[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Rules and Regulations]
[Pages 45721-45722]
[FR Doc No: 2017-20954]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Docket No. FAA-2016-9591; Airspace Docket No. 16-ASW-21]

Establishment of Temporary Restricted Area R-5602; Fort Sill, OK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Temporary final rule.

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SUMMARY: This action establishes temporary restricted area R-5602, over
the Fort Sill, OK, R-5601 restricted area complex, to support the U.S.
Army Maneuver & Fires Integration Experiment (MFIX) 2018 scheduled for
December 2017. MFIX 2018 is planned to exercise hazardous laser
operations conducting counter unmanned aircraft systems (UAS)
activities. The temporary restricted area will be in effect from
December 4 through December 15, 2017.

DATES: Effective date 0901 UTC, December 4, 2017, through December 15,
2017.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    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 the
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 temporary restricted airspace at Fort Sill, OK,
enhancing safety and accommodating essential military training during
the U.S. Army's MFIX 2018 exercise being held December 4 through 15,
2017.

History

    On February 23, 2017, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) (82 FR 11417), Docket No. FAA-
2016-9591, to establish a temporary restricted area designated to
support hazardous training activities conducted during MFIX 2018 within
the Fort Sill, OK, special use airspace (SUA) complex. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal. No comments were received.

The Rule

    The FAA is amending 14 CFR part 73 to establish temporary
restricted area R-5602 in support of MFIX 2018 during the period of
December 4 through 15, 2017, to contain hazardous laser activities
demonstrating counter UAS capabilities. To effectively segregate
nonparticipant air traffic from the hazardous activities associated
with MFIX 2018 at Fort Sill, OK, the R-5602 lateral boundaries overlie
the R-5601A, R-5601B, and a portion of R-5601F restricted areas and
extend approximately 8 nautical miles (NM) east beyond the R-5601A and
R-5601F eastern boundaries. R-5602 extends upward from 40,000 feet mean
sea level (MSL) to 60,000 feet MSL, is activated daily by a Notice to
Airmen (NOTAM), and is in effect only during the period of December 4
through December 15, 2017. This rule adds ``daily'' to the ``Time of
designation'' for clarity.
    Since R-5602 is a temporary area, it will not be depicted on the
Dallas-Ft. Worth Sectional Aeronautical Chart or the IFR Enroute High
Altitude Chart, H-6. However, a notice and graphic depiction will be
published on the FAA's SUA Web site at http://www.faa.gov/sua and in
the Notices to Airmen Publication (NTAP) available online at http://www.faa.gov/air_traffic/publications/notices/.

Regulatory Notices and Analyses

    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.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (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.

Environmental Review

    The FAA has determined that this action of establishing a temporary
restricted area R-5602 which partially overlays portions of the R-5601
restricted area complex at Fort Sill, OK, qualifies for FAA adoption in
accordance with FAA Order 1050.1F, paragraphs 8-2 and 9-2, Adoption of
Other Agencies' National Environmental Policy Act Documents, and
Written Re-evaluations, and 7400.2L, paragraph 32-2-3. The purpose of
temporarily creating and utilizing the temporary Restricted Area (RA)
is to safely segregate private and commercial aircraft from above-the-
horizon hazardous laser activities while supporting the U.S. Army MFIX
2018 planned for November 27 through December 15, 2017 (the proposed
temporary RA R-5602 would be active from December 4 through 15, 2017).
The FAA, after conducting an independent review and evaluation of the
United States Army's August 2017 Final Supplemental Environmental
Assessment for the Temporary Creation and Utilization of Restricted
Area R-5602 at Fort Sill, Oklahoma, has determined that the Army's
Supplemental EA and its supporting documentation adequately assesses
and discloses the environmental impacts of the proposed action,
including evaluation of the establishment of airspace for temporary
restricted airspace area R-5602. Based on the evaluation for potential
environmental impact in the above-mentioned EA, the FAA, as the
Cooperating Agency, concluded that adoption of the EA for the Temporary
Creation and Utilization of Restricted Area R-5602 is authorized in
accordance with 40 CFR 1506.3, Adoption. Accordingly, FAA adopts the
Army's Supplemental EA and takes full responsibility for the scope and
content that address the FAA's airspace establishment action.

