[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Proposed Rules]
[Pages 44326-44329]
[FR Doc No: 2021-17187]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0623]
RIN 1625-AA00

Safety Zone; M/V ZHEN HUA 24, Crane Delivery Operation,
Chesapeake Bay and Coastal Virginia

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a temporary moving
safety zone around M/V ZHEN HUA 24 during its transit through certain
waters of the Chesapeake Bay and Coastal Virginia. This action is
necessary to provide for the safety of life on these navigable waters
during the movement of the M/V ZHEN HUA 24 while it is transporting
four new Super-Post Panamax container cranes to the Port of Baltimore,
anticipated to arrive between September 4, 2021, and September 29,
2021. The Captain of the Port Virginia has determined that limited
maneuverability and unique cargo of this vessel are potential hazardous
to any person or vessel within the proposed safety zone. This proposed
rulemaking would prohibit persons and vessels from being in the safety
zone unless authorized by the Captain of the Port Virginia or a
designated representative. We invite your comments on this proposed
rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before August 23, 2021.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0623 using the Federal Decision Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Commander Ashley Holm,
Sector Virginia Waterways Management division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
CBBT Chesapeake Bay Bridge-Tunnel
COTP Captain of the Port

II. Background, Purpose, and Legal Basis

    On June 28, 2021, Ports America Chesapeake, LLC notified the Coast
Guard that the M/V ZHEN HUA 24 will be transporting four new Super-Post
Panamax container cranes to the Port of Baltimore. The vessel transit
is taking place from Shanghai, China. The M/V ZHEN HUA 24 is
anticipated to arrive between September 4, 2021, and September 29,
2021. The current estimated arrival date is September 5, 2021, but is
subject to change. These cranes will be delivered to, and installed at,
the Seagirt Marine Terminal at Baltimore, MD.
    The cranes exceed the beam of the M/V ZHEN HUA 24 on the port side
by approximately 129 feet and on the starboard side by approximately 40
feet. The total beam for the vessel with the cranes aboard is
approximately 300 feet. The maximum height of the cranes aboard the
vessel is approximately 326

feet. This beam width and cargo height will severely restrict the M/V
ZHEN HUA 24's ability to maneuver and create a hazard to navigation if
required to meet or pass other large vessels transiting the navigation
channels. Because of the size of the cargo and the width of the
navigation channels, vessels will not be able to transit safely around
the M/V ZHEN HUA 24 at close distances. During the inbound transit of
the M/V ZHEN HUA 24 the vessel will travel from sea into the Chesapeake
Bay, crossing the Chesapeake Bay Bridge-Tunnel (CBBT) and then
proceeding north toward Baltimore. During this time safety concerns
will be heightened due to the importance of CBBT and the Chesapeake's
sensitive estuary environment. Hazards associated with the movement of
a large freight vessel with an oversized cargo severely restricted in
its ability to maneuver while transiting confined shipping channels
include injury or loss of life and damage to property and the
environment resulting from collisions with other vessels. The COTP
Virginia has determined that potential hazards associated with the
crane delivery operation would be a safety concern for any vessel
required to transit the navigation channels in the Chesapeake Bay and
Coastal Virginia that would meet, pass, or overtake the M/V ZHEN HUA
24. These hazards can be mitigated with a 500 yard radius safety zone
around the vessel.
    The Coast Guard is requesting that interested parties provide
comments within a shortened comment period of 10 days instead of the
typical 30 days for this notice of proposed rulemaking. The Coast Guard
believes the 10-day comment period still provides for a reasonable
amount of time for interested parties to review the proposal and
provide informed comments on it while also ensuring that the Coast
Guard has time to review and respond to any significant comments and
has a final rule in effect in time for the scheduled event in order to
protect against the identified hazards.
    The Coast Guard is proposing this rulemaking under authority in 46
U.S.C. 70034 (previously 33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP is proposing to establish a temporary moving safety zone
with a radius of 500 yards centered around the M/V ZHEN HUA 24 during
the inbound transit through the territorial sea and the Chesapeake Bay
to Baltimore, MD. The M/V ZHEN HUA 24 is currently anticipated to
arrive at Baltimore sometime between September 4, 2021, and September
29, 2021. The current estimated arrival date is September 4, 2021, but
is subject to change. The inbound transit is expected to last
approximately 15 hours.
    Enforcement of the safety zone would begin when M/V ZHEN HUA 24
crosses the 12-mile line into the U.S.-Territorial Sea and end when the
vessel crosses the Virginia-Maryland state line. This enforcement
period would be broadcast to mariners via email, VHF-FM radio
notifications, and by COTP representatives on scene.
    The duration of the zone is intended to ensure the safety of
vessels and protect the environment and critical national
infrastructure such as the Chesapeake Bay bridge-tunnel during the
vessels transit to Baltimore. No vessel or person would be permitted to
enter the safety zone without obtaining permission from the COTP or a
designated representative.
    The regulatory text we are proposing appears at the end of this
document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size and
duration of the safety zone, which would impact only vessel traffic
required to transit certain navigation channels of the Chesapeake Bay
and the Coastal Virginia for an expected total no more than 15
enforcement-hours. Although these waterways support both commercial and
recreational vessel traffic, small portions of the waterway would be
restricted for a small period of time as the M/V ZHEN HUA 24 transits
northward in the Chesapeake Bay. Moreover, the Coast Guard would issue
a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent

with the fundamental federalism principles and preemption requirements
described in Executive Order 13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a
temporary safety zone that would prohibit entry within certain
navigable waters of the Chesapeake Bay and Coastal Virginia. Normally
such actions are categorically excluded from further review under
paragraph L60c of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 1. A Memorandum for the Record supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2021-0623 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T05-0623 to read as follows:

Sec.  165.T05-0623  Safety Zone; M/V ZHEN HUA 24, Crane Delivery
Operation, Chesapeake Bay and Coastal Virginia

    (a) Regulated Area. The rule establishes the following regulated
area as a temporary moving safety zone: All waters within a 500 yards
radius of the M/V ZHEN HUA 24 during its inbound transit to Baltimore,
MD. Inbound transit will begin when the M/V ZHEN HUA enters the U.S.
Territorial Sea, as defined in 33 CFR 2.22(a)(1), and end when the
vessel crosses the Virginia- Maryland State Line in the Chesapeake Bay,
a line starting at a point 38[deg]01'36'' N latitude, 75[deg]14'34'' W
longitude, then south east to a point 37[deg]19'14'' N latitude,
72[deg]13'13'' W longitude. These coordinates are based on WGS 84.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) means the Commander, U.S. Coast Guard
Sector Virginia.
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port Virginia (COTP) in
the enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by telephone at<PHONE_NUMBER> or on Marine Band Radio
VHF-FM channel 16 (156.8 MHz). Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.

