30-Day FRN 2023

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Federal Register / Vol. 88, No. 246 / Tuesday, December 26, 2023 / Notices

• Submitting under § 314.50(d)(1)(i)
chemistry, manufacturing, and controls
information, including the drug
substance, for the content and format of
an NDA for rare diseases; and
• Submitting under § 314.50(d)(5) and
(d)(5)(iv) clinical data of a drug,
including a description of any other
data information relevant to an
evaluation of the safety and
effectiveness of a drug.
• Submissions under 21 CFR part
314, subpart H, to grant accelerated
approval of new drugs for serious or
life-threatening illnesses.
• Submissions under §§ 312.47 and
312.82 for requesting meetings with
FDA about drug development programs.
The following collections of
information in the final guidance have
been approved under OMB control
number 0910–0014:
• Submitting under 21 CFR
312.23(a)(6)(i) (§ 312.23(a)(6)(i)) a
protocol for the duration of a trial and
the criteria to enter a trial and under
§ 312.23(a)(6)(i), (a)(6)(iii)(d) and (g) a
description of an estimate of patients
that will be involved in a trial,
including a description of the safety
exclusions and a description of clinical
procedures, laboratory, or other
methods.
• Submitting under § 312.23(a)(3)(i) a
brief introductory statement and general
investigational plan, including the route
of administration of a drug;
• Submitting under § 312.23(a)(7) and
(a)(7)(iv)(a) chemistry, manufacturing,
and controls information for the content
and format of an investigational new
drug application (IND) and the safety
and effectiveness of such information;
• Submitting under § 312.23(a)(8) and
(a)(8)(i) pharmacology, toxicology, and
drug disposition information for rare
diseases;
• Submitting under 312.23(a)(10)(iii)
plans for assessing pediatric safety and
effectiveness;
• Submitting under § 312.32(c)(1) IND
safety reports;
• Submissions under §§ 312.305(b)
and 312.310(b) for expanded access uses
and treatment of an individual patient.
The collections of information in 21
CFR part 316 for submitting the content
and format of NDAs for orphan drugs
have been approved under OMB control
number 0910–0167. The collections of
information pertaining to postmarketing
adverse drug experience reporting have
been approved under OMB control
number 0910–0230. The collections of

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information pertaining to expedited
review programs for serious conditions,
accelerated approval, breakthrough
therapy-designation, and fast-track
designation, have been approved under
OMB control number 0910–0765. The
collections of information in 21 CFR
part 58 pertaining to good laboratory
practices have been approved under
OMB control number 0910–0119. The
collection of information pertaining to
current good manufacturing practices
have been approved under OMB control
number 0910–0139.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–28310 Filed 12–22–23; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–30D]

Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before January 25, 2024.
ADDRESSES: Submit your comments to
[email protected] or by calling
(202) 264–0041 and [email protected]
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0313 and
project title for reference, to Sherrette A.
Funn, email: [email protected],
SUMMARY:

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[email protected] or call (202) 264–0041
the Reports Clearance Officer.
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: National Blood
Collection & Utilization Survey
(NBCUS)
Type of Collection: Revision
OMB No. 0990–30D–0313 Office of
the Assistant Secretary for Health/HHS

SUPPLEMENTARY INFORMATION:

Abstract
The Office of the Assistant Secretary
for Health (OASH) is requesting
approval for a three-year revised
information collection request (ICR)
titled ‘‘National Blood Collection &
Utilization Survey (NBCUS).’’ The
NBCUS is a biennial survey that
includes a core of standard questions on
blood collection, processing, and
utilization practices. Questions on
transfusion-transmitted infections,
transfusion associated circulatory
overload, acute hemolysis, delayed
hemolysis, and severe allergic reactions
are also included in the survey. The
rapidly changing environment in blood
supply and demand makes it important
to have regular, periodic data describing
the state of U.S. blood collections and
transfusions for understanding the
dynamics of blood safety and
availability. In 2023, two sections were
removed from the survey related to the
impact of the COVID–19 pandemic on
the blood supply during the course of
2020.
Survey respondents will consist of
blood collection centers and hospitals
that perform blood transfusions, except
those reporting fewer than 100 inpatient
surgeries per year. For the purposes of
this ICR, federal burden is only being
placed on facilities located within the
fifty states and the District of Columbia.
The total estimated burden is 5,106
hours.

