[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Notices]
[Pages 54388-54390]
[FR Doc No: 2020-19214]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-1918; FDA-2019-E-1934; and FDA-2019-E-1942]

Determination of Regulatory Review Period for Purposes of Patent
Extension; LUMOXITI

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for LUMOXITI and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of patents which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by November 2, 2020.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by March 1, 2021. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 2, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 2, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery

service acceptance receipt is on or before that date.

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 Nos.
FDA-2019-E-1918; FDA-2019-E-1934; and FDA-2019-E-1942 For
``Determination of Regulatory Review Period for Purposes of Patent
Extension; LUMOXITI.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product LUMOXITI
(moxetumomab pasudotox-tdfk). LUMOXITI is indicated for the treatment
of adult patients with relapsed or refractory hairy cell leukemia who
received at least two prior systemic therapies, including treatment
with a purine nucleoside analog. Subsequent to this approval, the USPTO
received patent term restoration applications for LUMOXITI (U.S. Patent
Nos. 8,809,502; 9,580,461; and 10,072,083) from the U.S. Department of
Health and Human Services, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated June 21, 2019, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of LUMOXITI represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
LUMOXITI is 4,320 days. Of this time, 4,092 days occurred during the
testing phase of the regulatory review period, while 228 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i))

became effective: November 17, 2006. FDA has verified the applicant's
claim that the date the investigational new drug application became
effective was on November 17, 2006.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): January 29, 2018. FDA has verified the
applicant's claim that the biologics license application (BLA) for
LUMOXITI (BLA 761104) was initially submitted on January 29, 2018.
    3. The date the application was approved: September 13, 2018. FDA
has verified the applicant's claim that BLA 761104 was approved on
September 13, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 159 days, 163 days, and 2 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: August 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19214 Filed 8-31-20; 8:45 am]
BILLING CODE 4164-01-P


E [C]/R Incorporated
                  Providing Environmental Technical Support Since 1989

MEMORANDUM

DATE:		January 20, 2011

TO:		Melanie King, EPA OAQPS/SPPD/ESG

FROM:	Tanya Parise, EC/R, Inc.

SUBJECT:	Summary of the December 15, 2010 Meeting with API Regarding CPMS Issues in Petition to Reconsider on RICE NESHAP

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

INTRODUCTION

      The American Petroleum Institute (API) requested this meeting with EPA to discuss the petition for reconsideration submitted by API on the National Emission Standards for Hazardous Air Pollutants (NESHAP) for stationary reciprocating internal combustion engines (RICE).  The most recent amendments to the NESHAP for stationary RICE were published in the Federal Register on August 20, 2010 (75 FR 51570).

ATTENDEES

Michael Horowitz, EPA
Jeff Adams, BP
Bob Wayland, EPA
John Admire, DCP Midstream
Melanie King, EPA (by phone)
Bill Grygar, Anadarko
Tanya Parise, EC/R (by phone)
Rebecca Rentz, Bracewell & Giuliani (by phone)
Michael McBride, Van Ness Feldman
Mike Wasson, Exterran (by phone)
Andrea Feldman, Van Ness Feldman
Tom Monahan, ExxonMobil (by phone)
Bill Wehrum, Hunton & Williams
Jeff Panek, IES (by phone)
John Wagner, API
Clay Freeberg, Chevron (by phone)
Matt Todd, API

SUMMARY OF MEETING

	API submitted a petition for reconsideration on October 19, 2010 on the stationary RICE NESHAP (EPA-HQ-OAR-2008-0708-0582).  The petition included a request for reconsideration on the monitoring requirements that were included in the August 20, 2010 final rule.  Specifically, API requested this meeting with EPA to discuss the continuous parametric monitoring system (CPMS) requirements that apply to existing stationary engines.  API provided an agenda for the meeting of CPMS issues it wanted to discuss, which follows this meeting summary.

