[Federal Register Volume 88, Number 237 (Tuesday, December 12, 2023)]
[Rules and Regulations]
[Pages 86046-86048]
[FR Doc No: 2023-27036]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0949]
RIN 1625-AA00

Safety Zone; Kaneohe Bay, Oahu, HI--Navy P8 Aircraft Salvage
Operations

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a 0.5 nautical mile radius
temporary safety zone for navigable waters in Kaneohe Bay, HI
encompassing the partially submerged Navy P8 aircraft. The safety zone
is needed to protect personnel, vessels, and the marine environment
from potential hazards created by salvage operations of the Navy P8
aircraft. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by the Captain of the Port, Sector
Honolulu.

DATES: This rule is effective without actual notice from December 12,
2023 through December 10, 2023. For the purposes of enforcement, actual
notice will be used from December 2, 2023. This rule will be enforced
each day it is in effect from 7 a.m. to 6 p.m. December 12, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0949 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email Chief Petty Officer Bradley Lindsey, Waterways Management
Division, U.S. Coast Guard Sector Honolulu; telephone<PHONE_NUMBER>,
[email protected].

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it would be impracticable and
contrary to the public interest. The Coast Guard was unable to publish
an NPRM and hold a reasonable comment period for this rulemaking due to
the emergent nature and logistical coordination of salvage operations.
It is impracticable to publish an NPRM because we must establish this
safety zone by December 2, 2023.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
respond to remove the existing threat to the environment and safeguard
against future potential threat to the environment as well as safety
hazards associated with emergency salvage operations of the Navy P8
aircraft.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Sector Honolulu (COTP) has determined
that potential hazards associated with emergency salvage operations
starting December 2, 2023, will be a safety concern for anyone within a
0.5 nautical mile radius of the Navy P8 aircraft. This rule is needed
to protect personnel, vessels, and the marine environment in the
navigable waters within the safety zone while salvage operations take
place.

IV. Discussion of the Rule

    This rule establishes a safety zone from 7 a.m. until 6 p.m. on
December 2, 2023, through December 10, 2023. The Coast Guard is
establishing a 0.5 nautical mile radius temporary safety zone for
navigable waters in Kaneohe Bay, HI encompassing the partially
submerged Navy P8 aircraft. The duration of the zone is intended to
protect personnel, vessels, and the marine environment in these
navigable waters while the aircraft is being salvaged. No vessel or
person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this 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 rule has not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866, as
amended by Executive Order 14094 (Modernizing Regulatory Review).

Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, and duration, of the safety zone. Vessel traffic will be able
to safely transit around this safety zone which would impact a small,
designated area of the navigable waters Kaneohe Bay of Oahu, Hawaii,
where vessel traffic is normally low. Moreover, the Coast Guard would
issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 and
publish a Marine Safety Information Bulletin (MSIB) on Homeport 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 rule
will 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
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    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 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.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will 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 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 rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it 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.

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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this 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 determined 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 rule involves a
safety zone lasting only 11 hours per day for 10 days that will
prohibit entry within 0.5 nautical miles of vessels and machinery being
used by personnel to salvage the Navy P8 aircraft. It is categorically
excluded from further review under paragraph L60(d) of Appendix A,
Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of
Environmental Consideration supporting this determination is available
in the docket. For instructions on locating the docket, see the
ADDRESSES section of this preamble.

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.

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 amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T14-0949 to read as follows:

Sec.  165.T14-0949  Safety Zone; Kaneohe Bay, Oahu, HI--Navy P8 Salvage
Operations.

    (a) Location. The following area is a safety zone: The Coast Guard
is establishing a 0.5 nautical mile radius temporary safety zone for
navigable waters in Kaneohe Bay, HI encompassing the partially
submerged Navy P8 aircraft. This zone extends from the surface of the
water to the ocean floor.
    (b) Definitions. As used in this section, 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 Honolulu (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 at the command center at<PHONE_NUMBER> or on VHF
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.

    Dated: December 1, 2023.
A.L. Kirksey,
Captain, U.S. Coast Guard, Captain of the Port Sector Honolulu.
[FR Doc. 2023-27036 Filed 12-11-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45454-45455]
[FR Doc No: 2018-19367]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0376]

Policy Regarding Quantitative Labeling of Dietary Supplements
Containing Live Microbials; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Policy Regarding Quantitative Labeling of Dietary Supplements
Containing Live Microbials.'' The draft guidance, when finalized, will
advise firms that manufacturer, market, or distribute dietary
supplements of FDA's intent to exercise enforcement discretion if a
firm wishes to specify the amount of a live microbial in colony forming
units (CFUs) in addition to the currently required unit of measure
(milligrams) in the Supplement Facts label.