List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 73 as follows:

PART 73--SPECIAL USE AIRSPACE

0
1. The authority citation for part 73 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.  73.56  Oklahoma (Amended)

0
2. Sec.  73.56 is amended as follows:
* * * * *

R-5602 Fort Sill, OK [Temporary]

    Boundaries. Beginning at lat. 34[deg]49'30'' N., long.
98[deg]08'43'' W.; to lat. 34[deg]36'36'' N., long. 98[deg]08'43'' W.;
to lat. 34[deg]36'36'' N., long. 98[deg]17'01'' W.; to lat.
34[deg]38'15'' N., long. 98[deg]17'01'' W.; to lat. 34[deg]38'15'' N.,
long. 98[deg]37'57'' W.; to lat. 34[deg]40'54'' N., long.
98[deg]37'56'' W.; to lat. 34[deg]42'07'' N., long. 98[deg]37'20'' W.;
to lat. 34[deg]43'21'' N., long. 98[deg]36'02'' W.; to lat.
34[deg]43'30'' N., long. 98[deg]35'40'' W.; to lat. 34[deg]45'03'' N.,
long. 98[deg]29'46'' W.; to lat. 34[deg]46'15'' N., long.
98[deg]25'01'' W.; to lat. 34[deg]47'00'' N., long. 98[deg]17'46'' W.;
to lat. 34[deg]46'45'' N., long. 98[deg]17'01'' W.; to lat.
34[deg]49'30'' N., long. 98[deg]17'01'' W.; to the point of beginning.
    Designated altitudes. 40,000 feet MSL to 60,000 feet MSL.
    Time of designation. December 4-15, 2017, daily, by NOTAM.
    Controlling agency. FAA, Fort Worth ARTCC.
    Using agency. U.S. Army, Commanding General, U.S. Army Fires Center
of Excellence, Fort Sill, OK.

    Issued in Washington, DC, on September 22, 2017.
Rodger A. Dean, Jr.,
Manager, Airspace Policy Group.
[FR Doc. 2017-20954 Filed 9-29-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 202 (Monday, October 20, 2014)]
[Notices]
[Pages 62629-62634]
[FR Doc No: 2014-24797]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0161]

Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
requirements relating to FDA's regulation of current good manufacturing
practice (CGMP) and related regulations for blood and blood components;
and requirements for donor testing, donor notification, and
``lookback.''

DATES: Submit either electronic or written comments on the collection
of information by December 19, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in the brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.

    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

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(a)). Section
351(a) 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 (FD&C) 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 FD&C Act (21 U.S.C. 321(g)(1)). Because blood and
blood components are drugs under the FD&C Act, blood and plasma
establishments must comply with the substantive provisions and related
regulatory scheme of the FD&C Act. For example, under section 501 of
the FD&C 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 CGMP and related regulations.
    The CGMP regulations (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 third-party 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 FDAs 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 2013, FDA received 72 of these reports.
    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.
    Under the third-party disclosure requirements, Sec.
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. The information collection
requirements under Sec.  606.121 are part of usual and customary
business practice.
    Sections 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. Also, 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 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, 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. Section 606.170(a) also requires that
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.
    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 416 licensed Source Plasma
establishments with multiple locations and approximately 1,265 licensed
blood collection establishments, for an estimated total of 1,681
licensed blood collection establishments. Also, there are an estimated
total of 680 unlicensed, registered blood collection establishments for
an approximate total of 2,361 collection establishments (416 + 1,265 +
680 = 2,361 establishments). Of these establishments, approximately 990
perform plateletpheresis and

