[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50710-50711]
[FR Doc No: 2016-18139]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-0974]

Determination That SAMSCA (Tolvaptan) Tablets, 60 Milligrams,
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that SAMSCA (tolvaptan) tablets, 60 milligrams (mg), were
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for tolvaptan tablets, 60 mg, if all other legal
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 240-
402-3543.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of

safety or effectiveness (Sec.  314.162 (21 CFR 314.162)).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161). FDA may not approve an ANDA that does not refer
to a listed drug.
    SAMSCA (tolvaptan) tablets, 60 mg, are the subject of NDA 22-275,
held by Otsuka America Pharmaceutical, and initially approved on May
19, 2009. SAMSCA is indicated for the treatment of clinically
significant hypervolemic and euvolemic hyponatremia (serum sodium <125
milliequivalents/liter or less marked hyponatremia that is symptomatic
and has resisted correction with fluid restriction), including patients
with heart failure and syndrome of inappropriate antidiuretic hormone
(SIADH).
    Otsuka America Pharmaceutical has never marketed SAMSCA (tolvaptan)
tablets, 60 mg. In previous instances (see, e.g., 72 FR 9763 (March 5,
2007), 61 FR 25497 (May 21, 1996)), the Agency has determined that, for
purposes of Sec. Sec.  314.161 and 314.162, never marketing an approved
drug product is equivalent to withdrawing the drug from sale.
    Gordon Johnston Regulatory Consultants, LLC, submitted a citizen
petition dated March 15, 2016 (Docket No. FDA-2016-P-0974), under 21
CFR 10.30, requesting that the Agency determine whether SAMSCA
(tolvaptan) tablets, 60 mg, were withdrawn from sale for reasons of
safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that SAMSCA (tolvaptan) tablets, 60 mg, were not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that SAMSCA
(tolvaptan) tablets, 60 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of SAMSCA (tolvaptan) tablets, 60 mg, from
sale. We have also independently evaluated relevant literature and data
for possible postmarketing adverse events. We have reviewed the
available evidence and determined that this drug product was not
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list SAMSCA (tolvaptan)
tablets, 60 mg, in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. ANDAs that
refer to SAMSCA (tolvaptan) tablets, 60 mg, may be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. If FDA determines that labeling for this
drug product should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.

    Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18139 Filed 8-1-16; 8:45 am]
 BILLING CODE 4164-01-P


Notes on FFC Meeting on March 20, 2003 Attendees: John Quarles, John Kolojeski, Ridgway Hall representing Narragansett Tracy Mehan, Geoff Grubbs, Sylvia Horwitz, Mary Smith representing EPA Representatives for Narragansett requested this meeting with Tracy Mehan, Assistant Administrator for the Office of Water, EPA to discuss issues related to the pending decision concerning the toxicity of FFC under the Clean Water Act. The following points were made by Narrangansett Representatives during the course of the meeting:

1. The legal focus of the FFC toxicity determination requested by the Massachusetts should be on whether FFC was considered on of the " cyanides" in 1976. A chronology ( attached) dating back to 1973 was handed to EPA officials at the meeting. Looking at this issue historically, it is clear that FFC was not a " cyanide" in 1976.

2. If EPA found in 2003 that FFC was toxic then it would have the authority to add FFC to the list of toxic pollutants. However, since Superfund incorporates only the older list of toxic pollutants, FFC would not be toxic for purpose of the pending Massachusetts litigation.

3. The Massachusetts court considered the fact that the total cyanides methods includes FFC and said that this was not dispositive of the FFC toxicity issue.

4. Regarding the current toxicity of FFC   FDA has approved the use of FFC   Gov. Thompson of HHS recently announced that the FDA is encouraging manufacturers to submit new drug applications as an antidote for radioactive cesium and thalium poisoning.   There is a real question about how easily FFC disassociates in the environment.

5. A determination that FFC is a toxic substance under the CWA would have significant impacts. A written summary of these impacts, taken from the Administrative Record, was handed out at the meeting ( attached).

EPA listened to these statement and asked several clarifying questions. Tracy Mehan indicated that EPA was having a peer review panel look at the science surrounding FFC and will be involving EPA's Office of Research and Development in this analysis. Narrangansett representatives asked for the charge to the peer review panel, and for any documents that were provided to the peer reviewers. EPA promised to provide those to Narrangansett representatives after the meeting.


[Federal Register Volume 85, Number 185 (Wednesday, September 23, 2020)]
[Notices]
[Page 59803]
[FR Doc No: 2020-20965]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1879]

Determination That PREXXARTAN (Valsartan) Oral Solution, 20
Milligrams/5 Milliliters and 80 Milligrams/20 Milliliters, Was Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that PREXXARTAN (valsartan) oral solution, 20 milligrams
(mg)/5 milliliters (mL) and 80 mg/20 mL, was not withdrawn from sale
for reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for valsartan
oral solution, 20 mg/5 mL and 80 mg/20 mL, if all other legal and
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240-
402-4510<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness
(Sec.  314.162 (21 CFR 314.162)).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    PREXXARTAN (valsartan) oral solution, 20 mg/5 mL and 80 mg/20 mL,
is the subject of NDA 209139, held by Carmel Biosciences, Inc., and
initially approved on December 19, 2017. PREXXARTAN is indicated for
hypertension in adults and children 6 years and older, to lower blood
pressure; for heart failure by significantly reducing hospitalization
for patients who are unable to swallow valsartan tablets; and for
stable left ventricular failure or left ventricular dysfunction
following myocardial infarction.
    PREXXARTAN (valsartan) oral solution, 20 mg/5 mL and 80 mg/20 mL,
is currently listed in the ``Discontinued Drug Product List'' section
of the Orange Book. Additionally, Carmel Biosciences has never marketed
PREXXARTAN (valsartan) oral solution, 20 mg/5 mL and 80 mg/20 mL. In
previous instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497,
May 21, 1996), the Agency has determined that, for purposes of
Sec. Sec.  314.161 and 314.162, never marketing an approved drug
product is equivalent to withdrawing the drug from sale.
    Novitium Pharma LLC submitted a citizen petition dated January 30,
2020 (Docket No. FDA-2020-P-0511), under 21 CFR 10.30, requesting that
the Agency determine whether PREXXARTAN (valsartan) oral solution, 20
mg/5 mL, was withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 80 mg/
20 mL strength, that strength has also been discontinued. On our own
initiative, we have also determined whether that strength was withdrawn
for safety or effectiveness reasons.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that PREXXARTAN (valsartan) oral solution, 20 mg/5
mL and 80 mg/20 mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that this drug product was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of PREXXARTAN (valsartan) oral
solution, 20 mg/5 mL and 80 mg/20 mL, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have reviewed the available evidence
and determined that this drug product was not withdrawn from sale for
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list PREXXARTAN
(valsartan) oral solution, 20 mg/5 mL and 80 mg/20 mL, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to PREXXARTAN
(valsartan) oral solution, 20 mg/5 mL and 80 mg/20 mL, may be approved
by the Agency as long as they meet all other legal and regulatory
requirements for the approval of ANDAs. If FDA determines that labeling
for this drug product should be revised to meet current standards, the
Agency will advise ANDA applicants to submit such labeling.

