[Federal Register Volume 77, Number 20 (Tuesday, January 31, 2012)]
[Proposed Rules]
[Pages 4702-4703]
[FR Doc No: 2012-2049]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0608; Airspace Docket No. 11-ASW-6]

Proposed Amendment of Class E Airspace; Leesville, LA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Leesville,
LA. Additional controlled airspace is necessary to accommodate new
Standard Instrument Approach Procedures (SIAP) at Leesville Airport.
The FAA is taking this action to enhance the safety and management of
Instrument Flight Rules (IFR) operations for SIAPs at the airport.

DATES: 0901 UTC. Comments must be received on or before March 16, 2012.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2011-0608/Airspace Docket No. 11-
ASW-6, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1<PHONE_NUMBER>), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2011-0608/
Airspace Docket No. 11-ASW-6.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Central Service Center, 2601 Meacham Blvd., Fort
Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by amending Class E airspace extending upward from
700 feet above the surface to accommodate

new standard instrument approach procedures at Leesville Airport,
Leesville, LA. Geographic coordinates would also be amended to coincide
with the FAA's aeronautical database. Controlled airspace is needed for
the safety and management of IFR operations at the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9V, dated August 9, 2011, and effective September 15, 2011, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace at Leesville Airport, Leesville,
LA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9V, Airspace Designations and Reporting Points, dated August 9,
2011, and effective September 15, 2011, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ASW LA E5 Leesville, LA [Amended]

Leesville Airport, LA
    (Lat. 31[deg]10[min]06[sec] N., long. 93[deg]20[min]33[sec] W.)
Leesville NDB
    (Lat. 31[deg]06[min]08[sec] N., long. 93[deg]20[min]31[sec] W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Leesville Airport, and within 3.6 miles
each side of the 345[deg] bearing from the airport extending from
the 6.5-mile radius to 12.2 miles north of the airport, and within
2.5 miles each side of the 000[deg] bearing of the Leesville NDB
extending from the 6.5-mile radius to 7.3 miles north of the
airport, excluding that airspace within the Fort Polk, LA, Class D
airspace area, and excluding that airspace within restricted area R-
3803A.

    Issued in Fort Worth, TX, on January 13, 2012.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2012-2049 Filed 1-30-12; 8:45 am]
BILLING CODE 4901-13-P


[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Pages 79692-79697]
[FR Doc No: 2011-32778]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0511]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practices and Related Regulations for Blood and Blood
Components; and Requirements for Donor Testing, Donor Notification, and
``Lookback''

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
23, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0116.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, (301)
796-7726<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practices and Related Regulations for Blood
and Blood Components; and Requirements for Donor Testing, Donor
Notification, and ``Lookback''--(OMB Control Number 0910-0116)--
Extension

    All blood and blood components introduced or delivered for
introduction into interstate commerce are subject to section 351(a) of
the Public Health Service Act (PHS Act) (42 U.S.C. 262). Section 351(a)
of the PHS Act requires that manufacturers of biological products,
which include blood and blood components intended for further
manufacture into injectable products, have a license, issued upon a
demonstration that the product is safe, pure, and potent and that the
manufacturing establishment meets all applicable standards, including
those prescribed in the FDA regulations designed to ensure the
continued safety, purity, and potency of the product. In addition,
under section 361 of the PHS Act (42 U.S.C. 264), by delegation from
the Secretary of Health and Human Services, FDA may make and enforce
regulations necessary to prevent the introduction, transmission, or
spread of communicable diseases from foreign countries into the States
or possessions, or from one State or possession into any other State or
possession.
    Section 351(j) of the PHS Act states that the Federal Food, Drug,
and Cosmetic Act also applies to biological products. Blood and blood
components for transfusion or for further manufacture into injectable
products are drugs, as that term is defined in section 201(g)(1) of the
Federal, Food, Drug, and Cosmetics Act (21 U.S.C. 321(g)(1)). Because
blood and blood components are drugs under the Federal, Food, Drug, and
Cosmetics Act, blood and plasma establishments must comply with the
substantive provisions and related regulatory scheme of the act. For
example, under section 501 of the Federal, Food, Drug, and Cosmetic Act
(21 U.S.C. 351(a)), drugs are deemed ``adulterated'' if the methods
used in their manufacturing, processing, packing, or holding do not
conform to current good manufacturing practice (CGMP) and related
regulations.
    The CGMP regulations in part 606 (21 CFR part 606)) and related
regulations implement FDA's statutory authority to ensure the safety,
purity, and potency of blood and blood components. The public health
objective in testing human blood donors for evidence of infection due
to communicable disease agents and in notifying donors is to prevent
the transmission of communicable disease. For example, the ``lookback''
requirements are intended to help ensure the continued safety of the
blood supply by providing necessary information to users of blood and
blood components and appropriate notification of recipients of
transfusion who are at increased risk for transmitting human
immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
    The information collection requirements in the CGMP, donor testing,
donor notification, and ``lookback'' regulations provide FDA with the
necessary information to perform its duty to ensure the safety, purity,
and potency of blood and blood components. These requirements establish
accountability and traceability in the processing and handling of blood
and blood components and enable FDA to perform meaningful inspections.
    The recordkeeping requirements serve preventive and remedial
purposes. The disclosure requirements identify the various blood and
blood components and important properties of the product, demonstrate
that the CGMP requirements have been met, and facilitate the tracing of
a product back to its original source. The reporting requirements
inform FDA of certain information that may require immediate corrective
action.
    Under the reporting requirements, Sec.  606.170(b), in brief,
requires that facilities notify FDA's Center for Biologics Evaluation
and Research