    (3) The Coast Guard will provide notice of the regulated area by
Marine Safety Information Bulletins, Local Notice to Mariners,
Broadcast Notice to Mariners, and on-scene designated representatives.
    (d) Enforcement officials. The U.S. Coast Guard may be assisted in
the patrol and enforcement of the safety zone by Federal, State, and
local agencies.
    (e) Enforcement period. This section will be enforced during
inbound transit of the M/V ZHEN HUA 24 through Coastal Virginia and
Chesapeake Bay on the way to the Port of Baltimore.

    Dated: August 6, 2021.
Jennifer A. Stockwell,
Captain, U.S. Coast Guard, Alternate Captain of the Port Virginia.
[FR Doc. 2021-17187 Filed 8-11-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Proposed Rules]
[Pages 68714-68716]
[FR Doc No: 2012-27824]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1055; Directorate Identifier 2012-NE-33-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Rolls-Royce Deutschland Ltd & Co KG (RRD) BR700-710A1-10 and BR700-
710A2-20 turbofan engines, and certain BR700-710C4-11 model engines.
This proposed AD was prompted by RRD performing an evaluation that
determined that certain high-pressure turbine (HPT) stage 1 and stage 2
discs from a specific supplier may contain steel inclusions that may
cause the discs to fail before they reach their current life limits.
This proposed AD would require reducing the life limits for certain HPT
stage 1 and stage 2 discs. We are proposing this AD to prevent failure
of the HPT stage 1 and stage 2 discs, which could result in uncontained
failure of the engine and damage to the airplane.

DATES: We must receive comments on this proposed AD by January 15,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    For service information identified in this proposed AD, contact
Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, Dahlewitz, 15827
Blankenfelde-Mahlow, Germany; phone: 49 0 33-7086-1883; fax: 49 0 33-
7086-3276. You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA.
For information on the availability of this material at the FAA, call
781-238-7125.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Robert Morlath, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-1055;
Directorate Identifier 2012-NE-33-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2012-0166, dated August 30, 2012 (referred to hereinafter as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    The results of a recent quality review of high pressure turbine
(HPT) stage 1 and stage 2 discs identified potential for steel
inclusions in some production scale parts. Further investigation
concluded that all affected parts were manufactured by Udimet 720I
and melted by a certain supplier. Subsequent evaluation concluded
that the affected parts life limitation values declared in the
engine Time Limits Manual cannot be supported for discs with
potential steel inclusion.
    This condition, if not corrected, could lead to an uncontained
HPT disc failure, potentially resulting in damage to, and/or reduced
control of the aeroplane.

The FAA has further determined that the risk to the engine is increased
by installing an HPT stage 1 disc and an HPT stage 2 disc from the
affected population, on the same engine. Therefore the FAA is
prohibiting the installation of an HPT stage 1 and HPT stage 2 disc
from the affected population in the same engine. You may obtain further
information by examining the MCAI in the AD docket.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of
Germany, and is approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, they have notified us of the
unsafe condition described in the MCAI and service information
referenced above. We are proposing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design. This proposed AD would require reducing the life limits for
certain HPT stage 1 and HPT stage 2 discs that have a serial number
listed in this proposed AD.

Costs of Compliance

    We estimate that this proposed AD would affect about 10 engines
installed on airplanes of U.S. registry. Prorated parts life will cost
about $210,000. Based on these figures, we estimate the cost of the
proposed AD on U.S. operators to be $2,100,000. Our cost estimate is
exclusive of possible warranty coverage.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

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

Rolls-Royce Deutschland Ltd & Co KG (Formerly Rolls-Royce
Deutschland GmbH, formerly BMW Rolls-Royce GmbH): Docket No. FAA-
2012-1055; Directorate Identifier 2012-NE-33-AD.

(a) Comments Due Date

    We must receive comments by January 15, 2013.

(b) Affected Airworthiness Directives (ADs)

    None.

(c) Applicability

    This AD applies to the following Rolls-Royce Deutschland Ltd &
Co KG (RRD) turbofan engines that have any of the high-pressure
turbine (HPT) stage 1 or stage 2 discs with a serial number (S/N)
listed in Table 1 to paragraph (c) of this AD, installed:
    (1) RRD BR700-710A1-10 and BR700-710A2-20 turbofan engines; and
    (2) BR700-710C4-11 model engines that have hardware
configuration standard 710C4-11 or 710C4-11/10 engraved on the
engine data plate.

    Table 1 to Paragraph (c)--Affected HPT Stage 1 and Stage 2 Discs
------------------------------------------------------------------------
S/Ns of HPT Stage 1 discs, Part No.     S/Ns of HPT Stage 2 discs, P/N
           (P/N) BRR23952                          BRR22008
------------------------------------------------------------------------
             LDRQA05719                           LDRQA05791
             LDRQA05720                           LDRQA05944
             LDRQA05721                           LDRQA05945
             LDRQA05722
             LDRQA05723
             LDRQA05724
             LDRQA05726
             LDRQA05727
             LDRQA05841
             LDRQA05842
------------------------------------------------------------------------

(d) Reason

    This AD was prompted by RRD performing an evaluation that
determined that certain HPT stage 1 and stage 2 discs from a
specific supplier may contain steel inclusions that may cause the
discs to fail before they reach their current life limits. We are
issuing this AD to prevent failure of the HPT stage 1 and stage 2
discs, which could result in uncontained failure of the engine and
damage to the airplane.

(e) Actions and Compliance

    Unless already done, remove from service the HPT stage 1 and
stage 2 discs listed by S/N in Table 1 to paragraph (c) of this AD,
at the following:
    (1) For BR700-710A1-10, BR700-710A2-20, and BR700-710C4-11
engine models (without RRD Mod 72-101466), remove the HPT stage 1
and stage 2 discs from service before accumulating 3,000 cycles-
since-new (CSN).
    (2) For the BR700-710C4-11 engine model (with RRD Mod 72-
101466), remove the HPT stage 1 and stage 2 discs from service
before accumulating 2,300 CSN.

