well as documents mentioned in this preamble as being available in the docket, will become part of this docket and will be available for inspection or copying at room PL   401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a. m. and 5 p. m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet at http:// dms. dot. gov.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call Tom Lawler, Project Manager, Office of Great Lakes Pilotage, Coast Guard, Commandant ( G   MW   1), at 202   267   1241. If you have questions on viewing to the docket, call Dorothy Beard, Chief, Dockets, Department of Transportation, at 202   366   5149.

SUPPLEMENTARY INFORMATION:

Regulatory History On July 19, 2002, we published a temporary final rule entitled `` Basic Rates and Charges on Lake Erie and the Navigable Waters From Southeast Shoal to Port Huron, MI'' in the Federal Register [ 67 FR 47464]. Background and Purpose On July 12, 2001, the Coast Guard published a final rule in the Federal Register [ 66 FR 36484] amending the ratemaking for the Great Lakes Pilotage. The new rates became effective August 13, 2001. Those rates were challenged in District Court by the Lake Pilots Association, representing the pilots in District Two. While preparing our defense, we discovered that we had inadvertently accounted for delay and detention hours in District Two differently from how we had in Districts One and Three. We also noticed minor errors in computing the rates in District Two. The Coast Guard has recently completed a study that addresses, among other things, the issue of how we should count hours of delay and detention when computing bridge hours in all three Districts. Also the Coast Guard is currently in the process of adjusting the pilotage rates in all three Districts. See [ USCG   2002   11288].

Discussion of Temporary Rule We did not publish a notice of proposed rulemaking ( NPRM) in order to extend this temporary final rule, and it takes effect immediately. Delay in implementing this rule would be contrary to the public interest. This rulemaking will maintain the status quo allowing litigation and associated rulemaking to be completed. While not agreeing with the allegations contained in the complaint of the Lakes Pilots' Association, for the VerDate Jan< 31> 2003 14: 37 Jul 22, 2003 Jkt 200001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 23JYR1. SGM 23JYR1


[Federal Register Volume 88, Number 119 (Thursday, June 22, 2023)]
[Rules and Regulations]
[Pages 40713-40715]
[FR Doc No: 2023-13269]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[USCG-2023-0524]
RIN 1625-AA00

Safety Zone; Atlantic Ocean, Virginia Beach, VA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters within 200-yards of the Virginia Beach oceanfront.
The safety zone is needed to protect mariners from the potential
hazards which would result if a large congregation of spectator vessels
anchors in close proximity to a shoreside concert on the Virginia Beach
oceanfront. Entry of vessels or persons into this zone when it is
subject to enforcement is prohibited unless

specifically authorized by the Captain of the Port, Sector Virginia, or
their designated representative. Vessels within the zone must leave the
zone before any period of enforcement begins.

DATES: This rule is effective June 23, 2023, through June 25, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0524 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email LCDR Ashley Holm, Chief Waterways Management Division
U.S. Coast Guard;<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the safety zone is needed for a
shoreside concert and immediate action is needed to protect mariners
from the potential safety hazards which could result if a large
congregation of vessels anchors in the vicinity of the concert,
creating unsafe conditions near the Virginia Beach oceanfront. It is
impracticable to publish an NPRM because we must establish this safety
zone by June 23, 2023.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
protect mariners from the potential safety hazards associated with
vessels congregating at the Virginia Beach oceanfront.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Sector Virginia (COTP) has determined
that potential hazards associated with a shoreside concert starting
June 23, 2023, will be a safety concern for anyone within 200-yards of
the beach. This rule is needed to protect mariners, vessels, and the
marine environment in the navigable waters within the safety zone
during the 3-day concert.

IV. Discussion of the Rule

    This rule establishes a safety zone which will be subject to
enforcement from 11 a.m. until midnight, each day from June 23-25,
2023. The safety zone will cover all navigable waters within 200 yards
of the Virginia Beach oceanfront shoreline bounded by the following
positions: 36[deg]49'49.20'' N, 075[deg]58'04.54'' W; 36[deg]49'49.3''
N, 075[deg]57'58.5'' W; 36[deg]50'13.2'' N, 075[deg]58'5.4'' W;
36[deg]50'13.2'' N, 075[deg]58'12.6'' W. The duration of the zone is
intended to protect mariners, vessels, and the marine environment in
these navigable waters during the 3-day concert. No vessel or person
will be permitted to enter the safety zone without obtaining permission
from the COTP or a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866, as
amended by Executive Order 14094 (Modernizing Regulatory Review).
Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which will
impact a small, designated area of the Atlantic Ocean in an area where
vessel traffic is normally low. Moreover, the Coast Guard will issue a
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
zone, and the rule will allow vessels to seek permission to enter the
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have Tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone that will prohibit entry within 200 yards of the Virginia
Beach oceanfront shoreline. It is categorically excluded from further
review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration
supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

    Accordingly, the Coast Guard amends 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T05-0524 to read as follows:

Sec.  165.T05-0524  Safety Zone; Atlantic Ocean, Virginia Beach, VA.

