[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Notices]
[Pages 29267-29268]
[FR Doc No: 2021-11388]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2021-D-0242, FDA-2021-D-0243, FDA-2021-D-0244, and
FDA-2021-D-0245]

Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food;
Compliance Policy Guide Sec. 570.200 Aflatoxins in Brazil Nuts;
Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and Peanut
Products; and Compliance Policy Guide Sec. 570.500 Aflatoxins in
Pistachio Nuts; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of four final Compliance Policy Guides (CPG) entitled
``Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food,''
``Compliance Policy Guide Sec. 570.200 Aflatoxins in Brazil Nuts,''
``Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and Peanut
Products,'' and ``Compliance Policy Guide Sec. 570.500 Aflatoxins in
Pistachio Nuts.'' These CPGs revise the existing CPGs by updating the
format and including references to other aflatoxins CPGs and a
reference to the Memorandum of Understanding between the Agricultural
Marketing Service (AMS) of the U.S. Department of Agriculture (USDA)
and FDA. The CPGs provide guidance for FDA staff on FDA's current
regulatory criteria for aflatoxins in human food, Brazil nuts, peanuts
and peanut products, and pistachio nuts.

DATES: The announcement of the guidances is published in the Federal
Register on June 1, 2021.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include Docket No. FDA-
2021-D-0242 for ``Compliance Policy Guide Sec. 555.400 Aflatoxins in
Human Food,'' Docket No. FDA-2021-D-0243 for ``Compliance Policy Guide
Sec. 570.200 Aflatoxins in Brazil Nuts,'' Docket No. FDA-2021-D-0244
for ``Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and
Peanut Products,'' and Docket No. FDA-2021-D-0245 for ``Compliance
Policy Guide Sec. 570.500 Aflatoxins in Pistachio Nuts.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidances to the
Office of Strategic Planning and Operational Policy, Office of
Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 4337, Silver Spring, MD 20993. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidances.

FOR FURTHER INFORMATION CONTACT: Mischelle Ledet, Office of Compliance,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of four CPGs for FDA staff
entitled ``Compliance Policy Guide Sec. 555.400 Aflatoxins in Human
Food,'' ``Compliance Policy Guide Sec. 570.200 Aflatoxins in Brazil
Nuts,'' ``Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts
and Peanut Products,'' and ``Compliance Policy Guide Sec. 570.500
Aflatoxins in Pistachio Nuts.'' We are issuing these guidances
consistent with our good guidance practices regulation (21 CFR 10.115).
We are issuing these four CPGs as final and without first providing an
opportunity to comment

because the revisions are non-substantive; for example, we revised the
CPGs' formats to be consistent with other CPGs, included references to
other aflatoxins CPGs, and included a reference to the Memorandum of
Understanding between USDA/AMS and FDA. Given the minor nature of these
revisions, an opportunity for public comment before we finalize the
CPGs is unnecessary. However, as is the case for all guidance
documents, the public may comment on any guidance document at any time
(Sec.  10.115(g)(5)).
    The guidances represent the current thinking of FDA on this topic.
They do not establish any rights for any person and are not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.
    These four CPGs update the previously issued ``CPG Sec. 555.400
Foods--Adulteration with Aflatoxin,'' ``CPG Sec. 570.200 Brazil Nuts--
Adulteration with Aflatoxin,'' ``CPG Sec. 570.375 Aflatoxin in Peanuts
and Peanut Products,'' and ``CPG Sec. 570.500 Pistachio Nuts--Aflatoxin
Adulteration.'' The CPGs are intended to provide guidance for FDA staff
regarding adulteration in human food, Brazil nuts, peanuts and peanut
products, and pistachio nuts due to the presence of aflatoxins and
explain when we may consider such foods to be adulterated under section
402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).

II. Paperwork Reduction Act of 1995

    These guidances contain no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidances at
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidances.

    Dated: May 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11388 Filed 5-28-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 9, 2010 (Volume 75, Number 45)]
[Rules and Regulations]
[Page 10667-10669]
[DOCID:fr09mr10-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0178; Directorate Identifier 2010-NM-039-AD;
Amendment 39-16224; AD 2010-05-14]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    The manufacturer has informed Transport Canada that a certain
number of the resolver stators, which were installed in the AOA
[angle of attack] transducers, were not cleaned correctly. This
condition can degrade the AOA transducer performance at low
temperatures resulting in freezing of the AOA transducer resolver,
which may provide inaccurate AOA data to the Stall Protection System
(SPS). If not corrected, this condition can result in early or late
activation of the stick shaker and/or stick pusher.

