Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices 68623 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[Assistance Listing Number: 93.576] 

Announcement of Intent To Award an 

Unsolicited Cooperative Agreement to 

Church World Services (CWS) 

Headquartered in New York, NY 

AGENCY: Refugee Program, Office of 

Refugee Resettlement (ORR), 

Administration for Children and 

Families (ACF), Department of Health 

and Human Services (HHS). 

ACTION: Notice of Issuance of an 

Unsolicited Award. 

SUMMARY: ACF, ORR, Refugee Program 

announces the intent to award an 

unsolicited cooperative agreement in 

the amount of up to $1,984,144 to 

Church World Services (CWS) in New 

York, NY. The purpose of this award is 

to provide enhanced refugee housing 

solutions for Afghan and Ukrainian 

humanitarian parolees and other ORReligible populations. This proposal 

seeks to create a local resources 

directory for housing, increase access to 

housing resources for vulnerable refugee 

and humanitarian parolee populations, 

expand innovative and replicable 

solutions through capacity building and 

key partnerships, address challenges to 

identifying and securing safe, affordable 

housing options, and provide a bank of 

housing resources for both refugees and 

community sponsors. 

DATES: The proposed period of 

performance is September 30, 2023, to 

September 29, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Yimeem Vu, Program Specialist, 

Administration for Children and 

Families, Office of Refugee 

Resettlement, Mary E. Switzer Building, 

330 C Street SW, Washington, DC 

20201. Telephone: 202–401–4825; 

Email: Yimeem.Vu@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: On March 

30, 2023, Church World Services (CWS), 

on behalf of its Refugee Housing 

Solutions (RHS) initiative, submitted an 

unsolicited proposal to ORR for 

‘‘Enhancing Refugee Housing 

Solutions.’’ One area of focus is directed 

towards eligible Ukrainian and Afghan 

Humanitarian Parolees and the other to 

all ORR-eligible populations. The first 

focus aims at addressing challenges in 

securing affordable, long-term housing 

for Afghan and Ukrainians through the 

following three means: (1) creating a 

‘Housing Hub’ with a local resources 

directory and information specific to 

housing solutions for these populations 

(and translated into relevant languages); 

(2) increasing access to housing 

resources for both eligible humanitarian 

parolees and their sponsors; and (3) 

expanding innovation efforts through 

capacity building and key partnerships. 

The second area of focus aims to 

address challenges in securing 

affordable housing for all ORR-eligible 

populations and identify more housing 

options for resettlement stakeholders to 

utilize. This proposal seeks to achieve 

this by advancing innovative housing 

initiatives (through consultation and 

guidance) in collaboration with new and 

existing partners from nontraditional 

resettlement backgrounds. 

RHS is currently funded by the 

Department of State’s Bureau of 

Population, Refugees, and Migration 

(PRM) to provide Reception and 

Placement housing education and 

training, targeted assistance, piloting of 

three housing initiatives, expanding 

housing access, and reimagining refugee 

housing. Unlike the proposals submitted 

to ORR, the work done by RHS through 

PRM funding does not include services 

specifically for Ukrainian and Afghan 

humanitarian parolees, in addition to 

other ORR-populations outside of 

refugees. In addition, some of the 

concurrent work of the PRM contract 

will bolster the initiatives proposed to 

ORR, including consulting on additional 

innovative housing pilot programs and 

collection of localized resources for a 

housing ‘hub’ and directory. Further, 

RHS receives a subaward from ORR for 

housing education, training, and 

technical assistance through the grant to 

the International Rescue Committee’s 

Switchboard. The activities of that 

subaward do not overlap with the 

suggested activities of these unsolicited 

proposals but could add to the bank of 

resources provided to newcomers and 

their sponsors as outlined in the first 

proposal. RHS is stating that their 

capacity to achieve the proposed 

activities is not possible with current 

levels of funding from PRM and the 

technical assistance subaward from 

ORR. 

ORR intends to award CWS with one 

cooperative agreement for the project 

‘‘Enhancing Refugee Housing 

Solutions.’’ After both internal and 

external reviews, ORR concluded with 

the intent to award this unsolicited 

proposal based on a desire to address 

stakeholder concerns regarding housing 

access and affordability and considering 

that the capacity of CWS would need to 

be expanded through additional funding 

to address these challenges. Various 

stakeholders across the nation, 

including grant recipient organizations, 

State Refugee Coordinators, local 

community and ethnic communitybased organizations, and beneficiaries 

have raised concerns over the last year 

of housing affordability and housing 

stock availability for the long-term 

placement of resettled refugees and 

newcomers, particularly those with 

large families, and often cite housing as 

the number one challenge facing 

resettlement. Further, ORR participates 

with RHS through various public/ 

private housing working groups. 

