[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Rules and Regulations]
[Page 29078]
[FR Doc No: 2019-13180]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0412]

Safety Zone; Chicago Harbor, Navy Pier Southeast, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the Navy Pier Southeast Safety
Zone within the Chicago Harbor during specified times on September 6,
2019 and September 7, 2019. This action is necessary and intended to
protect the safety of life and property on navigable waters prior to,
during, and immediately after firework displays. During the enforcement
periods listed below, entry into, transiting, or anchoring within the
safety zone is prohibited unless authorized by the Captain of the Port,
Lake Michigan or a designated representative.

DATES: The regulation in 33 CFR 165.931 will be enforced from 9:25 p.m.
through 9:45 p.m. on September 6, 2019, and September 7, 2019.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email LT John Ramos, Waterways
Management Division, Marine Safety Unit Chicago, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce Safety Zone;
Chicago Harbor, Navy Pier Southeast, Chicago, IL listed in 33 CFR
165.931, on September 06, 2019 and September 07, 2019 from 9:25 p.m.
through 9:45 p.m. This safety zone encompasses all waters of Lake
Michigan within Chicago Harbor bounded by coordinates beginning at
41[deg]53'23.3'' N, 087[deg]36'04.5'' W; then south to 41[deg]53'11.8''
N, 087[deg]36'04.1'' W; then west to 41[deg]53'12.1'' N,
087[deg]35'40.5'' W; then north to 41[deg]53'23.6'' N,
087[deg]35'40.07'' W; then east back to the point of origin (NAD 83).
Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port, Lake Michigan
or a designated on-scene representative.
    This notice of enforcement is issued under authority of 33 CFR
165.931 and 5 U.S.C. 552 (a). In addition to this notice in the Federal
Register, the Coast Guard will provide the maritime community with
advance notification of the above-specified enforcement periods of this
safety zone via Broadcast Notice to Mariners and Local Notice to
Mariners. The Captain of the Port Lake Michigan or a designated on-
scene representative may be contacted via Channel 16, VHF-FM or at
(414) 747-7182.

    Dated: June 14, 2019.
Thomas J. Stuhlreyer,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2019-13180 Filed 6-20-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Page 12645]
[FR Doc No: 2012-4967]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2011-0036]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 of the Code of Federal
Regulations (CFR), this document provides the public notice that by a
document dated April 11, 2011, the City of Chandler, AZ, has petitioned
the Federal Railroad Administration (FRA) for a waiver of compliance
from certain provisions of the Federal railroad safety regulations
contained at 49 CFR part 222. FRA assigned the petition Docket Number
FRA-2011-0036.
    The City of Chandler is seeking a waiver from the provisions of 49
CFR Section 222.9 (specifically, the definition of a non-traversable
curb) so that three existing public crossings (Ray Road (DOT
741579U), Pecos Road (DOT 741674P), and Germann Road
(DOT 741676D)) can be deemed acceptable supplemental safety
measures (SSM). The crossings, equipped with flashing lights, gates,
and medians, comply with all requirements necessary to be ``gates with
medians or channelization devices'' SSMs with non-traversable curbs;
except that the posted highway speed limit is 45 mph instead of 40 mph
as required in the definition.
    The City of Chandler is also seeking a waiver from the provisions
of 49 CFR Section 222.35(b)(1) so that the active grade crossing
warning devices at Commonwealth Avenue (DOT 741672B) and Frye
Road (DOT 741673H) are not required to be equipped with
constant warning time devices for the siding track at the crossings.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at http://www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by April 16, 2012 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78), or online at http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on February 17, 2012.
Ron Hynes,
Acting Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2012-4967 Filed 2-29-12; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: July 27, 2010 (Volume 75, Number 143)]
[Notices]
[Page 43968-43969]
[DOCID:fr27jy10-79]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-1783-000]

REP Energy LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

July 19, 2010.
    This is a supplemental notice in the above-referenced proceeding of
REP Energy LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 9, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any

FERC Online service, please e-mail<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-18309 Filed 7-26-10; 8:45 am]
BILLING CODE 6717-01-P


Category                      Primary      Low  estimate  High  estimate                                      Period           Notes
                                             estimate                                      Year  dollars  Discount  rate      covered
                                                                                (percent)        (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized..........................  ..............  ..............  ..............  ..............               7  ..............  ..............
    Monetized $millions/year............  ..............  ..............  ..............  ..............               3  ..............  ..............
    Annualized..........................  ..............  ..............  ..............  ..............               7  ..............  ..............
    Quantified..........................  ..............  ..............  ..............  ..............               3  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Qualitative.........................  Improved quality of prescription drug labeling
                                                     for health care providers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized..........................            $9.5  ..............  ..............            2011               7              10  ..............
    Monetized $millions/year............             9.2  ..............  ..............            2011               3              10  ..............
    Annualized..........................  ..............  ..............  ..............  ..............               7  ..............  ..............
    Quantified..........................  ..............  ..............  ..............  ..............               3  ..............  ..............
    Qualitative.........................  ..............  ..............  ..............  ..............  ..............  ..............  ..............
Transfers:
    Federal Annualized..................  ..............  ..............  ..............  ..............               7  ..............  ..............
    Monetized $millions/year............  ..............  ..............  ..............  ..............               3  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To:                                  From:
                                          To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Other Annualized....................  ..............  ..............  ..............  ..............               7  ..............  ..............
    Monetized $millions/year............  ..............  ..............  ..............  ..............               3  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To:                                  From:
                                          To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
--------------------------------------------------------------------------------------------------------------------------------------------------------
    State, Local or Tribal Government: No effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Small Business: The final rule will have significant impacts on some small pharmaceutical manufacturers and prescription drug
     repackagers and relabelers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Wages: No effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Growth: No effect
--------------------------------------------------------------------------------------------------------------------------------------------------------