(f) Installation Prohibition

    After the effective date of this AD, do not install an HPT stage
1 and an HPT stage 2 disc, identified by S/N in Table 1 to paragraph
(c) of this AD, in the same engine.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(h) Related Information

    (1) For more information about this AD, contact Robert Morlath,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to European Aviation Safety Agency Airworthiness
Directive 2012-0166, dated August 30, 2012, and Rolls-Royce
Deutschland Ltd & Co KG Alert Service Bulletin SB-BR700-72-A900508,
dated July 26, 2012, for related information. Contact Rolls-Royce
Deutschland Ltd & Co KG, Eschenweg 11, Dahlewitz, 15827
Blankenfelde-Mahlow, Germany; phone: 49 0 33-7086-1883; fax: 49 0
33-7086-3276, for a copy of this service information.
    (3) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on November 5, 2012.
Colleen M. D'Alessandro,
Assistant Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2012-27824 Filed 11-15-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Rules and Regulations]
[Pages 75495-75496]
[FR Doc No: 2022-26814]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 296

[Docket ID FEMA-2022-0037]
RIN 1660-AB14

Notification of Public Meetings on Hermit's Peak/Calf Canyon Fire
Assistance

AGENCY: Federal Emergency Management Agency (FEMA), Department of
Homeland Security (DHS).

ACTION: Announcement of additional in-person public meetings.

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SUMMARY: FEMA will hold additional in-person public meetings to solicit
public feedback about the Hermit's Peak/Calf Canyon Fire Assistance
interim final rule. FEMA is issuing this public meeting notification to
inform the public that FEMA is seeking input on the procedures for
claimants to seek compensation for injury or loss of property resulting
from the Hermit's Peak/Calf Canyon Fire.

DATES: Written comments in response to these public meetings may be
submitted until 11:59 p.m. Eastern Time (ET) on January 13, 2023. Late-
filed comments will be considered to the extent practicable. FEMA will
hold additional meetings on:

January 4, 2023, 5:30-7:00 p.m. MDT, Pe[ntilde]asco, New Mexico
January 9, 2023, 5:30-7:00 p.m. MDT, Angel Fire, New Mexico

    Depending on the number of speakers, the meetings may end before
the time indicated, following the last call for comments.

ADDRESSES: The additional public meetings will be held at the following
locations:

January 4, 2023 meeting at 13 School Road, Pe[ntilde]asco, NM 87553
January 9, 2023 meeting at 1 First National Place, Angel Fire, NM 87710

    Reasonable accommodations are available for people with
disabilities. To request a reasonable accommodation, contact the person
listed in the FOR FURTHER INFORMATION CONTACT section below as soon as
possible. Last minute requests will be accepted but may not be possible
to fulfill. Written comments related to these public meetings must be
submitted through the Federal eRulemaking Portal at https://www.regulations.gov. Search for FEMA-2022-0037 and follow the
instructions for submitting comments. All written comments received,
including any personal information provided, may be posted without
alteration at https://www.regulations.gov. All comments on the request
for information made during the meetings will be posted to https://www.regulations.gov, Docket ID FEMA-2022-0037.

FOR FURTHER INFORMATION CONTACT: Angela Gladwell, Office of Response
and Recovery,<PHONE_NUMBER>, [email protected]. Persons
with hearing or speech challenges may access this number through TTY by
calling the toll-free Federal Relay Service at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On September 30, 2022, President Biden
signed into law the Hermit's Peak/Calf Canyon Fire Assistance Act
(``Act'') as part of the Continuing Appropriations and Ukraine
Supplemental Appropriations Act, 2023, Public Law 117-180, 136 Stat.
2114 (2022). The Act provides compensation to injured persons impacted
by the Hermit's Peak/Calf Canyon Fire (Fire). It requires FEMA to
design and administer a claims program to compensate victims, for
injuries resulting from the fire and to provide for the expeditious
consideration and settlement for those claims and injuries. The Act
further directs FEMA to establish an arbitration process for disputes
regarding claims.
    On November 14, 2022, FEMA published an interim final rule (IFR)
establishing the procedures for the processing and payment of claims to
those injured by the Fire sustaining property, business, and/or
financial losses.\1\ The IFR requested public comment on these
procedures through January 13, 2022. FEMA's procedures in this IFR are
generally consistent with prior processes established for claims
associated with the Cerro Grande Fire Assistance Act.\2\ The first step
in the

claims process under this IFR (see, 44 CFR part 296) is for the
claimant to file a Notice of Loss with the Office of Hermit's Peak/Calf
Canyon Fire Claims (``Claims Office''). After receipt and
acknowledgement by the Claims Office, a Claims Reviewer will contact
the claimant to review the claim and help the claimant formulate a
strategy for obtaining any necessary supporting documentation to
complete the Proof of Loss. After discussion of the claim with the
Claims Reviewer, the claimant will review and sign a Proof of Loss and
submit it to the Claims Office. The Claims Reviewer will submit a
report to the Authorized Official for review to determine whether
compensation is due to the claimant. Once that review is completed, the
Authorized Official's written decision will be provided to the
claimant. If satisfied with the decision, the claimant will receive
payment after returning a completed Release and Certification Form. If
the claimant is not satisfied with the decision, they may file an
Administrative Appeal with the Director of the Claims Office. If the
claimant is not satisfied after appeal, the dispute may be resolved
through binding arbitration or heard in the United States District
Court for the District of New Mexico.
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    \1\ 87 FR 68085.
    \2\ The Cerro Grande Fire Assistance Act (Pub. L. 106-246
(2001)) required FEMA to design and administer a program for fully
compensating those who suffered injuries resulting from the Cerro
Grande Fire. The Cerro Grande fire resulted from a prescribed fire
ignited on May 4, 2000, by National Park Service fire personnel at
the Bandelier National Monument, New Mexico under an approved
prescribed fire plan. That fire burned approximately 47,750 acres
and destroyed over 200 residential structures. The Cerro Grande Fire
Assistance Act process is detailed in an interim final rule (65 FR
52259 (Aug. 27, 2000)) and a final rule (66 FR 15847 (Mar. 21,
2001)) that is now codified at 44 CFR part 295.
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    The IFR also announced that FEMA would hold four in-person public
meetings to seek feedback on the procedures for processing and payment
of claims to those injured by the Fire sustaining property, business,
and/or financial loss. This document announces that FEMA will hold two
additional public meetings. FEMA is holding these additional public
meetings to ensure that all interested parties have sufficient
opportunity to provide comments on the IFR during the comment period.
FEMA received a request to provide video conferencing at upcoming
public meetings. As these meetings are not held in FEMA facilities, the
Agency is unable to offer video conferencing. Transcripts of the
meetings will be posted to the public docket and FEMA will also post
transcripts of the meetings to https://www.fema.gov/hermits-peak. FEMA
will carefully consider all relevant comments received during the
public meetings and during the IFR comment period closing on January
13, 2023. All comments or remarks provided on the request for
information during the meeting will be transcribed and posted to the
rulemaking docket on https://www.regulations.gov.