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Federal Register / Vol. 88, No. 246 / Tuesday, December 26, 2023 / Notices

88927

ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent

Number of
respondents

Transfusing Hospitals .............................................................
Hospital Blood Banks ..............................................................
Community-based blood center ..............................................
Total .................................................................................

James Berger,
Senior Advisor for Blood and Tissue Safety,
Office of the Assistant Secretary for Health.
[FR Doc. 2023–28412 Filed 12–22–23; 8:45 am]
BILLING CODE 4150–41–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice of Purchased/Referred Care
Delivery Area Redesignation for the
Spokane Tribe of Indians in the State
of Washington
Indian Health Service, HHS.
Notice.

AGENCY:
ACTION:

Notice is hereby given that
the Indian Health Service (IHS) has
decided to expand the geographic
boundaries of the Purchased/Referred
Care Delivery Area (PRCDA) for the
Spokane Tribe to include the counties of
Spokane and Whitman in the State of
Washington. The final PRCDA for the
Spokane Tribe now includes the
Washington counties of Ferry, Lincoln,
Spokane, Stevens, and Whitman. The
sole purpose of this expansion is to
authorize additional Spokane Tribal
members and beneficiaries to receive
Purchased/Referred Care (PRC) services.
DATES: This expansion is effective as of
the publication date of this notice.
ADDRESSES: This notice can be found at
https://www.federalregister.gov. Written
requests for information should be
delivered to: CAPT John Rael, Director,
Office of Resource Access and
Partnerships, Indian Health Service,
5600 Fishers Lane, Mail Stop 10E85C,
Rockville, MD 20857, or by phone at
(301) 443–0969 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION: The IHS
provides services under regulations 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 a PRCDA,
as the geographic area within which
PRC will be made available by the IHS
to members of an identified Indian

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2754
83
53
2,890

Number
responses per
respondent

Average
burden per
response
(in hours)

1
1
1
........................

1 hour, 46 min ........................
1 hour, 46 min ........................
1 hour, 46 min ........................
.................................................

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
redesignation 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 redesignation 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 published a
proposed notice of redesignation and
requested public comments on August
9, 2023 (88 FR 53899). The IHS did not

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Total burden
hours
4,865
147
94
5,106

receive any comments to the notice of
the proposed expansion.
Two other Tribes currently have
PRCDAs which include one or both of
the counties to be included in the
Spokane Tribe’s expanded PRCDA—the
Coeur d’Alene Tribe (both Spokane and
Whitman Counties) and the Kalispel
Tribe of Indians (Spokane County only).
On December 10, 2021, the Portland
Area Director notified both Tribes of the
Spokane Tribe’s request to expand their
PRCDA, and requested any comments in
response. The Kalispel Tribe of Indians
did not provide any comments. The
Coeur d’Alene Tribe responded with
objections to the proposed expansion.
The Portland Area IHS engaged in
further conversations and
correspondence with the Coeur d’Alene
Tribe throughout 2021 and 2022.
Through letters from the Spokane
Tribe, dated May 31, 2022 and August
8, 2022, the Tribe expressed its support
for the expansion, described the
geographic proximity of Spokane and
Whitman counties to the Tribe’s
reservation, and explained that the
Tribe’s reservation expanded into
Spokane County in 2001 and that some
of the Tribe’s members reside in
Whitman County.
In support of this expansion, the IHS
adopts the following findings:
1. By expanding the PRCDA to
include Spokane County and Whitman
County, the Spokane Tribe’s eligible
population will be increased by an
estimated 480 Tribal members.
Although the Coeur d’Alene Tribe has a
PRCDA which includes these two
counties, the Coeur d’Alene Tribe does
not provide PRC services to Spokane
Tribal members residing in those
counties. Expansion of the Spokane
Tribe’s PRCDA to include Spokane and
Whitman Counties will therefore
increase access to care for those
individuals.
2. The IHS finds that the Tribal
members within the expanded PRCDA
are socially and economically affiliated
with the Spokane based on letters from
the Spokane Tribe, dated May 31, 2022
and August 8, 2022, which noted that
the Spokane Tribal Council had

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