Notice of Proposed Purchased/Referred Care Delivery Area Re-Designation for the Pokagon Band of Potawatomi Indians of Michigan and Indiana, 43415-43416 [2024-10845]
Download as PDF
Federal Register / Vol. 89, No. 97 / Friday, May 17, 2024 / Notices
TABLE 1—NEW DRAFT PRODUCT-—
Continued
SPECIFIC GUIDANCES FOR DRUG
PRODUCTS
Active Ingredient(s)
Lotilaner
Nalmefene hydrochloride
Omaveloxolone
Oxazepam
Pegcetacoplan
Perfluorohexyloctane
Pirtobrutinib
Rezafungin acetate
Sodium oxybate
Sparsentan
Tasimelteon
Tobramycin
Zavegepant hydrochloride
[FR Doc. 2024–10896 Filed 5–16–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
FDA is announcing the availability of
revised draft product-specific guidances
for industry for drug products
containing the following active
ingredients:
TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG
PRODUCTS
Active Ingredient(s)
Benzoyl peroxide; Erythromycin (multiple reference listed drugs)
Fluticasone furoate
Fluticasone furoate; Vilanterol trifenatate
Nitrofurantoin
Tretinoin
khammond on DSKJM1Z7X2PROD with NOTICES
For a complete history of previously
published Federal Register notices
related to product-specific guidances, go
to https://www.regulations.gov and
enter Docket No. FDA–2007–D–0369.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidances, when
finalized, will represent the current
thinking of FDA on, among other things,
the product-specific design of BE
studies to support ANDAs. They do not
establish any rights for any person and
are not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
IV. Paperwork Reduction Act of 1995
FDA tentatively concludes that these
draft guidances contain no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
17:20 May 16, 2024
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: May 14, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
III. Drug Products for Which Revised
Draft Product-Specific Guidances Are
Available
VerDate Sep<11>2014
V. Electronic Access
Jkt 262001
Notice of Proposed Purchased/
Referred Care Delivery Area ReDesignation for the Pokagon Band of
Potawatomi Indians of Michigan and
Indiana
Indian Health Service,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
This Notice advises the public
that the Indian Health Service (IHS)
proposes to expand the geographic
boundaries of the Purchased/Referred
Care Delivery Area (PRCDA) for the
Pokagon Band of Potawatomi Indians of
Michigan and Indiana to include the
counties of Kalamazoo, Kent, and
Ottawa in the State of Michigan. The
sole purpose of this expansion would be
to authorize additional Pokagon Band of
Potawatomi Indians of Michigan and
Indiana citizens and other PRC-eligible
individuals to receive PRC services.
DATES: Comments must be submitted by
June 17, 2024.
ADDRESSES: Because of staff and
resource limitations, we cannot accept
comments by facsimile (FAX)
transmission. You may submit
comments in one of four ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a Comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Carl Mitchell, Director,
Division of Regulatory and Policy
Coordination, Indian Health Service,
5600 Fishers Lane, Mail Stop: 09E70,
Rockville, Maryland 20857.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
43415
3. By express or overnight mail. You
may send written comments to the
above address.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to the address
above.
If you intend to deliver your
comments to the Rockville address,
please call telephone number (301) 443–
1116 in advance to schedule your
arrival with a staff member.
FOR FURTHER INFORMATION CONTACT:
CAPT John Rael, Director, Office of
Resource Access and Partnerships,
Indian Health Service, 5600 Fishers
Lane, Mail Stop: 10E85C, Rockville,
Maryland 20857. Telephone (301) 443–
0969 (This is not a toll free number).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment.
Background: The IHS provides
services under regulation in effect as of
September 15, 1987, and republished at
42 CFR part 136, subparts A–C. Subpart
C defines a Contract Health Service
Delivery Area (CHSDA), now referred to
as PRCDA, as the geographic area within
which PRC will be made available by
the IHS to members of an identified
Indian community who reside in the
PRCDA. Residence within a PRCDA by
a person who is within the scope of the
Indian health program, as set forth in 42
CFR 136.12, creates no legal entitlement
to PRC but only potential eligibility for
services. Services needed, but not
available at an IHS/Tribal facility, are
provided under the PRC program
depending on the availability of funds,
the relative medical priority of the
services to be provided, and the actual
availability and accessibility of alternate
resources in accordance with the
regulations.
