Amendments to National Marine Sanctuary Regulations; Delay of Effective Date, 56268-56269 [2022-19877]
Download as PDF
<![CDATA[
56268
Federal Register / Vol. 87, No. 177 / Wednesday, September 14, 2022 / Rules and Regulations
AIRAC date
State
City
Airport
FDC No.
North Platte Rgnl/Lee Bird
Fld.
North Platte Rgnl/Lee Bird
Fld.
El Paso Intl .......................
6-Oct-22 .......
NE
North Platte ......................
6-Oct-22 .......
NE
North Platte ......................
6-Oct-22 .......
TX
El Paso .............................
6-Oct-22 .......
6-Oct-22 .......
6-Oct-22 .......
WY
FL
KS
Big Piney ..........................
Daytona Beach ................
El Dorado .........................
6-Oct-22 .......
KS
El Dorado .........................
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
AL
AL
AL
AL
TN
VT
KY
WI
GA
TN
TN
GA
KS
Eufaula .............................
Eufaula .............................
Eufaula .............................
Eufaula .............................
Winchester .......................
Lyndonville .......................
Elizabethtown ...................
Sheboygan .......................
Savannah .........................
Athens ..............................
Athens ..............................
Canton ..............................
Washington ......................
6-Oct-22 .......
KS
Washington ......................
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
6-Oct-22
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
NM
KS
NM
TX
MI
OK
OK
OK
OH
OH
FL
OK
Santa Fe ..........................
Ulysses .............................
Santa Fe ..........................
Borger ..............................
West Branch ....................
Holdenville ........................
Holdenville ........................
Frederick ..........................
Oxford ..............................
Oxford ..............................
Boca Raton ......................
Norman ............................
6-Oct-22 .......
6-Oct-22 .......
IA
WA
Ames ................................
Bellingham .......................
Miley Meml Fld .................
Daytona Beach Intl ..........
El Dorado/Capt Jack
Thomas Meml.
El Dorado/Capt Jack
Thomas Meml.
Weedon Fld ......................
Weedon Fld ......................
Weedon Fld ......................
Weedon Fld ......................
Winchester Muni ..............
Caledonia County ............
Addington Fld ...................
Sheboygan County Meml
Savannah/Hilton Head Intl
McMinn County ................
McMinn County ................
Cherokee County Rgnl ....
Washington County Veteran’s Meml.
Washington County Veteran’s Meml.
Santa Fe Muni .................
Ulysses .............................
Santa Fe Muni .................
Hutchinson County ...........
West Branch Community
Holdenville Muni ...............
Holdenville Muni ...............
Frederick Rgnl ..................
Miami University ...............
Miami University ...............
Boca Raton ......................
University Of Oklahoma
Westheimer.
Ames Muni .......................
Bellingham Intl .................
6-Oct-22 .......
6-Oct-22 .......
OK
KS
Elk City .............................
Ulysses .............................
Elk City Rgnl Business ....
Ulysses .............................
8/5/22
RNAV (GPS) RWY 35, Amdt 1B.
2/2136
8/5/22
VOR RWY 35, Amdt 18D.
2/2211
8/2/22
2/2325
2/2367
2/2387
8/4/22
8/5/22
8/1/22
RNAV
1C.
RNAV
RNAV
RNAV
2/2390
8/1/22
RNAV (GPS) RWY 33, Amdt 1A.
2/3013
2/3014
2/3017
2/3019
2/3176
2/3180
2/3197
2/3319
2/3428
2/3856
2/3859
2/4025
2/4059
8/5/22
8/5/22
8/5/22
8/5/22
8/5/22
8/5/22
8/3/22
8/2/22
8/5/22
8/5/22
8/5/22
8/8/22
8/2/22
RNAV (GPS) RWY 18, Amdt 1B.
VOR RWY 18, Amdt 8B.
VOR/DME RWY 36, Amdt 3B.
RNAV (GPS) RWY 36, Amdt 1B.
RNAV (GPS) RWY 36, Orig-C.
RNAV (GPS) RWY 2, Orig-C.
VOR–A, Amdt 3A.