    (a) Location. The following area is a safety zone: All waters of
the Virginia Beach oceanfront, from surface to bottom, encompassed by a
line connecting the following points: 36[deg]49'49.20'' N,
075[deg]58'04.54'' W; 36[deg]49'49.3'' N, 075[deg]57'58.5'' W;
36[deg]50'13.2'' N, 075[deg]58'5.4'' W; 36[deg]50'13.2'' N,
075[deg]58'12.6'' W. These coordinates are based on WGS 84 coordinates.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Sector Virginia (COTP) in the enforcement of the
safety zone. The term also includes Virginia Beach Police Marine Patrol
to permit passage into or through the safety zone listed in paragraph
(a) of this section, or to notify vessels and individuals that they
have entered a safety zone and are required to depart immediately.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative. Vessels present must exit the safety
zone before the start of any period in which it is subject to
enforcement.
    (2) To seek permission to enter, contact the Virginia Beach Police
Marine Patrol on VHF-FM Channel 13 or 16. Those in the safety zone must
comply with all lawful orders or directions given to them by the COTP
or the COTP's designated representative.
    (d) Enforcement period[s]. This section will be enforced from 11
a.m. to midnight each day from June 23-25, 2023.

    Dated: June 15, 2023.
J.A. Stockwell,
Captain, U.S. Coast Guard, Captain of the Port, Sector Virginia.
[FR Doc. 2023-13269 Filed 6-21-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39672-39673]
[FR Doc No: 2016-14351]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Bioequivalence Recommendations; Draft and
Revised Draft Guidances for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
June 11, 2010, FDA announced the availability of a guidance for
industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific BE recommendations available to the public on FDA's
Web site. The BE recommendations identified in this notice were
developed using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 16, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Bioequivalence Recommendations;
Draft and Revised Draft Guidances for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover

sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific BE recommendations and
provide a meaningful opportunity for the public to consider and comment
on those recommendations. Under that process, draft recommendations are
posted on FDA's Web site and announced periodically in the Federal
Register. The public is encouraged to submit comments on those
recommendations within 60 days of their announcement in the Federal
Register. FDA considers any comments received and either publishes
final recommendations or publishes revised draft recommendations for
comment. Recommendations were last announced in the Federal Register on
April 15, 2016 (81 FR 22283). This notice announces draft product-
specific recommendations, either new or revised, that are posted on
FDA's Web site.

II. Drug Products for Which New Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing the availability of a new draft guidance for
industry on product-specific BE recommendations for drug products
containing the following active ingredients:

Table 1--New Draft Product-Specific BE Recommendations for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Amcinonide
Cariprazine hydrochloride
Cobimetinib fumarate
Empagliflozin; Metformin hydrochloride
Erythromycin ethylsuccinate
Everolimus
Flibanserin
Fluocinonide (multiple reference listed drugs)
Hydrocortisone
Lesinurad
Meloxicam
Methylergonovine maleate
Ombitasvir; paritaprevir; ritonavir
Prednicarbate
Propofol
Pseudoephedrine hydrochloride
Selexipag
Tacrolimus
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations Are Available

    FDA is announcing the availability of a revised draft guidance for
industry on product-specific BE recommendations for drug products
containing the following active ingredients:

   Table 2--Revised Draft Product-Specific BE Recommendations for Drug
                                Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Acetaminophen; hydrocodone bitartrate
Albuterol sulfate
Azelastine hydrochloride; Fluticasone propionate
Benzoyl peroxide; Clindamycin phosphate
Dexamethasone; Tobramycin (multiple reference listed drugs)
Lansoprazole
Loteprednol Etabonate
Loteprednol Etabonate; Tobramycin Ophthalmic
Mesalamine (multiple reference listed drugs)
Methylphenidate
Morphine sulfate
Paroxetine hydrochloride
Pomalidomide
Prednisolone Acetate
Rimexolone
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, go to http://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on the
product-specific design of BE studies to support ANDAs. They do not
establish any rights for any person and are not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14351 Filed 6-16-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28762-28763]
[FR Doc No: 2015-12072]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Vehicle Theft Prevention
Standard; Jaguar Land Rover North America, LLC

AGENCY: National Highway Traffic Safety Administration, NHTSA,
Department of Transportation, DOT.