DATES: Submit either electronic or written comments on the draft
guidance by November 6, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-D-0376 for ``Policy Regarding Quantitative Labeling of Dietary
Supplements Containing Live Microbials: Draft Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Dietary Supplement Programs, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Steven Tave, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``Policy Regarding Quantitative Labeling of Dietary
Supplements Containing Live Microbials.'' We are issuing the draft
guidance consistent with our good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternate approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
    The draft guidance, when finalized, would advise firms that
manufacture, market, or distribute dietary supplements of FDA's intent
to exercise enforcement discretion with respect to declaration of live
microbial quantity in CFUs, in addition to the quantitative amount by
weight declaration required by regulation, within the Supplement Facts
label of dietary supplements containing live microbials, provided that
certain conditions are met.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the

FDA website listed in the previous sentence to find the most current
version of the guidance.

III. Paperwork Reduction Act

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 101.36 have been approved under
OMB control number 0910-0381.

    Dated: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19367 Filed 9-6-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 238 (Wednesday, December 11, 2019)]
[Notices]
[Pages 67746-67747]
[FR Doc No: 2019-26655]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-E-2617]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 10, 2020. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 8, 2020.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 10, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 10, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-E-2617 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; VABOMERE.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in

its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, VABOMERE
(vaborbactam and meropenem) indicated for the treatment of patients 18
years and older with complicated urinary tract infections including
pyelonephritis caused by designated susceptible bacteria. Subsequent to
this approval, the USPTO received a patent term restoration application
for VABOMERE (U.S. Patent No. 8,680,136) from Rempex Pharmaceuticals,
Inc. and the USPTO requested FDA's assistance in determining the
patent's eligibility for patent term restoration. In a letter dated
September 18, 2018, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
VABOMERE represented the first permitted commercial marketing or use of
the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
VABOMERE is 1,316 days. Of this time, 1,072 days occurred during the
testing phase of the regulatory review period, while 244 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
January 23, 2014. The applicant claims February 6, 2014, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was January
23, 2014, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
29, 2016. FDA has verified the applicant's claim that the new drug
application (NDA) for VABOMERE (NDA 209776) was initially submitted on
December 29, 2016.
    3. The date the application was approved: August 29, 2017. FDA has
verified the applicant's claim that NDA 209776 was approved on August
29, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 12 days of patent term extension.

III. Petitions

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

    Dated: December 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26655 Filed 12-10-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 160 (Friday, August 19, 2022)]
[Notices]
[Pages 51155-51156]
[FR Doc No: 2022-17878]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2006-0028]

Eurofins Electrical and Electronic Testing NA, Inc. a/k/a MET
Laboratories, Inc.: Grant of Expansion of Recognition

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

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for Eurofins Electronic Testing NA, Inc. a/k/a
MET Laboratories, Inc., as a Nationally Recognized Testing Laboratory
(NRTL).

DATES: The expansion of the scope of recognition becomes effective on
August 19, 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; 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; telephone:<PHONE_NUMBER>; email:
[email protected]. OSHA's web page 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 Eurofins Electrical and Electronic Testing NA, Inc. a-k/
a MET Laboratories, Inc. (MET), as a NRTL. MET's expansion covers the
addition of one test standard to the NRTL scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified by 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 of the products.
    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.
    MET submitted an application, dated November 1, 2021 (OSHA-2006-
0028-0089), to expand the recognition to include one additional test
standard. The standard requested in the expansion application is a
replacement standard for ISA 12.12.01, which is currently included in
MET's NRTL scope of recognition. OSHA staff performed a detailed
analysis of the application packets and reviewed other pertinent
information. OSHA did not perform any on-site reviews in relation to
the application.
    OSHA published the preliminary notice announcing MET's expansion
application in the Federal Register on June 17, 2022 (87 FR 36541). The
agency requested comments by July 5, 2022, but it received no comments
in response to this notice. OSHA now is proceeding with this final
notice to grant expansion of MET's scope of recognition.
    To obtain or review copies of all public documents pertaining to
MET's application, go to http://www.regulations.gov or contact the
Docket Office, Occupational Safety and Health Administration, U.S.
Department of Labor, 200 Constitution Avenue NW,

Room N-3653, Washington, DC 20210. Docket No. OSHA-2006-0028 contains
all materials in the record concerning MET'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>.

II. Final Decision and Order

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

 Table 1--List of Appropriate Test Standard for Inclusion in MET's NRTL
                          Scope of Recognition
------------------------------------------------------------------------
           Test standard                     Test standard title
------------------------------------------------------------------------
UL 121201.........................  Nonincendive Electrical Equipment
                                     for Use in Class I and Class II,
                                     Division 2 and Class III, Divisions
                                     1 and 2 Hazardous (Classified)
                                     Locations.
------------------------------------------------------------------------

    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,
MET must abide by the following conditions of the recognition:
    1. MET must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in their operations as a NRTL, and provide details of the
change(s);
    2. MET must meet all the terms of the NRTL recognition and comply
with all OSHA policies pertaining to this recognition; and
    3. MET must continue to meet the requirements for recognition,
including all previously published conditions on MET'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 MET, subject to the limitations and conditions
specified above.