The regulations at 42 CFR part 136,
subpart C provide that, unless otherwise
designated, a PRCDA shall consist of a
county which includes all or part of a
reservation and any county or counties
which have a common boundary with
the reservation. 42 CFR 136.22(a)(6).
The regulations also provide that after
consultation with the Tribal governing
body or bodies on those reservations
included within the PRCDA, the
Secretary may, from time to time, redesignate areas within the United States
for inclusion in or exclusion from a
PRCDA. 42 CFR 136.22(b).
The regulations require that certain
criteria must be considered before any
E:\FR\FM\17MYN1.SGM
17MYN1
khammond on DSKJM1Z7X2PROD with NOTICES
43416
Federal Register / Vol. 89, No. 97 / Friday, May 17, 2024 / Notices
re-designation is made. The criteria are
as follows:
(1) The number of Indians residing in
the area proposed to be so included or
excluded;
(2) Whether the Tribal governing body
has determined that Indians residing in
the area near the reservation are socially
and economically affiliated with the
Tribe;
(3) The geographic proximity to the
reservation of the area whose inclusion
or exclusion is being considered; and
(4) The level of funding which would
be available for the provision of PRC.
Additionally, the regulations require
that any re-designation of a PRCDA
must be made in accordance with the
procedures of the Administrative
Procedure Act (5 U.S.C. 553). 42 CFR
136.22(c). In compliance with this
requirement, the IHS is publishing this
Notice and requesting public comments.
The Pokagon Band of Potawatomi
Indians of Michigan and Indiana
(Pokagon Band, or Tribe) is located in
Dowagiac, Michigan, and operates their
PRC program as a Tribal Health
Program. The IHS established the
Pokagon Band’s current PRCDA
consistent with the language of the Act
of September 21, 1994, restoring Federal
recognition to the Pokagon Band. Public
Law 103–323 (108 Stat. 2152); see also
72 FR 34262 (June 21, 2007). Although
the IHS has historically established
PRCDAs in accordance with
Congressional intent, the IHS has also
preserved regulatory flexibility to redesignate areas as appropriate for
inclusion in or exclusion from a PRCDA
under PRC regulations. See 81 FR 20388
(April 7, 2016).
The current PRCDA for the Pokagon
Band of Potawatomi Indians of
Michigan and Indiana currently consists
of 10 counties in Southwestern
Michigan and Northwestern Indiana.
See 72 FR 34262 (June 21, 2007). These
counties are Allegan, Berrien, Cass, and
Van Buren Counties in Michigan; and
Elkhart, Kosciusko, La Porte, Marshall,
St. Joseph, and Starke Counties in
Indiana. Pokagon Band of Potawatomi
Indians of Michigan and Indiana
citizens residing outside of the PRCDA
are eligible for direct care services;
however, they are not eligible for
Purchased/Referred Care (PRC) services.
The Pokagon Band estimates that
approximately 537 Pokagon citizens
reside in Kalamazoo, Kent, and Ottawa
Counties in Michigan and would
become PRC eligible through the
proposed re-designation and expansion
of the Tribe’s PRCDA. The Pokagon
Band states that these citizens, ‘‘by
virtue of their citizenship with the
Pokagon Band are socially and
VerDate Sep<11>2014
17:20 May 16, 2024
Jkt 262001
economically affiliated with the
Pokagon Band and belong to the
Pokagon Band community served by the
[Health] Center . . .’’ The Tribe also
considers certain other PRC-eligible
individuals to be socially and
economically affiliated with the
Pokagon Band and to belong to the
Pokagon Band community, including
non-Indian women pregnant with a
Pokagon Band citizen’s child, and
children of Pokagon Band citizens as
detailed in the Tribe’s PRCDA redesignation request. The Pokagon Band
would like to recognize these persons as
eligible for PRC services. The IHS
confirmed that there are Pokagon Band
citizens residing in each of the proposed
expansion counties. Accordingly, the
IHS proposes to expand the PRCDA of
the Pokagon Band of Potawatomi
Indians of Michigan and Indiana to
include the Michigan counties of
Kalamazoo, Kent, and Ottawa.