    Dated: September 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20965 Filed 9-22-20; 8:45 am]
BILLING CODE 4164-01-P


TOXIC CHEMICAL RELEASE REPORTING EPA Responses to Comments Received regarding the ICR Renewal for Form R EPA ICR Number 1363.14; OMB Control Number 2070 0093 Docket Number: OEI 2004 0006 Revised November 2, 2005 Commenter Major Comments ( summarized &

paraphrased) EPA's Response to Comment Fern Abrams Director, Environmental Policy IPC   Association Connecting Electronics Industries IPC believes that this Information Collection Request ( ICR) does not reflect the changes that were made in the Toxics Release Inventory ( TRI) Reporting Forms Modification Rule and recommends that EPA withdraw the current ICR and re propose a modified ICR, in concert with the Administrative Procedures Act ( APA).

In preparing a modified ICR, IPC urges EPA to consider its previous comments on that rule ( dated March 11, 2005).

IPC believes that EPA has underestimated the burden associated with TRI reporting and specifically PBT reporting.

The designation of lead as a persistent,

bioaccumulative, and toxic ( PBT) chemical and EPA agrees that the ICR supporting statement that was available in May 2005 ( when the first FR notice concerning this ICR was published) did not reflect the changes that were subsequently made in the TRI Reporting Forms Modification Rule, which was finalized on July 12, 2005 ( 70 FR 39931). The Agency has since modified the supporting statement for this ICR to reflect the finalization of the TRI Reporting Forms Modification Rule. Because the ICR process is not bound by APA requirements, EPA believes it is unnecessary to withdraw the current ICR. Interested parties will have the opportunity to comment on the modified supporting statement in the comment period that follows EPA's submittal of this ICR to OMB.

EPA disagrees with the commenter that the Agency has underestimated the burden associated with TRI reporting. The Agency notes that its burden estimates already show higher burden levels for PBT chemical reports than for non PBT reports in part because of the lack of availability of range reporting for the former.

Also, first year submissions are also higher than subsequent year submissions. Although the commenter states that the Agency has underestimated the reporting burden, it does not provide specific information or data supporting its position or a recommendation for how much the burden estimate should be adjusted upward.

The designation of lead as a PBT was addressed during the TRI Lead Rulemaking dated January 17, 2001. EPA's response to this 2 Commenter Major Comments ( summarized &

paraphrased) EPA's Response to Comment the elimination of the de minimis exemption for PBTs significantly increase the reporting burden on industry.

IPC believes that EPA should only seek a oneyear renewal of this ICR because an upcoming burden reduction rule is anticipated by December 2006. issue is available on the TRI Web site at http:// www. epa. gov/ tri/ lawsandregs/ lead/ tri_ pb_ rule. htm, or through EPA Docket ID Number OPPTS 400140.

To seek a one year renewal would put a tremendous burden on EPA because of the time and effort involved in renewing an ICR and a lack of adequate resources to do so. Interested parties have an opportunity to comment on burden estimates for the TRI Burden Reduction Proposed Rule, which was published on October 4, 2005 ( 70 FR 57822).

Howard Feldman American Petroleum Institute By using an average facility burden, EPA is not adequately addressing the reporting burden for larger, more complex facilities.

EPA fails to recognize that the burden associated with rule familiarization is incurred more than once. Many activities contribute to this burden, including the review of new Agency guidance and interpretations, as well as new environmental regulations from other programs. In addition, due to staff turnover and the need to bring in new personnel, the burden of rule familiarization may be incurred by a facility more than once. The Form R reporting burden will vary from facility to facility according to the complexity of the facility's operations and the knowledge and experience of the respondent who is completing the form. However, the purpose of the ICR supporting statement is not to characterize the relative burden across all facility sizes and classes, but rather to characterize the total burden and average facility burden. The Agency notes that although larger facilities may be more complex than smaller facilities, they are often better able to afford more knowledgeable and experienced technical support to facilitate compliance with environmental regulations.

The Agency agrees that it is important to address the burden associated with rule familiarization in subsequent reporting years,

and EPA is currently conducting an engineering analysis of the burden associated with both rule familiarization and compliance.

EPA disagrees with the commenter regarding the attribution of the burden associated with other programs' environmental regulations to the burden for Form R. The burden associated with other environmental regulations should be accounted for in the ICRs for those other regulations, not as part of the ICR for Form R. While it is possible that rule familiarization could be incurred by new staff in subsequent years, that familiarization burden is likely to be only a 3 Commenter Major Comments ( summarized &

paraphrased) EPA's Response to Comment EPA should undertake a new survey that more accurately characterizes the TRI reporting burden.

EPA should follow through on promulgating a TRI burden reduction rule. fraction of the time/ costs that were incurred initially due to the recordkeeping requirements for Form R. Having access to the Form Rs that were submitted in previous years, as well as the calculations used to estimate releases and transfers, is likely to mitigate the burden associated with rule familiarization in subsequent reporting years.

In general, federal agencies/ department do not conduct surveys of 10 or more people/ organizations when developing estimates for ICRs, simply because conducting such surveys would impose an additional burden on the public, which seems contrary to the intent of the Paperwork Reduction Act. EPA's TRI Program will wait until EPA has received and analyzed public comments on the proposed Burden Reduction Rule that was published on October 4,

2005 ( 70 FR 57822), before deciding whether or not to conduct a survey of the TRI reporting community concerning reporting burdens.

EPA promulgated a burden reduction rule, the TRI Reporting Forms Modification Rule, on July 12, 2005, and published a TRI Burden Reduction Proposed Rule on October 4, 2005. EPA also published a notice and notified Congress that it will be examining the possibility of modifying the frequency of reporting under the TRI Program.

The Agency will decide whether to pursue a change in reporting frequency after it has held discussions with a variety of stakeholders and conducted some initial analyses. More information on these activities can found on the TRI Web site at http:// www. epa. gov/ tri/ index. htm.