(CBER), as soon as possible after confirming a complication of blood
collection or transfusion to be fatal. The collecting facility is to
report donor fatalities, and the compatibility testing facility is to
report recipient fatalities. The regulation also requires the reporting
facility to submit a written report of the investigation within 7 days
after the fatality. In fiscal year 2010, FDA received 76 of these
reports.
    Section 610.40(c)(1)(ii) in part 610 (21 CFR part 610), in brief,
requires that each donation dedicated to a single identified recipient
be labeled as required under Sec.  606.121 and with a label containing
the name and identifying information of the recipient.
    Section 610.40(g)(2) requires an establishment to obtain written
approval from FDA to ship human blood or blood components for further
manufacturing use prior to completion of testing for evidence of
infection due to certain communicable disease agents.
    Section 610.40(h)(2)(ii)(A), in brief, requires an establishment to
obtain written approval from FDA to use or ship human blood or blood
components found to be reactive by a screening test for evidence of
certain communicable disease agent(s) or collected from a donor with a
record of a reactive screening test. Furthermore, Sec. Sec.
610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), in brief, require an
establishment to label certain reactive human blood and blood
components with the appropriate screening test results, and, if they
are intended for further manufacturing use into injectable products, to
include a statement on the label indicating the exempted use
specifically approved by FDA. Finally, Sec.  610.40(h)(2)(vi) requires
each donation of human blood or blood components, excluding Source
Plasma, that tests reactive by a screening test for syphilis and is
determined to be a biological false positive to be labeled with both
test results.
    Section 610.42(a) requires a warning statement ``indicating that
the product was manufactured from a donation found to be reactive by a
screening test for evidence of infection due to the identified
communicable disease agent(s)'' in the labeling for medical devices
containing human blood or a blood component found to be reactive by a
screening test for evidence of infection due to a communicable disease
agent(s) or syphilis.
    In brief, Sec. Sec.  610.46 and 610.47 require blood collecting
establishments to establish, maintain, and follow an appropriate system
for performing HIV and HCV prospective ``lookback'' when: (1) A donor
tests reactive for evidence of HIV or HCV infection; or (2) the
collecting establishment becomes aware of other reliable test results
or information indicating evidence of HIV or HCV infection
(``prospective lookback'') (see Sec. Sec.  610.46(a)(1) and
610.47(a)(1)). The requirement for ``an appropriate system'' requires
the collecting establishment to design standard operating procedures
(SOPs) to identify and quarantine all blood and blood components
previously collected from a donor who later tests reactive for evidence
of HIV or HCV infection, or when the collecting establishment is made
aware of other reliable test results or information indicating evidence
of HIV or HCV infection. Within 3 calendar days of the donor testing
reactive by an HIV or HCV screening test or the collecting
establishment becoming aware of other reliable test results or
information, the collecting establishment must, among other things,
notify consignees to quarantine all identified previously collected in-
date blood and blood components (Sec. Sec.  610.46(a)(1)(ii)(B) and
610.47(a)(1)(ii)(B)) and, within 45 days, notify the consignees of
supplemental test results, or the results of a reactive screening test
if there is no available supplemental test that is approved for such
use by FDA (Sec. Sec.  610.46(a)(3) and 610.47(a)(3)).
    Consignees also must establish, maintain, and follow an appropriate
system for performing HIV and HCV ``lookback'' when notified by the
collecting establishment that they have received blood and blood
components previously collected from donors who later tested reactive
for evidence of HIV or HCV infection, or when the collecting
establishment is made aware of other reliable test results or
information indicating evidence of HIV or HCV infection in a donor
(Sec. Sec.  610.46(b) and 610.47(b)). This provision for a system
requires the consignee to establish SOPs (standard operating
procedures) for, among other things, notifying transfusion recipients
of blood and blood components, or the recipient's physician of record
or legal representative, when such action is indicated by the results
of the supplemental (additional, more specific) tests or a reactive
screening test if there is no available supplemental test that is
approved for such use by FDA, or if under an investigational new drug
application (IND) or an investigational device exemption (IDE), is
exempted for such use by FDA. The consignee must make reasonable
attempts to perform the notification within 12 weeks of receipt of the
supplemental test result or receipt of a reactive screening test result
when there is no available supplemental test that is approved for such
use by FDA, or if under an IND or IDE, is exempted for such use by FDA
(Sec. Sec.  610.46(b)(3) and 610.47(b)(3)).
    Section 630.6(a) (21 CFR 630.6(a)) requires an establishment to
make reasonable attempts to notify any donor who has been deferred as
required by Sec.  610.41, or who has been determined not to be eligible
as a donor. Section 630.6(d)(1) requires an establishment to provide
certain information to the referring physician of an autologous donor
who is deferred based on the results of tests as described in Sec.
610.41.
    Under the recordkeeping requirements, Sec.  606.100(b), in brief,
requires that written SOPs be maintained for all steps to be followed
in the collection, processing, compatibility testing, storage, and
distribution of blood and blood components used for transfusion and
further manufacturing purposes. Section 606.100(c) requires the review
of all records pertinent to the lot or unit of blood prior to release
or distribution. Any unexplained discrepancy or the failure of a lot or
unit of final product to meet any of its specifications must be
thoroughly investigated, and the investigation, including conclusions
and followup, must be recorded.
    In brief, Sec.  606.110(a) provides that the use of
plateletpheresis and leukaphesis procedures to obtain a product for a
specific recipient may be at variance with the additional standards for
that specific product if, among other things, the physician certifies
in writing that the donor's health permits plateletpheresis or
leukapheresis. Section 606.110(b) requires establishments to request
prior approval from CBER for plasmapheresis of donors who do not meet
donor requirements. The information collection requirements for Sec.
606.110(b) are approved under OMB control number 0910-0338 and,
therefore, are not reflected in tables 1 and 2 of this document.
    Section 606.151(e) requires that SOPs for compatibility testing
include procedures to expedite transfusion in life-threatening
emergencies; records of all such incidents must be maintained,
including complete documentation justifying the emergency action, which
must be signed by a physician.
    So that each significant step in the collection, processing,
compatibility testing, storage, and distribution of each unit of blood
and blood components can be clearly traced, Sec.  606.160 requires that
legible and indelible contemporaneous records of each such step be made
and maintained for no less than 10 years. Section 606.160(b)(1)(viii)
requires