VIII. Paperwork Reduction Act of 1995

    This final rule contains information collection requirements that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The title, description, and respondent description of the
information collection provisions are shown in the following paragraphs
with an estimate of the total reporting and disclosure burdens.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing each collection of information.
    Title: Content and Format of Labeling for Human Prescription Drug
and Biological Products; Requirements for Pregnancy and Lactation
Labeling
    Description: The final rule amends FDA regulations concerning the
content and format of the ``Pregnancy,'' ``Labor and delivery,'' and
``Nursing mothers'' subsections of the ``Use in Specific Populations''
section of the labeling for human prescription drugs. The final rule
requires that labeling include, among other things, a summary of the
risks of using a drug during pregnancy and lactation and a discussion
of the data supporting that summary. The labeling also includes
relevant information to help health care providers make prescribing
decisions and counsel women about the use of drugs during pregnancy and
lactation. The final rule eliminates the current pregnancy categories
A, B, C, D, and X. In addition, the ``Labor and delivery'' subsection
has been eliminated because information on labor and delivery is
included in the ``Pregnancy'' subsection. The final rule also requires
that the labeling include relevant information about pregnancy testing,
contraception, and infertility for health care providers prescribing
for females and males of reproductive potential. The final rule is
intended to create a consistent format for providing information about
the risks and benefits of prescription drug and/or biological product
use during

pregnancy and lactation and by females and males of reproductive
potential.
    Under Sec.  201.57(c)(9)(i) and (c)(9)(ii), holders of approved
applications are required to provide new labeling content in a new
format--that is, to rewrite the pregnancy and lactation portions of
each drug's labeling. Under Sec.  201.57(c)(9)(iii), these application
holders are also required to include a new subsection 8.3, ``Females
and Males of Reproductive Potential,'' which requires that when
pregnancy testing or contraception is required or recommended before,
during, or after drug therapy or when there are human or animal data
that suggest drug-associated fertility effects, this subsection must
contain this information. These application holders are required to
submit supplements requiring prior approval by FDA before distribution
of the new labeling, as required in Sec.  314.70(b) or Sec.
601.12(f)(1).
    Under Sec.  201.80(f)(6)(i), holders of approved applications are
required to remove the pregnancy category designation (e.g.,
``Pregnancy Category C'') from the ``Pregnancy'' subsection of the
``Precautions'' section of the labeling. These application holders must
report the labeling change in their annual reports, as required in
Sec.  314.70(d) or Sec.  601.12(f)(3).
    The new content and format requirements of the final rule apply to
all applications that are required to comply with the PLR, including:
(1) Applications submitted on or after the effective date of the final
rule; (2) applications pending on the effective date of the final rule;
and (3) applications approved from June 30, 2001, to the effective date
of the final rule.
    The following submissions under the final rule are subject to the
PRA:
     Applications submitted on or after the effective date of
the final rule (Sec. Sec.  314.50, 314.70(b), 601.2, 601.12(f)(1));
     Amendments to applications pending on the effective date
of the final rule (Sec. Sec.  314.60, 601.2, 601.12(f)(1));
     Supplements to applications approved from June 30, 2001,
to the effective date of the final rule (Sec. Sec.  314.70(b),
601.12(f)(1));
     Annual reports for applications approved before June 30,
2001, that contain a pregnancy category, to report removal of the
pregnancy category letter in their labeling (Sec. Sec.  314.70(d),
601.12(f)(3)).
    The information collection requirements and burden estimates are
summarized in tables 3 and 4 of this document. The burden estimates are
based on data and timeframes used for section VII of this document
(Summary of Final Regulatory Impact Analysis) and for the final
regulatory impact analysis of the final rule (available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm). FDA estimates that approximately 4,000 applications
containing labeling consistent with this rulemaking will be submitted
to FDA during the 10-year period on or after the effective date of the
final rule by approximately 390 applicants and repackagers and
relabelers. The estimate of 4,000 applications includes labeling for
approximately 800 applications submitted under section 505(b) of the
FD&C Act or section 351 of the PHS Act, and 1,200 applications
submitted under section 505(j) of the FD&C Act, and revised labeling
from repackagers and relabelers for approximately 2,000 drug products.
This estimate also includes labeling amendments submitted to FDA for
applications pending on the effective date of the final rule. Based on
data provided in section VII of this document and in the final
regulatory impact analysis of the final rule, FDA estimates that for
future approvals it will take applicants approximately 40 hours to
prepare and submit labeling consistent with this rulemaking. The
estimate of 40 hours applies only to the requirements of this
rulemaking and does not indicate the total hours required to prepare
and submit complete labeling for these applications. The information
collection burden to prepare and submit labeling in accordance with
Sec. Sec.  201.56, 201.57, and 201.80 is approved by OMB under control
numbers 0910-0572 and 0910-0001.
    In addition, FDA estimates that approximately 10,150 supplements to
applications approved from June 30, 2001, to the effective date of the
final rule, or pending on the effective date, will be submitted to FDA
during the third, fourth, and fifth years after the effective date to
update labeling in accordance with this final rule. This estimate
includes approximately 1,080 NDA, BLA, and efficacy supplements,
approximately 1,320 ANDA supplements, and labeling supplements from
repackagers and relabelers for approximately 7,750 drug products. FDA
estimates that approximately 390 application holders and repackagers
and relabelers will submit these supplements, and that it will take
approximately 120 hours to prepare and submit each supplement.
    FDA also estimates that approximately 5,500 annual reports will be
submitted to FDA during the third year after the effective date for
applications approved before June 30, 2001, that contain a pregnancy
category (5,500 includes annual reports for approximately 1,340 NDAs
and BLAs and approximately 4,160 ANDAs containing labeling changes
resulting from this rulemaking). FDA estimates that approximately 320
application holders will submit these annual reports, and that it will
take approximately 40 hours for each submission.
    As indicated in tables 3 and 4 of this document, we estimate that
the total hours resulting from the information collection in this
rulemaking will be approximately 1,598,000 hours. The costs associated
with this rulemaking, including labor costs, are discussed in section
VII of this document and in the final regulatory impact analysis of the
final rule.
    Description of Respondents: Persons and businesses, including small
businesses and manufacturers.

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                          Average
  Type of submission  (21 CFR      Number of     responses per    Total annual      burden per     Total  hours
           section)               respondents     respondent        responses        response
----------------------------------------------------------------------------------------------------------------
Supplements to applications                390              26  10,150                       120       1,218,000
 approved 6/30/01 to effective                                   (Submitted 3rd,
 date (Sec.  Sec.   314.70(b),                                   4th, and 5th
 601.12(f)(1)).                                                  years after
                                                                 effective date).
Annual report submission of                320              17  5,500 (Submitted              40         220,000
 revised labeling for                                            3rd year after
 applications approved before                                    effective date).
 6/30/01 that contain a
 pregnancy category (Sec.
 Sec.   314.70(d),
 601.12(f)(3)).
                               ---------------------------------------------------------------------------------

    Total.....................  ..............  ..............  ................  ..............       1,438,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

                                               Table 4--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
       Type of submission (21 CFR section)           Number of     disclosures per       Total annual disclosures        Average burden    Total  hours
                                                    respondents       respondent                                         per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
New NDAs/ANDAs/BLAs/efficacy supplements                     390               10   4,000 (Submitted during 10-year                 40          160,000
 submitted on or after effective date, including                                     period after effective date).
 amendments to applications pending on effective
 date (Sec.  Sec.   314.50, 314.60, 314.70(b),
 601.2, 601.12(f)(1)).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

    The information collection provisions of this final rule have been
submitted to OMB for review, as required by section 3507(d) of the PRA.
Prior to the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. 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.