Nancy J. Dotson Eastman Chemical Company EPA should clarify within the text of this ICR the extent of its authority to disclose information that is claimed as confidential. EPA will disclose information submitted under EPCRA section 313 that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, EPCRA section 322 and the 4 Commenter Major Comments ( summarized &

paraphrased) EPA's Response to Comment Eastman Chemical Company disputes the EPA's burden estimates for Form R.

EPA should conduct a statistically valid survey across all industries and prepare burden estimates by industry.

Eastman urges EPA to propose changes that will result in significant burden reduction. procedures in 40 CFR part 350 and 40 CFR part 2. TSCA section 14 does not govern claims of confidentiality made under EPCRA section 313. The reference to TSCA section 14 was inadvertently included and has been removed from the ICR supporting statement as an authority for deciding whether to disclose information that is covered by a claim of confidentiality under EPCRA section 322.

The commenter asserts that EPA's average Form R burden estimate is low because, in its view, larger facilities are more complex and would take more time to complete a Form R than smaller facilities.

While we agree with the general statement that a larger or more complex facility may incur more burden than a smaller one, the Agency believes that the commenter has not adequately explained why this shows that EPA's average burden estimate ( which includes both large and small facilities) is low.

In general, federal agencies/ department do not conduct surveys of 10 or more people/ organizations when developing estimates for ICRs, simply because conducting such a survey would impose an additional burden on the public, which seems contrary to the intent of the Paperwork Reduction Act. EPA's TRI Program will wait until EPA has received and analyzed public comments on the TRI Burden Reduction Proposed Rule published on October 4, 2005,

before deciding whether or not to conduct a survey of the TRI reporting community concerning reporting burdens.

EPA promulgated a burden reduction rule, the TRI Reporting Forms Modification Rule on July 12, 2005 and published a TRI Burden Reduction Proposed Rule on Oct. 4, 2005. EPA also published a notice and notified Congress that it will be examining the possibility of altering the frequency of reporting under the TRI Program. The Agency will decide whether to pursue a change in reporting frequency after it has held discussions with a variety of stakeholders 5 Commenter Major Comments ( summarized &

paraphrased) EPA's Response to Comment and conducted some initial analyses. More information on these activities can found on the TRI Web site at http:// www. epa. gov/ tri/ index. htm.

Michael Walls American Chemistry Council American Chemistry Council disputes EPA's burden estimates. EPA should conduct a survey of reporting facilities to develop more accurate burden estimates.

EPA should clarify the relevance of TSCA Section 14 to the potential disclosure of information reported as confidential under EPCRA Section 313. In general, federal agencies/ department do not conduct surveys of 10 or more people/ organizations when developing estimates for ICRs, simply because conducting such a survey would impose an additional burden on the public, which seems contrary to the intent of the Paperwork Reduction Act. EPA's TRI Program will wait until EPA has received and analyzed public comments on the TRI Burden Reduction Proposed Rule published on October 4, 2005,

before deciding whether or not to conduct a survey of the TRI reporting community concerning reporting burdens.

EPA will disclose information submitted under EPCRA section 313 that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, EPCRA section 322 and the procedures in 40 CFR part 350 and 40 CFR part 2. TSCA section 14 does not govern claims of confidentiality made under EPCRA section 322. The reference to TSCA section 14 was inadvertently included and has been removed from the ICR supporting statement as an authority for deciding whether to disclose information that is covered by a claim of confidentiality under EPCRA section 322.


[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Rules and Regulations]
[Pages 21664-21672]
[FR Doc No: 2011-9341]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2011-0002]

Final Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: Base (1% annual-chance) Flood Elevations (BFEs) and modified
BFEs are made final for the communities listed below. The BFEs and
modified BFEs are the basis for the floodplain management measures that
each community is required either to adopt or to show evidence of being
already in effect in order to qualify or remain qualified for
participation in the National Flood Insurance Program (NFIP).

DATES: The date of issuance of the Flood Insurance Rate Map (FIRM)
showing BFEs and modified BFEs for each community. This date may be
obtained by contacting the office where the maps are available for
inspection as indicated in the table below.

ADDRESSES: The final BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Division, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>, or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the modified
BFEs for each community listed. These modified elevations have been
published in newspapers of local circulation and ninety (90) days have
elapsed since that publication. The Deputy Federal Insurance and
Mitigation Administrator has resolved any appeals resulting from this
notification.
    This final rule is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the proof Flood Insurance Study and FIRM available at the
address cited below for each community.
    The BFEs and modified BFEs are made final in the communities listed
below. Elevations at selected locations in each community are shown.
    National Environmental Policy Act. This final rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Consideration. An environmental impact assessment has not been
prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This final rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This final rule meets
the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.
    Accordingly, 44 CFR part 67 is amended as follows:

PART 67--[AMENDED]

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

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.11  [Amended]