	API indicated that it has concerns with the short and long-term impacts of the CPMS requirements for stationary engines, particularly with the short-term impacts because stationary engines at major sources that were originally covered under the 2004 rule will have to comply with these requirements in the near future.  According to API, there is inadequate time to implement the CPMS requirements for major sources.  API indicated that its long-term concerns are more related to existing stationary engines at area sources.  API was eager to assess how to reach productive next steps to resolve the issues associated with the CPMS requirements.

	According to API, 100 percent data capture is virtually impossible.  API indicated that it is not aware of any other EPA regulation that requires total data capture.  For instance, power failures and system reboots alone will make total capture of monitoring data impossible.  According to API, the 100 percent data capture requirement is impractical and the organization disagrees with this requirement.  Many EPA rules require 90 to 95 percent data capture and some require 70 percent data capture, according to API.  Further, API asked if every 15-minute increment would be a deviation and if the engine would be out of compliance if the data was not available.  In API's opinion, the lack of data does not necessarily mean that the engine was actually out of compliance.  API also indicated that the initial calibration of thermocouples would be problematic to complete within 90 days.  (This requirement relates to obtaining inlet catalyst temperature readings.)

	In terms of issues related to CPMS requirements for engines at area sources, API argued that there are a number of parameters at particularly rural area sources that are compelling reasons for not requiring CPMS at these locations.  Rural sites are often not manned, they may lack electricity, and it may be difficult to install and maintain controls at these remote sites, according to API.  Sites would necessitate reliable power sources in order to properly fulfill CPMS requirements and some rural sites do not have power at all.  In addition, many rural sites do not have communication access, which is another limiting factor.  Also, determining accurate load is not possible at many sites, e.g., in some cases an operator would be unable to measure the flow per engine because the engine is grouped with other engines.  Good infrastructure is needed and API indicated that it believes it is more of an issue with rural sources.  API indicated that it is technically feasible, but that it is not economically feasible and argued that EPA needs regulatory and economic justification for the CPMS requirements.

	API noted that it had provided comments on the original CPMS rule that have not been addressed.  In addition, there was no opportunity for comment on the engine CPMS requirements since it was just added to the final rule.  API recommended that EPA issue an administrative stay for the CPMS requirements specifically and asked what it could provide to assist EPA delaying the requirements for major sources.

      EPA noted that it is open to continued discussion and asked how the CPMS requirements in the final rule are different from how owners and operators of stationary engines are currently capturing monitoring data.  API could not provide a specific answer, but indicated that based on OECA's 2005 Questions and Answers document, there are companies that are not monitoring catalyst inlet temperature at all or if they are capturing data, companies are capturing 95 percent of the data at most.  API indicated that it would send a formal letter to EPA describing the specific issues it is requesting an administrative stay.  A follow-up meeting with API is scheduled for January 6, 2011 to further discuss these issues.

                                Meeting Agenda

Date:		December 15, 2010
Location:	EPA, Washington D.C.
Time:		1:00 p.m. to 2:00 p.m. ET

--------------------------------------------------------------------------------
Discussion of CPMS Issues in Petition to Reconsider Reciprocating Internal Combustion Engine NESHAP, Final Rule, 75 Fed. Reg. 51,570

1:00	Introductions & Meeting Objectives  -  Eliminate CPMS Requirements for Area Sources
         Technical Concerns/Deficiencies
                    *             Data availability requirements (100% data capture)
                    *             "Deviation" implications
                    *             Thermocouple calibration requirements
         Area Source Monitoring Compliance Implementation Issues

                    *             Area sources urban vs rural
                    *             Lack of site power
                    *             Site communication access is limited at area sources
                    *             Must be able to integrate with other monitoring equipment within a field.
                    *             Must be integrated with other field monitoring equipment and meet industry and company standards
                    *             Installation in weatherproof containers
                    *             Determining load during monthly differential pressure monitoring is impractical at area sources
         Need / Justification for Inclusion of CPMS and monitoring in August 2010 Area Source Rule
                    *             Addition of CPMS specifications without opportunity for public comment
                    *             CPMS specifications did not respond to ACC/API comments on CPMS of February 5, 2009 where applicable.
                    *             Maintenance and calibration of new data and monitoring equipment at remote area sources is difficult and costly.
                    *             Area source cost/benefit comment does not match actual O&G site limitations and CPMS specification.