    The unsafe condition is early or late activation of the stick
shaker or stick pusher, which can lead to loss of control of the
airplane. This AD requires actions that are intended to address the
unsafe condition described in the MCAI.

DATES: This AD becomes effective March 24, 2010.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of March 24,
2010.
    We must receive comments on this AD by April 23, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Wing Chan, Aerospace Engineer,
Avionics and Flight Test Branch, ANE-172, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    Transport Canada Civil Aviation, which is the aviation authority
for Canada, has issued Canadian Airworthiness Directive CF-2010-04,
dated January 27, 2010 (referred to after this as ``the MCAI''), to
correct an unsafe condition for the specified products. The MCAI
states:

    The manufacturer has informed Transport Canada that a certain
number of the resolver stators, which were installed in the AOA
[angle of attack] transducers, were not cleaned correctly. This
condition can degrade the AOA transducer performance at low
temperatures resulting in freezing of the AOA transducer resolver,
which may provide inaccurate AOA data to the Stall Protection System
(SPS). If not corrected, this condition can result in early or late
activation of the stick shaker and/or stick pusher.

    The unsafe condition is early or late activation of the stick
shaker or stick pusher, which can lead to loss of control of the
airplane. The required actions include inspecting to determine if
certain AOA transducers are installed, and replacement if necessary.
You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Bombardier has issued Alert Service Bulletin A601R-27-157, Revision
A, dated January 18, 2010. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because a
certain number of the resolver stators, which were installed in the AOA
transducers, were not cleaned correctly. This condition can degrade the
AOA transducer performance at low temperatures, resulting in freezing
of the AOA transducer resolver, which may provide inaccurate AOA data
to the SPS. If not corrected, this condition can result in early or
late activation of the stick shaker and/or stick pusher. Therefore, we
determined that notice and opportunity for public comment before
issuing this AD are impracticable and that good cause exists for making
this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address

listed under the ADDRESSES section. Include ``Docket No. FAA-2010-0178;
Directorate Identifier 2010-NM-039-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2010-05-14 Bombardier, Inc.: Amendment 39-16224. Docket No. FAA-
2010-0178; Directorate Identifier 2010-NM-039-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective March
24, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes, certificated in any
category, serial numbers (S/Ns) 7003 and subsequent equipped with
Thales angle of attack (AOA) transducers having part number (P/N)
45150340 or P/N C16258AA.

Subject

    (d) Air Transport Association (ATA) of America Code 27: Flight
Controls.

Reason

    (e) The mandatory continued airworthiness information (MCAI)
states:

    ``The manufacturer has informed Transport Canada that a certain
number of the resolver stators, which were installed in the AOA
transducers, were not cleaned correctly. This condition can degrade
the AOA transducer performance at low temperatures resulting in
freezing of the AOA transducer resolver, which may provide
inaccurate AOA data to the Stall Protection System (SPS). If not
corrected, this condition can result in early or late activation of
the stick shaker and/or stick pusher.''