ACTION: Grant of petition for exemption.

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

SUMMARY: This document grants in full the Jaguar Land Rover North
America LLC's, (Jaguar Land Rover) petition for an exemption of the
Jaguar XF vehicle line in accordance with 49 CFR part 543, Exemption
from the Theft Prevention Standard. This petition is granted because
the agency has determined that the antitheft device to be placed on the
line as standard equipment is likely to be as effective in reducing and
deterring motor vehicle theft as compliance with the parts-marking
requirements of the Theft Prevention Standard (49 CFR part 541).

DATES: The exemption granted by this notice is effective beginning with
model year (MY) 2016.

FOR FURTHER INFORMATION CONTACT: Mr. Hisham Mohamed, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, W43-
437, 1200 New Jersey Avenue SE., Washington, DC 20590. Mr. Mohamed's
phone number is<PHONE_NUMBER>. His fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a petition dated March 23, 2015, Jaguar
Land Rover requested an exemption from the parts-marking requirements
of the Theft Prevention Standard (49 CFR part 541) for the MY 2016
Jaguar XF vehicle line. The petition requested an exemption from parts-
marking pursuant to 49 CFR part 543, Exemption from Vehicle Theft
Prevention Standard, based on the installation of an antitheft device
as standard equipment for an entire vehicle line.
    Under Sec.  543.5(a), a manufacturer may petition NHTSA to grant an
exemption for one vehicle line per model year. In its petition, Jaguar
Land Rover provided a detailed description and diagrams of the
identity, design, and location of the components of the antitheft
device for the XF vehicle line. Jaguar Land Rover stated that its XF
vehicles will be equipped with a passive, transponder based, electronic
engine immobilizer device as standard equipment beginning with the 2016
model year. Key components of its antitheft device will include a power
train control module (PCM), instrument cluster, body control module
(BCM), remote frequency receiver (RFR), remote frequency actuator
(RFA), immobilizer antenna unit (IAU), Smart Key, door control units
(DCU), and a visual and audible perimeter alarm system. Jaguar Land
Rover also stated that the audible and visual perimeter alarm system
will be installed as standard equipment and can be armed with the Smart
Key or programmed to be passively armed. Jaguar Land Rover further
stated that the siren will sound and the vehicle's exterior lights will
flash if unauthorized entry is attempted by opening the hood, doors or
luggage compartment. Jaguar Land Rover's submission is considered a
complete petition as required by 49 CFR 543.7, in that it meets the
general requirements contained in Sec.  543.5 and the specific content
requirements of Sec.  543.6.
    Jaguar Land Rover stated that the Smart Key is programmed and
synchronized to the vehicle through means of an identification key code
and a randomly generated secret code that are unique to each vehicle.
Jaguar Land Rover further stated that the immobilizer device is armed
automatically when the Smart Key is removed from the vehicle.
    Jaguar Land Rover also stated that there are three methods the
driver can approach the vehicle and start the engine. Method one is
through automatic detection of the Smart Key via a remote frequency
challenge response sequence. Jaguar stated that when the driver
approaches the vehicle and pulls the driver's door handle (after
authentication of the correct Smart Key), the doors will unlock.
Specifically, when the ignition start button is pressed, a search to
find and authenticate the Smart Key commences within the vehicle
interior. If successful, this information is passed by a coded data
transfer to the BCM via the Remote Function Actuator. The BCM in turn,
will pass the ``valid key'' status to the instrument cluster, via a
coded data transfer. The BCM sends the key valid message to the PCM
which initiates a coded data transfer authorizing the engine to start.
Method two is accomplished by unlocking the vehicle with the Smart Key
unlock button. As the driver approaches the vehicle, the Smart Key
unlock button is pressed and the doors will unlock. Once the driver
presses the ignition start button, the operation process is the same as
method one. Method three is accomplished by using the emergency key
blade. If the Smart Key has a discharged battery or is damaged, there
is an emergency key blade that can be removed from the Smart Key and
used to unlock the doors. When the ignition start button is pressed a
search is commenced to find and authenticate the Smart Key within the
vehicle. Once the Smart Key is docked in the correct position and the
ignition start button is pressed again, the BCM and Smart key completes
a coded data exchange via the IAU. If successful, the BCM passes the
valid key status to the instrument cluster, via a coded data transfer.
The BCM then sends the key valid message to the PCM which initiates a
coded data transfer. If