records of the quarantine, notification, testing and disposition
performed under the HIV and HCV ``lookback'' provisions. Furthermore,
Sec.  606.160(b)(1)(ix) requires a blood collection establishment to
maintain records of notification of donors deferred or determined not
to be eligible for donation, including appropriate followup. Section
606.160(b)(1)(xi) requires an establishment to maintain records of
notification of the referring physician of a deferred autologous donor,
including appropriate followup.
    Section 606.165 (21 CFR 606.165), in brief, requires that
distribution and receipt records be maintained to facilitate recalls,
if necessary.
    Section 606.170(a) requires records to be maintained of any reports
of complaints of adverse reactions arising as a result of blood
collection or transfusion. Each such report must be thoroughly
investigated, and a written report, including conclusions and followup,
must be prepared and maintained. When an investigation concludes that
the product caused the transfusion reaction, copies of all such written
reports must be forwarded to and maintained by the manufacturer or
collecting facility.
    Section 610.40(g)(1) requires an establishment to appropriately
document a medical emergency for the release of human blood or blood
components prior to completion of required testing.
    In addition to the CGMP regulations in part 606, there are
regulations in part 640 (21 CFR part 640) that require additional
standards for certain blood and blood components as follows: Sections
640.3(a)(1), (a)(2), and (f); 640.4(a)(1) and (a)(2); 640.25(b)(4) and
(c)(1); 640.27(b); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c);
640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3);
640.65(b)(2); 640.66; 640.71(b)(1); 640.72; 640.73; and 640.76(a) and
(b). The information collection requirements and estimated burdens for
these regulations are included in the part 606 burden estimates, as
described in tables 1 and 2 of this document.
    Respondents to this collection of information are licensed and
unlicensed blood establishments that collect blood and blood
components, including Source Plasma and Source Leukocytes, inspected by
FDA, and other transfusion services inspected by Centers for Medicare
and Medicaid Services (CMS). Based on information received from CBER's
database systems, there are approximately 31 licensed Source Plasma
establishments with multiple locations and approximately 1,675
registered blood collection establishments, for an estimated total of
1,706 establishments. Of these establishments, approximately 1,032
perform plateletpheresis and leukopheresis. These establishments
annually collect approximately 38.3 million units of Whole Blood and
blood components, including Source Plasma and Source Leukocytes, and
are required to follow FDA ``lookback'' procedures. In addition, there
are another 4,059 establishments that fall under the Clinical
Laboratory Improvement Amendments of 1988 (formerly referred to as
facilities approved for Medicare reimbursement) that transfuse blood
and blood components.
    The following reporting and recordkeeping estimates are based on
information provided by industry, CMS, and FDA experience. Based on
information received from industry, we estimate that there are
approximately 21 million donations of Source Plasma from approximately
2 million donors and approximately 17.3 million donations of Whole
Blood, including approximately 261,000 (approximately 1.5 percent of
17.3 million) autologous donations, from approximately 10.9 million
donors. Assuming each autologous donor makes an average of 2 donations,
FDA estimates that there are approximately 130,500 autologous donors.
    FDA estimates that approximately 5 percent (3,600 of the 72,000
donations that are donated specifically for the use of an identified
recipient) would be tested under the dedicated donors' testing
provisions in Sec.  610.40(c)(1)(ii)).
    Under Sec. Sec.  610.40(g)(2) and (h)(2)(ii)(A), Source Leukocytes,
a licensed product that is used in the manufacture of interferon, which
requires rapid preparation from blood, is currently shipped prior to
completion of testing for evidence of certain communicable disease
agents. Shipments of Source Leukocytes are pre-approved under a
biologics license application and each shipment does not have to be
reported to the Agency. Based on information from CBER's database
system, FDA receives less than one application per year from
manufacturers of Source Leukocytes. However, for calculation purposes,
we are estimating one application annually.
    Under Sec. Sec.  610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), FDA
estimates that each manufacturer would ship an estimated 1 unit of
human blood or blood components per month (12 per year) that would
require two labels; one as reactive for the appropriate screening test
under Sec.  610.40(h)(2)(ii)(C), and the other stating the exempted use
specifically approved by FDA under Sec.  610.40(h)(2)(ii)(D). According
to CBER's database system, there are approximately 40 licensed
manufacturers that ship known reactive human blood or blood components.
    Based on information we received from industry, we estimate that
approximately 18,000 donations: (1) Annually test reactive by a
screening test for syphilis; (2) are determined to be biological false
positives by additional testing; and (3) are labeled accordingly (Sec.
610.40(h)(2)(vi)).
    Human blood or a blood component with a reactive screening test, as
a component of a medical device, is an integral part of the medical
device, e.g., a positive control for an in vitro diagnostic testing
kit. It is usual and customary business practice for manufacturers to
include on the container label a warning statement that identifies the
communicable disease agent. In addition, on the rare occasion when a
human blood or blood component with a reactive screening test is the
only component available for a medical device that does not require a
reactive component, then a warning statement must be affixed to the
medical device. To account for this rare occasion under Sec.
610.42(a), we estimate that the warning statement would be necessary no
more than once a year.
    FDA estimates that approximately 3,500 repeat donors will test
reactive on a screening test for HIV. We also estimate that an average
of three components was made from each donation. Under Sec. Sec.
610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 10,500 (3,500
x 3) notifications of the HIV screening test results to consignees by
collecting establishments for the purpose of quarantining affected
blood and blood components, and another 10,500 (3,500 x 3)
notifications to consignees of subsequent test results. We estimate an
average of 10 minutes per notification of consignees.
    We estimate that Sec.  610.46(b)(3) will require 4,059 consignees
to notify transfusion recipients, their legal representatives, or
physicians of record an average of 0.35 times per year resulting in a
total number of 1,755 (585 confirmed positive repeat donors x 3)
notifications. Under Sec.  610.46(b)(3), we also estimate 1 hour to
accommodate the time to gather test results and records for each
recipient and to accommodate multiple attempts to contact the
recipient.
    Furthermore, we estimate that approximately 7,800 repeat donors per
year would test reactive for antibody to HCV. Under Sec. Sec.
610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments

would notify the consignee 2 times for each of the 23,400 (7,800 x 3
components) components prepared from these donations, once for
quarantine purposes and again with additional HCV test results for a
total of 46,800 notifications as an annual ongoing burden. Under Sec.
610.47(b)(3), we estimate that approximately 4,059 consignees would
notify approximately 2,050 recipients or their physicians of record
annually. Finally, we estimate 1 hour to complete notification.
    Based on industry estimates, approximately 13 percent of
approximately 10 million potential donors (1.3 million donors) who come
to donate annually are determined not to be eligible for donation prior
to collection because of failure to satisfy eligibility criteria. It is
the usual and customary business practice of approximately 1,675 blood
collecting establishments to notify onsite and to explain why the donor
is determined not to be suitable for donating. Based on such available
information, we estimate that two-thirds (1,117) of the 1,675 blood
collecting establishments provided onsite additional information and
counseling to a donor determined not to be eligible for donation as
usual and customary business practice. Consequently, we estimate that
only one-third, or 558, approximately, blood collecting establishments
would need to provide, under Sec.  630.6(a), additional information and
onsite counseling to the estimated 433,000 (one-third of approximately
1.3 million) ineligible donors.
    It is estimated that another 4.5 percent of 10 million potential
donors (450,000 donors) are deferred annually based on test results. We
estimate that approximately 95 percent of the establishments that
collect 99 percent of the blood and blood components notify donors who
have reactive test results for HIV, Hepatitis B Virus (HBV), HCV, Human
T-Lymphotropic Virus (HTLV), and syphilis as usual and customary
business practice. Consequently, 5 percent of the 1,706 establishments
(85) collecting 1 percent (4,500) of the deferred donors (450,000)
would notify donors under Sec.  630.6(a).
    As part of usual and customary business practice, collecting
establishments notify an autologous donor's referring physician of
reactive test results obtained during the donation process required
under Sec.  630.6(d)(1). However, we estimate that approximately 5
percent of the 1,675 blood collection establishments (84) may not
notify the referring physicians of the estimated 2 percent of 130,500
autologous donors with the initial reactive test results (2,610) as
their usual and customary business practice.
    The recordkeeping chart reflects the estimate that approximately 95
percent of the recordkeepers, which collect 99 percent of the blood
supply, have developed SOPs as part of their customary and usual
business practice. Establishments may minimize burdens associated with
CGMP and related regulations by using model standards developed by
industries' accreditation organizations. These accreditation
organizations represent almost all registered blood establishments.
    Under Sec.  606.160(b)(1)(ix), we estimate the total annual records
based on the approximately 1.3 million donors determined not to be
eligible to donate and each of the estimated 1.75 million (1.3 million
+ 450,000) donors deferred based on reactive test results for evidence
of infection because of communicable disease agents. Under Sec.
606.160(b)(1)(xi), only the 1,675 registered blood establishments
collect autologous donations and, therefore, are required to notify
referring physicians. We estimate that 4.5 percent of the 130,500
autologous donors (5,872) will be deferred under Sec.  610.41, which in
turn will lead to the notification of their referring physicians.
    FDA has concluded that the use of untested or incompletely tested
but appropriately documented human blood or blood components in rare
medical emergencies should not be prohibited. We estimate the
recordkeeping under Sec.  610.40(g)(1) to be minimal with one or fewer
occurrences per year. The reporting of test results to the consignee in
Sec.  610.40(g) does not create a new burden for respondents because it
is the usual and customary business practice or procedure to finish the
testing and provide the results to the manufacturer responsible for
labeling the blood products.
    The hours per response and hours per record are based on estimates
received from industry or FDA experience with similar recordkeeping or
reporting requirements.
    In the Federal Register of July 28, 2011 (76 FR 45262), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
606.170(b) \1\..................              76               1              76              20           1,520
610.40(g)(2)....................               1               1               1               1               1
610.40(h)(2)(ii)(A).............               1               1               1               1               1
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,522
----------------------------------------------------------------------------------------------------------------
\1\ The reporting requirement in Sec.   640.73, which addresses the reporting of fatal donor reactions, is
  included in the estimate for Sec.   606.170(b).

                                 Table 2--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
606.100(b) \1\..................         \4\ 288            1.20             346              24           6,912
606.100(c)......................         \4\ 288              10           2,880               1           2,880
606.110(a) \2\..................          \5\ 52               1              52            0.50              26
                                                                                (30 min.)
606.151(e)......................         \4\ 288              12           3,456            0.08             276
                                                                                (5 min.)

606.160 \3\.....................         \4\ 288        1,329.86         383,000            0.75         287,250
                                                                                (45 min.)
606.160(b)(1)(viii).............  ..............  ..............  ..............  ..............  ..............
HIV consignee notification......           1,675           12.54          21,000             .17           3,570
                                                                                (10 min.)
                                           4,059            5.17          21,000             .17           3,570
                                                                                (10 min.)
HCV consignee notification......           1,675           27.94          46,800             .17           7,956
                                                                                (10 min.)
                                           4,059           11.53          46,800             .17           7,956
                                                                                (10 min.)
HIV recipient notification......           4,059            0.43           1,755             .17             298
                                                                                (10 min.)
HCV recipient notification......           4,059            0.51           2,050             .17             349
                                                                                (10 min.)
606.160(b)(1)(ix)...............           1,706        1,025.79       1,750,000            0.05          87,500
                                                                                (3 min.)
606.160(b)(1)(xi)...............           1,675            3.51           5,872            0.05             294
                                                                                (3 min.)
606.165.........................         \5\ 288        1,329.86         383,000            0.08          30,640
                                                                                (5 min.)
606.170(a)......................         \5\ 288              12           3,456               1           3,456
610.40(g)(1)....................           1,706               1           1,706            0.50             853
                                                                                (30 min.)
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         443,786
----------------------------------------------------------------------------------------------------------------
\1\ The recordkeeping requirements in Sec.  Sec.   640.3(a)(1), 640.4(a)(1), and 640.66, which address the
  maintenance of SOPs, are included in the estimate for Sec.   606.100(b).
\2\ The recordkeeping requirements in Sec.   640.27(b), which address the maintenance of donor health records
  for the plateletpheresis, are included in the estimate for Sec.   606.110(a).
\3\ The recordkeeping requirements in Sec.  Sec.   640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1);
  640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and
  (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which address the maintenance of various
  records are included in the estimate for Sec.   606.160.
\4\ Five percent of establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 that
  transfuse blood and components and FDA-registered blood establishments (0.05 x 4,059 + 1,706).
\5\ Five percent of plateletpheresis and leukopheresis establishments (0.05 x 1,032).