The unsafe condition is early or late activation of the stick shaker
or stick pusher, which can lead to loss of control of the airplane.
The required actions include inspecting to determine if certain AOA
transducers are installed, and replacement if necessary.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Do the following actions.
    (1) Within 250 flight hours after the effective date of this AD,
inspect to determine if the serial number of each AOA transducer
having P/N 45150340 or P/N C16258AA is listed in paragraph 1.A. of
Bombardier Alert Service Bulletin A601R-27-157, Revision A, dated
January 18, 2010. A review of airplane maintenance records is
acceptable in lieu of this inspection if the serial number of the
AOA transducer can be conclusively determined from that review.
    (i) If the serial number is not listed in paragraph 1.A. of
Bombardier Alert Service Bulletin A601R-27-157, Revision A, dated
January 18, 2010, no further action is required other than
compliance with paragraph (g)(2) of this AD.
    (ii) If the serial number is listed in paragraph 1.A. of
Bombardier Alert Service Bulletin A601R-27-157, Revision A, dated
January 18, 2010, and the serial number has the letter ``C'', no
further action is required other than compliance with paragraph
(g)(2) of this AD.
    (iii) If the serial number is listed in paragraph 1.A. of
Bombardier Alert Service Bulletin A601R-27-157, Revision A, dated
January 18, 2010, and the serial number does not have the letter
``C'': Before further flight, replace the AOA transducer with an AOA
transducer that is either outside the affected serial numbers
identified in paragraph 1.A. of Bombardier Alert Service Bulletin
A601R-27-157, Revision A, dated January 18, 2010, or that has the
letter ``C'' after the serial number, in accordance with paragraph
2., Part C, of the Accomplishment Instructions of Bombardier Alert
Service Bulletin A601R-27-157, Revision A, dated January 18, 2010.
    (2) As of the effective date of this AD, do not install any
replacement AOA transducer having P/N 45150340 or P/N C16258AA,
having a serial number listed in paragraph 1.A. of Bombardier Alert
Service Bulletin A601R-27-157, Revision A, dated January 18, 2010,
on any airplane, unless the transducer has been inspected by the
manufacturer and has the letter ``C'' after the serial number.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, New York 11590; telephone 516-
228-7300; fax<PHONE_NUMBER>. Before using any approved AMOC on any
airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District

Office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (i) Refer to MCAI Canadian Airworthiness Directive CF-2010-04,
dated January 27, 2010; and Bombardier Alert Service Bulletin A601R-
27-157, Revision A, dated January 18, 2010; for related information.

Material Incorporated by Reference

    (j) You must use Bombardier Alert Service Bulletin A601R-27-157,
Revision A, dated January 18, 2010, to do the actions required by
this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; e-mail<EMAIL_ADDRESS>Internet http://
www.bombardier.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on February 24, 2010.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-4712 Filed 3-8-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4271-4272]
[FR Doc No: 2022-01623]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below.
    The FIRM and FIS report are the basis of the floodplain management
measures that a 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 Federal Emergency Management Agency's (FEMA's)
National Flood Insurance Program (NFIP).

DATES: The date of May 17, 2022 has been established for the FIRM and,
where applicable, the supporting FIS report showing the new or modified
flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at https://msc.fema.gov by the date indicated above.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and 90 days have elapsed since that publication. The Deputy
Associate Administrator for Insurance and Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at https://msc.fema.gov.
    The flood hazard determinations are made final in the watersheds
and/or communities listed in the table below.

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

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
  Ford County, Illinois and Incorporated Areas Docket No.: FEMA-B-2105
------------------------------------------------------------------------
City of Gibson City....................  City Hall, 101 East 8th Street,
                                          Gibson City, IL 60936.
Unincorporated Areas of Ford County....  Ford County Courthouse, 200
                                          West State Street, Paxton, IL
                                          60957.
------------------------------------------------------------------------
   Osage County, Kansas and Incorporated Areas Docket No.: FEMA-B-2068
------------------------------------------------------------------------
City of Burlingame.....................  City Hall, 101 East Santa Fe
                                          Avenue, Burlingame, KS 66413.
City of Carbondale.....................  City Offices, 234 Main Street,
                                          Carbondale, KS 66414.
City of Lyndon.........................  City Hall, 730 Topeka Avenue,
                                          Lyndon, KS 66451.
City of Melvern........................  City Hall, 141 Southwest Main
                                          Street, Melvern, KS 66510.
City of Osage City.....................  City Hall, 201 South 5th
                                          Street, Osage City, KS 66523.
City of Overbrook......................  City Hall, 401 Maple Street,
                                          Overbrook, KS 66524.
City of Quenemo........................  City Hall, 109 East Maple
                                          Street, Quenemo, KS 66528.
City of Scranton.......................  Municipal Building, 120 West
                                          Boone Street, Scranton, KS
                                          66537.

