Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4077 

from the Performance Information 

section of SAM. 

As stated in 2 CFR 200, Uniform 

Administrative Requirements, Cost 

Principles, and Audit Requirements for 

Federal Awards, the Federal awarding 

agency is required to review information 

available through any OMB-designated 

repositories of government-wide 

eligibility qualification or financial 

integrity information, as appropriate. 

The Federal awarding agency is 

required to review the non-public 

segment of the OMB-designated 

integrity and performance system 

accessible through SAM (currently the 

FAPIIS), prior to making a Federal 

award where the Federal share is 

expected to exceed the simplified 

acquisition threshold (currently 

$250,000), defined in 41 U.S.C. 134, 

over the period of performance. 

For non-federal entities (NFEs), if the 

total value of the NFEs currently active 

grants, cooperative agreements, and 

procurement contracts from all Federal 

awarding agencies exceeds $10,000,000 

for any period of time during the period 

of performance of the Federal award, 

then the NFE must disclose 

semiannually, and maintain the 

currency of information reported to the 

SAM that is made available in the 

designated integrity and performance 

system (currently the FAPIIS) about 

civil, criminal, or administrative 

proceedings, as described in the award 

terms and conditions, for the most 

recent five year period. 

B. Annual Reporting Burden 

Proceedings Screening Question #1 

Respondents: 13,683. 

Respnoses per Respondent: 1. 

Total annual responses: 13,683. 

Hours per response: .1. 

Total response burden hours: 1,368. 

Proceedings Screening Question #2 

Respondents: 1,663. 

Responsed per Respondent: 1. 

Total annual responses: 1,663. 

Hours per response: .1. 

Total response burden hours: 166. 

Proceedings Details 

Respondents: 24. 

Responses per respondent: 2. 

Total annual responses: 48. 

Hours per response: .5. 

Total response burden hours: 24. 

C. Public Comments 

Public comments are particularly 

invited on: Whether our estimate of the 

public burden of this collection of 

information is accurate, and based on 

valid assumptions and methodology; 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and ways in which we can 

minimize the burden of the collection of 

information on those who are to 

respond, through the use of appropriate 

technological collection techniques or 

other forms of information technology. 

Obtaining Copies: Requesters may 

obtain a copy of the information 

collection documents from the GSA 

Regulatory Secretariat Division by 

calling 202–501–4755 or emailing 

GSARegSec@gsa.gov. Please cite OMB 

Control No. Please cite OMB Control 

No. 3090–0293, Reporting and Use of 

Information Concerning Integrity and 

Performance of Recipients of Grants and 

Cooperative Agreements, in all 

correspondence. 

Beth Anne Killoran, 

Deputy Chief Information Officer. 

[FR Doc. 2021–00867 Filed 1–14–21; 8:45 am] 

BILLING CODE 6820–WY–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Interventional Treatments 

for Acute and Chronic Pain: 

Systematic Review 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for Supplemental 

Evidence and Data Submissions 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review on 

Interventional Treatments for Acute and 

Chronic Pain: Systematic Review, which 

is currently being conducted by the 

AHRQ’s Evidence-based Practice 

Centers (EPC) Program. Access to 

published and unpublished pertinent 

scientific information will improve the 

quality of this review. 

DATES: Submission Deadline on or 

before February 16, 2021. 

ADDRESSES: 

Email submissions: epc@ahrq.hhs.gov 

Print submissions: 

Mailing Address: Center for Evidence 

and Practice Improvement, Agency for 

Healthcare Research and Quality. 

ATTN: EPC SEADs Coordinator, 5600 

Fishers Lane, Mail Stop 06E53A, 

Rockville, MD 20857. 

Shipping Address (FedEx, UPS, etc.): 

Center for Evidence and Practice 

Improvement, Agency for Healthcare 

Research and Quality. ATTN: EPC 

SEADs Coordinator, 5600 Fishers Lane, 

Mail Stop 06E77D, Rockville, MD 

20857. 

