Submission for OMB Review; ORR Serious Medical Procedure Request (SMR) Form (New Collection), 75327-75328 [2020-26121]
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Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
CQ4. What survivorship care
resources are available to providers who
care for adult survivors of childhood
cancer?
a. What are the intended outcomes of
the different resources available to care
providers?
b. What is the evidence of
effectiveness of the different resources
available to care providers?
c. What are the monetary costs to
access these resources?
Key Questions (KQs) for the Realist
Review
KQ1. For whom and under what
circumstances could different
survivorship care models for adult
survivors of childhood cancer that
include primary care be effective?
a. What are the key mechanisms by
which these models could be effective?
b. What are important contexts that
determine whether different
mechanisms could be effective?
KQ2. For whom and under what
circumstances could different
survivorship care resources for adult
survivors of childhood cancer be
effective in achieving their intended
outcomes?
a. For survivors and their families
i. What are the key mechanisms by
which these resources could lead to
their intended outcome?
ii. What are important contexts that
determine whether different
mechanisms could lead to outcomes?
b. For care providers
i. What are the key mechanisms by
which these resources could lead to
their intended outcome?
ii. What are important contexts that
determine whether different
mechanisms could lead to outcomes?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
Interventions
• Models of childhood cancer
survivorship care for use in adult
survivors
Æ Models of childhood cancer
survivorship care for use in adult
survivors that include primary care
• Survivorship resources available to
adult survivors of childhood cancer
and their families
• Survivorship resources available to
care providers of adult survivors of
childhood cancer
Comparators
• Optional (will not require a
comparison)
Outcomes
List of outcomes will be informed by
contextual questions but may include:
• Intermediate patient health outcomes
• Morbidity
• Mortality
• Relapse
• Quality of life
• Psychosocial outcomes
• Mental health outcomes
• Caregiver burden
• Satisfaction with care
• Educational attainment
• Adherence with care
• Cost and resource utilization
• Unintended consequences
• Additional burdens
• Late effects—new cancers, cardiac or
respiratory issues, etc. from original
treatment
Timing
• After the transition from childhood
cancer care
Settings
• All care settings
Dated: November 19, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020–26041 Filed 11–24–20; 8:45 am]
BILLING CODE 4160–90–P
We will adapt the PICOTS framework
(populations, interventions,
comparators, outcomes, timing, and
setting) to inform our realist review. The
PICOTS include but are not limited to
the following.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
jbell on DSKJLSW7X2PROD with NOTICES
Population(s)
• Adult survivors of childhood cancer
(cancer diagnosed prior to age 21years
old) with no evidence of clinical
disease; and their families
• Care providers of adult survivors of
childhood cancer
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16:27 Nov 24, 2020
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Submission for OMB Review; ORR
Serious Medical Procedure Request
(SMR) Form (New Collection)
ACTION:
Request for public comment.
The Office of Refugee
Resettlement (ORR), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing to collect
data for a new data collection, the
Serious Medical Procedure Request
(SMR) Form.
SUMMARY:
Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Description: Children with complex
medical/dental conditions may require
surgical intervention or procedures in
order to maintain and promote their
health while in ORR custody.
Procedures requiring general anesthesia,
surgeries, and invasive diagnostic
procedures (e.g., cardiac catheterization,
invasive biopsy, amniocentesis) require
advance ORR approval. Before a
decision can be rendered by ORR, data
on clinical indications, risks and
benefits of the surgery/procedure,
potential adverse outcomes if services
are not rendered, timeframe for
recovery, follow-up care, and points of
contact must be collected and submitted
to ORR. The form is not required for
emergency procedures, procedures
performed during hospitalization, or
procedures resulting from complication
of a previously approved procedure.
Respondents: Healthcare providers,
ORR grantee staff.
Annual Burden Estimates:
Office of Refugee Resettlement,
Administration for Children and
Families, HHS.
AGENCY:
PO 00000
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Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices
ESTIMATED OPPORTUNITY BURDEN FOR RESPONDENTS
Annual
number of
respondents
Instrument
Healthcare providers:
Serious Medical Procedure Request (SMR) Form .......
Annual
number of
responses per
respondent
195
Average
burden hours
per response
1
.22
Total burden
hours
Annual burden
hours
128.7
42.9
Estimated Total Annual Burden
Hours: 42.9.
Annual
number of
respondents
Instrument
ORR Grantee Staff:
Serious Medical Procedure Request (SMR) Form .......
Annual
number of
responses per
respondent
195
Average
burden hours
per response
1
.08
Total burden
hours
Annual burden
hours
46.8
15.6
Estimated Total Annual Burden
Hours: 15.6.