Unincorporated Areas of Osage County...  Osage County Courthouse, 717
                                          Topeka Avenue, Lyndon, KS
                                          66451.
------------------------------------------------------------------------
Wyoming County, Pennsylvania (All Jurisdictions) Docket No.: FEMA B-1921
                             and FEMA-B-2101
------------------------------------------------------------------------
Borough of Laceyville..................  Municipal Building, 342 Church
                                          Street, Laceyville, PA 18623.
Borough of Meshoppen...................  Municipal Building, 154 Oak
                                          Street, Meshoppen, PA 18630.
Borough of Tunkhannock.................  Borough Office, 126 Warren
                                          Street, Tunkhannock, PA 18657.
Township of Braintrim..................  Braintrim Township Municipal
                                          Building, 220 Main Street,
                                          Laceyville, PA 18623.
Township of Eaton......................  Eaton Township Municipal
                                          Building, 1331 Hunter Highway,
                                          Tunkhannock, PA 18657.
Township of Exeter.....................  Exeter Township Municipal
                                          Building, 2690 Sullivans
                                          Trail, Falls, PA 18615.
Township of Falls......................  Municipal Building, 220
                                          Buttermilk Road, Falls, PA
                                          18615.
Township of Mehoopany..................  Municipal Building, 237
                                          Schoolhouse Road, Mehoopany,
                                          PA 18629.
Township of Meshoppen..................  Municipal Building, 527
                                          Benninger Road, Meshoppen, PA
                                          18630.
Township of Northmoreland..............  Northmoreland Township
                                          Municipal Building, 15
                                          Municipal Lane, Dallas, PA
                                          18612.
Township of Tunkhannock................  Municipal Building, 113
                                          Tunkhannock Township Drive,
                                          Tunkhannock, PA 18657.
Township of Washington.................  Washington Township Municipal
                                          Building, 184 Keiserville
                                          Road, Tunkhannock, PA 18657.
Township of Windham....................  Windham Township Municipal
                                          Building, 149 Palen Street,
                                          Mehoopany, PA 18629.
------------------------------------------------------------------------
  Middlesex County, Virginia and Incorporated Areas Docket No.: FEMA-B-
                                  2017
------------------------------------------------------------------------
Unincorporated Areas of Middlesex        Middlesex County Department of
 County.                                  Planning, 865 General Puller
                                          Highway, Saluda, Virginia,
                                          23149.
------------------------------------------------------------------------
 Orange County, Virginia and Incorporated Areas Docket No.: FEMA-B-2013
------------------------------------------------------------------------
Town of Gordonsville...................  Town Office, 112 South Main
                                          Street, Gordonsville, VA
                                          22942.
Town of Orange.........................  Town Hall, Office of Community
                                          Development and Planning, 119
                                          Belleview Avenue, 3rd Floor,
                                          Orange, VA 22960.
Unincorporated Areas of Orange County..  Orange County Planning and
                                          Development Services
                                          Department, 128 West Main
                                          Street, Orange, VA 22960.
------------------------------------------------------------------------
Westmoreland County, Virginia and Incorporated Areas Docket No.: FEMA-B-
                             2003 and B-2101
------------------------------------------------------------------------
Town of Montross.......................  Town Hall, 15869 Kings Highway,
                                          Montross, VA 22520.
Unincorporated Areas of Westmoreland     Westmoreland County George D.
 County.                                  English, Sr. Memorial
                                          Building, 111 Polk Street,
                                          Montross, VA 22520.
------------------------------------------------------------------------

[FR Doc. 2022-01623 Filed 1-26-22; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 96 (Monday, May 19, 2014)]
[Notices]
[Pages 28735-28736]
[FR Doc No: 2014-11517]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0056]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ZIOPTAN and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: 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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks 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 drug 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 drug product ZIOPTAN
(tafluprost). ZIOPTAN is indicated for reducing elevated intraocular
pressure in patients with open-angle glaucoma or ocular hypertension.
Subsequent to this

approval, the Patent and Trademark Office received a patent term
restoration application for ZIOPTAN (U.S. Patent No. 5,886,035) from
Asahi Glass Company Ltd., and the Patent and Trademark Office requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated February 19, 2013, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of ZIOPTAN represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
ZIOPTAN is 3,881 days. Of this time, 3,481 days occurred during the
testing phase of the regulatory review period, while 400 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: June 28, 2001. The applicant claims June 24, 2001, as the
date the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was June 28,
2001, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: January 7,
2011. FDA has verified the applicant's claim that the new drug
application (NDA) for ZIOPTAN (NDA 202514) was submitted on January 7,
2011.
    3. The date the application was approved: February 10, 2012. FDA
has verified the applicant's claim that NDA 202514 was approved on
February 10, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 5 years of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 18, 2014. 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 November 17, 2014. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (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.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. 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. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11517 Filed 5-16-14; 8:45 am]
BILLING CODE 4160-01-P