IX. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that this final
rule does not contain policies that have substantial direct effects on
the States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

X. References

    In addition to the references placed on display in the Division of
Dockets Management for the proposed rule under Docket No. FDA-2006-N-
0515 (formerly Docket No. 2006N-0467), the following references are on
display in the Division of Dockets Management under Docket No. FDA-
2006-N-0515 (formerly Docket No. 2006N-0467) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified all Web site addresses in this reference section, but we
are not responsible for any subsequent changes to the Web sites after
this document publishes in the Federal Register.)

1. Decision Partners, LLC, ``Evaluation of How Best to Communicate
to Healthcare Providers about the Risks and Benefits of Prescription
Drug Use for Pregnant and Nursing Women: A Mental Models Research
Report,'' September 2009 (available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm).
2. Final Regulatory Impact Analysis for Docket No. FDA-2006-N-0515
(formerly Docket No. 2006N-0467) (available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm
and at http://www.regulations.gov).
3. U.S. Food and Drug Administration, ``Guidance for Industry,
Warnings and Precautions, Contraindications, and Boxed Warning
Sections of Labeling for Human Prescription Drug and Biological
Products--Content and Format,'' 2011.
4. Kweder, S.L., ``Drugs and Biologics in Pregnancy and
Breastfeeding: FDA in the 21st Century.'' Birth Defects Research
Part A: Clinical and Molecular Teratology. 82(9):605-609, September
2008.
5. Adam, M.P., J.E. Polifka, and J.M. Friedman, ``Evolving Knowledge
of the Teratogenicity of Medications in Human Pregnancy.'' American
Journal of Medical Genetics Part C: Seminars in Medical Genetics.
157C(3):175-182, August 15, 2011.
6. Law, R., P. Bozzo, G. Koren, et al. ``FDA Pregnancy Risk
Categories and the CPS. Do They Help or Are They a Hindrance?''
Canadian Family Physician. 56:239-241, March 2010.
7. U.S. Food and Drug Administration ``Guidance for industry,
Establishing Pregnancy Exposure Registries,'' 2002.
8. U.S. Food and Drug Administration ``Guidance for Industry,
Reproductive and Developmental Toxicities--Integrating Study Results
to Assess Concerns,'' 2011.
9. Rynn, L., J. Cragan, and A. Correa, ``Update on Overall
Prevalence of Major Birth Defects--Atlanta, Georgia, 1978-2005.''
Centers for Disease Control and Prevention Morbidity and Mortality
Weekly Report. 57(01):1-5, January 11, 2008.
10. American College of Obstetricians and Gynecologists Frequently
Asked Questions: Miscarriage and Molar Pregnancy, 2011 (available at
http://www.acog.org/~/media/For%20Patients/
faq090.pdf?dmc=1&ts=20140130T1655496642).
11. U.S. Food and Drug Administration, ``Reviewer Guidance,
Evaluating the Risks of Drug Exposure in Human Pregnancies,'' 2005.
12. U.S. Food and Drug Administration, ``Guidance for industry,
Considerations for Developmental Toxicity Studies for Preventive and
Therapeutic Vaccines for Infectious Disease Indications,'' 2006.
13. U.S. Food and Drug Administration, ``Guidance for industry, M3
(R2) Nonclinical Safety Studies for the Conduct of Human Clinical
Trials and Marketing Authorization for Pharmaceuticals and the
International Conference on Harmonisation S5 (R2) Guideline:
Detection of Toxicity to Reproduction for Medicinal Products and
Toxicity to Male Fertility,'' 2010.
14. Tracy, T.S., et al. ``Temporal Changes in Drug Metabolism
(CYP1A2, CYP2D6 and CYP3A Activity) During Pregnancy.'' American
Journal of Obstetrics and Gynecology. 192(2):633-639, February 2005.
15. Anderson, G.D., ``Pregnancy-Induced Changes in
Pharmacokinetics.'' Clinical Pharmacokinetics. 44(10):989-1008,
2005.

16. American Academy of Pediatrics Policy Statement. ``Breastfeeding
and the Use of Human Milk.'' Pediatrics. 129(3):e827-841, 2012.
17. Sachs, H.C. and Committee on Drugs. ``The Transfer of Drugs and
Therapeutics Into Human Breast Milk: An Update on Selected Topics.''
Pediatrics. 132(3):e796-809, September 2013.
18. U.S. Food and Drug Administration, ``Draft Guidance for industry
Clinical Lactation Studies--Study Design, Data Analysis, and
Recommendations for Labeling,'' 2005.
19. Proposed Pregnancy and Lactation Labeling Rule (available at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm).
20. Public Comments on Proposed Pregnancy and Lactation Labeling
Rule (available at http://www.regulations.gov/#!docketDetail;D=FDA-
2006-N-0515).

List of Subjects in 21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
201 is amended as follows:

PART 201--LABELING

0
1. The authority citation for 21 CFR part 201 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

Sec.  201.56  [Amended]

0
2. Amend Sec.  201.56 in paragraph (d)(1) by removing from the list of
headings and subheadings the subheadings ``8.2 Labor and delivery'' and
``8.3 Nursing mothers'' and adding in their places the subheadings
``8.2 Lactation'' and ``8.3 Females and Males of Reproductive
Potential'', respectively.
0
3. Amend Sec.  201.57 by revising paragraphs (c)(9)(i), (ii), and (iii)
to read as follows:

Sec.  201.57  Specific requirements on content and format of labeling
for human prescription drug and biological products described in Sec.
201.56(b)(1).