Erik A. Hooks,
Deputy Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-26814 Filed 12-8-22; 8:45 am]
BILLING CODE 9111-68-P


[Federal Register Volume 77, Number 79 (Tuesday, April 24, 2012)]
[Rules and Regulations]
[Pages 24397-24399]
[FR Doc No: 2012-9814]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0136-201162; FRL-9662-8]

Approval and Promulgation of Implementation Plans: Georgia;
Approval of Substitution for Transportation Control Measures

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; notice of administrative change.

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SUMMARY: EPA is making an administrative change to update the Code of
Federal Regulations (CFR) to reflect a change made to the Georgia State
Implementation Plan (SIP) on November 5, 2009, as a result of EPA's
concurrence on a substitute transportation control measure (TCM) for
the Atlanta portion of the Georgia SIP. On February 5, 2010, the State
of Georgia, through the Environmental Protection Division (EPD),
submitted a revision to the Georgia SIP requesting that EPA update its
SIP to reflect a substitution of a TCM. The substitution was made
pursuant to the TCM substitution provisions contained in Clean Air Act
(CAA). EPA concurred on this substitution on November 5, 2009. In this
administrative action, EPA is updating the non-regulatory provisions of
the Georgia SIP to reflect the substitution. In summary, the
substitution that EPA concurred on was a conversion of high occupancy
vehicle (HOV) lanes to high occupancy toll lanes (HOT). EPA has
determined that this action falls under the ``good cause'' exemption in
the Administrative Procedures Act (APA) which, upon finding ``good
cause,'' authorizes agencies to dispense with public participation
which allows an agency to make an action effective immediately (thereby
avoiding the 30-day delayed effective date otherwise provided for in
the APA).

DATES: This action is effective April 24, 2012.

ADDRESSES: SIP materials which are incorporated by reference into 40
Code of Federal Regulations (CFR) part 52 are available for inspection
at the following location: Environmental Protection

Agency, Region 4, 61 Forsyth Street SW., Atlanta, GA 30303. Publicly
available materials are available either electronically in
www.regulations.gov or in hard copy at the Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 to 4:30,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Ms. Dianna B. Smith at the above
Region 4 address or at<PHONE_NUMBER>. Ms. Smith may also be contacted
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On November 5, 2009, EPA issued a
concurrence letter to Georgia stating that the substitution of a HOT
lane TCM for an existing HOV lane TCM met the CAA section 176(c)(8)
requirements for substituting TCMs in an area's approved SIP. See also
EPA's Guidance for Implementing the CAA section 176(c)(8)
Transportation Control Measure Substitution and Addition Provision
contained in the Safe, Accountable, Flexible, Efficient Transportation
Equity Act: A Legacy for Users which was signed into law on August 10,
2005, dated January 2009. This substitution was an update to TCMs
previously approved on March 18, 1999, and April 26, 1999. As a part of
the concurrence process, the public was provided an opportunity to
comment on proposed TCM substitution. Public notice and comment was
provided by the Atlanta metropolitan planning organization, Atlanta
Regional Commission (ARC), during the revision to the transportation
improvement program to incorporate the HOT lane substitution project.
The public notice was published in the Daily Report and on the ARC Web
page at: www.atlantaregional.com. Through this concurrence process, EPA
determined that the requirements of CAA section 176(c)(8) were met,
including the requirement that the substitute measures achieve
equivalent or greater emissions reductions than the control measure to
be replaced. Upon EPA's concurrence, the HOT lane substitution took
effect as a matter of federal law. A copy of EPA's concurrence letter
is included in the Docket for this action. This letter can be accessed
at www.regulations.gov using Docket ID No. EPA-R04-OAR-2012-0136. In
accordance with the requirements for TCM substitution, on February 5,
2010, EPD submitted a request for EPA to update the Atlanta portion of
the Georgia SIP to reflect EPA's previous approval of the TCM
substitution of the HOV lane with the HOT lane conversion TCM in its
SIP (the subject of this administrative change). Today, EPA is taking
administrative action to update the non-regulatory provisions of the
Georgia SIP in 40 CFR 52.570(e) to reflect EPA's concurrence on the
substitution of a TCM for the conversion of HOV lanes to HOT lanes:

------------------------------------------------------------------------
                                   Applicable
  Name of nonregulatory SIP       geographic or     State submittal date/
          provision            nonattainment area      effective date
------------------------------------------------------------------------
1. High Occupancy Vehicle     Atlanta Metropolitan  11/15/93 and amended
 (HOV) lane on I-85 from       Area.                 on 6/17/96 and 2/5/
 Chamblee-Tucker Road to                             10.
 State Road 316 High
 Occupancy Toll (HOT) lane
 on I-85 from Chamblee-
 Tucker Road to State Road
 316.
------------------------------------------------------------------------

    EPA has determined that today's action falls under the ``good
cause'' exemption in the section 553(b)(3)(B) of the APA which, upon
finding ``good cause,'' authorizes agencies to dispense with public
participation and section 553(d)(3) which allows an agency to make an
action effective immediately (thereby avoiding the 30-day delayed
effective date otherwise provided for in the APA). Today's
administrative action simply codifies provisions which are already in
effect as a matter of law in Federal and approved state programs.
    Under section 553 of the APA, an agency may find good cause where
procedures are ``impractical, unnecessary, or contrary to the public
interest.'' Public comment for this administrative action is
``unnecessary'' because the substitution was made through the process
included in CAA section 176(c)(8) and because the public already had an
opportunity to comment on this substitution during the public comment
period prior to approval of the substitution. Immediate notice of this
action in the Federal Register benefits the public by providing the
public notice of the updated Georgia SIP Compilation and
``Identification of Plan'' portion of the Federal Register.

Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
administrative action is not a ``significant regulatory action'' and is
therefore not subject to review by the Office of Management and Budget.
This action is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866. Because the
Agency has made a ``good cause'' finding that this action is not
subject to notice-and-comment requirements under the APA or any other
statute as indicated in the Supplementary Information section above, it
is not subject to the regulatory flexibility provisions of the
Regulatory Flexibility Act (5 U.S.C 601 et seq.), or to sections 202
and 205 of the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L.
104-4). In addition, this action does not significantly or uniquely
affect small governments or impose a significant intergovernmental
mandate, as described in sections 203 and 204 of UMRA.
    This administrative action also does not have a substantial direct
effect on one or more Indian tribes, on the relationship between the
federal government and Indian tribes, or on the distribution of power
and responsibilities between the federal government and Indian tribes,
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
nor will it have substantial direct effects on the states, on the
relationship between the national government and the states, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999).
    This administrative action also is not subject to Executive Order
13045 (62 FR 19885, April 23, 1997), because it is not economically
significant. This administrative action does not involve technical
standards; thus the requirements of section 12(d) of the

National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) do not apply. The administrative action also does not involve
special consideration of environmental justice related issues as
required by Executive Order 12898 (59 FR 7629, February 16, 1994). This
administrative action does not impose an information collection burden
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Submission to Congress and the Comptroller General

    The Congressional Review Act (CRA) (5 U.S.C. 801 et seq.), as added
by the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. Section 808 allows the issuing agency to
make a rule effective sooner than otherwise provided by the CRA if the
agency makes a good cause finding that notice and public procedure is
impracticable, unnecessary or contrary to the public interest. Today's
administrative action simply codifies a provision which is already in
effect as a matter of law in Federal and approved state programs. 5
U.S.C. 808(2). These announced actions were effective upon EPA's
concurrence. EPA will submit a report containing this action and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this action in the Federal Register. This update to
Georgia's SIP Compilation is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: March 29, 2012.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.

    40 CFR part 52, is amended as follows:

PART 52--[AMENDED]

0
1. The authority for citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart L--Georgia

0
2. Section 52.570(e), is amended by revising the first entry ``1. High
Occupancy Vehicle (HOV) lane on I-85 from Chamblee-Tucker Road to State
Road 316'' to read as follows:

Sec.  52.570  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Georgia Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
    Name of nonregulatory SIP       Applicable geographic or    State submittal date/
            provision                  nonattainment area          effective date           EPA approval date
----------------------------------------------------------------------------------------------------------------
1. High Occupancy Vehicle (HOV)    Atlanta Metropolitan Area  11/15/93 and amended on   3/18/99, 4/26/99 and 11/
 lane on I-85 from Chamblee-                                   6/17/96 and 2/5/10.       5/09.
 Tucker Road to State Road 316.
 High Occupancy Toll (HOT) lane
 on I-85 from Chamblee-Tucker
 Road to State Road 316.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2012-9814 Filed 4-23-12; 8:45 am]
BILLING CODE P


[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Notices]
[Pages 68273-68275]
[FR Doc No: 2014-26917]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0279]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Marketing Act of 1987;
Administrative Procedures, Policies, and Requirements

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 information collection in
the regulations on the Prescription Drug Marketing Act of 1987;
Administrative Procedures, Policies, and Requirements.

DATES: Submit either electronic or written comments on the collection
of information by January 13, 2015.

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 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.

Prescription Drug Marketing Act of 1987; Administrative Procedures,
Policies, and Requirements--21 CFR Part 203--(OMB Control Number 0910-
0435)--Extension

    FDA is requesting OMB approval under the PRA (44 U.S.C. 3501-3520)
for the reporting and recordkeeping requirements contained in the
regulations implementing the Prescription Drug Marketing Act of 1987
(PDMA). PDMA was intended to ensure that drug products purchased by
consumers are safe and effective and to avoid an unacceptable risk that
counterfeit, adulterated, misbranded, subpotent, or expired drugs are
sold.
    PDMA was enacted by Congress because there were insufficient
safeguards in the drug distribution system to prevent the introduction
and retail sale of substandard, ineffective, or counterfeit drugs, and
that a wholesale drug diversion submarket had developed that prevented
effective control over the true sources of drugs.
    Congress found that large amounts of drugs had been reimported into
the United States as U.S. goods returned causing a health and safety
risk to U.S. consumers because the drugs may become subpotent or
adulterated during foreign handling and shipping. Congress also found
that a ready market for prescription drug reimports had been the
catalyst for a continuing series of

frauds against U.S. manufacturers and had provided the cover for the
importation of foreign counterfeit drugs.
    Congress also determined that the system of providing drug samples
to physicians through manufacturers' representatives had resulted in
the sale to consumers of misbranded, expired, and adulterated
pharmaceuticals.
    The bulk resale of below-wholesale priced prescription drugs by
health care entities for ultimate sale at retail also helped to fuel
the diversion market and was an unfair form of competition to
wholesalers and retailers who had to pay otherwise prevailing market
prices.
    FDA is requesting OMB approval for the following existing reporting
and recordkeeping requirements:

                     Table 1--Reporting Requirements
------------------------------------------------------------------------
          21 CFR section                         Requirement
------------------------------------------------------------------------
203.11............................  Applications for re-importation to
                                     provide emergency medical care.
203.30(a)(1) and (b)..............  Drug sample requests (drug samples
                                     distributed by mail or common
                                     carrier).
203.30(a)(3), (a)(4), and (c).....  Drug sample receipts (receipts for
                                     drug samples distributed by mail or
                                     common carrier).
203.31(a)(1) and (b)..............  Drug sample requests (drug samples
                                     distributed by means other than the
                                     mail or a common carrier).
203.31(a)(3), (a)(4), and (c).....  Drug sample receipts (drug samples
                                     distributed by means other than the
                                     mail or a common carrier).
203.37(a).........................  Investigation of falsification of
                                     drug sample records.
203.37(b).........................  Investigation of a significant loss
                                     or known theft of drug samples.
203.37(c).........................  Notification that a representative
                                     has been convicted of certain
                                     offenses involving drug samples.
203.37(d).........................  Notification of the individual
                                     responsible for responding to a
                                     request for information about drug
                                     samples.
203.39(g).........................  Preparation by a charitable
                                     institution of a reconciliation
                                     report for donated drug samples.
------------------------------------------------------------------------