leukopheresis. These establishments annually collect approximately 40
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 4,961
establishments that fall under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) (Public Law 100-578) (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 25 million donations of Source Plasma from approximately
2 million donors and approximately 15 million donations of Whole Blood,
including approximately 225,000 (approximately 1.5 percent of 15
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 112,500 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 preapproved under a
biologics license application (BLA) 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 that Sec.  610.46(b)(3) will require 4,961 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. Also under Sec.  610.46(b)(3), we estimate and include
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 4,961 consignees would
notify approximately 2,050 recipients or their physicians of record
annually.
    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 1,945 (1,265
+ 680) 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 (1,297) of the
1,945 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 648, approximately, blood collecting
establishments would need to provide, under Sec.  630.6(a), additional
information and onsite counseling to the estimated 433,333 (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 1,681 establishments
(84) 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 1,265 blood collection establishments (63) may not
notify the referring physicians of the estimated 2 percent of 112,500
autologous donors with the initial reactive test results (2,250) 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 1,945 registered blood establishments
collect autologous donations and, therefore, are required to notify
referring physicians. We estimate that 4.5 percent of the 112,500
autologous donors (5,063) 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) is part of 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 average burden per response (hours) and average burden per
recordkeeping (hours) are based on estimates received from industry or
FDA experience with similar reporting or recordkeeping requirements.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
606.170(b) \2\..................              72               1              72              20           1,440
610.40(g)(2)....................               1               1               1               1               1
610.40(h)(2)(ii)(A).............               1               1               1               1               1
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,442
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 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 \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.100(b) \2\..............................         \5\ 366               1             366  24........................................           8,784
606.100(c)..................................         \5\ 366              10           3,660  1.........................................           3,660
606.110(a) \3\..............................          \6\ 50               1              50  0.5 (30 minutes)..........................              25
606.151(e)..................................         \5\ 366              12           4,392  0.08 (5 minutes)..........................             351
606.160 \4\.................................         \5\ 366        1,046.45         383,000  0.75 (45 minutes).........................         287,250
606.160(b)(1)(viii).........................           1,945           10.80          21,000  0.17 (10 minutes).........................           3,570
HIV consignee notification..................           4,961            4.23          21,000  0.17 (10 minutes).........................           3,570
606.160(b)(1)(viii).........................           1,945           24.06          46,800  0.17 (10 minutes).........................           7,956
HCV consignee notification..................           4,961            9.43          46,800  0.17 (10 minutes).........................           7,956
HIV recipient notification..................           4,961            0.35           1,755  0.17 (10 minutes).........................             298
HCV recipient notification..................           4,961            0.41           2,050  0.17 (10 minutes).........................             349
606.160(b)(1)(ix)...........................           2,361          741.21       1,750,000  0.05 (3 minutes)..........................          87,500
606.160(b)(1)(xi)...........................           1,945            2.60           5,063  0.05 (3 minutes)..........................             253
606.165.....................................         \5\ 366        1,046.45         383,000  0.08 (5 minutes)..........................          30,640
606.170(a)..................................         \5\ 366              12           4,392  1.........................................           4,392
610.40(g)(1)................................           2,361               1           2,361  0.5 (30 minutes)..........................           1,180
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................         447,734
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ 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).
\3\ 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).
\4\ 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.
\5\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,961 +
  2,361 = 366).
\6\ Five percent of plateletpheresis and leukopheresis establishments (0.05 x 990 = 50).

                                                Table 3--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  No. of
               21 CFR section                     No. of       responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.170(a)..................................         \2\ 366              12           4,392  0.5 (30 minutes)..........................           2,196

610.40(c)(1)(ii)............................           2,361            1.52           3,600  0.08 (5 minutes)..........................             288
610.40(h)(2)(ii)(C) and (h)(2)(ii)(D).......              40              12             480  0.20 (12 minutes).........................              96
610.40(h)(2)(vi)............................           2,361            7.62          18,000  0.08 (5 minutes)..........................           1,440
610.42(a)...................................               1               1               1  1.........................................               1
610.46(a)(1)(ii)(B).........................           1,945            5.40          10,500  0.17 (10 minutes).........................           1,785
610.46(a)(3)................................           1,945            5.40          10,500  0.17 (10 minutes).........................           1,785
610.46(b)(3)................................           4,961            0.35           1,755  1.........................................           1,755
610.47(a)(1)(ii)(B).........................           1,945           12.03          23,400  0.17 (10 minutes).........................           3,978
610.47(a)(3)................................           1,945           12.03          23,400  0.17 (10 minutes).........................           3,978
610.47(b)(3)................................           4,961            0.41           2,050  1.........................................           2,050
630.6(a) \3\................................             648          668.72         433,333  0.08 (5 minutes)..........................          34,667
630.6(a) \4\................................              84           53.57           4,500  1.5 (90 minutes)..........................           6,750
630.6(d)(1).................................              63           35.71           2,250  1.........................................           2,250
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          63,019
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,961 +
  2,361 = 366).
\3\ Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria.
\4\ Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents.

    Dated: October 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24797 Filed 10-17-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Rules and Regulations]
[Pages 33097-33099]
[FR Doc No: 2021-13200]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0432; Project Identifier 2013-SW-074-AD; Amendment
39-21587; AD 2021-11-25]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters (Type Certificate
Previously Held by Eurocopter France) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus Helicopters (Type Certificate previously held by
Eurocopter France) Model AS350B3 and EC130T2 helicopters. This AD was
prompted by a report of failure of an engine digital electronic control
unit (DECU). This AD requires revising the existing Rotorcraft Flight
Manual (RFM) for your helicopter. The FAA is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective July 29, 2021.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of July 29, 2021.