RNAV (GPS) RWY 31, Orig-C.
RNAV (GPS) RWY 10, Amdt 2B.
RNAV (GPS) RWY 20, Amdt 1C.
RNAV (GPS) RWY 2, Orig-C.
RNAV (GPS) RWY 5, Amdt 1B.
RNAV (GPS) RWY 17, Amdt 1A.
2/4060
8/2/22
RNAV (GPS) RWY 35, Amdt 1A.
2/5667
2/5691
2/5841
2/6319
2/6458
2/6472
2/6474
2/6487
2/6623
2/6625
2/6895
2/7210
8/9/22
8/8/22
8/9/22
8/1/22
8/10/22
8/10/22
8/10/22
8/10/22
8/10/22
8/10/22
8/5/22
7/27/22
VOR/DME-A, Amdt 1B.
RNAV (GPS) RWY 12, Amdt 2.
VOR RWY 33, Amdt 9B.
RNAV (GPS) RWY 35, Amdt 1.
RNAV (GPS) RWY 9, Orig-A.
RNAV (GPS) RWY 17, Orig-A.
RNAV (GPS) RWY 35, Orig-A.
RNAV (GPS) RWY 35, Orig-A.
RNAV (GPS) RWY 23, Orig-A.
RNAV (GPS) RWY 5, Orig-A.
RNAV (GPS) RWY 5, Amdt 1.
LOC RWY 3, Amdt 4A.
2/8536
2/8592
6/23/22
8/3/22
2/9269
2/9934
8/3/22
8/8/22
RNAV
RNAV
2.
RNAV
RNAV
Interim final rule; delay of
effective date.
BILLING CODE 4910–13–P
On May 13, 2022, the
National Oceanic and Atmospheric
Administration (NOAA) published an
interim final rule that appeared in the
Federal Register and that amended the
Office of National Marine Sanctuaries
(ONMS) regulations. That rule was
published with a 30-day comment
period, which ended on June 13, 2022,
and a 45-day delayed effective date
(June 27, 2022). A subsequent notice
delaying the effective date until
September 26, 2022, was published on
June 24, 2022. This action further delays
the effective date of the interim final
rule by an additional 120 days, until
January 24, 2023.
SUMMARY:
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
15 CFR Part 922
[Docket No. 220908–0186]
khammond on DSKJM1Z7X2PROD with RULES
RIN 0648–AV85
Amendments to National Marine
Sanctuary Regulations; Delay of
Effective Date
Office of National Marine
Sanctuaries (ONMS), National Oceanic
and Atmospheric Administration
(NOAA), Department of Commerce
(DOC).
AGENCY:
VerDate Sep<11>2014
16:35 Sep 13, 2022
Jkt 256001
As of September 14, 2022, the
effective date for the interim final rule
DATES:
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
Subject
2/2134
ACTION:
[FR Doc. 2022–19750 Filed 9–13–22; 8:45 am]
FDC Date
(GPS) Y RWY 26L, Amdt
(GPS) RWY 31, Orig-D.
(GPS) RWY 34, Amdt 2E.
(GPS) RWY 15, Amdt 1A.
(GPS) RWY 19, Amdt 1B.
(GPS) Y RWY 34, Amdt
(GPS) RWY 17, Amdt 2A.
(GPS) RWY 17, Amdt 1B.
published at 87 FR 29606, May 13,
2022, and delayed at 87 FR 37728, June
24, 2022, is further delayed until
January 24, 2023.
FOR FURTHER INFORMATION CONTACT:
Vicki Wedell, NOAA Office of National
Marine Sanctuaries, (240) 533–0650,
Vicki.Wedell@noaa.gov.
SUPPLEMENTARY INFORMATION: In
response to the interim final rule
published on May 13, 2022 (87 FR
29606), which updated and streamlined
ONMS regulations, NOAA received
eight comments before the end of the
comment period on June 13, 2022. The
submitted comments are posted at
regulations.gov under docket NOAA–
NOS–2011–0120. Based on issues raised
by some of the public comments, NOAA
is preparing technical corrections and
responses to those comments for the
final rule. A subsequent notice delaying
E:\FR\FM\14SER1.SGM
14SER1
Federal Register / Vol. 87, No. 177 / Wednesday, September 14, 2022 / Rules and Regulations
the effective date until September 26,
2022, was published on June 24, 2022
(87 FR 37228). In this action, NOAA is
delaying the effective date of the interim
final rule by an additional 120 days, to
January 24, 2023. This action does not
extend or reopen the comment period
for NOAA’s previous request for
comments on the interim final rule.
