88926 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 

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 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: 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 

Sherrette.Funn@hhs.gov or by calling 

(202) 264–0041 and PRA@HHS.GOV 

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: Sherrette.Funn@hhs.gov, 

PRA@HHS.GOV or call (202) 264–0041 

the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: 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 

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. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 246 / Tuesday, December 26, 2023 / Notices 88927 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondent 

Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Transfusing Hospitals ............................................................. 2754 1 1 hour, 46 min ........................ 4,865 

Hospital Blood Banks .............................................................. 83 1 1 hour, 46 min ........................ 147 

Community-based blood center .............................................. 53 1 1 hour, 46 min ........................ 94 

Total ................................................................................. 2,890 ........................ ................................................. 5,106 

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 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice. 

SUMMARY: 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 

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 

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 


khammond on DSKJM1Z7X2PROD with NOTICES