                             Table 3--Estimated Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
         21 CFR section             respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
606.170(a)......................         \1\ 288            1.20             346            0.50             173
                                                                                (30 min.)
610.40(c)(1)(ii)................           1,706            2.11           3,600            0.08             288
                                                                                (5 min.)
610.40(h)(2)(ii)(C) and                       40              12             480            0.20              96
 (h)(2)(ii)(D)..................                                                       (12 min.)
610.40(h)(2)(vi)................           1,706           10.55          18,000            0.08           1,440
                                                                                (5 min.)
610.42(a).......................               1               1               1               1               1
610.46(a)(1)(ii)(B).............           1,675            6.27          10,500            0.17           1,785
                                                                                (10 min.)
610.46(a)(3)....................           1,675            6.27          10,500            0.17           1,785
                                                                                (10 min.)
610.46(b)(3)....................           4,059            0.43           1,755               1           1,755
610.47(a)(1)(ii)(B).............           1,675           13.97          23,400            0.17           3,978
                                                                                (10 min.)
610.47(a)(3)....................           1,675           13.97          23,400            0.17           3,978
                                                                                (10 min.)
610.47(b)(3)....................           4,059            0.51           2,050               1           2,050
630.6(a) \2\....................             558          755.98         433,000            0.08          34,640
                                                                                (5 min.)
630.6(a) \3\....................              85           52.94           4,500            1.50           6,750
                                                                                (90 min.)
630.6(d)(1).....................              84           31.07           2,610               1           2,610
                                 -------------------------------------------------------------------------------

    Total.......................  ..............  ..............  ..............  ..............          61,329
----------------------------------------------------------------------------------------------------------------
\1\ Five percent of establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 that
  transfuse blood and components and FDA-registered blood establishments (0.05 x 4,059 + 1,706).
\2\ Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility
  criteria.
\3\ Notification of donors deferred based on reactive test results for evidence of infection due to communicable
  disease agents.

    Dated: December 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32778 Filed 12-21-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Proposed Rules]
[Pages 62448-62450]
[FR Doc No: 2016-21724]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Part 391

[Docket No. FMCSA-2005-23151]
RIN 2126-AA95

Medical Review Board Task Report on Insulin Treated Diabetes
Mellitus and Commercial Motor Vehicle Drivers

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

ACTION: Notice of availability; request for comments.

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

SUMMARY: In May 2015, FMCSA published a notice of proposed rulemaking
(NPRM) in the Federal Register to allow drivers with stable, well-
controlled insulin-treated diabetes mellitus (ITDM) to be qualified to
operate commercial motor vehicles (CMVs) in interstate commerce. The
comment period closed on July 6, 2015 and the Agency received over
1,250 comments. In that same month, FMCSA requested the Medical Review
Board (MRB) to provide the Agency with advice by reviewing and
analyzing the comments and providing recommendations to FMCSA for its
consideration. The Agency announces the availability of the MRB's
report and requests comments on the MRB recommendations. The Final MRB
Task 15-01 Report is posted in the docket at FMCSA-2005-23151.

DATES: Comments must be received on or before November 8, 2016.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2005-23151 using any of the
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, Room W12-140, 1200 New Jersey Avenue SE., Washington,
DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include FMCSA and docket number FMCSA-2005-
23151. Note that DOT posts all comments received without change to
www.regulations.gov, including any personal information included in a
comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line FDMS is available 24 hours each
day, 365 days each year. If you want acknowledgment that we received
your comments, please include a self-addressed, stamped envelope or
postcard or print the acknowledgement page that appears after
submitting comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, 1200 New
Jersey Ave. SE., Washington, DC 20590, or by phone at<PHONE_NUMBER> or
by email at<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, contact Docket Services, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2005-23151), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. FMCSA recommends that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so that FMCSA can contact you if there are questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
put the

docket number, FMCSA-2005-23151, in the keyword box, and click
``Search.'' When the new screen appears, click on the ``Comment Now!''
button and type your comment into the text box on the following screen.
Choose whether you are submitting your comment as an individual or on
behalf of a third party and then submit. If you submit your comments by
mail or hand delivery, submit them in an unbound format, no larger than
8\1/2\ by 11 inches, suitable for copying and electronic filing. If you
submit comments by mail and would like to know that they reached the
facility, please enclose a stamped, self-addressed postcard or
envelope.
    FMCSA will consider these comments, in addition to the comments
submitted in response to the NPRM, in determining how to proceed with
this rulemaking.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2005-23151, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
Internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays.

II. Background

    Diabetes mellitus is a disease manifested by the body's inability
to maintain normal function of insulin, a substance that controls
glycemic levels in the blood. Diabetes presents a major health
challenge, particularly those who drive CMVs in interstate commerce.
Under 49 CFR 391.41(b)(3), a person is physically qualified to drive a
commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control. Since 2003, FMCSA has maintained an exemption
program for individuals that use insulin to treat their diabetes
mellitus, that allows them to drive in interstate commerce if their
diabetes is stable and they meet criteria of the program. 68 FR 52441
(Sept. 3, 2003), as revised, 70 FR 67777 (Nov. 8, 2005).
    In May 2015, FMCSA issued an NPRM in the Federal Register to allow
drivers with stable, well-controlled ITDM to be qualified to operate
CMVs in interstate commerce. The NPRM would enable individuals with
ITDM to obtain a Medical Examiner's Certificate (MEC) from a Certified
Medical Examiner (CME) at least annually in order to operate in
interstate commerce as long as evidence is presented by the treating
clinician who prescribes insulin documenting that the driver's
condition is stable and well-controlled. The comment period on the NPRM
closed on July 6, 2015, and the Agency received more than 1,250
comments.