         Inadequate Implementation Time for 2004 RICE MACT Systems at Major Sources and Need for Administrative Stay of Performance Specifications and Calibration Standard
         Schedule Next Meeting to Discuss Other Issues Outlined in the Petition for Reconsideration
         2:00	Conclude Meeting


[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Rules and Regulations]
[Page 10029]
[FR Doc No: 2021-02644]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Parts 59, 61 and 62

[Docket ID FEMA-2018-0026]
RIN 1660-AA95

National Flood Insurance Program: Conforming Changes To Reflect
the Biggert-Waters Flood Insurance Reform Act of 2012 (BW-12) and the
Homeowners Flood Insurance Affordability Act of 2014 (HFIAA), and
Additional Clarifications for Plain Language; Correction

AGENCY: Federal Emergency Management Agency; DHS.

ACTION: Final rule; correction.

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SUMMARY: On July 20, 2020, FEMA published in the Federal Register a
final rule revising the National Flood Insurance Program (NFIP)
regulations to codify certain provisions of the Biggert-Waters Flood
Insurance Reform Act of 2012 and the Homeowner Flood Insurance
Affordability Act of 2014, and to clarify certain existing NFIP rules
relating to NFIP operations and the Standard Flood Insurance Policy.
This final rule provides corrections to those instructions, to be used
in lieu of the information published July 20.

DATES: This correction is effective October 1, 2021.

ADDRESSES: The docket for this rulemaking is available for inspection
using the Federal eRulemaking Portal at http://www.regulations.gov and
can be viewed by following that website's instructions.

FOR FURTHER INFORMATION CONTACT: Kelly Bronowicz, Director,
Policyholder Services Division, Federal Insurance and Mitigation
Administration, Federal Emergency Management Agency, 400 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In FR Doc. 2020-09260, beginning on page
43946 in the Federal Register of Monday, July 20, 2020, the following
corrections are made:

PART 61--INSURANCE COVERAGE AND RATES

Sec.  61.6   [Corrected]

0
1. On page 43958, in the amendment to Sec.  61.6, in ``Table 1 to
Paragraph (a)--Maximum Amounts of Coverage Available'', the center
heading ``Bulding Coverage'' is corrected to read ``Building
Coverage'';

Appendix A(1) to Part 61 [Corrected]

0
2. On page 43968, in the first column, in Appendix A(1) to part 61,
article VIII.D.3.c, ``If this policy is cancelled pursuant to
VIII.D.4.b,'' is corrected to read ``If this policy is cancelled
pursuant to VIII.D.3.b,'';

Appendix A(2) to Part 61 [Corrected]

0
3. On page 43976, in the second column, in Appendix A(2) to part 61,
article VIII.D.3.c, ``If this policy is cancelled pursuant to
VIII.D.4.b,'' is corrected to read ``If this policy is cancelled
pursuant to VIII.D.3.b,'''

Appendix A(3) to Part 61 [Corrected]

0
4. On page 43984, in the third column, in Appendix A(3) to part 61,
article IX.D.3.c, ``If this policy is cancelled pursuant to
VIII.D.3.a,'' is corrected to read ``If this policy is cancelled
pursuant to IX.D.3.b,'';

Sec.  62.6   [Corrected]

0
5. On page 43986, in the third column, instruction number 18 and the
corresponding CFR text is corrected to read as follows:
    18. In Sec.  62.6, revise the section heading, redesignate
paragraphs (a) and (b) as paragraphs (b) and (c), add new paragraph
(a), and revise newly redesignated paragraph (b) introductory text.
    The addition and revision read as follows:

Sec.  62.6   Brokers and agents writing NFIP policies through the NFIP
Direct Servicing Agent.