ADDRESSES: For Airbus Helicopters service information identified in
this final rule, contact Airbus Helicopters, 2701 N Forum Drive, Grand
Prairie, TX 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(972) 641-3775; or at https://www.airbus.com/helicopters/services/technical-support.html. For Safran Turbomeca service information
identified in this final rule, contact Safran Helicopter Engines, S.A.,
64511 Bordes, France; phone: +33 (0) 5 59 74 45 11. You may view the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort
Worth, TX 76177. The Airbus Helicopters service information is also
available at https://www.regulations.gov by searching for and locating
Docket No. FAA-2017-0432.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2017-0432; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
European Aviation Safety Agency (now European Union Aviation Safety
Agency) (EASA) AD, the EASA safety information bulletin (SIB), any
service information that is incorporated by reference, any comments
received, and other information. The street address for Docket
Operations is U.S. Department of Transportation, Docket Operations, M-
30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jon Jordan, Rotorcraft Flight Test
Pilot, Southwest Section, Flight Test Branch, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Airbus Helicopters
(Type Certificate previously held by Eurocopter France) Model AS350B3
and EC130T2 helicopters with an ARRIEL 2D engine and THALES full
authority digital engine control (FADEC) part number (P/N) C13165DA00
without amendment A or P/N C13165FA00 without amendment B, installed.
The NPRM published in the Federal Register on March 22, 2021 (86 FR
15140). In the NPRM, the FAA proposed to require revising the Emergency
Procedures of the existing RFM for your helicopter by inserting
Appendix 4. of Airbus Helicopters Alert Service Bulletin (ASB) No.
AS350-01.00.67 or ASB No. EC130-04A004, each Revision 2 and dated
February 17, 2014 (ASB AS350-01.00.67 and ASB EC130-04A004) or a
different document with information identical to that in Appendix 4.,
as applicable to your helicopter model. As an optional terminating
action for the RFM revision, the NPRM proposed to allow installing
amendment A on FADEC P/N C13165DA00 or amendment B on FADEC P/N
C13165FA00.
    The NPRM was prompted by EASA AD 2013-0287, dated December 5, 2013
(EASA AD 2013-0287), issued by EASA, which is the Technical Agent for
the Member States of the European Union, to correct an unsafe condition
for Eurocopter (formerly Eurocopter France, Aerospatiale) Model AS 350
B3 and EC 130 T2 helicopters with an ARRIEL 2D engine and THALES FADEC
P/N C13165DA00 or P/N C13165FA00 installed. EASA advises of a report of
an in-flight event where the pilot noticed that the temporary amber
governor (GOV) light had illuminated, followed by the failure of the
vehicle engine monitoring display (VEMD) screens, and no availability
of the automatic or auxiliary engine back-up control ancillary unit
(EBCAU). Subsequent investigation identified an internal failure of the
engine DECU, which led to loss of fuel flow regulation (frozen fuel
metering unit). This failure was not indicated to the pilot by a red
GOV warning light as expected, but with amber GOV indication and loss
of VEMD display instead. EASA also advises that if this fuel metering
unit is frozen in the open position, it may lead to a rotor overspeed,
and if it is frozen in the closed position, it may lead to
unavailability of engine power. EASA states that this condition, if not
addressed, could result in the pilot identifying the type of failure
condition incorrectly, possibly resulting in an improper response.
    Accordingly, and pending the development of a DECU assembly design
improvement, the EASA AD requires incorporating a new procedure into
the Emergency Procedures section of the RFM and informing all flight
crews of the RFM change. EASA considers its AD an interim action and
states that further AD action may follow.
    After EASA issued EASA AD 2013-0287, EASA issued SIB No. 2013-23,
dated December 19, 2013, for Eurocopter AS 350 B3 and EC 130 T2
helicopters with a Turbom[eacute]ca ARRIEL 2D engine installed. The SIB
recommends modifying certain electronic engine control units (EECUs).

Comments

    The FAA received comments from an anonymous commenter. The
commenter stated that the EECU or DECU is an engine component and
requested this be reflected as an engine AD and not an airframe AD. The
commenter further stated that this AD is unnecessary because the flight
manual revision is required as part of the certification of the
aircraft and is already regulatory as the flight manual is an FAA
approved manual. The FAA does not agree; EASA, as the state of design
authority for Airbus Helicopters, determined that the unsafe condition
exists only in the Model AS 350 B3 and EC 130 T2 helicopters.
Additionally, one of the actions mitigating the unsafe condition is
modification of the RFM. Consequently, EASA issued AD 2013-0287 against
the airframe. As the validating authority, the FAA, in accordance with
the bilateral agreement with the European Union, did not find just
cause to change the effectivity for

the FAA AD. Per 14 CFR 21.5, an approved RFM must be presented to the
owner upon delivery of the rotorcraft. Unless required through an
operational certificate or operational specification, the rotorcraft
owner is not required by regulation to adopt flight manual revisions
made after delivery of the rotorcraft. To mandate a change to the RFM
to address the unsafe condition, the FAA must issue an AD.