* * * * *
    (c) * * *
    (9) * * *
    (i) 8.1 Pregnancy. This subsection of the labeling must contain the
following information in the following order under the subheadings
``Pregnancy Exposure Registry,'' ``Risk Summary,'' ``Clinical
Considerations,'' and ``Data'':
    (A) Pregnancy exposure registry. If there is a scientifically
acceptable pregnancy exposure registry for the drug, contact
information needed to enroll in the registry or to obtain information
about the registry must be provided following the statement: ``There is
a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to (name of drug) during pregnancy.''
    (B) Risk summary. The Risk Summary must contain risk statement(s)
based on data from all relevant sources (human, animal, and/or
pharmacologic) that describe, for the drug, the risk of adverse
developmental outcomes (i.e., structural abnormalities, embryo-fetal
and/or infant mortality, functional impairment, alterations to growth).
When multiple data sources are available, the statements must be
presented in the following order: Human, animal, pharmacologic. The
source(s) of the data must be stated. The labeling must state the
percentage range of live births in the United States with a major birth
defect and the percentage range of pregnancies in the United States
that end in miscarriage, regardless of drug exposure. If such
information is available for the population(s) for which the drug is
labeled, it must also be included. When use of a drug is
contraindicated during pregnancy, this information must be stated first
in the Risk Summary. When applicable, risk statements as described in
paragraphs (c)(9)(i)(B)(1) and (2) of this section must include a
cross-reference to additional details in the relevant portion of the
``Data'' subheading in the ``Pregnancy'' subsection of the labeling. If
data demonstrate that a drug is not systemically absorbed following a
particular route of administration, the Risk Summary must contain only
the following statement: ``(Name of drug) is not absorbed systemically
following (route of administration), and maternal use is not expected
to result in fetal exposure to the drug.''
    (1) Risk statement based on human data. When human data are
available that establish the presence or absence of any adverse
developmental outcome(s) associated with maternal use of the drug, the
Risk Summary must summarize the specific developmental outcome(s);
their incidence; and the effects of dose, duration of exposure, and
gestational timing of exposure. If human data indicate that there is an
increased risk for a specific adverse developmental outcome in infants
born to women exposed to the drug during pregnancy, this risk must be
quantitatively compared to the risk for the same outcome in infants
born to women who were not exposed to the drug but who have the disease
or condition for which the drug is indicated to be used. When risk
information is not available for women with the disease or condition
for which the drug is indicated, the risk for the specific outcome must
be compared to the rate at which the outcome occurs in the general
population. The Risk Summary must state when there are no human data or
when available human data do not establish the presence or absence of
drug-associated risk.
    (2) Risk statement based on animal data. When animal data are
available, the Risk Summary must summarize the findings in animals and
based on these findings, describe, for the drug, the potential risk of
any adverse developmental outcome(s) in humans. This statement must
include: The number and type(s) of species affected, timing of
exposure, animal doses expressed in terms of human dose or exposure
equivalents, and outcomes for pregnant animals and offspring. When
animal studies do not meet current standards for nonclinical
developmental toxicity studies, the Risk Summary must so state. When
there are no animal data, the Risk Summary must so state.
    (3) Risk statement based on pharmacology. When the drug has a well-
understood mechanism of action that may result in adverse developmental
outcome(s), the Risk Summary must explain the mechanism of action and
the potential associated risks.
    (C) Clinical considerations. Under the subheading ``Clinical
Considerations,'' the labeling must provide relevant information, to
the extent it is available, under the headings ``Disease-associated
maternal and/or embryo/fetal risk,'' ``Dose adjustments during
pregnancy and the postpartum period,'' ``Maternal adverse reactions,''
``Fetal/Neonatal adverse reactions,'' and ``Labor or delivery'':
    (1) Disease-associated maternal and/or embryo/fetal risk. If there
is a serious known or potential risk to the pregnant woman and/or the
embryo/fetus associated with the disease or condition for which the
drug is indicated to be used, the labeling must describe the risk.
    (2) Dose adjustments during pregnancy and the postpartum period. If
there are pharmacokinetic data that support dose adjustment(s) during
pregnancy and the postpartum period, a summary of this information must
be provided.
    (3) Maternal adverse reactions. If use of the drug is associated
with a maternal adverse reaction that is unique to pregnancy or if a
known adverse reaction occurs with increased frequency or severity in
pregnant