0
2. The tables published under the authority of Sec.  67.11 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                                      * Elevation in
                                                                      feet (NGVD)  +
                                                                    Elevation in feet
                                                                    (NAVD)
           Flooding source(s)              Location of referenced     Depth in feet      Communities  affected
                                                 elevation             above ground
                                                                    [caret] Elevation
                                                                     in  meters (MSL)
                                                                         Modified
----------------------------------------------------------------------------------------------------------------
                               Crittenden County, Arkansas, and Incorporated Areas
                                             Docket No.: FEMA-B-1045
----------------------------------------------------------------------------------------------------------------
Mississippi River......................  Approximately at River                  +212  Unincorporated Areas of
                                          Mile 700.                                     Crittenden County.
                                         Approximately at River                  +226
                                          Mile 727.
                                         Approximately at River                  +234
                                          Mile 741.
                                         Approximately at River                  +237
                                          Mile 750.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES
                                    Unincorporated Areas of Crittenden County
Maps are available for inspection at the Crittenden County Courthouse, 85 Jackson Street, Marion, AR 72482.
                                 Madison County, Indiana, and Incorporated Areas
                                             Docket No.: FEMA-B-1037
----------------------------------------------------------------------------------------------------------------
Alexandria Creek.......................  Approximately 150 feet                  +853  City of Alexandria,
                                          upstream of the                               Unincorporated Areas of
                                          confluence with Pipe                          Madison County.
                                          Creek.
                                         Approximately 2,100 feet                +861
                                          upstream of 11th Street.
Big Duck Creek.........................  At South P Street........               +843  City of Elwood,
                                                                                Unincorporated Areas of
                                                                                Madison County.
                                         Approximately 1,700 feet                +856
                                          upstream of North 20th
                                          Street.
Boland Ditch...........................  Approximately 700 feet                  +872  City of Anderson.
                                          downstream of
                                          Meadowbrook Parkway.
                                         Approximately 4,190 feet                +881
                                          upstream of Main Street.
Fall Creek.............................  Approximately 630 feet                  +821  Unincorporated Areas of
                                          downstream of                                 Madison County.
                                          Reformatory Road.
                                         Approximately 9,980 feet                +862
                                          upstream of State Route
                                          67.
Foster Branch..........................  Approximately 2,060 feet                +816  Town of Ingalls, Town of
                                          downstream of Fall Creek                      Pendleton,
                                          Road.                                         Unincorporated Areas of
                                                                                Madison County.
                                         Approximately 240 feet                  +860
                                          upstream of Old State
                                          Road 132.
Pipe Creek.............................  Approximately 1,425 feet                +820  City of Alexandria,
                                          downstream of Conrail                         Unincorporated Areas of
                                          Railroad.                                     Madison County.
                                         Approximately 2,690 feet                +857
                                          upstream of Washington
                                          Street.
Prairie Creek..........................  Approximately 2,460 feet                +851  Unincorporated Areas of
                                          upstream of State Route                       Madison County.
                                          67.
                                         Approximately 4,460 feet                +851
                                          upstream of State Route
                                          67.
West Fork White River..................  At State Route 13 North..               +805  City of Anderson, Town of
                                                                                Chesterfield, Town of
                                                                                Country Club Heights,
                                                                                Town of River Forest,
                                                                                Town of Woodlawn
                                                                                Heights, Unincorporated
                                                                                Areas of Madison County.
                                         At County Line Road/South               +872
                                          1000 West.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Alexandria
Maps are available for inspection at the City of Alexandria Office, 125 North Wayne Street, Alexandria, IN
 46001.

City of Anderson
Maps are available for inspection at the City Building, 120 East 8th Street, Anderson, IN 46016.

City of Elwood
Maps are available for inspection at City Hall, 1505 South B Street, Elwood, IN 46036.

Town of Chesterfield
Maps are available for inspection at the Government Center, 17 Veterans Boulevard, Chesterfield, IN 46017.

Town of Country Club Heights
Maps are available for inspection at 1202 North Madison Avenue, Anderson, IN 46011.

Town of Ingalls
Maps are available for inspection at the Town Center, 247 Meridian Street, Ingalls, IN 46048.

Town of Pendleton
Maps are available for inspection at the Town Hall, 100 West State Street, Pendleton, IN 46064.

Town of River Forest
Maps are available for inspection at 53 River Forest Street, Anderson, IN 46011.

Town of Woodlawn Heights
Maps are available for inspection at 1301 Van Buskirk Road, Anderson, IN 46011.

                                     Unincorporated Areas of Madison County
Maps are available for inspection at the Madison County Government Center, 16 East 9th Street, Room 200,
 Anderson, IN 46018.
----------------------------------------------------------------------------------------------------------------
                                    Lee County, Iowa, and Incorporated Areas
                                             Docket No.: FEMA-B-1106
----------------------------------------------------------------------------------------------------------------
Des Moines River (backwater effects      At the confluence with                  +499  City of Keokuk.
 from Mississippi River).                 the Mississippi River.
                                         Approximately 700 feet                  +499
                                          upstream of Burlington
                                          Northern Railroad.
Devils Creek (backwater effects from     Just upstream of the                    +524  City of Fort Madison,
 Mississippi River).                      confluence with the                           Unincorporated Areas of
                                          Mississippi River.                            Lee County.
                                         Approximately 900 feet                  +524
                                          downstream of 235th
                                          Street.
Dry Creek (backwater effects from        Just upstream of the                    +525  City of Fort Madison.
 Mississippi River).                      confluence with the
                                          Mississippi River.
                                         Approximately 100 feet                  +525
                                          downstream of Atchison
                                          Topeka and Santa Fe
                                          Railway (Southernmost
                                          Track).
Fork Creek (backwater effects from       Just upstream of the                    +526  City of Fort Madison.
 Mississippi River).                      confluence with the
                                          Mississippi River.
                                         Approximately 100 feet                  +526
                                          downstream of Burlington
                                          Northern Railroad.
French Creek...........................  Approximately 600 feet                  +558  Unincorporated Areas of
                                          upstream of B Avenue.                         Lee County.
                                         Approximately 700 feet                  +558
                                          upstream of B Avenue.
Horton Creek (backwater effects from     At the downstream side of               +523  City of Montrose.
 Mississippi River).                      Burlington Northern
                                          Railroad.
                                         Approximately 200 feet                  +523
                                          downstream of 2nd Street.
Jack Creek (backwater effects from       Approximately 1,300 feet                +523  City of Montrose.
 Mississippi River).                      upstream of 1st Street.
                                         At the downstream side of               +523
                                          Burlington Northern
                                          Railroad.
Mississippi River......................  At the confluence with                  +499  City of Fort Madison,
                                          the Des Moines River.                         City of Keokuk, City of
                                                                                Montrose, Unincorporated
                                                                                Areas of Lee County.
                                         Approximately 4.7 miles                 +529
                                          downstream of the
                                          confluence with the
                                          Skunk River.
Mississippi River Tributary (backwater   Approximately 100 feet                  +524  Unincorporated Areas of
 effects from Mississippi River).         upstream of Atchison                          Lee County.
                                          Topeka and Santa Fe
                                          Railway.
                                         Approximately 0.6 miles                 +524
                                          upstream of Ortho Road.
Soap Creek.............................  Just upstream of the                    +500  City of Keokuk.
                                          confluence with the
                                          Mississippi River.
                                         Approximately 500 feet                  +502
                                          downstream of 7th Street.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Fort Madison
Maps are available for inspection at 811 Avenue E, Fort Madison, IA 52627.

City of Keokuk
Maps are available for inspection at 415 Blondeau Street, Keokuk, IA 52632.

City of Montrose
Maps are available for inspection at 102 South 2nd Street, Montrose, IA 52639.

                                       Unincorporated Areas of Lee County
Maps are available for inspection at 933 Avenue H, Fort Madison, IA 52627.
----------------------------------------------------------------------------------------------------------------
                                 Franklin County, Kansas, and Incorporated Areas
                                    Docket Nos.: FEMA-B-1057 and FEMA-B-1105
----------------------------------------------------------------------------------------------------------------
Marias des Cygnes River................  At South East Street.....               +882  City of Rantoul.
                                         Approximately 800 feet                  +882
                                          upstream of Vermont Road.