National Marine Sanctuaries Act
The National Marine Sanctuaries Act
(NMSA) authorizes the Secretary of
Commerce to designate, manage, and
protect, as a national marine sanctuary,
any area of the marine environment that
is of special national significance due to
its conservation, recreational,
ecological, historical, scientific,
cultural, archeological, educational, or
esthetic qualities (16 U.S.C. 1431 et
seq.). NMSA provides the legal basis
and serves as the authority under which
NOAA issues this action.
Nicole R. LeBoeuf,
Assistant Administrator for Ocean Services
and Coastal Zone Management, National
Ocean Service, National Oceanic and
Atmospheric Administration.
[FR Doc. 2022–19877 Filed 9–13–22; 8:45 am]
BILLING CODE 3510–NK–P
such use, and directs FDA to specify by
regulation the deadline of submission.
DATES: This rule is effective November
14, 2022. For additional information on
the effective and compliance dates, see
section V of this document.
ADDRESSES: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number found in brackets in the
heading of this final rule into the
‘‘Search’’ box and follow the prompts,
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
With regard to the final rule: Allison
Hoffman, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3138, Silver Spring,
MD 20993, 301–796–9203,
Allison.Hoffman@fda.hhs.gov.
With regard to the information
collection: Domini Bean, Office of
Operations, Food and Drug
Administration, Three White Flint
North 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
5733, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 300
[Docket No. FDA–2019–N–5553]
RIN 0910–AI36
Annual Summary Reporting
Requirements Under the Right to Try
Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, the Agency, or
we) is issuing a final rule to specify the
deadline and content for submission of
an annual summary of investigational
drugs supplied under the Trickett
Wendler, Frank Mongiello, Jordan
McLinn, and Matthew Bellina Right to
Try Act of 2017 (Right to Try Act) and
the uses for which the investigational
drugs were supplied. This final rule
implements a provision in the Right to
Try Act that requires sponsors and
manufacturers who provide an ‘‘eligible
investigational drug’’ under the
provisions of the Right to Try Act to
submit to FDA an annual summary of
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:35 Sep 13, 2022
Jkt 256001
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the
Final Rule
C. Legal Authority
D. Costs and Benefits
II. Background
A. Need for the Regulation/History of the
Rulemaking
B. Summary of Comments to the Proposed
Rule
C. General Overview of the Final Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA
Response
A. Introduction
B. Description of General Comments and
FDA Response
C. Comments on the Submission Deadline
D. Comments on Combining Right to Try
Reporting
E. Comments on Submitting Dosing
Information
F. Comments on Adverse Event Reporting
G. Comments on the Definition of
Manufacturer or Sponsor
H. Comments on Reporting Patient
Demographic Information
I. Comments on Outcomes Reporting
J. Comments on the Clarity of the Proposed
Rule
V. Effective/Compliance Date(s)
VI. Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
56269
X. Consultation and Coordination with
Indian Tribal Governments
XI. Reference
I. Executive Summary
A. Purpose of the Final Rule
The purpose of this rule is to
implement provisions of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), added by the Right to Try Act,
which requires sponsors and
manufacturers who provide an ‘‘eligible
investigational drug’’ under the Right to
Try Act to submit to FDA an annual
summary of such use, and directs FDA
to specify by regulation the deadline of
submission. The rule provides
information on the necessary contents of
the annual summary and the deadline
for its submission.
B. Summary of the Major Provisions of
the Final Rule
The rule adds a new subpart to the
regulations, to specify the deadline and
content for submission of an annual
summary of investigational drugs
supplied under the Right to Try
provisions of the FD&C Act and the uses
for which they were supplied. The Right
to Try Act provides that the
manufacturer or sponsor of an eligible
investigational drug shall submit to FDA
an annual summary of any use of such
drug supplied under the FD&C Act. Per
the statute, the summary shall include
the number of doses supplied, the
number of patients treated, the use for
which the drug was made available, and
any known serious adverse events from
use of the drug.