MRB Tasking

    The MRB was established to provide FMCSA with medical advice and
recommendations on medical standards and guidelines for the physical
qualifications of operators of CMVs, medical examiner education, and
medical research. 49 U.S.C. 31149(a)(1). The MRB, in view of its
statutory creation and advisory function, is chartered by the
Department of Transportation as an advisory committee under the
provisions of the Federal Advisory Committee Act. 5 U.S.C. App. See
http://www.facadatabase.gov/committee/committee.aspx?cid=2084&aid=47.
See also Announcement of Establishment of the Federal Motor Carrier
Safety Administration Medical Review Board, 70 FR 57642 (Oct. 3, 2005).
The members of the MRB are appointed by the Secretary to reflect
expertise in a variety of medical specialties relevant to the driver
fitness requirements of FMCSA. 49 U.S.C. 31149(a)(2).
    In an effort to assist in the development of the final rule, on
July 15, 2015, FMCSA requested advice from the MRB for the Agency to
consider. Specifically, FMCSA asked the members to review and analyze
all comments from medical professionals and associations, and identify
factors the Agency should consider when making a decision about the
next steps in the diabetes rulemaking. A public meeting to discuss this
matter was held by the MRB on July 21 and 22, 2015. The Agency received
the MRB's final report on September 1, 2015. Details of the meeting,
including the original task, final report and supporting materials used
by the MRB are posted on the Agency's public Web site: https://www.fmcsa.dot.gov/medical-review-board-mrb-meeting-topics.

MRB Final Report

    The MRB's final report is available in the docket for this
rulemaking (in addition to being available on the Agency's public Web
site). The final report contains a number of detailed recommendations
for FMCSA to consider as it develops a final rule. The Agency believes
that public comment on the recommendations will assist it in evaluating
the advice it has received from the MRB. Comments must be limited to
addressing the recommendations in the MRB final report. A summary of
the report's major recommendations is set out below:
    The MRB recommended that ITDM drivers be medically disqualified
unless they meet the following requirements demonstrating their stable,
well-controlled ITDM:
    1. The driver must provide an FMCSA Drivers With Insulin Treated
Diabetes Mellitus Assessment Form (set out in the recommendations) to a
medical examiner that has been completed and signed by the treating
clinician. The treating clinician must be a Doctor of Medicine, a
Doctor of Osteopathy, a Nurse Practitioner or a Physician's Assistant
who prescribed insulin to the driver and is knowledgeable regarding the
treatment of diabetes.
    2. The driver must receive a complete ophthalmology or optometry
exam, including dilated retinal exam, at least every 2 years
documenting the presence or absence of retinopathy/macular edema and
the degree of retinopathy and/or macular edema if present (using the
International Classification of Diabetic Retinopathy and Diabetic
Macular Edema).
    The MRB recommended that medical examiners be allowed to certify an
ITDM driver as medically qualified for a time period of no longer than
1 year only if the driver has not experienced any of the 8
disqualifying factors below (which the MRB believes should be listed in
49 CFR 391.46):
    1. Any episode of severe hypoglycemia within the previous 6 months.
    2. Blood sugar less than 60 milligrams per deciliter (mg/dL)
demonstrated in current glucose logs.
    3. Hypoglycemia appearing in the absence of warning symptoms (i.e.,
hypoglycemic unawareness).
    4. An episode of severe hypoglycemia, blood sugar less than 60 mg/
dl, or hypoglycemic unawareness within the previous 6 months; the
driver should be medically disqualified and must remain disqualified
for at least 6 months.
    5. Uncontrolled diabetes, as evidenced by Hemoglobin A1c (HbA1c)
level greater than 10 percent. A driver could be reinstated when HbA1c
level is less than or equal to 10 percent.
    6. Stage 3 or 4 diabetic retinopathy; a driver should be
permanently disqualified.
    7. Signs of target organ damage; a driver should be disqualified
until the

matter is resolved by treatment, if possible.
    8. Inadequate record of self-monitoring of blood glucose; a driver
should be disqualified for inadequate records until the driver can
demonstrate adequate evidence of glucose records (minimum 1 month).
    In addition, the MRB stated that, if a driver is medically
disqualified due to not meeting the ITDM criteria listed above, the
driver should remain disqualified for at least 6 months.

Comments Requested

    Comments are requested on any and all of the recommendations
provided in the advisory final report from the Medical Review Board but
only on those recommendations. To the extent possible, comments should
include supporting materials, such as, for example, data analyses,
studies, reports, or journal articles. FMCSA will consider these
comments, in addition to the comments submitted in response to the
NPRM, in determining how to proceed with this rulemaking.

    Issued on: August 30, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-21724 Filed 9-8-16; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Pages 8158-8160]
[FR Doc No: 2010-3465]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61522; File No. SR-ISE-2010-12]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Modify Trading Hours for Foreign Currency Options

February 16, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 2, 2010, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change, as
described in Items I, II, and III below, which items

have been prepared by the Exchange. The Exchange has filed the proposal
as a ``non-controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend ISE Rule 2210 regarding the trading
hours for foreign currency options (``FX Options'') traded on the
Exchange. The text of the proposed rule change is available on the
Exchange's Web site http://www.ise.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this filing is to amend ISE Rule 2210 regarding the
trading hours for FX Options traded on the Exchange. Currently, under
ISE Rule 2210(a), FX Options may be traded on the Exchange between the
hours of 9:30 a.m. and 4:15 p.m. Eastern time, except on the last day
of trading during expiration week, in which case trading ceases at 12
p.m. Eastern time. ISE now proposes to open trading in FX Options at
7:30 a.m. Eastern time, two hours earlier than the current opening
time. In support of this proposed rule change, ISE will ensure that
quotes and trades are disseminated over the Options Price Reporting
Authority during the time FX Options are open for trading on the
Exchange. Further, the Exchange notes that FX Options are listed and
traded only on ISE. As such, (1) FX Options are not fungible with
foreign currency options listed by any other exchange, and (2) orders
in FX Options will not trade at inferior prices, thus preserving
intermarket protection against trade-throughs.
    In support of this proposed rule change, the Exchange notes that
there are several market centers that account for a significant portion
of all foreign exchange transactions and which are active in the
foreign exchange markets prior to the Exchange's current opening time.
By opening trading in FX Options at 7:30 a.m. Eastern time, ISE hopes
to attract new participants and liquidity from Western Europe,
specifically the United Kingdom. According to the Bank for
International Settlements' Triennial Central Bank Survey of Foreign
Exchange and Derivatives Market Activity in 2007, trading activity in
the United Kingdom accounts for approximately 34% of foreign exchange
transactions. Although foreign exchange trading occurs 24 hours a day,
trading activity at each market center is consolidated into
approximately 8-10 hours per day. In the United Kingdom, specifically
in London, the most active trading times correspond to between 2 a.m.
Eastern time and 12 p.m. Eastern time. In the United States,
specifically in New York, trading is most active between 8 a.m. Eastern
time and 5 p.m. Eastern time. The overlap in trading hours between the
two market centers results in a period of concentrated liquidity and is
often considered a peak time for transactions in the foreign exchange
market. That hypothesis is also supported by the fact that key economic
statistics for North America are traditionally released prior to 9:30
a.m. Eastern time.\5\
---------------------------------------------------------------------------