If the Pokagon Band’s PRCDA redesignation and expansion is finalized
as proposed, the Tribe’s expanded
PRCDA would overlap the existing
PRCDAs of three other Tribes: the
Nottawaseppi Band of Huron
Potawatomi (Kalamazoo, Kent, and
Ottawa Counties); the Match-E-Be-NashShe-Wish Band of Pottawatomi Indians
of Michigan (Kalamazoo, Kent, and
Ottawa Counties); and Little River Band
of Ottawa Indians (Kent and Ottawa
Counties). The IHS has consulted with
each of the overlapping Tribes regarding
the proposed expansion of the Pokagon
Band’s PRCDA, and none of the
overlapping Tribes has expressed a
current concern regarding the proposed
re-designation and expansion.
Under 42 CFR 136.23, those otherwise
eligible Indians who do not reside on a
reservation, but reside within a PRCDA,
must be either members of the Tribe or
other IHS beneficiaries who maintain
close economic and social ties with the
Tribe. In this case, applying the
aforementioned PRCDA re-designation
criteria required by operative
regulations codified at 42 CFR part 136,
subpart C, the following findings are
made:
1. By expanding the PRCDA to
include Kalamazoo, Kent, and Ottawa
Counties in Michigan, the Pokagon
Band of Potawatomi Indians of
Michigan and Indiana’s PRC eligible
population will increase by an
estimated 537 Tribal citizens.
2. The IHS finds that the Tribal
citizens and other PRC-eligible
individuals within the expanded
PRCDA are socially and economically
affiliated with the Pokagon Band based
on a Tribal resolution in which the
Pokagon Band Tribal Council identified
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
its intent to expand the PRCDA to
include Kalamazoo, Kent, and Ottawa
Counties in Michigan, and stated that
the Tribal citizens and certain other
individuals residing in such areas are
socially and economically affiliated
with the Pokagon Band.
3. The expanded PRCDA counties
form a contiguous area with the existing
PRCDA, and Pokagon Band citizens
reside in each of the counties proposed
for inclusion in the expanded PRCDA.
For these reasons, the IHS has
determined the additional counties
proposed for inclusion herein to be
geographically proximate, meaning ‘‘on
or near,’’ to the existing PRCDA.
4. The Pokagon Band has indicated
that its PRC program can continue
providing the same level of care to the
PRC-eligible population if the PRCDA is
expanded as proposed, without
requiring additional funding or
reduction of the current medical priority
level.
This Notice does not contain
reporting or recordkeeping requirements
subject to prior approval by the Office
of Management and Budget under the
Paperwork Reduction Act of 1980.
Roselyn Tso,
Director, Indian Health Service.
[FR Doc. 2024–10845 Filed 5–16–24; 8:45 am]
BILLING CODE 4166–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Initial Review Group;
Transition to Independence Study
Section (I), June 5, 2024, 8 a.m. to June
6, 2024, 1 p.m., Cambria Hotel
Rockville, 1 Helen Heneghan Way,
Rockville, Maryland 20850 which was
published in the Federal Register on
May 10, 2024, FR Doc 2024–10229, 89
FR 40496. This notice is being amended
to change the meeting format from inperson to virtual and the meeting time
from 8 a.m. to 1 p.m. to 11 a.m. to 4 p.m.
The meeting will now be held virtually,
June 5, 2024, 11 a.m. to June 6, 2024, 4
p.m., National Cancer Institute Shady
Grove, 9609 Medical Center Drive,
Room 7W238, Rockville, Maryland
20850. The meeting is closed to the
public.
E:\FR\FM\17MYN1.SGM
17MYN1
Agencies
[Federal Register Volume 89, Number 97 (Friday, May 17, 2024)]
[Notices]
[Pages 43415-43416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10845]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Notice of Proposed Purchased/Referred Care Delivery Area Re-
Designation for the Pokagon Band of Potawatomi Indians of Michigan and
Indiana
AGENCY: Indian Health Service, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This Notice advises the public that the Indian Health Service
(IHS) proposes to expand the geographic boundaries of the Purchased/
Referred Care Delivery Area (PRCDA) for the Pokagon Band of Potawatomi
Indians of Michigan and Indiana to include the counties of Kalamazoo,
Kent, and Ottawa in the State of Michigan. The sole purpose of this
expansion would be to authorize additional Pokagon Band of Potawatomi
Indians of Michigan and Indiana citizens and other PRC-eligible
individuals to receive PRC services.