FOR FURTHER INFORMATION CONTACT: 

Jenae Benns, Telephone: 301–427–1496 

or Email: epc@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the 

Evidence-based Practice Centers (EPC) 

Program to complete a review of the 

evidence for Interventional Treatments 

for Acute and Chronic Pain: Systematic 

Review. AHRQ is conducting this 

systematic review pursuant to Section 

902 of the Public Health Service Act, 42 

U.S.C. 299a. 

The EPC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Interventional Treatments 

for Acute and Chronic Pain, including 

those that describe adverse events. The 

entire research protocol is available 

online at: https://

effectivehealthcare.ahrq.gov/products/ 

interventional-treatments-pain/protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Interventional 

Treatments for Acute and Chronic Pain 

helpful: 

■ A list of completed studies that 

your organization has sponsored for this 

indication. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

■ For completed studies that do not 

have results on ClinicalTrials.gov, a 

summary, including the following 

elements: Study number, study period, 

design, methodology, indication and 

diagnosis, proper use instructions, 

inclusion and exclusion criteria, 

primary and secondary outcomes, 

baseline characteristics, number of 

patients screened/eligible/enrolled/lost 

to follow-up/withdrawn/analyzed, 

effectiveness/efficacy, and safety results. 

■ A list of ongoing studies that your 

organization has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

4078 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

criteria, and primary and secondary 

outcomes. 

■ Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

organization for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution is very beneficial to 

the Program. Materials submitted must 

be publicly available or able to be made 

public. Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the EPC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EPC Program website and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

https://www.effective

healthcare.ahrq.gov/email-updates. 

The systematic review will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. 

Key Questions (KQs) 

KQ1: What are the effectiveness and 

harms of selected interventional 

procedures (vertebral augmentation 

procedures, piriformis injection, 

sphenopalatine block, occipital nerve 

stimulation, cooled or pulsed 

radiofrequency ablation, intradiscal and 

facet joint platelet rich plasma, 

intradiscal methylene blue, intradiscal 

ozone, and peripheral nerve 

stimulation) versus placebo, a sham 

procedure, or no interventional 

procedure for Medicare beneficiaries 

with pain? 

a. How do the effectiveness and harms 

vary according to demographic (age, sex, 

race/ethnicity), clinical (type of pain, 

severity of pain, prior treatments, 

medical and psychiatric co-morbidities), 

and technical factors (variations in 

techniques, intensity, frequency, dose, 

and number of treatments)? 

PICOTS (Populations, Interventions, 

Comparators, Outcomes, Timing, 

Settings) 

PICOTS Inclusion Exclusion 

Population ....................... Adults with pain of any duration (pain conditions for each 

interventional procedure specified below); will highlight 

studies of populations applicable to Medicare, defined 

as persons enrolled in Medicare, age >55 years, or 

persons with disability (including end-stage renal disease [ESRD]), if available.

Population subgroups of interest include those based on 

demographics (age, sex, race/ethnicity) and clinical 

factors (type of pain, severity of pain, prior treatments, 

medical and psychiatric co-morbidities, including presence of disability [including ESRD], prior substance 

use disorder, and psychological co-morbidities).

• Patients undergoing end-of-life care, terminally ill (e.g., 

hospice) patients; those under supervised palliative 

care; those with pain due to metastatic or advanced 

cancer. 

• Children. 

Intervention ..................... (1) Vertebral augmentation procedures (vertebroplasty 

and kyphoplasty) for pain due to vertebral compression 

fracture.

(2) Piriformis injection (local anesthetic, corticosteroid, 

and/or botulinum toxin) for piriformis syndrome.

(3) Sphenopalatine block for trigeminal neuralgia or 

headache.

(4) Occipital stimulation for headache ...............................

(5) Cooled radiofrequency denervation for degenerative 

back or hip pain and pulsed radiofrequency 

denervation for degenerative back pain.

(6) Intradiscal and facet joint platelet rich plasma for presumed discogenic back pain.

(7) Intradiscal stem cells for presumed discogenic back 

pain.

(8) Intradiscal methylene blue for presumed discogenic 

back pain.