women, the labeling must describe the adverse reaction and available
intervention(s) for monitoring or mitigating the reaction. The labeling
must describe, if known, the effect of dose, timing, and duration of
exposure on the risk to the pregnant woman of experiencing the adverse
reaction.
    (4) Fetal/Neonatal adverse reactions. If it is known or anticipated
that treatment of the pregnant woman increases or may increase the risk
of an adverse reaction in the fetus or neonate, the labeling must
describe the adverse reaction, the potential severity and reversibility
of the adverse reaction, and available intervention(s) for monitoring
or mitigating the reaction. The labeling must describe, if known, the
effect of dose, timing, and duration of exposure on the risk.
    (5) Labor or delivery. If the drug is expected to affect labor or
delivery, the labeling must provide information about the effect of the
drug on the pregnant woman and the fetus or neonate; the effect of the
drug on the duration of labor and delivery; any increased risk of
adverse reactions, including their potential severity and
reversibility; and must provide information about available
intervention(s) that can mitigate these effects and/or adverse
reactions. The information described under this heading is not required
for drugs approved for use only during labor and delivery.
    (D) Data--(1) ``Data'' subheading. Under the subheading ``Data,''
the labeling must describe the data that are the basis for the Risk
Summary and Clinical Considerations.
    (2) Human and animal data headings. Human and animal data must be
presented separately, beneath the headings ``Human Data'' and ``Animal
Data,'' and human data must be presented first.
    (3) Description of human data. For human data, the labeling must
describe adverse developmental outcomes, adverse reactions, and other
adverse effects. To the extent applicable, the labeling must describe
the types of studies or reports, number of subjects and the duration of
each study, exposure information, and limitations of the data. Both
positive and negative study findings must be included.
    (4) Description of animal data. For animal data, the labeling must
describe the following: Types of studies, animal species, dose,
duration and timing of exposure, study findings, presence or absence of
maternal toxicity, and limitations of the data. Description of maternal
and offspring findings must include dose-response and severity of
adverse developmental outcomes. Animal doses or exposures must be
described in terms of human dose or exposure equivalents and the basis
for those calculations must be included.
    (ii) 8.2 Lactation. This subsection of the labeling must contain
the following information in the following order under the subheadings
``Risk Summary,'' ``Clinical Considerations,'' and ``Data'':
    (A) Risk summary. When relevant human and/or animal lactation data
are available, the Risk Summary must include a cross-reference to the
``Data'' subheading in the ``Lactation'' subsection of the labeling.
When human data are available, animal data must not be included unless
the animal model is specifically known to be predictive for humans.
When use of a drug is contraindicated during breastfeeding, this
information must be stated first in the Risk Summary.
    (1) Drug not absorbed systemically. If data demonstrate that the
drug is not systemically absorbed by the mother, the Risk Summary must
contain only the following statement: ``(Name of drug) is not absorbed
systemically by the mother following (route of administration), and
breastfeeding is not expected to result in exposure of the child to
(name of drug).''
    (2) Drug absorbed systemically. If the drug is absorbed
systemically, the Risk Summary must describe the following to the
extent relevant information is available:
    (i) Presence of drug in human milk. The Risk Summary must state
whether the drug and/or its active metabolite(s) are present in human
milk. If there are no data to assess this, the Risk Summary must so
state. If studies demonstrate that the drug and/or its active
metabolite(s) are not detectable in human milk, the Risk Summary must
state the limits of the assay used. If studies demonstrate the presence
of the drug and/or its active metabolite(s) in human milk, the Risk
Summary must state the concentration of the drug and/or its active
metabolite(s) in human milk and the actual or estimated daily dose for
an infant fed exclusively with human milk. The actual or estimated
amount of the drug and/or its active metabolite(s) ingested by the
infant must be compared to the labeled infant or pediatric dose, if
available, or to the maternal dose. If studies demonstrate the presence
of the drug and/or its active metabolite(s) in human milk but the drug
and/or its active metabolite(s) are not expected to be systemically
bioavailable to the breast-fed child, the Risk Summary must describe
the disposition of the drug and/or its active metabolite(s). If only
animal lactation data are available, the Risk Summary must state only
whether or not the drug and/or its active metabolite(s) were detected
in animal milk and specify the animal species.
    (ii) Effects of drug on the breast-fed child. The Risk Summary must
include information, on the known or predicted effects on the child
from exposure to the drug and/or its active metabolite(s) through human
milk or from contact with breast or nipple skin (for topical products).
The Risk Summary also must include information on systemic and/or local
adverse reactions. If there are no data to assess the effects of the
drug and/or its active metabolite(s) on the breast-fed child, the Risk
Summary must so state.
    (iii) Effects of drug on milk production. The Risk Summary must
describe the effects of the drug and/or its active metabolite(s) on
milk production. If there are no data to assess the effects of the drug
and/or its active metabolite(s) on milk production, the Risk Summary
must so state.
    (3) Risk and benefit statement. For drugs absorbed systemically,
unless breastfeeding is contraindicated during drug therapy, the
following risk and benefit statement must appear at the end of the Risk
Summary: ``The developmental and health benefits of breastfeeding
should be considered along with the mother's clinical need for (name of
drug) and any potential adverse effects on the breast-fed child from
(name of drug) or from the underlying maternal condition.''
    (B) Clinical considerations. Under ``Clinical Considerations,'' the
following information must be provided to the extent it is available
and relevant:
    (1) Minimizing exposure. The labeling must describe ways to
minimize exposure in the breast-fed child if: The drug and/or its
active metabolite(s) are present in human milk in clinically relevant
concentrations; the drug does not have an established safety profile in
infants; and the drug is used either intermittently, in single doses,
or for short courses of therapy. When applicable, the labeling must
also describe ways to minimize a breast-fed child's oral intake of
topical drugs applied to the breast or nipple skin.
    (2) Monitoring for adverse reactions. The labeling must describe
available intervention(s) for monitoring or mitigating the adverse
reaction(s) presented in the Risk Summary.
    (C) Data. Under the subheading ``Data,'' the labeling must describe
the data that are the basis for the Risk Summary and Clinical
Considerations.
    (iii) 8.3 Females and males of reproductive potential. When
pregnancy

testing and/or contraception are required or recommended before,
during, or after drug therapy and/or when there are human and/or animal
data that suggest drug-associated fertility effects, this subsection of
labeling must contain this information under the subheadings
``Pregnancy Testing,'' ``Contraception,'' and ``Infertility,'' in that
order.
* * * * *

Sec.  201.80  [Amended]

0
4. Amend Sec.  201.80 as follows:
0
a. Remove the paragraph heading ``Pregnancy category A.'' and the words
``Pregnancy Category A.'' from paragraph (f)(6)(i)(a);
0
b. Remove the paragraph heading ``Pregnancy category B.'' and the words
``Pregnancy Category B.'' both times they appear from paragraph
(f)(6)(i)(b);
0
c. Remove the paragraph heading ``Pregnancy category C.'' and the words
``Pregnancy Category C.'' both times they appear from paragraph
(f)(6)(i)(c);
0
d. Remove the paragraph heading ``Pregnancy category D.'' and the words
``Pregnancy Category D.'' from paragraph (f)(6)(i)(d); and
0
e. Remove the paragraph heading ``Pregnancy category X.'' and the words
``Pregnancy Category X.'' from paragraph (f)(6)(i)(e).

    Dated: November 25, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28241 Filed 12-3-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 2 (Monday, January 5, 2015)]
[Notices]
[Pages 216-217]
[FR Doc No: 2014-30823]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP15-279-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Sec.  4(d) rate filing per 154.204: Neg Rate Agmt
Filing (AEP 34154) to be effective 1/1/2015.
    Filed Date: 12/29/14.
    Accession Number: 20141229-5025.
    Comments Due: 5 p.m. ET 1/12/15.

    Docket Numbers: RP15-280-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) rate filing per 154.204: Cap Rel Neg Rate
Agmt (EnCana 37663 to BP 43578) to be effective 1/1/2015.
    Filed Date: 12/29/14.
    Accession Number: 20141229-5026.
    Comments Due: 5 p.m. ET 1/12/15.

    Docket Numbers: RP15-281-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) rate filing per 154.204: Cap Rel Neg Rate
Agmt (JW 34690 to QWest 43634) to be effective 1/1/2015.

    Filed Date: 12/29/14.
    Accession Number: 20141229-5027.
    Comments Due: 5 p.m. ET 1/12/15.

    Docket Numbers: RP15-282-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) rate filing per 154.204: Amendment to Neg
Rate Agmt (QEP 37657-126) to be effective 12/20/2014.
    Filed Date: 12/29/14.
    Accession Number: 20141229-5028.
    Comments Due: 5 p.m. ET 1/12/15.