                   Table 2--Recordkeeping Requirements
------------------------------------------------------------------------
          21 CFR section                         Requirement
------------------------------------------------------------------------
203.23(a) and (b).................  Credit memo for returned drugs.
203.23(c).........................  Documentation of proper storage,
                                     handling, and shipping conditions
                                     for returned drugs.
203.30(a)(2) and 203.31(a)(2).....  Verification that a practitioner
                                     requesting a drug sample is
                                     licensed or authorized by the
                                     appropriate State authority to
                                     prescribe the product.
203.31(d)(1) and (d)(2)...........  Contents of the inventory record and
                                     reconciliation report required for
                                     drug samples distributed by
                                     representatives.
203.31(d)(4)......................  Investigation of apparent
                                     discrepancies and significant
                                     losses revealed through the
                                     reconciliation report.
203.31(e).........................  Lists of manufacturers' and
                                     distributors' representatives.
203.34............................  Written policies and procedures
                                     describing administrative systems.
203.37(a).........................  Report of investigation of
                                     falsification of drug sample
                                     records.
203.37(b).........................  Report of investigation of
                                     significant loss or known theft of
                                     drug samples.
203.38(b).........................  Records of drug sample distribution
                                     identifying lot or control numbers
                                     of samples distributed. (The
                                     information collection in 21 CFR
                                     203.38(b) is already approved under
                                     OMB control number 0910-0139).
203.39(d).........................  Records of drug samples destroyed or
                                     returned by a charitable
                                     institution.
203.39(e).........................  Record of drug samples donated to a
                                     charitable institution.
203.39(f).........................  Records of donation and distribution
                                     or other disposition of donated
                                     drug samples.
203.39(g).........................  Inventory and reconciliation of drug
                                     samples donated to charitable
                                     institutions.
203.50(a).........................  Drug origin statement.
203.50(b).........................  Retention of drug origin statement
                                     for 3 years.
203.50(d).........................  List of authorized distributors of
                                     record.
------------------------------------------------------------------------

    The reporting and recordkeeping requirements are intended to help
achieve the following goals: (1) To ban the reimportation of
prescription drugs produced in the United States, except when
reimported by the manufacturer or under FDA authorization for emergency
medical care; (2) to ban the sale, purchase, or trade, or the offer to
sell, purchase, or trade, of any prescription drug sample; (3) to limit
the distribution of drug samples to practitioners licensed or
authorized to prescribe such drugs or to pharmacies of hospitals or
other health care entities at the request of a licensed or authorized
practitioner; (4) to require licensed or authorized practitioners to
request prescription drug samples in writing; (5) to mandate storage,
handling, and recordkeeping requirements for prescription drug samples;
(6) to prohibit, with certain exceptions, the sale, purchase, or trade
of, or the offer to sell, purchase, or trade, prescription drugs that
were purchased by hospitals or other health care entities, or which
were donated or supplied at a reduced price to a charitable
organization; (7) to require unauthorized wholesale distributors to
provide, prior to the wholesale distribution of a prescription drug to
another wholesale distributor or retail pharmacy, a statement
identifying each prior sale, purchase, or trade of the drug.
    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  per response           Total hours
                                                respondents     respondent      respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.11 Re-importation.......................               1               1               1  .50 (30 minutes)..........................               1
203.30(a)(1) and (b) Drug sample requests...          61,961              12         743,532  .06 (4 minutes)...........................          44,612

203.30(a)(3), (a)(4), (c) Drug sample                 61,961              12         743,532  .06 (4 minutes)...........................          44,612
 receipts.
203.31(a)(1) and (b) Drug sample requests...         232,355             135      31,367,925  .04 (2 minutes)...........................       1,254,717
203.31(a)(3), (a)(4),(c) Drug sample                 232,355             135      31,367,925  .03 (2 minutes)...........................         941,038
 receipts.
203.37(a) Falsification of records..........              50               4             200  .25 (15 minutes)..........................              50
203.37(b) Loss or theft of samples..........              50              40            2000  .25 (15 minutes)..........................             500
203.37(c) Convictions.......................               1               1               1  1.........................................               1
203.37(d) Contact person....................              50               1              50  .08 (5 minutes)...........................               4
203.39(g) Reconciliation report.............               1               1               1  1.........................................               1
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       2,285,536
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                    Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of      records per    Total annual        Average burden per record-keeping        Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.23(a) and (b) Returned drugs............          31,676               5         158,380  .25 (15 minutes)..........................          39,595
203.23(c) Returned drugs documentation......          31,676               5         158,380  .08 (5 minutes)...........................          12,670
203.30(a)(2) and 203.31(a)(2) Practitioner             2,208             100         220,800  .50 (30 minutes)..........................         110,400
 verification.
203.31(d)(1) and (d)(2) Inventory record and           2,208               1           2,208  40........................................          88,320
 reconciliation report.
203.31(d)(4) Investigation of discrepancies              442               1             442  24........................................          10,608
 and losses.
203.31(e) Representatives lists.............           2,208               1           2,208  1.........................................           2,208
203.34 Administrative systems...............              90               1              90  40........................................           3,600
203.37(a) Falsification of drug sample                    50               4             200  6.........................................            1200
 records.
203.37(b) Loss or theft of drug samples.....              50              40            2000  6.........................................          12,000
203.39(d) Destroyed or returned drug samples              65               1              65  1.........................................              65
203.39(e) Donated drug samples..............           3,221               1           3,221  .50 (30 minutes)..........................           1,611
203.39(f) Distribution of donated drug                 3,221               1           3,221  8.........................................          25,768
 samples.
203.39(g) Drug samples donated to charitable           3,221               1           3,221  8.........................................          25,768
 institutions.
203.50(a) Drug origin statement.............             125             100          12,500  .17 (10 minutes)..........................           2,125
203.50(b) Drug origin statement retention...             125             100          12,500  .50 (30 minutes)..........................           6,250
203.50(d) Authorized distributors of record.             691               1             691  2.........................................           1,382
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................         343,570
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: November 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26917 Filed 11-13-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Page 22693]
[FR Doc No: 2014-09220]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-0178]

Guidance for Industry on Interpreting Sameness of Monoclonal
Antibody Products Under the Orphan Drug Regulations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Interpreting
Sameness of Monoclonal Antibody Products Under the Orphan Drug
Regulations.'' The purpose of this guidance is to provide sponsors and
manufacturers FDA's current thinking on the criteria by which two
monoclonal antibody products would be considered the same under the
Orphan Drug Act and implementing regulations.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marjorie Shapiro, Center for Drug
Evaluation and Research (HFD-123), Food and Drug Administration, 9000
Rockville Pike, Bethesda, MD 20892,<PHONE_NUMBER>, or Henry Startzman,
Office of Orphan Products Development, Office of Special Medical
Programs, Food and Drug Administration, 10903 New Hampshire Ave, Silver
Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Interpreting Sameness of Monoclonal Antibody Products Under
the Orphan Drug Regulations.''
    On July 26, 1999 (64 FR 40381), FDA announced the availability of
the draft version of this guidance. The public comment period closed on
October 25, 1999. A number of comments were received from the public,
all of which the Agency considered carefully as it finalized the
guidance and made appropriate changes. Any changes to the guidance were
minor and made to clarify statements in the draft guidance.
    In the Federal Register of December 29, 1992 (57 FR 62076), FDA
published the orphan drug regulations final rule, and on June 12, 2013
(78 FR 35117) the Agency finalized certain amendments to the final rule
in order to clarify regulatory provisions and make minor improvements
to address issues that have arisen since 1992. The final rule
established in part 316 (21 CFR part 316) regulations that prescribe
certain incentives for the development of ``orphan drugs'', drugs which
are intended for use in rare diseases or conditions. One of the
incentives for orphan drug development is to obtain exclusive approval
for the pioneer product for a period of 7 years during which no
approval will be given to a subsequent sponsor of the same drug product
for the same indication unless it proves to be clinically superior, as
defined in Sec.  316.3(b)(3). In determining whether or not two
products would be considered the same, FDA recognized that different
criteria were necessary for macromolecules versus small molecules
(Sec.  316.3(b)(13)).
    Macromolecules include a variety of structures including proteins,
nucleic acids, carbohydrates and closely related, complex, partly
definable drugs such as live viral vaccines. The current definition of
sameness for protein drugs (Sec.  316.3(b)(13)(ii)(A)), however, does
not consider the unique nature of antibodies. This final document is
intended to describe FDA's thinking on the criteria by which two
monoclonal antibody products would be considered the same under the
Orphan Drug Act and its implementing regulations.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on Interpreting Sameness of Monoclonal
Antibody Products Under the Orphan Drug Regulations. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Comments

