Proposed Information Collection Activity; Serious Medical Procedure Request (SMR) Form (Office of Management and Budget #: 0970-0561), 62798-62799 [2023-19795]
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62798
Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices
ANNUAL BURDEN ESTIMATES
SCWS web-based survey ................................................................................
SCWS focus group ..........................................................................................
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)
Office of Refugee Resettlement,
Administration for Children and
Families, U.S. Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Administration for
Children and Families’ (ACF) Office of
Refugee Resettlement is requesting a 3year 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
SUMMARY:
Total number
of
responses per
respondent
Total number
of
respondents
Instrument
60
30
1
1
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).
Average
burden
hours per
response
Total/annual
burden hours
0.5
1.5
30
45
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.
ddrumheller on DSK120RN23PROD with NOTICES1
ESTIMATED REPORTING TIME FOR RESPONDENTS
Total number
of respondents
Total number
of responses
per
respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
Instrument
Respondent
SMR Form ...........................
Care Provider Program
Staff.
Surgeons ............................
250
1.38
.07
24.15
8
250
1.38
.17
58.65
20
.............................................
........................
........................
........................
........................
28
Total Annual Burden
Estimate.
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Federal Register / Vol. 88, No. 176 / Wednesday, September 13, 2023 / Notices
62799
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.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:37 Sep 12, 2023
Jkt 259001
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,
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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,
1 See 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.
E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 88, Number 176 (Wednesday, September 13, 2023)]
[Notices]
[Pages 62798-62799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19795]
-----------------------------------------------------------------------
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 [email protected].
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total number Average burden
Instrument Respondent Total number of responses hours per Total burden Annual burden
of respondents per respondent response hours 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 62799]]
Estimated Recordkeeping Time
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total number of Average burden
Instrument Respondent Total number of responses per hours per Total burden Annual burden
respondents respondent response hours 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