    Docket Numbers: RP15-283-000.
    Applicants: Ozark Gas Transmission, L.L.C.
    Description: Sec.  4(d) rate filing per 154.204: Statements of
Negotiated Rates Tariff Volume to be effective 2/1/2015.
    Filed Date: 12/29/14.
    Accession Number: 20141229-5029.
    Comments Due: 5 p.m. ET 1/12/15.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 29, 2014.
 Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2014-30823 Filed 1-2-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 30, 2008 (Volume 73, Number 126)]
[Notices]
[Page 36953-36954]
[DOCID:fr30jn08-143]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Request for Applications for the Federal Motor Carrier Safety
Administration Medical Review Board

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

ACTION: Request for applications for the Medical Review Board.

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

SUMMARY: FMCSA solicits applications from interested physicians to
serve on the Agency's Medical Review Board (MRB). The MRB, authorized
by the Safe, Accountable, Flexible, Efficient Transportation Equity
Act: A Legacy for Users (SAFETEA-LU), provides scientific advice to the
Secretary of Transportation (the Secretary) and the FMCSA Administrator
on medical issues relating to the physical qualification standards for
commercial motor vehicle (CMV) drivers. In 2006, the Secretary
appointed five physicians for 2-year terms to serve on the MRB. In
2008, the Secretary reappointed the physicians to the MRB, with the
chairperson currently serving a 2-year term, and the other four members
serving staggered 1-year terms. In 2009, the Secretary will appoint
three new members to a 2-year term, and reappoint one of the current
members to a 1-year term to ensure the MRB will operate continuously
with five active members. As a result, the chairperson's and one of the
members' terms will expire in 2010 and the other three members' terms
will expire in 2011.

DATES: Applications must be received by July 30, 2008. FMCSA will
periodically call for applications as deemed necessary.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER>, FMCSA, U.S. Department of Transportation, 1200
New Jersey Avenue, SE., Washington, DC 20590. Office hours are from 8
a.m. to 5 p.m., E.T., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Background

    FMCSA has current statutory authority under 49 U.S.C. 31502 and
31136 to determine the physical qualifications of interstate CMV
drivers. The physical qualifications regulations for commercial motor
vehicle (CMV) drivers in interstate commerce are found in 49 CFR
391.41. Section 391.43 contains instructions to medical examiners for
performing physical examinations of CMV drivers. FMCSA medical
standards and guidelines are critical medical program components in
accomplishing FMCSA's mission to reduce crashes, injuries, and
fatalities involving large trucks and buses.
    In 2005, Congress passed the Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users (SAFETEA-LU) (Pub. L.
109-59). Section 4116(a) of SAFETEA-LU (codified at 49 U.S.C. 31149)
required FMCSA to establish the MRB to provide scientific advice on
matters related to CMV driver health and safety. The Charter for the
MRB was originally approved and filed with the General Services
Administration on September 20, 2005 [FR 70 57642], and renewed on
November 2, 2007.
    The MRB promotes CMV safety by providing science-based medical
expertise on the medical qualification of CMV drivers, reviewing and
revising medical standards, and interpreting medical research. These
activities address the appropriateness and

viability of the medical standards in the Federal Motor Carrier Safety
Regulations, the framework that relates driver health to safe CMV
operation. The MRB assesses and provides recommendations to FMCSA about
regulations that may need to be changed or updated. FMCSA's MRB
provides information, advice, and recommendations to the Secretary of
Transportation and the FMCSA Administrator on the development and
implementation of science-based physical qualification standards
applicable to interstate CMV drivers, and implementation of a national
registry of medical examiners. The MRB does not hold regulatory
development responsibilities, manage programs, or make decisions
affecting such programs. The MRB provides a forum for the development,
consideration, and communication of information from a knowledgeable,
scientific perspective. The MRB began operations in February 2006, with
formal deliberations beginning in August 2006. The MRB meets quarterly
each year and has issued many recommendations on cardiovascular
diseases, seizure disorders, musculoskeletal diseases, and other topics
pertinent to the certified driver medical examination.

II. Request for Applications

    FMCSA seeks physicians from many different medical specialties to
develop science-based CMV physical qualification standards, medical
advisory criteria and safety policies. As members of the Agency's MRB,
physicians will provide expert guidance on medical guidelines and
standards. The Agency is committed to appointing physicians with
diverse professional backgrounds and taking into account gender,
ethnicity, demographic and socioeconomic factors. To be eligible for
appointment, physicians must (a) Be a U.S. citizen; (b) not be a
Federal government employee; (c) have a U.S. medical license (as a
Medical Doctor or Doctor of Osteopathy) and is in good standing with a
State medical licensing authority; (d) be able to attend three to four
face-to-face meetings a year and three to five 1 hour teleconferences,
and spend approximately 5 hours per month providing additional
consultation. Interested physicians should have a commitment to
transportation safety and health, an understanding of evidence-based
medicine and research methods, knowledge of transportation medical
issues, history of excellence in original medical research demonstrated
through publications in peer-reviewed journals, experience on panels
that develop medical standards and a record of leadership activities in
transportation safety and medical professional organizations.
    MRB members are special government employees under the Federal
Advisory Committee Act of 1972, Public Law 92-463. While attending
meetings or conducting business of the Committee, expenses for travel
and subsistence or per diem allowances will be paid by FMCSA.
    Applications should be submitted online at http://
www.mrb.fmcsa.dot.gov. For additional information, please contact
Jennifer Musick at<PHONE_NUMBER>, extension 237, or via e-mail at
<EMAIL_ADDRESS>FMCSA will accept applications through July
30, 2008, and will periodically call for applications as the MRB work
continues.

    Issued on: June 20, 2008.
John H. Hill,
Administrator.
[FR Doc. E8-14758 Filed 6-27-08; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 85, Number 62 (Tuesday, March 31, 2020)]
[Notices]
[Pages 17908-17910]
[FR Doc No: 2020-06613]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88468; File No. SR-CboeBZX-2020-028]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Expand
the Trading Hours Applicable to Managed Portfolio Shares To Include all
Trading Sessions