    (a) A broker or agent selling policies of flood insurance placed
with the NFIP at the offices of its servicing agent must be duly
licensed by the state insurance regulatory authority in the state in
which the property is located.
    (b) The earned commission which will be paid to any property or
casualty insurance agent or broker, with respect to each policy or
renewal the agent duly procures on behalf of the insured, in connection
with policies of flood insurance placed with the NFIP at the offices of
its servicing agent, but not with respect to policies of flood
insurance issued pursuant to subpart C of this part, will not be less
than $10 and is computed as follows:
* * * * *

MaryAnn Tierney,
Acting Deputy Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-02644 Filed 2-17-21; 8:45 am]
BILLING CODE 9111-52-P


[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Pages 70193-70194]
[FR Doc No: 2014-27857]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1804]

Immediately in Effect Guidance Document: Product Labeling for
Laparoscopic Power Morcellators; Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance for industry and FDA staff entitled
``Immediately in Effect Guidance Document: Product Labeling for
Laparoscopic Power Morcellators.'' FDA is issuing this guidance to
recommend the addition of specific safety statements to the product
labeling for laparoscopic power morcellators (LPMs). The Agency is
making these recommendations in light of scientific information that
suggests that the use of these devices contributes to the dissemination
and upstaging of an occult uterine malignancy in women undergoing
laparoscopic gynecologic surgery for presumed fibroids. FDA believes
this effort will promote the safe and effective use of LPMs when used
for gynecologic surgeries.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Immediately in Effect Guidance Document: Product Labeling for
Laparoscopic Power Morcellators'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Immediately in Effect Guidance Document: Product
Labeling for Laparoscopic Power Morcellators.'' This guidance is being
implemented without prior public comment because the Agency has
determined that prior public participation is not feasible or
appropriate (21 CFR 10.115(g)(2)). FDA believes that immediate
implementation of the guidance is needed to assist in addressing a
significant public health issue. Although this guidance document is
immediately in effect, FDA will consider all comments received and
revise the guidance document when appropriate.
    As the number of laparoscopic and minimally invasive procedures has
increased through the introduction of new surgical technologies and
techniques, additional safety information has become available
regarding the use of LPMs. Recent discussions within the patient and
clinical communities, as well as the peer-reviewed medical literature,
have raised awareness of the risk of spreading unsuspected cancerous
tissue beyond the uterus when LPMs are used during gynecologic
surgeries intended to treat benign fibroids. Numerous case reports and
case series have been published that describe the iatrogenic
dissemination, implantation, and subsequent growth of unsuspected
neoplastic tissue within the peritoneal cavity following laparoscopic
morcellation of uterine tissue believed to contain fibroids based on
preoperative diagnosis.
    FDA's recent analysis of available information suggested that the
risk of an occult uterine sarcoma in a woman undergoing surgical
intervention for presumed fibroids is substantially higher than had
previously been assumed or reported. FDA's analysis also suggested that
patient outcomes, including survival, may be significantly adversely
impacted from this upstaging of disease. Patient selection and choice
of surgical technique can reduce the risk of spreading cancer.
Specifically, the prevalence of unsuspected cancer in women undergoing
hysterectomy for fibroids increases with age such that the benefit/risk
profile of using LPMs is worse in peri- and post-menopausal women
compared to pre-menopausal women. The surgical technique of en bloc
tissue removal eliminates the need to perform morcellation, thereby
reducing the risk of iatrogenic dissemination and upstaging an occult
sarcoma. Importantly, no screening procedure that can reliably detect
sarcoma preoperatively has been identified.
    FDA considers this new scientific information to represent a
significant change to the benefit/risk profile for these devices,
prompting the issuance of a Safety Communication on April 17, 2014
(Ref. 1), and convening of the FDA's Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory Committee on July 10-11, 2014
(Ref. 2), to further discuss the use and labeling of LPMs during
gynecologic surgeries. FDA is issuing this document after considering
the input of the Panel and other stakeholders, including comments made
during the Open Public Hearing portion of the Panel meeting.
    As a result of the new information and discussions during the
public Advisory Committee meeting, FDA recommends that manufacturers of
LPMs with a general indication or a specific gynecologic indication
prominently include two specific Contraindications and a specific Boxed
Warning in their product labeling. FDA believes this may be information
that manufacturers should disclose to users under sections 201(n),
502(a), and 502(f)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(n), 352(a) and 352(f)(2)). The issuance of this guidance
represents another step in addressing this serious public health issue.
In the future, additional safety communications, guidance, or
rulemaking may be undertaken to further support the safe and effective
use of LPMs.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on product labeling for LPMs. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by

downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Immediately in Effect
Guidance Document: Product Labeling for Laparoscopic Power
Morcellators'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document. Please use the document
number 1400052 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 part 807, subpart E have been
approved under OMB control number 0910-0120; and the collections of
information in 21 CFR part 801 have been approved under OMB control
number 0910-0485.
    In addition, FDA concludes that the labeling statements in the
guidance do not constitute a ``collection of information'' under the
Paperwork Reduction Act. Rather, the labeling statements are ``public
disclosure of information originally supplied by the Federal government
to the recipient for the purpose of disclosure to the public.'' (5 CFR
1320.3(c)(2)).

V. Comments

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

VI. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) 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 the Web site addresses in this reference section, but FDA
is not responsible for any subsequent changes to the Web sites after
this document publishes in the Federal Register.)

1. FDA Center for Devices and Radiological Health, Safety
Communications Page, ``Laparoscopic Uterine Power Morcellation in
Hysterectomy and Myomectomy,'' (http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm).
2. Public meeting in 2014, Obstetrics and Gynecology Devices Panel
of the Medical Devices Advisory Committee, Federal Register notice,
available at http://www.gpo.gov/fdsys/pkg/FR-2014-06-09/pdf/2014-13290.pdf.

    Dated: November 19, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27857 Filed 11-24-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 3 (Friday, January 4, 2013)]
[Notices]
[Page 718]
[FR Doc No: 2012-31686]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may 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>.

------------------------------------------------------------------------
                                                         Presenter or
            Docket No.                Filed date          requester
------------------------------------------------------------------------
Prohibited:
    1. ER13-3351-000; EL13-21-000           12-2-12  Robert
                                                      Weisenmiller.\1\
    2. EL12-9-000, et al.\2\.....          12-14-12  Kenneth Wiseman.
Exempt:
    1. P-2662-000................           12-6-12  Tyrone Williams.\3\
    2. ER13-351-000; EL13-21-0003           12-7-12  Hons. Barbara Boxer
                                                      and Dianne
                                                      Feinstein.
------------------------------------------------------------------------
\1\ Email record.
\2\ An email record (12/14/2012) and a letter (12/26/2012) were received
  in the following docket numbers: EL12-9-000; ER12-2331-000; EL11-50-
  000 and EL12-56-000.
\3\ Email record.

    Dated: December 28, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-31686 Filed 1-3-13; 8:45 am]
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[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Notices]
[Pages 8174-8175]
[FR Doc No: 2013-02446]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0002; Internal Agency Docket No. FEMA-B-1289]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Title
44, Part 65 of the Code of Federal Regulations (44 CFR part 65). The
LOMR will be used by insurance agents and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will become effective on the
dates listed in the table below and revise the FIRM panels and FIS
report in effect prior to this determination for the listed
communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has ninety (90)
days in which to request through the community that the Deputy
Associate Administrator for Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is 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.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