C. Legal Authority
The enacted provisions of the Right to
Try Act, in conjunction with FDA’s
general rulemaking authority serve as
FDA’s legal authority for this rule.
D. Costs and Benefits
This final rule establishes the
deadline for submission of annual
summaries of use of investigational
drugs supplied under the FD&C Act.
The rule also establishes the required
contents of these submissions.
The benefits of this rule consist of
societal and public health outcomes that
may accrue from the disclosure of the
use of investigational drugs and any
known serious adverse events provided
in these annual summary reports. There
is no data that would allow us to predict
the magnitude of generated benefits, and
thus we are unable to quantify the
expected benefits of this rule.
Costs are estimated as the time spent
by firms to prepare and submit these
annual summary reports. The total
estimated present value of this rule’s
E:\FR\FM\14SER1.SGM
14SER1
]]>Agencies
[Federal Register Volume 87, Number 177 (Wednesday, September 14, 2022)]
[Rules and Regulations]
[Pages 56268-56269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19877]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
15 CFR Part 922
[Docket No. 220908-0186]
RIN 0648-AV85
Amendments to National Marine Sanctuary Regulations; Delay of
Effective Date
AGENCY: Office of National Marine Sanctuaries (ONMS), National Oceanic
and Atmospheric Administration (NOAA), Department of Commerce (DOC).
ACTION: Interim final rule; delay of effective date.
-----------------------------------------------------------------------
SUMMARY: On May 13, 2022, the National Oceanic and Atmospheric
Administration (NOAA) published an interim final rule that appeared in
the Federal Register and that amended the Office of National Marine
Sanctuaries (ONMS) regulations. That rule was published with a 30-day
comment period, which ended on June 13, 2022, and a 45-day delayed
effective date (June 27, 2022). A subsequent notice delaying the
effective date until September 26, 2022, was published on June 24,
2022. This action further delays the effective date of the interim
final rule by an additional 120 days, until January 24, 2023.
DATES: As of September 14, 2022, the effective date for the interim
final rule published at 87 FR 29606, May 13, 2022, and delayed at 87 FR
37728, June 24, 2022, is further delayed until January 24, 2023.
FOR FURTHER INFORMATION CONTACT: Vicki Wedell, NOAA Office of National
Marine Sanctuaries, (240) 533-0650, [email protected].
SUPPLEMENTARY INFORMATION: In response to the interim final rule
published on May 13, 2022 (87 FR 29606), which updated and streamlined
ONMS regulations, NOAA received eight comments before the end of the
comment period on June 13, 2022. The submitted comments are posted at
regulations.gov under docket NOAA-NOS-2011-0120. Based on issues raised
by some of the public comments, NOAA is preparing technical corrections
and responses to those comments for the final rule. A subsequent notice
delaying
[[Page 56269]]
the effective date until September 26, 2022, was published on June 24,
2022 (87 FR 37228). In this action, NOAA is delaying the effective date
of the interim final rule by an additional 120 days, to January 24,
2023. This action does not extend or reopen the comment period for
NOAA's previous request for comments on the interim final rule.
National Marine Sanctuaries Act
The National Marine Sanctuaries Act (NMSA) authorizes the Secretary
of Commerce to designate, manage, and protect, as a national marine
sanctuary, any area of the marine environment that is of special
national significance due to its conservation, recreational,
ecological, historical, scientific, cultural, archeological,
educational, or esthetic qualities (16 U.S.C. 1431 et seq.). NMSA
provides the legal basis and serves as the authority under which NOAA
issues this action.
Nicole R. LeBoeuf,
Assistant Administrator for Ocean Services and Coastal Zone Management,
National Ocean Service, National Oceanic and Atmospheric
Administration.
[FR Doc. 2022-19877 Filed 9-13-22; 8:45 am]
BILLING CODE 3510-NK-P