March 25, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 23, 2020, Cboe BZX Exchange, Inc. (``Exchange'' or ``BZX'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe BZX Exchange, Inc. (the ``Exchange'' or ``BZX'') proposes to
expand the trading hours applicable to Managed Portfolio Shares to
include all trading sessions instead of just Regular Trading Hours. The
text of the proposed rule change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange received approval to add new Rule 14.11(k) for the
purpose of permitting the listing and trading of Managed Portfolio
Shares, which are securities issued by an actively managed open-end
management investment company,\3\ on December 16, 2019.\4\ Rule
14.11(k)(2)(B) currently provides that transactions in Managed
Portfolio Shares will occur only during Regular Trading Hours. The
Exchange is proposing to change rule 14.11(k)(2)(B) in order to allow
for trading in Managed Portfolio Shares during all trading sessions on
the Exchange, which would include the Early Trading Session,\5\ the
Pre-Opening Session,\6\ Regular Trading Hours, and the After Hours
Trading Session.\7\ The Exchange notes that Managed Portfolio Shares
are currently the only product-type that is not available for trading
during all trading sessions on the Exchange. As such, this proposal
would allow Managed Portfolio Shares to be traded on the Exchange in a
manner identical to all other products listed and/or traded on the
Exchange. The Exchange proposes to implement this change immediately.
---------------------------------------------------------------------------

    \3\ As defined in Rule 14.11(k)(3)(A), the term ``Managed
Portfolio Share'' means a security that (a) represents an interest
in an investment company registered under the Investment Company Act
of 1940 (``Investment Company'') organized as an open-end management
investment company, that invests in a portfolio of securities
selected by the Investment Company's investment adviser consistent
with the Investment Company's investment objectives and policies;
(b) is issued in a Creation Unit (as defined in Rule
14.11(k)(3)(F)), or multiples thereof, in return for a designated
portfolio of instruments (and/or an amount of cash) with a value
equal to the next determined net asset value and delivered to the
Authorized Participant (as defined in the Investment Company's Form
N-1A filed with the Commission) through a Confidential Account; (c)
when aggregated into a Redemption Unit (as defined in Rule
14.11(k)(3)(G)), or multiples thereof, may be redeemed for a
designated portfolio of instruments (and/or an amount of cash) with
a value equal to the next determined net asset value delivered to
the Confidential Account (as defined in Rule 14.11(k)(3)(D)) for the
benefit of the Authorized Participant; and (d) the portfolio
holdings for which are disclosed within at least 60 days following
the end of every fiscal quarter.
    \4\ See Securities Exchange Act Release No. 87759 (December 16,
2019), 84 FR 70223 (December 20, 2019) (SR-CboeBZX-2019-047).
    \5\ As defined in Rule 1.5(ee), the term ``Early Trading
Session'' shall mean the time between 7:00 a.m. and 8:00 a.m.
Eastern Time.
    \6\ As defined in Rule 1.5(r), the term ``Pre-Opening Session''
shall mean the time between 8:00 a.m. and 9:30 a.m. Eastern Time.
    \7\ As defined in Rule 1.5(c), the term ``After Hours Trading
Session'' shall mean the time between 4:00 p.m. and 8:00 p.m.
Eastern Time
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\8\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \9\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In particular, the Exchange believes that allowing Managed
Portfolio Shares to trade during all trading sessions on the Exchange
will remove impediments to and perfect a national market system by
reducing the complexity and potential investor confusion that could be
associated with limiting the trading hours for one product type. The
Exchange notes that other trading platforms will not necessarily be
restricted in the hours during which they will offer trading series of
Managed Portfolio Shares and believes that allowing them to trade
during all trading sessions on the Exchange will eliminate confusion
and complexity related to which platforms are offering trading in
Managed Portfolio Shares at different times of the day. The proposed
change would further reduce complexity by allowing the Exchange (and
other venues) to accommodate the listing and trading series of Managed
Portfolio Shares without requiring the Exchange to implement and
maintain separate trading hour requirements for one product type.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange notes that the
proposed rule change, rather, will facilitate the listing and trading
of Managed Portfolio Shares in a manner that is consistent with other
product types listed and traded on the Exchange as well as on other
trading platforms, enhancing competition among market participants,
product types, and platforms, to the benefit of investors and the
marketplace.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \12\ normally
does not become operative for 30 days after the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\13\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange states that
waiver of the operative delay would allow trading of Managed Portfolio
Shares on the Exchange during all trading sessions as soon as possible,
making the treatment of Managed Portfolio Shares consistent with all
other product types listed on the Exchange and reducing confusion and
complexity associated with Managed Portfolio Shares. In addition, the
Exchange states that the proposal raises no novel or unique issues in
that it would allow Managed Portfolio Shares to trade in a manner
identical to all other products listed and/or traded on the Exchange
and consistent with the

exemptive relief granted by the Commission. The Exchange further notes
that it does not currently list any series of Managed Portfolio Shares,
so there is no immediate impact of implementing such functionality. For
these reasons, the Commission believes that waiver of the 30-day
operative delay is consistent with the protection of investors and the
public interest. Accordingly, the Commission waives the 30-day
operative delay and designates the proposed rule change operative upon
filing.\14\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeBZX-2020-028 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-CboeBZX-2020-028. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBZX-2020-028 and should be submitted
on or before April 21, 2020.
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    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-06613 Filed 3-30-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 6, 2006 (Volume 71, Number 234)]
[Notices]
[Page 70750]
[DOCID:fr06de06-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-26-000]

Jo-Caroll Energy, Inc.; Notice of Application

November 29, 2006.
    Take notice that on November 22, 2006, Jo-Caroll Energy, Inc (JCE),
793 U.S. Route 20 West, Elizabeth, Illinois 61028, a rural electric
distribution cooperative, filed with the Federal Energy Regulatory
Commission an abbreviated application pursuant to section 7(f) of the
Natural Gas Act (NGA), as amended, requesting the determination of a
service area within which JCE may, without further commission
authorization, enlarge or expand its natural gas distribution
facilities. JCE also requests: (i) A finding that JCE qualifies as a
local distribution company (LDC) for purposes of section 311 of the
Natural Gas Policy Act of 1978 (NGPA); (ii) a waiver of the
Commission's accounting and reporting requirements and other regulatory
requirements ordinarily applicable to natural gas companies under the
NGA and NGPA; and (iii) such further relief as the Commission may deem
appropriate, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. The filing may
also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,

contact<PHONE_NUMBER>.
    Any questions regarding the application should be directed to
Michael Hastings, Jo-Caroll Energy, Inc., 793 U.S. Route 20 West,
Elizabeth, Illinois 61028,<PHONE_NUMBER> (telephone),
<EMAIL_ADDRESS>or Joshua L. Menter, counsel for JCE, Miller,