    \5\ The Bureau of Labor Statistics releases Consumer Price Index
(CPI) data at 8:30 a.m. Eastern time, and the Bureau of Economic
Analysis releases quarterly Gross Domestic Product data at 8:30 a.m.
Eastern time. Similarly, Statistics Canada releases Canadian CPI
data at 7 a.m. Eastern time.
---------------------------------------------------------------------------

    Foreign currency futures listed on the Chicago Mercantile Exchange
(``CME'') and the Intercontinental Exchange (``ICE'') are available for
trading virtually 24 hours a day. The CME also provides virtually an
all day market for trading in options contracts on foreign currency
futures.\6\ Several ISE members are also members of CME and ICE, and
actively trade foreign exchange derivative products at those two
exchanges. ISE believes amending its rule to allow for an earlier
opening will attract greater participation in the Exchange's FX
Options.
---------------------------------------------------------------------------

    \6\ CME's trading hours are available at http://www.cmegroup.com/trading_hours/fx-hours.html.
---------------------------------------------------------------------------

2. Statutory Basis
    The basis under the Securities Exchange Act of 1934 (``Exchange
Act'') for this proposed rule change is found in Section 6(b)(5).
Specifically, the Exchange believes the proposed rule change is
consistent with Section 6(b)(5) requirements that the rules of an
exchange be designed to promote just and equitable principles of trade,
serve to remove impediments to and perfect the mechanism of a free and
open market and a national market system, and, in general, to protect
investors and the public interest. In particular, permitting trading to
begin earlier in the day will permit investors greater opportunity to
participate in the market, thereby removing an impediment to trading.

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to section 19(b)(3)(A) \7\ of the Act and Rule 19b-
4(f)(6) \8\ thereunder. The Exchange provided the Commission with
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at least
five business days prior to the date of filing the proposed rule
change.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is

necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

    Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
    Send an e-mail to<EMAIL_ADDRESS>Please include File No.
SR-ISE-2010-12 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-ISE-2010-12. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule changes between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File No. SR-ISE-2010-12 and should be
submitted on or before March 16, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-3465 Filed 2-22-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Rules and Regulations]
[Pages 57524-57525]
[FR Doc No: 2015-23991]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-1871; Airspace Docket No. 15-AGL-10]

Establishment of Class E Airspace; Iron Mountain, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace at the Iron Mountain
VHF Omni-Directional Radio Range/Distance Measuring Equipment (VOR/
DME), Iron Mountain, MI, to facilitate vectoring of Instrument Flight
Rules (IFR) aircraft under control of Minneapolis Air Route Traffic
Control Center (ARTCC). This action enhances the safety and efficiency
of aircraft operations within the National Airspace System (NAS). A
minor change in the regulatory text is made to align the new Class E
airspace with Minneapolis ARTCC's airspace.

DATES: Effective date: 0901 UTC, December 10, 2015. The Director of the
Federal Register approves this incorporation by reference action under
1 Code of Federal Regulations, Part 51, subject to the annual revision
of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Z, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. For further information, you can
contact the Airspace Policy and ATC Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 29591;
telephone:<PHONE_NUMBER>. The Order is also available for inspection at
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Raul Garza, Jr., Central Service
Center, Operations Support Group, Federal Aviation Administration,
Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone
817-868-2927.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 (f),
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at the Iron Mountain VOR/DME,
Iron Mountain, MI.

History

    On June 24, 2015, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to establish Class E airspace for
the Iron Mountain, MI area, creating controlled airspace at the Iron
Mountain VOR/DME within Minneapolis ARTCC boundaries (80 FR 36262)
Docket No. FAA-2015-1871. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received. Subsequent to
publication, the FAA found that the airspace coordinates in the legal
description will change slightly to allow alignment of the new Class E
airspace with the boundaries of Minneapolis ARTCC.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9Z dated August 6, 2015, and effective September 15,
2015, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Z, airspace Designations and
Reporting Points, dated August 6, 2015, and effective September 15,
2015. FAA Order 7400.9Z is publicly available as listed in the
ADDRESSES section of this final rule. FAA Order 7400.9Z lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by establishing Class E airspace extending upward from 1,200
feet above the surface at the Iron Mountain VOR/DME navigation aid,
Iron Mountain, MI, to contain aircraft while in IFR conditions under
control of Minneapolis ARTCC by safely vectoring aircraft from en route
airspace to terminal areas. Controlled airspace is needed for the
safety and management of IFR operations within the confines of
Minneapolis ARTCC airspace.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR part 71.1 of FAA Order
7400.9Z, Airspace Designations and Reporting Points, dated August 6,
2015, and effective September 15, 2015, is amended as follows:

Paragraph 6006 Enroute Domestic Airspace Areas

* * * * *

AGL MI E6 Iron Mountain, MI [New]

Iron Mountain VOR/DME, MI
    Lat. 45[deg]48'58'' N., long. 088[deg]06'44'' W.