Nugent Creek...........................  Just upstream of Marshall               +904  City of Ottawa,
                                          Road.                                         Unincorporated Areas of
                                                                                Franklin County.
                                         Just downstream of I-35..               +940
Pottawatomie Creek.....................  At the confluence with                  +874  City of Lane.
                                          Unnamed Tributary
                                          between Walnut Street
                                          and Cherry Street in
                                          eastern portion of the
                                          city.
                                         Just upstream of the                    +875
                                          intersection of Lane
                                          Road and South Kansas
                                          Avenue.
Rock Creek.............................  Just upstream of East                   +902  City of Ottawa,
                                          15th Street.                                  Unincorporated Areas of
                                                                                Franklin County.
                                         Just downstream of I-35..               +913
Walnut Creek...........................  Just upstream of I-35....              +1012  City of Wellsville,
                                                                                Unincorporated Areas of
                                                                                Franklin County.
                                         Just upstream of Utah                  +1040
                                          Road.
Walnut Creek Tributary.................  At the confluence with                 +1030  Unincorporated Areas of
                                          Walnut Creek.                                 Franklin County.
                                         Approximately 800 feet                 +1038
                                          downstream of Hedge Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Lane
Maps are available for inspection at 520 3rd Street, Lane, KS 66042.

City of Ottawa
Maps are available for inspection at 101 South Hickory Street, 2nd Floor, Ottawa, KS 66067.

City of Rantoul
Maps are available for inspection at 120 East Main Street, Rantoul, KS 66079.

City of Wellsville
Maps are available for inspection at 411 Main Street, Wellsville, KS 66092.

                                     Unincorporated Areas of Franklin County
Maps are available for inspection at 315 South Main Street, Suite 202, Ottawa, KS 66067.
----------------------------------------------------------------------------------------------------------------
                                 Barren County, Kentucky, and Incorporated Areas
                                             Docket No.: FEMA-B-1080
----------------------------------------------------------------------------------------------------------------
Barren River Lake......................  Entire shoreline.........               +590  Unincorporated Areas of
                                                                                Barren County.
Barren River Tributary 32.1 (backwater   From the confluence with                +590  Unincorporated Areas of
 effects from Barren River Lake).         Barren River Lake to                          Barren County.
                                          approximately 0.2 mile
                                          upstream of the
                                          confluence with Barren
                                          River Lake.
Beaver Creek (backwater effects from     From the confluence with                +590  Unincorporated Areas of
 Barren River Lake).                      Barren River Lake to                          Barren County.
                                          approximately 4.0 miles
                                          upstream of the
                                          confluence with Barren
                                          River Lake.
Beaver Creek Tributary 1 (backwater      From the confluence with                +590  Unincorporated Areas of
 effects from Barren River Lake).         Barren River Lake to                          Barren County.
                                          approximately 0.7 mile
                                          upstream of the
                                          confluence with Barren
                                          River Lake.
Beaver Creek Tributary 1.4 (backwater    From the confluence with                +590  Unincorporated Areas of
 effects from Barren River Lake).         Beaver Creek Tributary 1                      Barren County.
                                          to approximately 1.5
                                          miles upstream of the
                                          confluence with Beaver
                                          Creek Tributary 1.
Beaver Creek Tributary 47 (backwater     From the confluence with                +590  Unincorporated Areas of
 effects from Barren River Lake).         Beaver Creek to                               Barren County.
                                          approximately 0.3 mile
                                          upstream of the
                                          confluence with Beaver
                                          Creek.
Coon Creek (backwater effects from       From the confluence with                +590  Unincorporated Areas of
 Barren River Lake).                      Barren River Lake to                          Barren County.
                                          approximately 0.8 mile
                                          upstream of the
                                          confluence with Barren
                                          River Lake.
Dry Creek (backwater effects from        From the confluence with                +590  Unincorporated Areas of
 Barren River Lake).                      Barren River Lake to                          Barren County.
                                          approximately 1.0 mile
                                          upstream of the
                                          confluence with Barren
                                          River Lake.

Peter Creek (backwater effects from      From the confluence with                +590  Unincorporated Areas of
 Barren River Lake).                      Barren River Lake to                          Barren County.
                                          approximately 2.2 miles
                                          upstream of the
                                          confluence with Barren
                                          River Lake.
Rose Creek (backwater effects from       From the confluence with                +590  Unincorporated Areas of
 Barren River Lake).                      Skaggs Creek to                               Barren County.
                                          approximately 1.6 miles
                                          upstream of the
                                          confluence with Skaggs
                                          Creek.
Skaggs Creek (backwater effects from     From the confluence with                +590  Unincorporated Areas of
 Barren River Lake).                      Barren River Lake to                          Barren County.
                                          approximately 2.3 miles
                                          upstream of the
                                          confluence with Barren
                                          River Lake.
South Fork Beaver Creek (backwater       From the confluence with                +590  Unincorporated Areas of
 effects from Barren River Lake).         Beaver Creek to                               Barren County.
                                          approximately 0.4 mile
                                          upstream of the
                                          confluence with Beaver
                                          Creek.
South Glover Creek (backwater effects    From the confluence with                +590  Unincorporated Areas of
 from Barren River Lake).                 Barren River Lake to                          Barren County.
                                          approximately 1.5 miles
                                          upstream of the
                                          confluence with Barren
                                          River Lake.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

                                      Unincorporated Areas of Barren County
Maps are available for inspection at 117 North Public Square, Suite 3A, Glasgow, KY 42141.
----------------------------------------------------------------------------------------------------------------
                                  Clinton County, Michigan (All Jurisdictions)
                                             Docket No.: FEMA-B-1053
----------------------------------------------------------------------------------------------------------------
Looking Glass River....................  Just upstream of South                  +805  Charter Township of Bath,
                                          Chandler Road.                                Township of Victor.
                                         Approximately 9,000 feet                +807
                                          upstream of Babcock Road.
Prairie Creek and Gunderman Lake Drain.  At the confluence with                  +817  Charter Township of
                                          Remy Chandler Drain.                          DeWitt.
                                         Approximately 7,410 feet                +832
                                          upstream of West Stoll
                                          Road.
Remy Chandler Drain....................  Approximately 350 feet                  +834  Charter Township of Bath,
                                          downstream of I-69.                           Charter Township of
                                                                                DeWitt, City of East
                                                                                Lansing.
                                         Approximately 1,140 feet                +841
                                          upstream of Coleman Road.
Steel and Walbridge Drain..............  At the confluence with                  +730  City of St. Johns,
                                          Spaulding Drain.                              Township of Bingham.
                                         Approximately 600 feet                  +752
                                          upstream of Glastonbury
                                          Drive.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

Charter Township of Bath
Maps are available for inspection at 14480 Webster Road, Bath, MI 48808.