Balis & O'Neil, P.C., 1140 19th Street, NW., Washington, DC 20036,
(202) 296-2960 (telephone<EMAIL_ADDRESS>    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date, file with the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426, a motion to
intervene in accordance with the requirements of the Commission's Rules
of Practice and Procedure (18 CFR 385.214 or 385.211) and the
Regulations under the NGA (18 CFR 157.10). A person obtaining party
status will be placed on the service list maintained by the Secretary
of the Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission and must mail a copy to the applicant
and to every other party in the proceeding. Only parties to the
proceeding can ask for court review of Commission orders in the
proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

    Comment Date: 5 p.m. eastern time on December 14, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-20595 Filed 12-5-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 209 (Tuesday, October 29, 2019)]
[Notices]
[Pages 57877-57878]
[FR Doc No: 2019-23585]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4258]

Type V Drug Master Files for Center for Drug Evaluation and
Research-Led Combination Products Using Device Constituent Parts With
Electronics or Software; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Type V
DMFs for CDER-Led Combination Products Using Device Constituent Parts
With Electronics or Software.'' A drug master file (DMF) is a voluntary
submission to FDA that may be used to provide confidential detailed
information about facilities, processes, or articles used in the
manufacturing, processing, packaging, and storing of one or more human
drugs. This draft guidance explains when a Type V DMF may be used to
submit information regarding a combination product for which the Center
for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e.,
a CDER-led combination product) and which features a device constituent
part with electronics and/or software that is planned to be used as a
platform, that is, may be used in multiple CDER-led combination
products. The draft guidance also describes the administrative process
and outlines the recommended content for these Type V DMF submissions
and amendments.

DATES: Submit either electronic or written comments on the draft
guidance by December 30, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2019-D-4258 for ``Type V DMFs for CDER-Led Combination Products
Using Device Constituent Parts With Electronics or Software.'' 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kimberly Peters, Center for Drug
Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm.
4314, 10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Type V DMFs for CDER-Led Combination Products Using Device

Constituent Parts With Electronics or Software.'' Some CDER-led
combination products feature a device constituent part with electronics
and/or software that may be used as a platform across multiple
products. An application for such a combination product may necessitate
review by multiple centers, offices, and divisions within FDA. In
addition, because the device constituent part may be used as a platform
in multiple CDER-led combination products, the same device information
may be applicable to and used to support multiple CDER submissions. For
such combination products, a Type V DMF can be an efficient mechanism
to provide information regarding the device constituent part when the
same information is applicable to several CDER applications, and
additional measures to ensure consistency are needed.
    Further, because of rapid advances in technology, the device
constituent part of these types of combination products could be
modified frequently. Knowledge of these modifications is important in
determining whether they have any impact on the safety and
effectiveness of the combination product or its indications for use.
Amendments to the Type V DMF provide a regulatory pathway for the DMF
holder to report device modifications and for FDA to be notified of and
to review device modifications.
    Once FDA reviews the Type V DMF device information for one CDER
application, its review may be applicable to other CDER applications if
the device information remains unchanged and is pertinent to products
in other CDER applications that also incorporate the DMF by reference.
FDA's ability to use previously completed scientific reviews for a DMF
can contribute to an efficient FDA review process and help ensure
consistency across CDER applications referencing the same information.
    This draft guidance applies to Type V DMF submissions as described
above for CDER-led combination products. Specifically, the information
in this draft guidance may be appropriate for device constituent parts
with electronics and/or software that meet the statutory definition of
a device and perform functions such as the following:
     Facilitate drug delivery in a manner that may include
patient input or analysis (e.g., an electromechanically driven pen
injector with software that allows input of patient or dosing
information or that analyzes dosing or device use information).
     Provide information that is used in making a decision
regarding treatment, therapy, or drug delivery.
     Interface with other devices or systems to provide patient
use or other information to the user or health care provider (e.g.,
physiological parameters).
     Control or drive the features of the user interface.
    This draft guidance addresses process and general content
expectations for Type V DMFs for such device constituent parts. It does
not address FDA premarket review standards or expectations for such
constituent parts or the combination products that include them. This
draft guidance is also not intended to suggest that a Type V DMF should
be submitted to CDER if the sponsor has rights of reference to a device
master file located in another center containing the same information.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Type V DMFs
for CDER-Led Combination Products Using Device Constituent Parts With
Electronics or Software.'' 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

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 314.420 have been approved under
OMB control number 0910-0001.

III. Electronic Access

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

    Dated: October 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23585 Filed 10-28-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Pages 32972-32973]
[FR Doc No: 2014-13295]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket No. FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1292]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency; DHS.

ACTION: Notice; correction.

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SUMMARY: On January 28, 2013, FEMA published in the Federal Register a
proposed flood hazard determination notice that contained an erroneous
table. This notice provides corrections to that table, to be used in
lieu of the information published at 78 FR 5823. The table provided
here represents the proposed flood hazard determinations and
communities affected for Spencer County, Indiana, and Incorprated
Areas.

DATES: Comments are to be submitted on or before September 8, 2014.

ADDRESSES: The Preliminary Flood Insurance Rate Map (FIRM), and where
applicable, the Flood Insurance Study (FIS) report for each community
are available for inspection at both the online location and the
respective Community Map Repository address listed in the table below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1292, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER> or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at

www.floodmaps.fema.gov/fhm/fmx_main.html.

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

Correction

    In the proposed flood hazard determination notice published at 78
FR 5823 in the January 28, 2013, issue of the Federal Register, FEMA
published a table titled Spencer County, Indiana, and Incorporated
Areas. This table contained inaccurate information as to the watershed
or communities affected by the proposed flood hazard determinations. In
this document, FEMA is publishing a table containing the accurate
information. The information provided below should be used in lieu of
that previously published.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Spencer County, Indiana, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata..
------------------------------------------------------------------------
City of Rockport.......................  City Hall, 426 Main Street,
                                          Rockport, IN 47635.
Town of Dale...........................  Town Hall, 103 South Wallace
                                          Street, Dale, IN 47523.
Town of Grandview......................  Town Hall, 316 Main Street,
                                          Grandview, IN 47615.
Town of Richland.......................  Town of Richland, 4259 North
                                          State Road 161, Richland, IN
                                          47634.
Town of Santa Claus....................  Town Hall, 90 North Holiday
                                          Boulevard, Santa Claus, IN
                                          47579.
Unincorporated Areas of Spencer County.  Spencer County Plan Commission,
                                          Spencer County Courthouse,
                                          Room 12, 200 Main Street,
                                          Rockport, IN 47635.
------------------------------------------------------------------------

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

    Dated: May 9, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2014-13295 Filed 6-6-14; 8:45 am]
BILLING CODE 9110-12-P