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

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and
have been approved under OMB control numbers 0910-0167 (21 CFR part
316), 0910-0001 (21 CFR part 314), and 0910-0014 (21 CFR part 312).

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09220 Filed 4-22-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 17 (Wednesday, January 26, 2022)]
[Notices]
[Pages 4049-4050]
[FR Doc No: 2022-01454]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2016-0022]

Bay Area Compliance Laboratories Corp.: Grant of Expansion of
Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for Bay Area Compliance Laboratories Corp. as
a Nationally Recognized Testing Laboratory (NRTL).

DATES: The expansion of the scope of recognition becomes effective on
January 26, 2022.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor; telephone:
(202) 693-2110; email: [email protected]. OSHA's website includes
information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of Bay Area Compliance Laboratories Corp. (BACL) as a NRTL.
BACL's expansion covers the addition of seven recognized testing
standards to the NRTL scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition, and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that require
testing and certification.

    The agency processes applications by a NRTL for initial
recognition, or for expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides the preliminary finding and, in the second
notice, the agency provides the final decision on the application.
These notices set forth the NRTL's scope of recognition or
modifications of that scope. OSHA maintains an informational web page
for each NRTL that details the scope of recognition. These pages are
available from the agency's website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    BACL submitted an application, dated July 20, 2017 (OSHA-2016-0022-
0011),\1\ to expand its NRTL scope of recognition to include seven
additional test standards. OSHA performed a detailed analysis of the
application packet and reviewed other pertinent information. OSHA did
not perform any on-site reviews in relation to this application.
---------------------------------------------------------------------------

    \1\ OSHA notes that in the preliminary notice, it accidentally
listed this document's docket number as OSHA-2016-0022-0009.
---------------------------------------------------------------------------

    OSHA published the preliminary notice announcing BACL's expansion
application in the Federal Register on October 22, 2021 (86 FR 58694).
The agency requested comments by November 8, 2022, but it received no
comments in response this notice. OSHA now is proceeding with this
final notice to grant expansion of BACL's scope of recognition.
    To obtain or review copies of all public documents pertaining to
BACL's application, go to www.regulations.gov or contact the Docket
Office, Occupational Safety and Health Administration, U.S. Department
of Labor. Docket No. OSHA-2016-0022 contains all materials in the
record concerning BACL's recognition. Please note: Due to the COVID-19
pandemic, the Docket Office is closed to the public at this time but
can be contacted at<PHONE_NUMBER>, TTY<PHONE_NUMBER>.

II. Final Decision and Order

    OSHA staff examined BACL's expansion application and examined other
pertinent information. Based on a review of this evidence, OSHA finds
that BACL meets the requirements of 29 CFR 1910.7 for expansion of
recognition, subject to the limitation and conditions listed below.
OSHA, therefore, is proceeding with this final notice to grant
expansion of BACL's scope of recognition. OSHA limits the expansion of
BACL's scope of recognition to testing and certification of products
for demonstration of conformance to the test standards listed in Table
1.

Table 1--List of Appropriate Test Standards for Inclusion in BACL's NRTL
                          Scope of Recognition
------------------------------------------------------------------------
       Test standard                     Test standard title
------------------------------------------------------------------------
UL 153.....................  Portable Electric Lamps.
UL 935.....................  Standard for Fluorescent-Lamp Ballasts.
UL 1310....................  Standard for Class 2 Power Units.
UL 1598....................  Luminaires.
UL 1598C...................  Standard for Light-Emitting Diode (LED)
                              Retrofit Luminaire Conversion Kits.
UL 1993....................  Self-Ballasted Lamps and Lamp Adapters.
UL 8750....................  Standard for Light-Emitting Diode (LED)
                              Equipment for Use in Lighting Products.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, a
NRTL's scope of recognition does not include these products.
    The American National Standards Institute (ANSI) may approve the
test standards listed above as American National Standards. However,
for convenience, the use of the designation of the standards-developing
organization for the standard as opposed to the ANSI designation may
occur. Under the NRTL Program's policy (see OSHA Instruction CPL 01-00-
004, Chapter 2, Section VIII), only standards determined to be
appropriate test standards may be approved for NRTL recognition. Any
NRTL recognized for a particular test standard may use either the
proprietary version of the test standard or the ANSI version of that
standard. Contact ANSI to determine whether a test standard is
currently ANSI-approved.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
BACL must abide by the following conditions of the recognition:
    1. BACL must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. BACL must meet all the terms of the recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. BACL must continue to meet the requirements for recognition,
including all previously published conditions on BACL's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of BACL, subject to the limitation and conditions
specified above.

III. Authority and Signature

    Douglas L. Parker, Assistant Secretary of Labor for Occupational
Safety and Health, authorized the preparation of this notice.
Accordingly, the agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 8-2020 (85 FR 58393, Sept.
18, 2020), and 29 CFR 1910.7.

    Signed at Washington, DC, on January 18, 2022.
Douglas L. Parker,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2022-01454 Filed 1-25-22; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)]
[Notices]
[Pages 28356-28358]
[FR Doc No: 2017-12913]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0026]

Curtis-Strauss LLC: Application for Expansion of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the application of Curtis-
Strauss LLC for expansion of its recognition as a Nationally Recognized
Testing Laboratory (NRTL) and presents the Agency's preliminary finding
to grant the application.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before July 6, 2017.