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: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR Part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These 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. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is 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.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Chief executive                          Online location of
         State and county           Location and case        officer of         Community map        letter of map       Effective date of    Community
                                           No.               community            repository            revision           modification          No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oklahoma:
    Tulsa........................  City of              The Honorable Herb   106 North 12th       http://www.rampp-    March 28, 2013             400360
                                    Collinsville (12-    Weaver, Mayor,       Street,              team.com/lomrs.hrm.
                                    06-4005P).           City of              Collinsville, OK
                                                         Collinsville, 106    74021.
                                                         North 12th Street,
                                                         Collinsville, OK
                                                         74021.
    Tulsa........................  Unincorporated       The Honorable John   Tulsa County Annex   http://www.rampp-    March 28, 2013             400462
                                    areas of Tulsa       Smaligo, Chairman,   Building, 633 West   team.com/lomrs.hrm.
                                    County (12-06-       Tulsa County Board   3rd Street, Room
                                    4005P).              of Commissioners,    140, Tulsa, OK
                                                         500 South Denver     74127.
                                                         Avenue, Tulsa, OK
                                                         74103.
Texas:
    Bexar........................  Unincorporated       The Honorable        Bexar County Public  http://www.rampp-    March 25, 2013             480035
                                    areas of Bexar       Nelson W. Wolff,     Works Department,    team.com/lomrs.hrm.
                                    County (12-06-       Bexar County         233 North Pecos-La
                                    2613P).              Judge, Paul          Trinidad, Suite
                                                         Elizondo Tower,      420, San Antonio,
                                                         101 West Nueva       TX 78207.
                                                         Street, 10th
                                                         Floor, San
                                                         Antonio, TX 78205.
    Harris.......................  Unincorporated       The Honorable Ed     Harris County,       http://www.rampp-    March 28, 2013             480287
                                    areas of Harris      Emmett, Harris       10555 Northwest      team.com/lomrs.hrm.
                                    County (12-06-       County Judge, 1001   Freeway, Houston,
                                    1133P).              Preston Street,      TX 77092.
                                                         Suite 911,
                                                         Houston, TX 77002.
    Travis.......................  City of Austin (12-  The Honorable Lee    Watershed            http://www.rampp-    April 1, 2013              480624
                                    06-2306P).           Leffingwell,         Protection           team.com/lomrs.hrm.
                                                         Mayor, City of       Department, 505
                                                         Austin, P.O. Box     Barton Springs
                                                         1088, Austin, TX     Road, 12th Floor,
                                                         78767.               Austin, TX 78704.
    Travis.......................  Unincorporated       The Honorable        Travis County        http://www.rampp-    April 1, 2013              481026
                                    areas of Travis      Samuel T. Biscoe,    Permits Counter,     team.com/lomrs.hrm.
                                    County (12-06-       Travis County        700 Lavaca Street,
                                    2306P).              Judge, P.O. Box      Suite 547, Austin,
                                                         1748, Austin, TX     TX 78701.
                                                         78767.
    Webb.........................  City of Laredo (12-  The Honorable Raul   1120 San Bernardo    http://www.rampp-    March 18, 2013             480651
                                    06-2634P).           G. Salinas, Mayor,   Avenue, Laredo, TX   team.com/lomrs.hrm.
                                                         City of Laredo,      78042.
                                                         1110 Houston
                                                         Street, Laredo, TX
                                                         78040.
Virginia: Prince William           Unincorporated       The Honorable        Prince William       http://www.rampp-    March 18, 2013             510119
                                    areas of Prince      Melissa S. Peacor,   County Watershed     team.com/lomrs.hrm.
                                    William County (12-  County Executive,    Management Branch,
                                    03-0457P).           Prince William       5 County Complex
                                                         County, 1 County     Court, Suite 170,
                                                         Complex Court,       Prince William, VA
                                                         Prince William, VA   22192.
                                                         22192.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

James A. Walke,
Acting Deputy Associate Administrator for Mitigation, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2013-02446 Filed 2-4-13; 8:45 am]
BILLING CODE 9110-12-P