III. Authority and Signature

    James S. Frederick, Deputy 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 August 5, 2022.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2022-17878 Filed 8-18-22; 8:45 am]
BILLING CODE 4510-26-P


3
180
,462
11.
3
216,508
1
3
.
1
2
2
4
,514
1
3
.
0
Vermont
43,400
9.
7
55,490
1
2
.
1
5
9
,539
12.
7
57,969
12.
2
72,274
15
.
0
7
3
,074
1
4
.
9
Virginia
551
,390
10.
5
616,160
1
1.
4
660,055
12.
1
676
,348
12.
1
748,668
1
3
.
3
8
1
5
,491
1
4
.
2
Washington
511
,851
11.
9
530,013
1
1.
9
641,694
14.
3
634
,069
13.
8
718,004
1
5
.
5
7
0
1
,296
1
4
.
6
West Virginia
162
,187
11.
7
173,501
1
2.
5
179,052
12.
8
166
,795
11.
8
219,922
1
5
.
5
2
0
5
,113
1
4
.
3
Wisconsin
411
,281
10.
6
434,848
1
0.
9
473,049
11.
7
451
,051
11.
0
516,521
1
2
.
4
5
5
5
,467
1
3
.
1
Wyoming
40,169
11.
8
41,239
1
1
.
6
4
0
,858
11.
1
42,219
11.
2
48,222
12
.
7
4
9
,767
1
2
.
6
Note:
(2) Represents estimates based on 2005 adult population estimates obtained from the U.S. Census Bureau.
(1) Lifetime prevalence was defined as answering yes to "Have you ever been told by a doctor, nurse or other health
professional that you had asthma?"
N/A: Not available
SOURCE: BEHAVIORAL RISK FACTOR SURVEILLANCE SURVEY,  2000-2005
2000
20
01
2003
2005
20
04
LIFETIME PREVALENCE
<s>1</s>
2002

TABLE 13: ASTHMA-ESTIMATED CURRENT PREVALENCE (%) IN ADULTS, BY STATE, 2000-2005
STATE
NUMBER
%
NUMBER
%
NUMBER
%
NUMBER
%
NUMBER
%
NUMBER
(2)
%
United States
14
,665,135
7.
2
1
5
,139,313
7.
1
15,960,496
7
.
5
1
6
,640,152
7.
7
17,624,929
8
.
1
17,835,234
8
.
0
Alabama
19
9,227
6.
1
2
1
1
,835
6.
3
240
,795
7
.
2
2
5
3
,590
7.
5
293,302
8
.
6
246
,232
7
.
1
Alaska
29,977
6
.
9
32
,179
7.
2
3
2,851
7
.
4
41,766
9
.
1
4
1
,028
9
.
0
3
7
,076
7
.
8
Arizona
30
3,723
8.
6
3
1
6
,659
8.
2
356
,712
9
.
0
3
4
1
,357
8.
3
297,681
7
.
2
322
,555
7
.
4
Arkansas
12
5,142
6.
6
1
3
9
,615
6.
9
152
,569
7
.
6
1
4
8
,628
7.
3
150,688
7
.
4
157
,765
7
.
5
California
1,793,998
7
.
3
1,751,211
7.
0
1
,633,769
6
.
4
2
,171,227
8
.
4
2,011,241
7
.
7
1,902,981
7
.
2
Colorado
19
9,982
6.
6
2
5
9
,324
8.
0
255
,409
7
.
7
2
8
1
,149
8.
3
297,140
8
.
7
285
,741
8
.
2
Connecticut
19
6,115
7.
8
2
0
4
,445
7.
8
220
,216
8
.
5
2
1
6
,680
8.
3
253,416
9
.
7
214
,023
8
.
0
Delaware
40,536
7
.
1
45
,025
7.
5
4
6,112
7
.
6
46,213
7
.
5
6
2
,935
10.
0
5
5
,050
8
.
5
District of Columbia
32,278
7
.
9
33
,283
7.
4
4
1,246
9
.
1
35,548
7
.
8
4
1
,568
9
.
2
4
0
,267
9
.
2
Florida
6
7
2
,793
5.
7
7
2
2
,627
5.
7
833
,013
6
.
5
8
0
1
,089
6.
1
961,017
7
.
3
933
,095
6
.
8
Georgia
3
5
8
,829
6.
2
4
4
2
,374
7.
2
459
,342
7
.
4
4
4
9