Conclusion

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA reviewed the relevant
data, considered the comments received, and determined that air safety
requires adopting this AD as proposed. Accordingly, the FAA is issuing
this AD to address the unsafe condition on these helicopters.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Airbus Helicopters ASB AS350-01.00.67 and ASB
EC130-04A004. ASB AS350-01.00.67 applies to Model AS350B3 helicopters
and ASB EC130-04A004 applies to Model EC130T2 helicopters. This service
information provides a new RFM procedure in the event of illumination
of the amber GOV followed by the loss of the VEMD display.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA also reviewed Safran Turbomeca Mandatory Service Bulletin
No. 292 73 2852, Revision B, dated February 12, 2014. This service
information specifies replacing certain FADEC D EECUs with certain
amended FADEC D EECUs.

Differences Between This AD and the EASA AD

    The EASA AD applies to Model AS350B3 and EC130T2 helicopters, with
an ARRIEL 2D engine and THALES FADEC P/N C13165DA00 or P/N C13165FA00
installed, whereas this AD applies to those helicopters except not
those with THALES FADEC P/N C13165DA00 with amendment A or P/N
C13165FA00 with amendment B installed. This AD also allows installing
those amendments on the FADEC as an optional terminating action,
whereas the EASA AD does not.

Costs of Compliance

    The FAA estimates that this AD affects up to 628 helicopters of
U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Revising the existing RFM for your helicopter takes about 0.25
work-hour for an estimated cost of $21 per helicopter and up to $13,188
for the U.S. fleet.

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.
    The FAA is 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 helicopters identified in this rulemaking action.

Regulatory Findings

    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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Amendment

    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 airworthiness
directive:

2021-11-25 Airbus Helicopters (Type Certificate Previously Held by
Eurocopter France): Amendment 39-21587; Docket No. FAA-2017-0432;
Project Identifier 2013-SW-074-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective July 29, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Helicopters (Type Certificate
previously held by Eurocopter France) Model AS350B3 and EC130T2
helicopters, certificated in any category, with an ARRIEL 2D engine
and THALES full authority digital engine control (FADEC) part number
(P/N) C13165DA00 without amendment A or P/N C13165FA00 without
amendment B, installed.

    Note 1 to paragraph (c):  Helicopters with an AS350B3e
designation are Model AS350B3 helicopters.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 7321, Engine Fuel
Control/Turbine Engines.

(e) Unsafe Condition

    This AD was prompted by a report of failure of an engine digital
electronic control unit. The FAA is issuing this AD to prevent
incorrect indicator illumination, display failure, and loss of fuel
flow regulation (frozen fuel metering unit). The unsafe condition,
if not addressed, could result in misleading information to the
pilot, rotor overspeed or unavailability of engine power, and
subsequent loss of control of the helicopter.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) Within 25 hours time-in-service after the effective date of
this AD, revise the Emergency Procedures of the existing Rotorcraft
Flight Manual (RFM) for your helicopter by inserting Appendix 4. of
Airbus Helicopters Alert Service Bulletin (ASB) No. AS350-01.00.67
or ASB No. EC130-04A004, each Revision 2 and dated February 17, 2014
(ASB AS350-01.00.67 or ASB EC130-04A004), as applicable to your
helicopter

model. Inserting a different document with information identical to
that in Appendix 4. of ASB AS350-01.00.67 or ASB EC130-04A004, as
applicable to your helicopter model, is acceptable for compliance
with the requirement of this paragraph.
    (2) As an optional terminating action for the requirement of
paragraph (g)(1) of this AD, install amendment A on FADEC P/N
C13165DA00 or amendment B on FADEC P/N C13165FA00.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (i)(1) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD, contact Jon Jordan,
Rotorcraft Flight Test Pilot, Southwest Section, Flight Test Branch,
FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817)
222-5110; email<EMAIL_ADDRESS>    (2) Safran Turbomeca Mandatory Service Bulletin No. 292 73 2852,
Revision B, dated February 12, 2014, which is not incorporated by
reference, contains additional information about the subject of this
AD. Contact Safran Helicopter Engines, S.A., 64511 Bordes, France;
phone: +33 (0) 5 59 74 45 11 for this service information. You may
view this service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort
Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (3) The subject of this AD is addressed in European Aviation
Safety Agency (now European Union Aviation Safety Agency) (EASA) AD
2013-0287, dated December 5, 2013. You may view the EASA AD at
https://www.regulations.gov in Docket No. FAA-2017-0432.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Airbus Helicopters Alert Service Bulletin No. AS350-
01.00.67, Revision 2, dated February 17, 2014.
    (ii) Airbus Helicopters Alert Service Bulletin No. EC130-04A004,
Revision 2, dated February 17, 2014.
    (3) For Airbus Helicopters service information identified in
this AD, contact Airbus Helicopters, 2701 N Forum Drive, Grand
Prairie, TX 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(972) 641-3775; or at https://www.airbus.com/helicopters/services/technical-support.html.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this 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, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 24, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-13200 Filed 6-23-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 78 (Monday, April 26, 2021)]
[Notices]
[Page 22093]
[FR Doc No: 2021-08594]