DATES: Comments must be submitted by June 17, 2024.
ADDRESSES: Because of staff and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. You may submit comments in
one of four ways (please choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
Comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Carl Mitchell, Director, Division of Regulatory and
Policy Coordination, Indian Health Service, 5600 Fishers Lane, Mail
Stop: 09E70, Rockville, Maryland 20857.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the above address.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to the address above.
If you intend to deliver your comments to the Rockville address,
please call telephone number (301) 443-1116 in advance to schedule your
arrival with a staff member.
FOR FURTHER INFORMATION CONTACT: CAPT John Rael, Director, Office of
Resource Access and Partnerships, Indian Health Service, 5600 Fishers
Lane, Mail Stop: 10E85C, Rockville, Maryland 20857. Telephone (301)
443-0969 (This is not a toll free number).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment.
Background: The IHS provides services under regulation in effect as
of September 15, 1987, and republished at 42 CFR part 136, subparts A-
C. Subpart C defines a Contract Health Service Delivery Area (CHSDA),
now referred to as PRCDA, as the geographic area within which PRC will
be made available by the IHS to members of an identified Indian
community who reside in the PRCDA. Residence within a PRCDA by a person
who is within the scope of the Indian health program, as set forth in
42 CFR 136.12, creates no legal entitlement to PRC but only potential
eligibility for services. Services needed, but not available at an IHS/
Tribal facility, are provided under the PRC program depending on the
availability of funds, the relative medical priority of the services to
be provided, and the actual availability and accessibility of alternate
resources in accordance with the regulations.
The regulations at 42 CFR part 136, subpart C provide that, unless
otherwise designated, a PRCDA shall consist of a county which includes
all or part of a reservation and any county or counties which have a
common boundary with the reservation. 42 CFR 136.22(a)(6). The
regulations also provide that after consultation with the Tribal
governing body or bodies on those reservations included within the
PRCDA, the Secretary may, from time to time, re-designate areas within
the United States for inclusion in or exclusion from a PRCDA. 42 CFR
136.22(b).
The regulations require that certain criteria must be considered
before any
[[Page 43416]]
re-designation is made. The criteria are as follows:
(1) The number of Indians residing in the area proposed to be so
included or excluded;
(2) Whether the Tribal governing body has determined that Indians
residing in the area near the reservation are socially and economically
affiliated with the Tribe;
(3) The geographic proximity to the reservation of the area whose
inclusion or exclusion is being considered; and
(4) The level of funding which would be available for the provision
of PRC. Additionally, the regulations require that any re-designation
of a PRCDA must be made in accordance with the procedures of the
Administrative Procedure Act (5 U.S.C. 553). 42 CFR 136.22(c). In
compliance with this requirement, the IHS is publishing this Notice and
requesting public comments.
The Pokagon Band of Potawatomi Indians of Michigan and Indiana
(Pokagon Band, or Tribe) is located in Dowagiac, Michigan, and operates
their PRC program as a Tribal Health Program. The IHS established the
Pokagon Band's current PRCDA consistent with the language of the Act of
September 21, 1994, restoring Federal recognition to the Pokagon Band.
Public Law 103-323 (108 Stat. 2152); see also 72 FR 34262 (June 21,
2007). Although the IHS has historically established PRCDAs in
accordance with Congressional intent, the IHS has also preserved
regulatory flexibility to re-designate areas as appropriate for
inclusion in or exclusion from a PRCDA under PRC regulations. See 81 FR
20388 (April 7, 2016).
The current PRCDA for the Pokagon Band of Potawatomi Indians of
Michigan and Indiana currently consists of 10 counties in Southwestern
Michigan and Northwestern Indiana. See 72 FR 34262 (June 21, 2007).