ESTIMATED RECORDKEEPING BURDEN FOR RESPONDENTS
Annual
number of
respondents
Instrument
ORR Grantee Staff:
Serious Medical Procedure Request (SMR) Form .......
Estimated Total Annual Burden
Hours: 15.6.
Authority: 6 U.S.C. Section 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. 2020–26121 Filed 11–24–20; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3077]
jbell on DSKJLSW7X2PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Obtaining
Information To Understand Challenges
and Opportunities Encountered by
Compounding Outsourcing Facilities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
VerDate Sep<11>2014
16:27 Nov 24, 2020
Jkt 253001
Annual
number of
responses per
respondent
195
1
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by December
28, 2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0883. Also include
the FDA docket number found in
brackets in the heading of this
document.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Average
burden hours
per response
.08
Total burden
hours
Annual burden
hours
46.8
15.6
collection of information to OMB for
review and clearance.
Obtaining Information To Understand
Challenges and Opportunities
Encountered by Compounding
Outsourcing Facilities
OMB Control Number 0910–0883—
Extension
This information collection supports
Agency-sponsored research. Drug
compounding is generally the practice
of combining, mixing, or altering
ingredients of a drug to create a
medication tailored to the needs of an
individual patient. Although
compounded drugs can serve an
important medical need for certain
patients when an approved drug is not
medically appropriate, they also present
a risk to patients. Compounded drugs
are not FDA-approved. Therefore, they
do not undergo premarket review by
FDA for safety, effectiveness, and
quality. Since compounded drugs are
subject to a lower regulatory standard
than approved drugs, Federal law places
conditions on compounding that are
designed to protect the public health.
The Drug Quality and Security Act of
2013 (Pub. L. 113–54) created
‘‘outsourcing facilities’’—a new industry
sector of drug compounders held to
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]]>Agencies
[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75327-75328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26121]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; ORR Serious Medical Procedure Request
(SMR) Form (New Collection)
AGENCY: Office of Refugee Resettlement, Administration for Children and
Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office of Refugee Resettlement (ORR), Administration for
Children and Families (ACF), U.S. Department of Health and Human
Services (HHS), is proposing to collect data for a new data collection,
the Serious Medical Procedure Request (SMR) Form.
DATES: Comments due within 30 days of publication. OMB must make a
decision about the collection of information between 30 and 60 days
after publication of this document in the Federal Register. Therefore,
a comment is best assured of having its full effect if OMB receives it
within 30 days of publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
SUPPLEMENTARY INFORMATION:
Description: Children with complex medical/dental conditions may
require surgical intervention or procedures in order to maintain and
promote their health while in ORR custody. Procedures requiring general
anesthesia, surgeries, and invasive diagnostic procedures (e.g.,
cardiac catheterization, invasive biopsy, amniocentesis) require
advance ORR approval. Before a decision can be rendered by ORR, data on
clinical indications, risks and benefits of the surgery/procedure,
potential adverse outcomes if services are not rendered, timeframe for
recovery, follow-up care, and points of contact must be collected and
submitted to ORR. The form is not required for emergency procedures,
procedures performed during hospitalization, or procedures resulting
from complication of a previously approved procedure.
Respondents: Healthcare providers, ORR grantee staff.
Annual Burden Estimates:
[[Page 75328]]
Estimated Opportunity Burden for Respondents
----------------------------------------------------------------------------------------------------------------
Annual number Annual number Average
Instrument of of responses burden hours Total burden Annual burden
respondents per respondent per response hours hours
----------------------------------------------------------------------------------------------------------------
Healthcare providers:
Serious Medical Procedure 195 1 .22 128.7 42.9
Request (SMR) Form.........
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 42.9.
----------------------------------------------------------------------------------------------------------------
Annual number Annual number Average
Instrument of of responses burden hours Total burden Annual burden
respondents per respondent per response hours hours
----------------------------------------------------------------------------------------------------------------
ORR Grantee Staff:
Serious Medical Procedure 195 1 .08 46.8 15.6
Request (SMR) Form.........
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 15.6.
Estimated Recordkeeping Burden for Respondents
----------------------------------------------------------------------------------------------------------------
Annual number Annual number Average
Instrument of of responses burden hours Total burden Annual burden
respondents per respondent per response hours hours
----------------------------------------------------------------------------------------------------------------
ORR Grantee Staff:
Serious Medical Procedure 195 1 .08 46.8 15.6
Request (SMR) Form.........
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 15.6.
Authority: 6 U.S.C. Section 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. 2020-26121 Filed 11-24-20; 8:45 am]
BILLING CODE 4184-45-P