successful, the engine will be authorized to start.
    In addressing the specific content requirements of 543.6, Jaguar
Land Rover provided information on the reliability and durability of
its proposed device. To ensure reliability and durability of the
device, Jaguar Land Rover conducted tests based on its own specified
standards. Jaguar Land Rover provided a detailed list of the tests
conducted (i.e., temperature and humidity cycling, high and low
temperature cycling, mechanical shock, random vibration, thermal
stress/shock tests, material resistance tests, dry heat, dust and fluid
ingress tests). Jaguar Land Rover stated that it believes that its
device is reliable and durable because it complied with specified
requirements for each test. Additionally, Jaguar Land Rover stated that
its key recognition sequence includes more than a billion code
combinations, which include encrypted data that are secure against
copying. Jaguar Land Rover also stated that the coded data transfer
between its modules use a unique secure identifier, a random number and
a secure public algorithm. Jaguar Land Rover further explained that
since its XF vehicle line will utilize push button vehicle ignition, it
does not have a conventional mechanical key barrel and therefore
believes that forcibly bypassing the key-locking system would be
virtually impossible.
    Jaguar Land Rover also stated that the current generation Jaguar XF
vehicle line produced since MY 2009, is installed with an engine
immobilizer device as standard equipment. Jaguar Land Rover noted that
since the current generation Jaguar XF vehicles have only been
available with an engine immobilizer, there is no comparative data
available for the XF vehicle line without an immobilizer. However,
Jaguar Land Rover stated that the immobilizer is substantially similar
to the antitheft device installed on the Jaguar XK, Jaguar XJ, Land
Rover LR2, Land Rover Range Rover Evoque, and Land Rover Discovery
Sport vehicle lines previously granted an exemption by the agency.
Jaguar Land Rover stated that based on the MY 2012 final theft data
published by NHTSA, the Jaguar Land Rover vehicles equipped with
immobilizers had a theft rate of 0.76 per thousand vehicles,
comparatively below NHTSA's overall theft rate of 1.13 thefts per
thousand vehicles for MY 2012 passenger vehicles stolen in CY 2012. The
theft rates for the Jaguar XK, XJ, Land Rover Evoque, and Land Rover
LR2 using an average of 3 MY's data are 1.0803, 0.9199, 0.5501 and
0.4141, respectively. Jaguar Land Rover believes these low theft rates
further demonstrate the effectiveness of its immobilizer device.
Additionally, as further evidence of the effectiveness of its
immobilizer device, Jaguar Land Rover submitted a Highway Loss Data
Institute news release (July 19, 2000) showing an average reduction in
theft losses of about 50 percent for vehicles installed with an
immobilizer device.
    Based on the supporting evidence submitted by Jaguar Land Rover on
its device, the agency believes that the antitheft device for the XF
vehicle line is likely to be as effective in reducing and deterring
motor vehicle theft as compliance with the parts-marking requirements
of the Theft Prevention Standard (49 CFR 541). The agency concludes
that the device will provide the five types of performance listed in
Sec.  543.6(a)(3): promoting activation; attracting attention to the
efforts of an unauthorized person to enter or move a vehicle by means
other than a key; preventing defeat or circumvention of the device by
unauthorized persons; preventing operation of the vehicle by
unauthorized entrants; and ensuring the reliability and durability of
the device.
    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7 (b), the agency grants
a petition for exemption from the parts-marking requirements of part
541 either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of part 541. The agency
finds that Jaguar Land Rover has provided adequate reasons for its
belief that the antitheft device for its XF vehicle line is likely to
be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of the Theft Prevention
Standard (49 CFR part 541). This conclusion is based on the information
Jaguar Land Rover provided about its device.
    For the foregoing reasons, the agency hereby grants in full Jaguar
Land Rover's petition for exemption for the Jaguar Land Rover XF
vehicle line from the parts-marking requirements of 49 CFR part 541.
The agency notes that 49 CFR part 541, Appendix A-1, identifies those
lines that are exempted from the Theft Prevention Standard for a given
model year. 49 CFR part 543.7(f) contains publication requirements
incident to the disposition of all part 543 petitions. Advanced
listing, including the release of future product nameplates, the
beginning model year for which the petition is granted and a general
description of the antitheft device is necessary in order to notify law
enforcement agencies of new vehicle lines exempted from the parts-
marking requirements of the Theft Prevention Standard.
    If Jaguar Land Rover decides not to use the exemption for this
line, it must formally notify the agency. If such a decision is made,
the line must be fully marked according to the requirements under 49
CFR parts 541.5 and 541.6 (marking of major component parts and
replacement parts).
    NHTSA notes that if Jaguar Land Rover wishes in the future to
modify the device on which this exemption is based, the company may
have to submit a petition to modify the exemption. Part 543.7(d) states
that a part 543 exemption applies only to vehicles that belong to a
line exempted under this part and equipped with the antitheft device on
which the line's exemption is based. Further, part 543.9(c)(2) provides
for the submission of petitions ``to modify an exemption to permit the
use of an antitheft device similar to but differing from the one
specified in that exemption.''
    The agency wishes to minimize the administrative burden that part
543.9(c)(2) could place on exempted vehicle manufacturers and itself.
The agency did not intend in drafting part 543 to require the
submission of a modification petition for every change to the
components or design of an antitheft device. The significance of many
such changes could be de minimis. Therefore, NHTSA suggests that if the
manufacturer contemplates making any changes, the effects of which
might be characterized as de minimis, it should consult the agency
before preparing and submitting a petition to modify.