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

Federal Aviation Administration

Notice of Intent To Rule on Request for Change in Land Use From
Aeronautical to Non Aeronautical for 16.2 Acres of Land at Pittsfield
Municipal Airport, Pittsfield, MA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for public comments.

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SUMMARY: Notice is being given that the FAA is considering a request
from the Town of Pittsfield, MA to change 16.2 acres of land from
aeronautical to non-aeronautical use for non-aeronautical revenue
generation at Pittsfield Municipal Airport, Pittsfield, MA. The airport
has two projects. The fire project is the installation of a solar farm
and the second is a municipal water tank that will service the airport.
The solar facility will be built on three on airport sites, totaling
15.5 acres, and will produce 6 mW of energy. The power produced will go
into the electrical grid, however, the airport will have a long term
land lease with the solar utility, generating a long term revenue
stream for the airport. The lease revenue will be placed in the
airport's operating and maintenance fund. The municipal water tank will
serve the community as well as the airport, significantly enhancing the
existing airport water system and serve future development on the
airport as well. The tank and access road requires approximately .73
acres and will not interfere with future development of the airport.

DATES: Comments must be received on or before May 26, 2021.

ADDRESSES: You may send comments using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, and follow the instructions on providing comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W 12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Interested persons may inspect the request and supporting documents
by contacting the FAA at the address listed under FOR FURTHER
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:  Mr. Jorge E. Panteli, Compliance and
Land Use Specialist, Federal Aviation Administration New England Region
Airports Division, 1200 District Avenue, Burlington, Massachusetts
01803. Telephone:<PHONE_NUMBER>.

    Authority: 49 U.S.C. 47107(h)(2).

    Issued in Burlington, Massachusetts on April 21, 2021.
Julie Seltsam-Wilps,
Deputy Director, ANE-600.
[FR Doc. 2021-08594 Filed 4-23-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: May 24, 2007 (Volume 72, Number 100)]
[Notices]
[Page 29145]
[DOCID:fr24my07-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER07-608-000, ER07-608-001, and ER07-608-002]

Gerdau Ameristeel Energy, Inc.; Notice of Issuance of Order

May 18, 2007.
    Gerdau Ameristeel Energy, Inc. (Gerdau) filed an application for
market-based rate authority, with an accompanying rate schedule. The
proposed market-based rate schedule provides for the sale of energy,
capacity and ancillary services at market-based rates. Gerdau also
requested waivers of various Commission regulations. In particular,
Gerdau requested that the Commission grant blanket approval under 18
CFR part 34 of all future issuances of securities and assumptions of
liability by Gerdau.
    On May 17, 2007, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the requests
for blanket approval under part 34 (Director's Order). The Director's
Order also stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard concerning the
blanket approvals of issuances of securities or assumptions of
liability by Gerdau should file a protest with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing protests is
June 18, 2007.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Gerdau is authorized to issue
securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Gerdau compatible with the
public interest, and is reasonably necessary or appropriate for such
purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Gerdau's issuance of securities or assumptions
of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-9977 Filed 5-23-07; 8:45 am]

BILLING CODE 6717-01-P


Allen Basala/ RTP/ USEPA/ US 08/ 31/ 2005 03: 16 PM To Amy_ E._ Flynn@ omb. eop. gov cc Jim Ketcham Colwill/ DC/ USEPA/ US@ EPA, John Silvasi/ RTP/ USEPA/ US@ EPA, Jan Tierney/ DC/ USEPA/ US@ EPA, Thomas Gillis/ DC/ USEPA/ US@ EPA, Peter Nagelhout/ DC/ USEPA/ US@ EPA, Larry Sorrels/ RTP/ USEPA/ US@ EPA, Ron Evans/ RTP/ USEPA/ US@ EPA, Jason Burnett/ DC/ USEPA/ US@ EPA Subject Per discussion Amy,

I have attached redline strikes of the difference analysis as well as appendix B. Here are the changes made to each p our discussions this morning. Also, we had inadvertently left off a change agreed to with Margo S. several days ago.