These counties are Allegan, Berrien, Cass, and Van Buren Counties in
Michigan; and Elkhart, Kosciusko, La Porte, Marshall, St. Joseph, and
Starke Counties in Indiana. Pokagon Band of Potawatomi Indians of
Michigan and Indiana citizens residing outside of the PRCDA are
eligible for direct care services; however, they are not eligible for
Purchased/Referred Care (PRC) services.
The Pokagon Band estimates that approximately 537 Pokagon citizens
reside in Kalamazoo, Kent, and Ottawa Counties in Michigan and would
become PRC eligible through the proposed re-designation and expansion
of the Tribe's PRCDA. The Pokagon Band states that these citizens, ``by
virtue of their citizenship with the Pokagon Band are socially and
economically affiliated with the Pokagon Band and belong to the Pokagon
Band community served by the [Health] Center . . .'' The Tribe also
considers certain other PRC-eligible individuals to be socially and
economically affiliated with the Pokagon Band and to belong to the
Pokagon Band community, including non-Indian women pregnant with a
Pokagon Band citizen's child, and children of Pokagon Band citizens as
detailed in the Tribe's PRCDA re-designation request. The Pokagon Band
would like to recognize these persons as eligible for PRC services. The
IHS confirmed that there are Pokagon Band citizens residing in each of
the proposed expansion counties. Accordingly, the IHS proposes to
expand the PRCDA of the Pokagon Band of Potawatomi Indians of Michigan
and Indiana to include the Michigan counties of Kalamazoo, Kent, and
Ottawa.
If the Pokagon Band's PRCDA re-designation and expansion is
finalized as proposed, the Tribe's expanded PRCDA would overlap the
existing PRCDAs of three other Tribes: the Nottawaseppi Band of Huron
Potawatomi (Kalamazoo, Kent, and Ottawa Counties); the Match-E-Be-Nash-
She-Wish Band of Pottawatomi Indians of Michigan (Kalamazoo, Kent, and
Ottawa Counties); and Little River Band of Ottawa Indians (Kent and
Ottawa Counties). The IHS has consulted with each of the overlapping
Tribes regarding the proposed expansion of the Pokagon Band's PRCDA,
and none of the overlapping Tribes has expressed a current concern
regarding the proposed re-designation and expansion.
Under 42 CFR 136.23, those otherwise eligible Indians who do not
reside on a reservation, but reside within a PRCDA, must be either
members of the Tribe or other IHS beneficiaries who maintain close
economic and social ties with the Tribe. In this case, applying the
aforementioned PRCDA re-designation criteria required by operative
regulations codified at 42 CFR part 136, subpart C, the following
findings are made:
1. By expanding the PRCDA to include Kalamazoo, Kent, and Ottawa
Counties in Michigan, the Pokagon Band of Potawatomi Indians of
Michigan and Indiana's PRC eligible population will increase by an
estimated 537 Tribal citizens.
2. The IHS finds that the Tribal citizens and other PRC-eligible
individuals within the expanded PRCDA are socially and economically
affiliated with the Pokagon Band based on a Tribal resolution in which
the Pokagon Band Tribal Council identified its intent to expand the
PRCDA to include Kalamazoo, Kent, and Ottawa Counties in Michigan, and
stated that the Tribal citizens and certain other individuals residing
in such areas are socially and economically affiliated with the Pokagon
Band.
3. The expanded PRCDA counties form a contiguous area with the
existing PRCDA, and Pokagon Band citizens reside in each of the
counties proposed for inclusion in the expanded PRCDA. For these
reasons, the IHS has determined the additional counties proposed for
inclusion herein to be geographically proximate, meaning ``on or
near,'' to the existing PRCDA.
4. The Pokagon Band has indicated that its PRC program can continue
providing the same level of care to the PRC-eligible population if the
PRCDA is expanded as proposed, without requiring additional funding or
reduction of the current medical priority level.
This Notice does not contain reporting or recordkeeping
requirements subject to prior approval by the Office of Management and
Budget under the Paperwork Reduction Act of 1980.
Roselyn Tso,
Director, Indian Health Service.
[FR Doc. 2024-10845 Filed 5-16-24; 8:45 am]
BILLING CODE 4166-14-P