Charter Township of DeWitt
Maps are available for inspection at 1401 West Herbison Road, DeWitt, MI 48820.

City of East Lansing
Maps are available for inspection at 410 Abbott Road, East Lansing, MI 48823.

City of St. Johns
Maps are available for inspection at 100 East State Street, Suite 1100, St. Johns, MI 48879.

Township of Bingham
Maps are available for inspection at 1637 South DeWitt Road, St. Johns, MI 48879.

Township of Victor
Maps are available for inspection at 6843 East Alward Road, Laingsburg, MI 48848.
----------------------------------------------------------------------------------------------------------------
                                Clay County, Mississippi, and Incorporated Areas
                                             Docket No.: FEMA-B-1093
----------------------------------------------------------------------------------------------------------------
Tombigbee River........................  Approximately 1.7 miles                 +177  Unincorporated Areas of
                                          upstream of the                               Clay County.
                                          confluence with Tibbee
                                          Creek.

                                         Approximately 4.2 miles                 +188
                                          upstream of the
                                          confluence with Town
                                          Creek East.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

                                       Unincorporated Areas of Clay County
Maps are available for inspection at the Clay County Courthouse, 205 Court Street, West Point, MS 39773.
----------------------------------------------------------------------------------------------------------------
                                 Cooper County, Missouri, and Incorporated Areas
                                             Docket No.: FEMA-B-1087
----------------------------------------------------------------------------------------------------------------
Missouri River.........................  Approximately 1,500 feet                +587  City of Boonville,
                                          upstream of the Moniteau                      Unincorporated Areas of
                                          County boundary.                              Cooper County.
                                         Approximately 2,500 feet                +610
                                          downstream of the Saline
                                          County boundary.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Boonville
Maps are available for inspection at 1200 Locust Street, Boonville, MO 65233.

                                      Unincorporated Areas of Cooper County
Maps are available for inspection at 200 Main Street, Room 4, Boonville, MO 65233.
----------------------------------------------------------------------------------------------------------------
                                 Dawson County, Nebraska, and Incorporated Areas
                                             Docket No.: FEMA-B-1087
----------------------------------------------------------------------------------------------------------------
North Channel Platte River.............  Approximately 1.2 miles                +2548  City of Gothenburg.
                                          downstream of Cottonwood
                                          Drive.
                                         Just upstream of I-80....              +2566
Platte River...........................  Approximately 0.6 mile                 +2381  City of Gothenburg, City
                                          downstream of Plum Creek                      of Lexington,
                                          Parkway.                                      Unincorporated Areas of
                                                                                Dawson County.
                                         Approximately 2.2 miles                +2398
                                          upstream of Plum Creek
                                          Parkway.
                                         Approximately 1.6 miles                +2550
                                          downstream of State
                                          Highway 47.
                                         Approximately 2.2 miles                +2572
                                          upstream of State
                                          Highway 47.
Spring Creek...........................  Approximately 1,500 feet               +2367  City of Lexington,
                                          southeast of the                              Unincorporated Areas of
                                          intersection of Road 436                      Dawson County.
                                          and East Prospect Road.
                                         On Spring Creek just                   +2424
                                          downstream of Road 431.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

City of Gothenburg
Maps are available for inspection at 409 9th Street, Gothenburg, NE 69138.

City of Lexington
Maps are available for inspection at 406 East 7th Street, Lexington, NE 68850.

                                      Unincorporated Areas of Dawson County
Maps are available for inspection at 700 North Washington Street, Lexington, NE 68850.
----------------------------------------------------------------------------------------------------------------
                                   Seneca County, Ohio, and Incorporated Areas
                                             Docket No.: FEMA-B-1085
----------------------------------------------------------------------------------------------------------------
Morrison Creek (backwater effects from   At the confluence with                  +717  Unincorporated Areas of
 Sandusky River).                         the Sandusky River.                           Seneca County.

                                         Approximately 700 feet                  +717
                                          upstream of the
                                          confluence with the
                                          Sandusky River.
Sandusky River.........................  Approximately 1.0 mile                  +709  City of Tiffin,
                                          downstream of Huss                            Unincorporated Areas of
                                          Street.                                       Seneca County.
                                         Approximately 1,600 feet                +745
                                          downstream of U.S. Route
                                          224.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES
City of Tiffin
Maps are available for inspection at 51 East Market Street, Tiffin, OH 44883.

                                      Unincorporated Areas of Seneca County
Maps are available for inspection at 109 South Washington Street, Suite 2002, Tiffin, OH 44883.
----------------------------------------------------------------------------------------------------------------
                                 Jackson County, Oregon, and Incorporated Areas
                                             Docket No.: FEMA-B-1085
----------------------------------------------------------------------------------------------------------------
Daisy Creek............................  At the confluence with                 +1274  City of Central Point,
                                          Griffin Creek.                                Unincorporated Areas of
                                                                                Jackson County.
                                         Just upstream of Beall                 +1299
                                          Lane.
Elk Creek..............................  At the confluence with                 +1271  City of Central Point,
                                          Bear Creek.                                   Unincorporated Areas of
                                                                                Jackson County.
                                         Just upstream of Beall                 +1297
                                          Lane.
Griffin Creek..........................  At the confluence with                 +1214  City of Central Point,
                                          Bear Creek.                                   Unincorporated Areas of
                                                                                Jackson County.
                                         Just downstream of Taylor              +1267
                                          Road.
                                         Just upstream of Beall                 +1301
                                          Lane.
Horn Creek.............................  At the confluence with                 +1264  City of Central Point,
                                          Jackson Creek.                                Unincorporated Areas of
                                                                                Jackson County.
                                         Just downstream of                     +1281
                                          Mendolia Way.
                                         Just upstream of Grant                 +1290
                                          Road.
Jackson Creek..........................  Just downstream of Scenic              +1235  City of Central Point,
                                          Avenue.                                       Unincorporated Areas of
                                                                                Jackson County.
                                         Just downstream of Taylor              +1266
                                          Road.
                                         Just upstream of Beall                 +1301
                                          Lane.
Jackson Creek Overbank.................  At the confluence with                 +1238  City of Central Point,
                                          Jackson Creek.                                Unincorporated Areas of
                                                                                Jackson County.
                                         At the divergence from                 +1258
                                          Griffin Creek.
Mingus Creek...........................  Just downstream of Pine                +1261  City of Central Point,
                                          Street.                                       Unincorporated Areas of
                                                                                Jackson County.
                                         Just upstream of Highway               +1295
                                          99.
Rouge River............................  Approximately 500 feet                  +975  Unincorporated Areas of
                                          upstream of Savage                            Jackson County.
                                          Rapids Dam.
                                         Approximately 1.02 miles                +987
                                          upstream of the
                                          confluence with Little
                                          Savage Creek.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES
City of Central Point
Maps are available for inspection at City Hall, 140 South 3rd Street, Central Point, OR 97502.