I assume this completes the changes to the economics package.

Allen O: 919 541 5622 H: 919 467 4584 Change to the title of Appendix B.

Impact of Selected Federal and Local Measures on Predicted 8 hour Design Values in the Eastern U. S. Illustrative Control Strategies and Projected 2010 8 hour Ozone Levels in 16 Nonattainment Areas Change to page 4 Appendix B wording on model versus data limitations.

As used in this analysis, AirControlNET included a broad menu of stationary source control measures ( e. g., ad on control technologies and combustion controls) but did not provide a comprehensive menu of existing controls know to be available for all types of sources. For example, due to model limitations a lack of data on the percentage of emiss reductions and associated costs, the analysis did not consider additional state strategies to reduce emissions from fuels, highway vehicles, or non road engines. The model also is limited in terms of the This lack of data also limited the number of control measures considered in area emissions sectors.

Emission reduction possibilities are considered within and nearby the non attainment area. 5 5These area are within state but not more than 100 km for VOC emissions and no more than 200 km for NOx emissions. The controls are presented on a cost per ton of VOC or NOx reduced and put in ascending order. Controls are selected until the emission reduction target is met or until a cost per ton level of $ 10,000 is reached. This limitation was used in this analysis to avoid large upward biases in the control cost in view of the limited number of control measures that cou be considered for selection in the local control strategy.

Change on page 10 to delete the introductory sentence.

Ozone Mortality Health Benefits. Ozone mortality is one category where new studies suggest significant additional economic benefits.

Change to the title page of the difference analysis Appendix B: Impact of Selected Federal and Local Control Measures on Predicted 8 hour Desi Values in the Eastern U. S. Illustrative Control Strategies and Projected 2010 8 hour Ozone Levels in 16 Nonattainment Areas Changes to the difference analysis Section 6.1 Achieving targeted tarted reductions from certain EGUs can lower the overall cost of the local attainment strategy where the incremental cost of targeted EGU emission reductions is less than the cost of achieving similar reductions and air quality improvements from other types of sources.

The intent of these consultations would not be to upset market behavior or incentives. Furthermore Rather, w anticipate that these consultations will affect individual control decisions for a few areas.

Changes to the difference analysis Section 6.2 For Subpart 2 areas that are classified as moderate or higher choosing to use the 2004 emissions inventory, th RFP requirement must be met at the start of the ozone season in 2009. In moderate areas with a 12 month ozone season, the RFP requirement would have to be met by 1 01 09.


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. EPA, Manufacturing, Energy and Transportation Div. 2. OMB control number b. G None a 2 0 6 0  0 0 8 0 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS CFR 40, Part 60, Subpart L  Secondary Lead Smelters 8. Agency form number( s) ( If applicable) 112 8. 06 9. Keywords Air pollution control , Environmental Protection 10. Abstract Owners or operators of secondary lead smelters subject to NSPS must notify EPA of construction, reconstruction, modification, anticipated and actual startup dates, and results of performance tests. Records of performance test results, startups, shutdowns, and malfunctions must be maintained to ensure compliance.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 23 b. Total annual responses 23 1. Percentage of these responses collected electronically 10 % c. Total annual hours requested 35 d. Current OMB inventory 35 e. Difference 0 f. Explanation of difference 1. Program Change 2. Adjustment 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. _ X_ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. Q Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe) Initial startup, Construction, reconstruction, modification, performance tests 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Deborah Thomas Phone: 202 564 5041 OMB 83 I 10/ 95


[Federal Register: January 29, 2008 (Volume 73, Number 19)]
[Notices]
[Page 5245-5246]
[DOCID:fr29ja08-103]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

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

Extension:
    Rule 19b-4 and Form 19b-4; OMB Control No. 3235-0045; SEC File
No. 270-38.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for approval of extension of the existing
collection of information provided for in the following rule: Rule 19b-
4 (17 CFR 240.19b-4).
    Section 19(b) of the Securities Exchange Act of 1934 (``Act'') (15
U.S.C. 78s(b)) requires each self-regulatory organization (``SRO'') to
file with the Commission copies of any proposed rule, or any proposed
change in, addition to, or deletion from the rules of such SRO. Rule
19b-4 implements the requirements of Section 19(b) by requiring the
SROs to file their proposed rule changes on Form 19b-4 and by
clarifying which actions taken by SROs are deemed proposed rule changes
and so must be filed pursuant to Section 19(b).
    The collection of information is designed to provide the Commission
with the information necessary to determine, as required by the Act,
whether the proposed rule change is consistent with the Act and the
rules thereunder. The information is used to determine if the proposed
rule change should be approved or if proceedings should be instituted
to determine whether the proposed rule change should be disapproved.
    The respondents to the collection of information are self-
regulatory organizations (as defined by the Act), including national
securities exchanges, national securities associations, registered
clearing agencies and the Municipal Securities Rulemaking Board.
    Twenty-two respondents file an average total of 1,279 responses per
year. Each response takes approximately 23.22 hours to complete. Thus,
the estimated annual response burden is 29,698 hours. At an average
cost per response of $6,150.31, the resultant total related cost of
compliance for these respondents is $7,866,246 per year (1,279
responses x $6,150.31/response = $7,866,246).
    Compliance with Rule 19b-4 is mandatory. Information received in
response to Rule 19b-4 shall not be kept confidential; the information
collected is public information.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments should be directed to (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312 or send an e-
mail to<EMAIL_ADDRESS>Comments