Through these conversations and 

presentations, it is apparent that RHS is 

unique in its mission to provide refugee 

housing technical assistance, identity 

solutions specific to refugee housing, 

and represent RHS partners, including 

all 10 national resettlement agencies, in 

housing concerns. However, RHS is not 

currently funded at a capacity that 

allows them to expand capabilities and 

advance innovative and replicable 

housing solutions to meet the needs of 

all ORR-eligible populations. 

Statutory Authority: Immigration and 

Nationality Act section 412(c)(1)(A), 8 

U.S.C. 1522(c)(1)(A). 

Elizabeth Leo, 

Senior Grants Policy Specialist, Office of 

Grants Policy, Office of Administration. 

[FR Doc. 2023–22028 Filed 9–29–23; 4:15 pm] 

BILLING CODE 4184–89–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–P–2656] 

Determination That ULTRAM 

(Tramadol Hydrochloride) Tablets, 50 

Milligrams, Was Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) has determined that ULTRAM 

(tramadol hydrochloride) Tablets, 50 

milligrams (mg), was not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

this drug product, and it will allow FDA 

to continue to approve ANDAs that refer 

to the product as long as they meet 

relevant legal and regulatory 

requirements. 


lotter on DSK11XQN23PROD with NOTICES1
68624 Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices 

FOR FURTHER INFORMATION CONTACT: Joan 

Dailey, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6248, Silver Spring, 

MD 20993–0002, 301–796–6357, 

Joan.Dailey@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

ULTRAM (tramadol hydrochloride) 

Tablets, 50 mg, is the subject of NDA 

020281, held by Janssen 

Pharmaceuticals, Inc., and initially 

approved on March 3, 1995. ULTRAM 

is indicated for the management of pain 

severe enough to require an opioid 

analgesic and for which alternative 

treatments are inadequate. 

ULTRAM (tramadol hydrochloride) 

Tablets, 50 mg, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Hyman, Phelps & McNamara, P.C. 

submitted a citizen petition dated June 

28, 2023 (Docket No. FDA–2023–P– 

2656), under 21 CFR 10.30, requesting 

that the Agency determine whether 

ULTRAM (tramadol hydrochloride) 

Tablets, 50 mg, was withdrawn from 

sale for reasons of safety or 

effectiveness. The citizen petition noted 

that FDA has already determined that 

the 100 mg tablet strength of the same 

drug was not discontinued for reasons 

of safety or effectiveness (see the 

Federal Register of April 27, 2022 (87 

FR 25028)). 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that ULTRAM (tramadol 

hydrochloride) Tablets, 50 mg, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that ULTRAM (tramadol 

hydrochloride) Tablets, 50 mg, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of ULTRAM 

(tramadol hydrochloride) Tablets, 50 

mg, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list ULTRAM (tramadol 

hydrochloride) Tablets, 50 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of approved ANDAs that refer to this 

drug product. Additional ANDAs for 

this drug product may also be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: September 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21990 Filed 10–3–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4158] 

User Fee Rates for Fiscal Year 2024; 

Change of Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice that the courier address for the 

U.S. Bank will change. This change has 

a direct impact on the Fiscal Year 2024 

Federal Register notices for the 

following FDA User Fee programs: 

Prescription Drug User Fee 

Amendments (PDUFA), Medical Device 

User Fee Amendments (MDUFA), 

Generic Drug User Fee Amendments 

(GDUFA), Biosimilar User Fee 

Amendments (BsUFA), Food Safety 

Modernization Act (FSMA), and 

Compounding Quality Act (CQA). The 

new physical address will be 3180 Rider 

Trail South, Earth City, MO 63045. 

FOR FURTHER INFORMATION CONTACT: 

Olufunmilayo Ariyo, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 62080, Beltsville, MD 20705–4304, 

240–402–4989; or the User Fees Support 

Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

purpose of this notice is to inform the 

public that the physical address for 

overnight packages for the U.S. Bank 

will change on October 6, 2023. The 

building’s street address has changed 

from 1005 Convention Plaza, St. Louis, 

MO 63101, to 3180 Rider Trail South, 

Earth City, MO 63045. The last date to 

use the old address to deliver a check 

by courier, such as Federal Express or 

UPS, is October 5, 2023, and payers 

must use the new address for any 

packages beginning October 6, 2023, to 

prevent any disruption to the processing 

of their overnight package payments. 

Note that this new address is for courier 

delivery only. 

If checks are to be sent by a courier 

that requires a street address, the courier 

can deliver the checks to: 

• For CQA and MDUFA: U.S. Bank, 

ATTN: Government Lockbox 979033, 

3180 Rider Trail South, Earth City, MO 

63045. 

• For BsUFA, FSMA, and GDUFA: 

U.S. Bank, ATTN: Government Lockbox 

979108, 3180 Rider Trail South, Earth 

City, MO 63045. 

• For PDUFA: U.S. Bank, ATTN: 

Government Lockbox 979107, 3180 


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