                                     Unincorporated Areas of Jackson County
Maps are available for inspection at City Hall, 10 South Oakdale Avenue, Room 200, Medford, OR 97501.
----------------------------------------------------------------------------------------------------------------

                            Fairfield County, South Carolina, and Incorporated Areas
                                             Docket No.: FEMA-B-1110
----------------------------------------------------------------------------------------------------------------
McCulley Creek.........................  Approximately 1,370 feet                +350  Town of Winnsboro,
                                          downstream of State Road                      Unincorporated Areas of
                                          S-20-56.                                      Fairfield County.
                                         Approximately 560 feet                  +396
                                          downstream of Dogwood
                                          Avenue.
Sand Creek.............................  Approximately 1.4 miles                 +378  Town of Winnsboro,
                                          downstream of Pumphouse                       Unincorporated Areas of
                                          Road.                                         Fairfield County.
                                         Approximately 169 feet                  +522
                                          downstream of U.S. Route
                                          321.
Sand Creek Tributary 10................  At the confluence with                  +429  Unincorporated Areas of
                                          Sand Creek.                                   Fairfield County
                                         Approximately 0.7 mile                  +489
                                          upstream of the
                                          confluence with Sand
                                          Creek.
Sand Creek Tributary 11................  At the confluence with                  +449  Town of Winnsboro.
                                          Sand Creek.
                                         Approximately 1,473 feet                +544
                                          upstream of U.S. Route
                                          321.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

Town of Winnsboro
Maps are available for inspection at the Town Hall, 117 South Congress Street, Winnsboro, SC 29180.

                                    Unincorporated Areas of Fairfield County
Maps are available for inspection at the Winnsboro Town Hall, 117 South Congress Street, Winnsboro, SC 29180.
----------------------------------------------------------------------------------------------------------------
                            Greenwood County, South Carolina, and Incorporated Areas
                                             Docket No.: FEMA-B-1093
----------------------------------------------------------------------------------------------------------------
Lake Greenwood.........................  Entire shoreline within                 +442  Unincorporated Areas of
                                          community.                                    Greenwood County.
Ninety-Six Creek.......................  Approximately 1.0 mile                  +399  Unincorporated Areas of
                                          downstream of U.S. Route                      Greenwood County.
                                          702.
                                         Approximately 1,655 feet                +403
                                          upstream of U.S. Route
                                          702.
Rocky Creek Tributary..................  Approximately 516 feet                  +575  City of Greenwood.
                                          downstream of Bypass 72.
                                         Approximately 2,177 feet                +590
                                          upstream of Bypass 72.
Saluda River...........................  Approximately 3.9 miles                 +448  Town of Ware Shoals,
                                          downstream of U.S. Route                      Unincorporated Areas of
                                          25.                                           Greenwood County.
                                         Approximately 200 feet                  +531
                                          upstream of Saluda
                                          Avenue.
Sample Branch..........................  Approximately 1,206 feet                +527  City of Greenwood,
                                          upstream of the                               Unincorporated Areas of
                                          confluence with Rocky                         Greenwood County.
                                          Creek.
                                         Approximately 130 feet                  +563
                                          upstream of Dry Branch
                                          Court.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES
City of Greenwood
Maps are available for inspection at City Hall, 520 Monument Street, Greenwood, SC 29648.

Town of Ware Shoals
Maps are available for inspection at the Town Hall, 8 Mill Street, Ware Shoals, SC 29692.

                                    Unincorporated Areas of Greenwood County
Maps are available for inspection at the Greenwood County Courthouse, 600 Monument Street, Greenwood, SC 29646.
----------------------------------------------------------------------------------------------------------------
                              Barbour County, West Virginia, and Incorporated Areas
                                             Docket No.: FEMA-B-1083
----------------------------------------------------------------------------------------------------------------
Tygart Valley River....................  Approximately 40 feet                  +1696  Unincorporated Areas of
                                          downstream of the                             Barbour County.
                                          confluence with Big Run.

                                         Approximately 175 feet                 +1706
                                          upstream of the
                                          confluence with
                                          Tributary No. 1 to
                                          Tygart Valley River.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

                                     Unincorporated Areas of Barbour County
Maps are available for inspection at the Barbour County Courthouse, 8 North Main Street, Philippi, West Virginia
 26416.
----------------------------------------------------------------------------------------------------------------

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

    Dated: April 8, 2011.
Sandra K. Knight,
Deputy Federal Insurance and Mitigation Administrator, Mitigation,
Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2011-9341 Filed 4-15-11; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Notices]
[Pages 78321-78322]
[FR Doc No: 2011-32221]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request;

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 489 and Form F-N; SEC File No. 270-361; OMB Control No.
3235-0411.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Rule 489 (17 CFR 230.489) under the Securities Act of 1933 (15
U.S.C. 77a et seq.) requires foreign banks and foreign insurance
companies and holding companies and finance subsidiaries of foreign
banks and foreign insurance companies that are exempted from the
definition of ``investment company'' by virtue of rules 3a-1 (17 CFR
270.3a-1), 3a-5 (17 CFR 270.3a-5), and 3a-6 (17 CFR 270.3a-6) under the
Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.) to file Form
F-N (17 CFR 239.43) to appoint an agent for service of process when
making a public offering of securities in the United States.
    During calendar year 2010, approximately 13 entities were required
by rule 489 to make 15 Form F-N submissions. The Commission has
previously estimated that the total annual burden associated with
information collection and Form F-N preparation and submission is one
hour per filing. Based on the Commission's experience with disclosure
documents generally, the Commission continues to believe that this
estimate is appropriate.
    Estimates of average burden hours are made solely for the purposes
of the Paperwork Reduction Act and are not derived from a comprehensive
or even representative survey or study of the

costs of Commission rules and forms. The collection of information
under rule 489 and Form F-N is mandatory. The information provided
under rule 489 and Form F-N will not be kept confidential. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312; or send an
email to<EMAIL_ADDRESS>
     December 12, 2011.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-32221 Filed 12-15-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 113 (Tuesday, June 12, 2018)]
[Notices]
[Page 27356]
[FR Doc No: 2018-12552]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83388; File No. SR-CboeBZX-2017-006]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove a Proposed Rule Change, as
Modified by Amendment No. 1 Thereto, To List and Trade Shares of Series
of the Cboe Vest S&P 500 Enhanced Growth Strategy ETF Under the ETF
Series Solutions Trust Under Rule 14.11(c)(3)