must be submitted within 30 days of this notice.

    Dated: January 16, 2008.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-1506 Filed 1-28-08; 8:45 am]

BILLING CODE 8011-01-P


IMPORTANT NOTE TO USER:

The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font ( Times New Roman 8pt).

 Do not change table lines ( although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5.1, so the text will scramble.

If you have any problems or questions, please call your OEI Desk Officer. PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ OECA/ OC 2. OMB control number b. X None a__ __ __ __  __ __ __ __ 2 0 2 0 3. Type of information collection ( check one) a. X New collection b. G Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title: State Review Framework 8. Agency form number( s) ( If applicable) : 2185.01 9. Keywords: Framework, oversight, consistent, results, data, Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act 10. Abstract: The State Review Framework (" Framework") is an oversight tool designed to assess state performance in enforcement and compliance assurance. The Framework's goal is to evaluate state performance by examining existing data to provide a consistent level of oversight and develop a uniform mechanism by which EPA Regions, working collaboratively with their states, can ensure that state lead environmental agencies are consistently implementing the national compliance and enforcement program in order to meet agreed upon goals. Furthermore, the Framework is designed to foster dialogue on enforcement and compliance performance between the states that will enhance relationships and increase feedback, which will in turn lead to consistent program management and improved environmental results. Specifically, the Framework is a structured process that creates a comprehensive picture of a state's ( or Region's, for states with EPA implemented programs) enforcement and compliance assurance performance by employing existing data available in EPA's existing national database and categorized in management reports for each state. By the end of calender year 2005 EPA expects to automate the management reports and make them available to the Regions and States. No new data collection is required for the national databases. Additional data will be obtained from the review of a state environmental agency's compliance and enforcement files. While no new data is required to be created in these files; this ICR covers the provision and examination of a state's files for the purposes of ensuring the state's practices and performance are consistent with agreed upon procedures. The Framework process asks state and local governments to examine the existing data described above and account for their enforcement and compliance activities in three core programs: Clean Air Act (" CAA"), Stationary Sources; Clean Water Act (" CWA"), National Pollutant Discharge Elimination System (" NPDES"); and Resource Conservation and Recovery Act (" RCRA"), Subtitle C. The Framework process looks at thirteen ( 13) elements. The EPA evaluates the twelve ( 12) primary elements, and a thirteenth optional element, using data and file review metrics that require no new reporting burden.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. Business or other for profit e. X Federal Government c. Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 40 b. Total annual responses 13 1. Percentage of these responses collected electronically 100 % c. Total hours requested 5,122 d. Current OMB inventory 0 e. Difference 5,122 f. Explanation of difference 1. Program Change 5,122 2. Adjustment 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. P Program planning or management b. X Program evaluation f. __ Research c. __ General purpose statistics g. __ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. X Other ( describe) Every 3 years 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Arthur Horowitz Phone: ( 202) 564 2612 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Page 16176]
[FR Doc No: 2022-06019]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
                  Docket Nos.                    File date                  Presenter or requester
----------------------------------------------------------------------------------------------------------------
Prohibited:
    1. CP16-10-000............................     3-3-2022  FERC Staff.\1\
        CP21-57-000
    2. CP21-57-000............................     3-7-2022  FERC Staff.\2\
    3. CP16-10-000............................    3-15-2022  FERC Staff.\3\
        CP21-57-000
Exempt:
    None......................................
----------------------------------------------------------------------------------------------------------------
\1\ Emailed comments dated 3/3/22 from Steve Legge.
\2\ Memorandum regarding ex parte communication from February 2022 with Dennis Tidrig and 11 other individuals.
\3\ Emailed comments dated 3/15/22 from Steve Legge.

    Dated: March 16, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-06019 Filed 3-21-22; 8:45 am]
BILLING CODE 6717-01-P