ADDRESSES: Submit comments by any of the following methods:
    1. Electronically: Submit comments and attachments electronically
at http://www.regulations.gov, which is the Federal eRulemaking Portal.
Follow the instructions online for making electronic submissions.
    2. Facsimile: If submissions, including attachments, are not longer
than 10 pages, commenters may fax them to the OSHA Docket Office at
(202) 693-1648.
    3. Regular or express mail, hand delivery, or messenger (courier)
service: Submit comments, requests, and any attachments to the OSHA
Docket Office, Docket No. OSHA-2009-0026, Technical Data Center, U.S.
Department of Labor, 200 Constitution Avenue NW., Room N-3508,
Washington, DC 20210; telephone:<PHONE_NUMBER> (TTY number: (877) 889-
5627). Note that security procedures may result in significant delays
in receiving comments and other written materials by regular mail.
Contact the OSHA Docket Office for information about security
procedures concerning delivery of materials by express mail, hand
delivery, or messenger service. The hours of operation for the OSHA
Docket Office are 10:00 a.m.-2:30 p.m., e.t.
    4. Instructions: All submissions must include the Agency name and
the OSHA docket number (OSHA-2009-0026). OSHA places comments and other
materials, including any personal information, in the public docket
without revision, and these materials will be available online at
http://www.regulations.gov. Therefore, the Agency cautions commenters
about submitting statements they do not want made available to the
public, or submitting comments that contain personal information
(either about themselves or others) such as Social Security numbers,
birth dates, and medical data.
    5. Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket are listed in the http://www.regulations.gov index; however, some information (e.g.,
copyrighted material) is not publicly available to read or download
through the Web site. All submissions, including copyrighted material,
are available for inspection at the OSHA Docket Office. Contact the
OSHA Docket Office for assistance in locating docket submissions.
    6. Extension of comment period: Submit requests for an extension of
the comment period on or before July 6, 2017 to the Office of Technical
Programs and Coordination Activities, Directorate of Technical Support
and Emergency Management, Occupational Safety and Health
Administration, U.S. Department of Labor, 200 Constitution Avenue NW.,
Room N-3655, Washington, DC 20210, or by fax to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, 200 Constitution Avenue
NW., Room N-3647, Washington, DC 20210; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-3655, Washington, DC 20210; phone:
(202) 693-2110 or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Notice of the Application for Expansion

    The Occupational Safety and Health Administration is providing
notice that Curtis-Strauss LLC (CSL), is applying for expansion of its
current recognition as an NRTL. CSL requests the addition of five test
standards to its NRTL scope of recognition.
    OSHA recognition of an NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by its
applicable test standard; and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The Agency processes applications by an NRTL for initial
recognition and for an expansion or renewal of this recognition,
following requirements in Appendix A to 29 CFR 1910.7. This appendix
requires that the Agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding. In the second notice,
the Agency provides its final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational Web page for each NRTL,
including CSL, which details the NRTL's scope of recognition. These
pages are available from the OSHA Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.
    CSL currently has one facility (site) recognized by OSHA for
product testing and certification, with its headquarters located at:
Curtis-Strauss LLC, Littleton Distribution Center, One Distribution
Center Circle, Suite #1, Littleton, MA 01460. A complete list of CSL's
scope of recognition is available at https://www.osha.gov/dts/otpca/nrtl/csl.html.

II. General Background on the Application

    CSL submitted an application, dated December 30, 2016 (OSHA-2009-
0026-0073), to expand its recognition to include five additional test
standards. OSHA staff performed a detailed analysis of the application
packet and reviewed other pertinent information. OSHA did not perform
any on-site reviews in relation to this application.
    Table 1 below lists the appropriate test standards found in CSL's
application for expansion for testing and certification of products
under the NRTL Program.

  Table 1--Proposed List of Appropriate Test Standards for Inclusion in
                     CSL's NRTL Scope of Recognition
------------------------------------------------------------------------
           Test standard                     Test standard title
------------------------------------------------------------------------
UL 763............................  Motor-Operated Commercial Food
                                     Preparing Machines.
UL 197............................  Commercial Electric Cooking
                                     Appliances.
UL 982............................  Motor-Operated Household Food
                                     Preparing Machines.
UL 60335-2-3......................  Safety of Household and Similar
                                     Electrical Appliances, Part 2:
                                     Particular Requirements for
                                     Electric Irons.
UL 60335-2-34.....................  Safety of Household and Similar
                                     Electrical Appliances, Part 2-34:
                                     Particular Requirements for Motor-
                                     Compressors.
------------------------------------------------------------------------

III. Preliminary Findings on the Application

    CSL submitted an acceptable application for expansion of its scope
of recognition. OSHA's review of the application file, and pertinent
documentation, indicates that CSL can meet the requirements prescribed
by 29 CFR 1910.7 for expanding its recognition to include the addition
of these five test standards for NRTL testing and certification listed
above. This preliminary finding does not constitute an interim or
temporary approval of CSL's application.
    OSHA welcomes public comment as to whether CSL meets the
requirements of 29 CFR 1910.7 for expansion of its recognition as an
NRTL. Comments should consist of pertinent written documents and
exhibits. Commenters needing more time to comment must submit a request
in writing, stating the reasons for the request. Commenters must submit
the written request for an extension by the due date for comments. OSHA
will limit any extension to 10 days unless the requester justifies a
longer period. OSHA may deny a request for an extension if the request
is not adequately justified. To obtain or review copies of the exhibits
identified in this notice, as well as comments submitted to the docket,
contact the Docket Office, Room N-3508, Occupational Safety and Health
Administration, U.S. Department of Labor, at the above address. These
materials also are available online at http://www.regulations.gov under
Docket No. OSHA-2009-0026.
    OSHA staff will review all comments to the docket submitted in a
timely manner and, after addressing the issues raised by these
comments, will recommend to the Assistant Secretary for Occupational
Safety and Health whether to grant CSL's application for expansion of
its scope of recognition. The Assistant Secretary will make the final
decision on granting the application. In making this decision, the
Assistant Secretary may undertake other proceedings prescribed in
Appendix A to 29 CFR 1910.7.
    OSHA will publish a public notice of its final decision in the
Federal Register.

IV. Authority and Signature

    Dorothy Dougherty, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is

issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of
Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR
1910.7.

    Signed at Washington, DC, on June 15, 2017.
Dorothy Dougherty,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2017-12913 Filed 6-20-17; 8:45 am]
BILLING CODE 4510-26-P