    Authority:  49 U.S.C. 33106; delegation of authority at 49 CFR
1.50.

    Under authority delegated in 49 CFR part 1.95.
Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2015-12072 Filed 5-18-15; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7557-7558]
[FR Doc No: 2016-02912]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0002; Internal Agency Docket No. FEMA-B-1557]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before May 12, 2016.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1557, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
For communities with multiple ongoing Preliminary studies, the studies
can be identified by the unique project number and Preliminary FIRM
date listed in the tables. Additionally, the current effective FIRM and
FIS report for each community are accessible online through the FEMA
Map Service Center at www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: January 22, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.
    I. Non-watershed-based studies:

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Maricopa County, Arizona and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
        Project: 15-09-0355S Preliminary Date: September 30, 2015
------------------------------------------------------------------------
Town of Wickenburg.....................  Town Hall, 155 North Tegner
                                          Street, Suite A, Wickenburg,
                                          AZ 85390.
Unincorporated Areas of Maricopa County  Flood Control District of
                                          Maricopa County, 2801 West
                                          Durango Street, Phoenix, AZ
                                          85009.
------------------------------------------------------------------------

          Santa Clara County, California and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
           Project: 11-09-2194S Preliminary Date: July 8, 2015
------------------------------------------------------------------------
City of Milpitas.......................  Engineering Division, 455 East
                                          Calaveras Boulevard, Milpitas,
                                          CA 95035.
City of Mountain View..................  Public Works Department, 500
                                          Castro Street, Mountain View,
                                          CA 94041.
City of Palo Alto......................  Public Works Engineering
                                          Department, 250 Hamilton
                                          Avenue, Palo Alto, CA 94301.
City of San Jose.......................  Department of Public Works, 200
                                          East Santa Clara Street, Tower
                                          -3rd Floor, San Jose, CA
                                          95113.
City of Santa Clara....................  Planning and Inspection
                                          Department, 1500 Warburton
                                          Avenue, Santa Clara, CA 95050.
City of Sunnyvale......................  Department of Public Works, 456
                                          West Olive Avenue, Sunnyvale,
                                          CA 94086.
Unincorporated Areas of Santa Clara      Department of Planning and
 County.                                  Development, 70 West Hedding
                                          Street, East Wing, 7th Floor,
                                          San Jose, CA 95110.
------------------------------------------------------------------------
          Santa Cruz County, California and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
        Project: 11-09-0853S Preliminary Date: September 28, 2015
------------------------------------------------------------------------
City of Capitola.......................  City Hall, 420 Capitola Avenue,
                                          Capitola, CA 95010.
City of Santa Cruz.....................  City Hall, Planning Department:
                                          Permits, Building, Zoning, 809
                                          Center Street, Room 206, Santa
                                          Cruz, CA 95060.
Unincorporated Areas of Santa Cruz       County of Santa Cruz, Planning
 County.                                  Department, 701 Ocean Street,
                                          4th Floor, Santa Cruz, CA
                                          95060.
------------------------------------------------------------------------
              Noble County, Indiana and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
        Project:15-05-4783S Preliminary Date: September 18, 2015
------------------------------------------------------------------------
Unincorporated Areas of Noble County...  Noble County South Complex,
                                          2090 North State Road 9, Suite
                                          2, Albion, IN 46701.
------------------------------------------------------------------------
            Olmsted County, Minnesota and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
        Project:15-05-5175S Preliminary Date: September 14, 2015
------------------------------------------------------------------------
 City of Eyota.........................  City Hall, 38 South Front
                                          Street Southwest, Eyota, MN
                                          55934.
City of Pine Island....................  City Hall, 250 South Main
                                          Street, Pine Island, MN 55963.
------------------------------------------------------------------------

[FR Doc. 2016-02912 Filed 2-11-16; 8:45 am]
BILLING CODE 9110-12-P