June 6, 2018.
    On November 21, 2017, Cboe BZX Exchange, Inc. (``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares (``Shares'') of series of
the Cboe Vest S&P 500[reg] Enhanced Growth Strategy ETF under Exchange
Rule 14.11(c)(3), which governs the listing and trading of Index Fund
Shares. The proposed rule change was published for comment in the
Federal Register on December 11, 2017.\3\ On January 19, 2018, the
Commission extended the time period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to approve or disapprove the proposed
rule change.\4\ On March 9, 2018, the Commission initiated proceedings
to determine whether to disapprove the proposed rule change.\5\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 82216 (December 5,
2017), 82 FR 58235.
    \4\ See Securities Exchange Act Release No. 82552, 83 FR 3819
(January 26, 2018).
    \5\ See Securities Exchange Act Release No. 82843, 83 FR 11264
(March 14, 2018).
---------------------------------------------------------------------------

    On April 13, 2018, the Exchange filed Amendment No. 1 to the
proposed rule change.\6\ The Commission has received no comments on the
proposed rule change.
---------------------------------------------------------------------------

    \6\ In Amendment No. 1, which amended and replaced the proposed
rule change in its entirety, the Exchange: (a) Clarified the
requirements and applicability of BZX Rule 14.11(c)(3) as it
pertains to the Shares; (b) supplemented its description of the
indexes; (c) supplemented its description of outcome periods; (d)
clarified its assertions relating to susceptibility of manipulation
of the Shares; (e) made certain corrections to maintain consistency
with defined terms; (f) provided a description of the suitability
requirements with respect to Exchange members; and (g) made other
technical and non-substantive corrections and updates. Because
Amendment No. 1 does not materially alter the substance of the
proposal or raise unique or novel regulatory issues, Amendment No. 1
is not subject to notice and comment. Amendment No. 1 is available
at: https://www.sec.gov/comments/sr-cboebzx-2017-006/cboebzx2017006-3458512-162202.pdf.
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    Section 19(b)(2) of the Act \7\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of the filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for notice and comment in the
Federal Register on December 11, 2017. June 9, 2018, is 180 days from
that date, and August 8, 2018, is 240 days from that date.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider the proposed
rule change, as modified by Amendment No. 1. Accordingly, pursuant to
Section 19(b)(2) of the Act,\8\ the Commission designates August 8,
2018, as the date by which the Commission shall either approve or
disapprove the proposed rule change (File No. SR-CboeBZX-2017-006), as
modified by Amendment No. 1.
---------------------------------------------------------------------------

    \8\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-12552 Filed 6-11-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43551-43552]
[FR Doc No: 2021-16929]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3931]

Nonmetastatic Castration-Resistant Prostate Cancer:
Considerations for Metastasis-Free Survival Endpoint in Clinical
Trials; Guidance 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 a final guidance for industry entitled
``Nonmetastatic Castration-Resistant Prostate Cancer: Considerations
for Metastasis-Free Survival Endpoint in Clinical Trials.'' Recent
approvals of several drug products for patients with nonmetastatic
castration-resistant prostate cancer have been supported by randomized
clinical trials demonstrating improvements in metastasis-free survival.
This guidance intends to inform potential future applicants regarding
the Agency's expectations for collection, analysis, and reporting of
data pertaining to metastasis-free survival. This guidance finalizes
the draft guidance of the same title issued on November 14, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on August 9, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2018-D-3931 for ``Nonmetastatic Castration-Resistant Prostate
Cancer: Considerations for Metastasis-Free Survival Endpoint in
Clinical Trials.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this 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; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240-
402-0489; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm 7268, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Nonmetastatic Castration-Resistant Prostate Cancer:
Considerations for Metastasis-Free Survival Endpoint in Clinical
Trials.'' Nonmetastatic castration-resistant prostate cancer (nmCRPC)
is defined by rising prostate-specific antigen (PSA) despite castrate
levels of testosterone and no radiographic evidence of distant
metastatic disease. Despite earlier detection of localized prostate
cancer and advances in surgical and radiation techniques, many patients
will continue to have rising PSA after local therapy (e.g., surgery,
radiation) for recurrent disease and subsequent androgen deprivation
therapy. Patients with nmCRPC can have a prolonged disease course
following the detection of a rising PSA until documentation of distant
metastases or death. Such a prolonged assessment period (in which
patients may receive multiple therapies) with low death rates may make
the use of overall survival impractical as a primary endpoint to
support approval of products in this disease setting.
    These issues were discussed at an Oncologic Drugs Advisory
Committee meeting in 2011, during which the committee acknowledged that
endpoints that can be measured earlier in the course of disease, such
as metastasis-free survival, defined as the time from randomization to
distant radiographic disease or death, would be useful in assessing the
treatment effect of products in patients with nmCRPC. Additionally, the
Oncologic Drugs Advisory Committee noted that the transition from
nmCRPC to radiographically detectable metastatic disease (e.g., bone
disease or visceral disease) is a clinically relevant event that can be
associated with morbidity and the need for additional medical
interventions. Conversely, local progression events may be treated with
local therapies, may never progress to distant disease, and may not
lead to systemic morbidity. Thus, a large treatment effect on
metastasis-free survival with an acceptable safety profile could
demonstrate clinical benefit and support product approval.
    This guidance finalizes the draft guidance of the same title issued
on November 14, 2018, (83 FR 56857). Changes from the draft to the
final include clarifying edits and expanding upon certain
recommendations in the draft guidance.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Nonmetastatic Castration-Resistant
Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint
in Clinical Trials.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014. The collections of information in 21 CFR parts 50 and
56 (Protection of Human Subjects and Institutional Review Boards) have
been approved under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or
https://www.regulations.gov.

    Dated: August 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16929 Filed 8-6-21; 8:45 am]
BILLING CODE 4164-01-P