    That airspace extending upward from 1,200 feet above the surface
within an area bounded by lat. 47[deg]50'36'' N., long.
089[deg]41'25'' W.; to lat. 47[deg]54'30'' N., long. 088[deg]46'30''
W.; thence clockwise via the arc of a 35-mile radius centered on the
McKay TACAN to lat. 47[deg]50'36'' N., long. 089[deg]41'25'' W.; to
lat. 47[deg]05'00'' N., long. 087[deg]00'00'' W.; to lat.
47[deg]01'28'' N., long. 086[deg]59'15'' W.; to lat. 46[deg]53'22''
N., long. 088[deg]21'39'' W.; to Iron Mountain VOR/DME; to Ironwood
VORTAC; to lat. 46[deg]51'42'' N., long. 090[deg]20'18'' W.; thence
to the point of beginning, excluding that airspace within Federal
airways and within Canadian airspace.

    Issued in Fort Worth, TX, on August 26, 2015.
Walter Tweedy,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2015-23991 Filed 9-23-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)]
[Notices]
[Page 7091]
[FR Doc No: 2016-02636]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM15-11-000]

Reliability Standard for Transmission System Planned Performance
for Geomagnetic Disturbance Events; Supplemental Notice of Agenda and
Discussion Topics for Staff Technical Conference

    This notice establishes the agenda and topics for discussion at the
technical conference to be held on March 1, 2016, to discuss issues
related to the proposed Reliability Standard for Transmission System
Planned Performance for Geomagnetic Disturbance Events.\1\ The
technical conference will start at 9:00 a.m. and end at approximately
5:00 p.m. (Eastern Time) in the Commission Meeting Room at the
Commission's Headquarters, 888 First Street NE., Washington, DC. The
technical conference will be led by Commission staff. Commissioners may
attend and participate. All interested parties are invited to attend,
and registration is not required.
---------------------------------------------------------------------------

    \1\ On April 30, 2012, Commission staff held a technical
conference to discuss ``issues related to the reliability of the
Bulk-Power System as affected by geomagnetic disturbances,'' and
``the risks and impacts from geomagnetically induced currents to
transformers and other equipment on the Bulk-Power System, as well
as options for addressing or mitigating the risks and impacts.''
    http://www.ferc.gov/eventcalendar/Files/20120420162925-AD12-13-000a.pdf.
---------------------------------------------------------------------------

    The topics and related questions to be discussed during this
conference are provided as an attachment to this Notice. The purpose of
the technical conference is to facilitate a structured dialogue on
issues identified by the Commission in the Notice of Proposed
Rulemaking (NOPR) in this proceeding and raised in public comments to
the NOPR. Prepared remarks will be presented by invited panelists.
    This event will be webcast and transcribed. The free webcast allows
listening only. Anyone with internet access who desires to listen to
this event can do so by navigating to the ``FERC Calendar'' at
www.ferc.gov, and locating the technical conference in the Calendar of
Events. Opening the technical conference in the Calendar of Events will
reveal a link to its webcast. The Capitol Connection provides technical
support for the webcast and offers the option of listening to the
meeting via phone-bridge for a fee. If you have any questions, visit
www.CapitolConnection.org or call<PHONE_NUMBER>. The webcast will be
available on the Calendar of Events at www.ferc.gov for three months
after the conference. Transcripts of the conference will be available
for a fee from Ace-Federal Reporters, Inc.<PHONE_NUMBER>).
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER>
with the requested accommodations.
    There is no fee for attendance. However, members of the public are
encouraged to preregister online at: https://www.ferc.gov/whats-new/registration/03-01-16-form.asp.
    For more information about the technical conference, please
contact: Sarah McKinley, Office of External Affairs,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
    Dated: February 4, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-02636 Filed 2-9-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11453-11454]
[FR Doc No: 2023-03768]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2023-0002; Internal Agency Docket No. FEMA-B-2313]

Proposed Flood Hazard Determinations

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

ACTION: Notice.

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

DATES: Comments are to be submitted on or before May 24, 2023.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA

Map Service Center at https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2313, to
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].

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

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

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

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                                             Community map repository
               Community                             address
------------------------------------------------------------------------
              Woodbury County, Iowa and Incorporated Areas
           Project: 23-07-0012S Preliminary Date: July 8, 2022
------------------------------------------------------------------------
City of Anthon.........................  City Hall, 301 East Main
                                          Street, Anthon, IA 51004.
City of Bronson........................  City Hall, 100 East 1st Street,
                                          Bronson, IA 51007.
City of Correctionville................  City Hall, 312 Driftwood
                                          Street, Correctionville, IA
                                          51016.
City of Cushing........................  City Hall, 200 Main Street,
                                          Cushing, IA 51018.
City of Danbury........................  City Hall, 207 1st Street,
                                          Danbury, IA 51019.
City of Hornick........................  City Hall, 400 Main Street,
                                          Hornick, IA 51026.
City of Lawton.........................  City Hall, 315 Ash Street,
                                          Lawton, IA 51030.
City of Moville........................  City Hall, 21 West Main Street,
                                          Moville, IA 51039.
City of Oto............................  City Hall, 27 Washington
                                          Street, Oto, IA 51044.
City of Pierson........................  City Hall, 201 Main Street,
                                          Pierson, IA 51048.
City of Salix..........................  City Hall, 317 Tipton Street,
                                          Salix, IA 51052.
City of Sioux City.....................  City Hall--Planning Division,
                                          405 6th Street, Sioux City, IA
                                          51102.
City of Sloan..........................  City Hall, 428 Evans Street,
                                          Sloan, IA 51055.
City of Smithland......................  City Hall, 110 West Jackson
                                          Street, Smithland, IA 51056.
Unincorporated Areas of Woodbury County  Woodbury County Courthouse,
                                          Community and Economic
                                          Development, 620 Douglas
                                          Street, Sioux City, IA 51101.
Winnebago Tribe of Nebraska............  Winnebago Tribe of Nebraska,
                                          Blackhawk Center--
                                          Administrative Offices, 100
                                          Bluff Street, Winnebago, NE
                                          68071.
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[FR Doc. 2023-03768 Filed 2-22-23; 8:45 am]
BILLING CODE 9110-12-P