Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices 75327 

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) 

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. 

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 

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 

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: 


jbell on DSKJLSW7X2PROD with NOTICES
75328 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices 

ESTIMATED OPPORTUNITY BURDEN FOR RESPONDENTS

Instrument 

Annual 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

Healthcare providers: 

Serious Medical Procedure Request (SMR) Form ....... 195 1 .22 128.7 42.9 

Estimated Total Annual Burden 

Hours: 42.9. 

Instrument 

Annual 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

ORR Grantee Staff: 

Serious Medical Procedure Request (SMR) Form ....... 195 1 .08 46.8 15.6 

Estimated Total Annual Burden 

Hours: 15.6. 

ESTIMATED RECORDKEEPING BURDEN FOR RESPONDENTS

Instrument 

Annual 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

ORR Grantee Staff: 

Serious Medical Procedure Request (SMR) Form ....... 195 1 .08 46.8 15.6 

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] 

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. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

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. 

FOR FURTHER INFORMATION CONTACT: 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. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

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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