62798 Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument 

Total number 

of 

respondents 

Total number 

of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total/annual 

burden hours 

SCWS web-based survey ................................................................................ 60 1 0.5 30 

SCWS focus group .......................................................................................... 30 1 1.5 45 

Estimated Total Annual Burden 

Hours: 75. 

Authority: Title II, section 203(b)(4) of 

the Child Abuse Prevention and 

Treatment and Adoption Reform Act of 

1978 (42 U.S.C. 5113(b)(4)). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–19775 Filed 9–12–23; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Serious Medical Procedure 

Request (SMR) Form (Office of 

Management and Budget #: 0970–0561) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, U.S. Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families’ (ACF) Office of 

Refugee Resettlement is requesting a 3- 

year extension of the Serious Medical 

Procedure Request (SMR) Form (Office 

of Management and Budget #0970–0561, 

expiration February 29, 2024). Revisions 

are proposed to the currently approved 

form. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: ACF’s ORR places 

unaccompanied children in their 

custody in care provider programs until 

unification with a qualified sponsor. 

Care provider programs are required to 

provide children with a range of 

services including medical, dental, and 

mental healthcare. Children identified 

as having a serious medical or dental 

condition may require a procedure 

while in ORR custody to maintain and 

promote their health and wellbeing. 

Procedures requiring general anesthesia, 

surgeries, and invasive diagnostic 

procedures (e.g., cardiac catheterization, 

invasive biopsy, amniocentesis) require 

advance ORR approval. Before ORR can 

approve, data must be collected on the 

SMR form and submitted to ORR by the 

care provider program (e.g., care 

provider program’s contact information, 

child demographics, authorized 

consenter, unification status) and the 

lead surgeon (e.g., reason for the 

procedure, potential risks/ 

complications/adverse outcomes if the 

procedure is not performed, timing, 

recovery timeframe, planned follow-up 

procedures, hospital points of contact). 

ORR will waive the completion of the 

SMR form if it is deemed to be in the 

best interest of the child (e.g., during a 

hospitalization or emergency 

department visit, related to a medical 

emergency). 

The form is used as a worksheet for 

care provider program staff and 

surgeons to compile information that 

would otherwise have been collected 

during the health evaluation. Once 

completed, care provider program staff 

upload the form and supporting 

documentation into ORR’s secure, 

electronic data record system and send 

an email notification to ORR staff that 

the SMR packet is ready for review. 

ORR has incorporated changes to the 

form to streamline the flow of data 

collection, clarify intent and purpose of 

the form and fields, improve data 

quality, and ensure alignment with ORR 

program policies. The overall estimated 

time per form has increased by 1 minute 

and has been adjusted to reflect a 

decrease by 1 minute for care provider 

program staff and an increase by 2 

minutes for surgeons. 

Respondents: Care provider program 

staff, surgeons. 

Annual Burden Estimates 

There are currently about 250 

programs that use the SMR form. Over 

the past 2 years, an annual average of 

115 SMR forms were submitted across 

all programs. For each form, a care 

provider program staff member 

completes page 1, and a surgeon 

completes pages 2 and 3. 

ESTIMATED REPORTING TIME FOR RESPONDENTS

Instrument Respondent Total number 

of respondents 

Total number 

of responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

SMR Form ........................... Care Provider Program 

Staff.

250 1.38 .07 24.15 8 

Surgeons ............................ 250 1.38 .17 58.65 20 

Total Annual Burden 

Estimate.

............................................. ........................ ........................ ........................ ........................ 28 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices 62799 

1See Oxandrin (oxandrolone) tablets product 

labeling (NDA 013718, supplement 023), approved 

on June 20, 2005, available at https://

www.accessdata.fda.gov/drugsatfda_docs/label/ 

2005/013718s023lbl.pdf. 

ESTIMATED RECORDKEEPING TIME

Instrument Respondent Total number 

of respondents 

Total number 

of responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

SMR Form ..... Care Provider Program Staff ................... 250 1.38 .08 27.6 9 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 6 U.S.C 279: Exhibit 1, part 

A.2 of the Flores Settlement Agreement 

(Jenny Lisette Flores, et al., v. Janet 

Reno, Attorney General of the United 

States, et al., Case No. CV 85–4544–RJK 

[C.D. Cal. 1996]) 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–19795 Filed 9–12–23; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–P–0558] 

Determination That Oxandrin 

(Oxandrolone) Tablets, 2.5 Milligrams 

and 10 Milligrams, Were Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that Oxandrin 

(oxandrolone) tablets, 2.5 milligrams 

(mg) and 10 mg, were withdrawn from 

sale for reasons of safety or 

effectiveness. The Agency will not 

accept or approve abbreviated new drug 

applications (ANDAs) for Oxandrin 

(oxandrolone) tablets, 2.5 mg and 10 mg. 

FOR FURTHER INFORMATION CONTACT: 

Alexandria Fujisaki, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6222, 

Silver Spring, MD 20993–0002, 301– 

796–3600, Alexandria.Fujisaki@

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 

(§ 314.162 (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. 

The anabolic steroid Oxandrin 

(oxandrolone) tablets, 2.5 mg and 10 mg, 

is the subject of NDA 013718, held by 

Gemini Laboratories LLC (Gemini), and 

initially approved on July 21, 1964 (for 

the 2.5 mg strength) and November 5, 

2001 (for the 10 mg strength). Oxandrin 

is indicated as follows: ‘‘as adjunctive 

therapy to promote weight gain after 

weight loss following extensive surgery, 

chronic infections, or severe trauma, 

and in some patients who without 

definite pathophysiologic reasons fail to 

gain or to maintain normal weight, to 

offset the protein catabolism associated 

with prolonged administration of 

corticosteroids, and for the relief of the 

bone pain frequently accompanying 

osteoporosis.’’ 1

In a letter dated March 26, 2019, 

Gemini requested that FDA withdraw 

approval of NDA 013718 for Oxandrin 

(oxandrolone) tablets, 2.5 mg and 10 mg, 

under § 314.150(c) (21 CFR 314.150(c)), 

stating that the product was no longer 

being marketed. Subsequently, on 

December 16, 2022, FDA notified 

Gemini that the Agency believes a 

potential problem associated with 

oxandrolone tablets is sufficiently 

serious that the drug product should be 

removed from the market, and to enable 

withdrawal of approval of its 

application under § 314.150(d). After 

FDA notified Gemini that it believes the 

potential problems associated with the 

drug are sufficiently serious that the 

drug should be removed from the 

market pursuant to § 314.150(d), Gemini 

requested in a letter dated December 19, 

2022, that FDA withdraw approval of 

NDA 013718 for Oxandrin 

(oxandrolone) tablets, 2.5 mg and 10 mg 

under § 314.150(d). In the Federal 

Register of June 28, 2023 (88 FR 41970), 

FDA announced that it was 

withdrawing approval of NDA 013718, 

effective June 28, 2023. 

Novitium Pharma LLC submitted a 

citizen petition dated April 6, 2022 

(Docket No. FDA–2022–P–0558), under 

21 CFR 10.30, requesting that the 

Agency determine whether Oxandrin 

(oxandrolone) tablets, 2.5 mg and 10 mg, 

were withdrawn from sale for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that Oxandrin 

(oxandrolone) tablets, 2.5 mg and 10 mg, 


ddrumheller on DSK120RN23PROD with NOTICES1