(9) Intradiscal ozone for radicular low back pain or nonradicular, presumed discogenic back pain.

(10) Peripheral nerve stimulation for ulnar, median, or radial neuropathy.

Technical factors of interest as potential modifiers of 

treatment effect include variations in techniques, intensity, frequency, dose, or number of treatments.

• Minimally invasive surgical procedures 

• Orthopedic intra-articular and soft tissue injections 

• Local soft tissue injections 

• Other interventional procedures and conditions not listed as included 

Comparator ..................... Placebo, sham interventional procedure, or no interventional procedure.

For cooled and pulsed radiofrequency denervation: 

standard (thermal, continuous) radiofrequency 

denervation.

Active treatments, other than standard radiofrequency 

denervation as a comparison for cooled radiofrequency 

denervation. 

Outcome ......................... • Primary: Pain, function ...................................................

• Secondary: HRQOL, emotional function (e.g., depression, anxiety), opioid use, surgery rates.

• Global improvement .......................................................

• Harms (e.g., bleeding, infection, other complications), 

adverse events, unintended consequences.

Patient-oriented outcomes: 

• Non-validated instruments for outcomes (e.g., pain, 

function, HRQOL, depression, etc.). 

• Intermediate outcomes (e.g., range of motion, physical 

strength, etc.). 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4079 

PICOTS Inclusion Exclusion 

Timing ............................. Duration of followup: ≥1 month; categorized as short 

term (1 to <6 months), intermediate term (≥6 to <12 

months) and long term (≥12 months) following intervention.

<1 month. 

Setting ............................. Any ..................................................................................... None. 

Study design, publication 

type.

Randomized clinical trials and cohort studies if RCTs are 

not available..

Large (n > 500) case series for serious, rare harms ........

• Case reports. 

• Case series (other than large case series for serious, 

rare harms). 

• Case-control studies, cross-sectional studies. 

• Conference proceedings, editorials, letters, white papers, citations that have not been peer-reviewed. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2021–00800 Filed 1–14–21; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Notice of Meetings 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of five AHRQ 

Subcommittee meetings. 

SUMMARY: The subcommittees listed 

below are part of AHRQ’s Health 

Services Research Initial Review Group 

Committee. Grant applications are to be 

reviewed and discussed at these 

meetings. Each subcommittee meeting 

will be closed to the public. 

DATES: See below for dates of meetings: 

1. Healthcare Safety and Quality 

Improvement Research (HSQR) 

Date: February 3–4, 2021 

2. Healthcare Effectiveness and 

Outcomes Research (HEOR) 

Date: February 10–11, 2021 

3. Health System and Value Research 

(HSVR) 

Date: February 11–12, 2021 

4. Health Care Research and Training 

(HCRT) 

Date: February 25–26, 2021 & March 

1–2, 2021 

5. Healthcare Information Technology 

Research (HITR) 

Date: February 25–26, 2021 

ADDRESSES: Agency for Healthcare 

Research and Quality (Virtual Review), 

5600 Fishers Lane, Rockville, Maryland 

20857. 

FOR FURTHER INFORMATION CONTACT: (to 

obtain a roster of members, agenda or 

minutes of the non-confidential portions 

of the meetings.) 

Jenny Griffith, Committee 

Management Officer, Office of 

Extramural Research Education and 

Priority Populations, Agency for 

Healthcare Research and Quality 

(AHRQ), 5600 Fishers Lane, Rockville, 

Maryland 20857, Telephone (301) 427– 

1557. 

SUPPLEMENTARY INFORMATION: In 

accordance with section 10 (a)(2) of the 

Federal Advisory Committee Act (5 

U.S.C. App. 2), AHRQ announces 

meetings of the above-listed scientific 

peer review groups, which are 

subcommittees of AHRQ’s Health 

Services Research Initial Review Group 

Committee. The subcommittee meetings 

will be closed to the public in 

accordance with the provisions set forth 

in 5 U.S.C. App. 2 section 10(d), 5 

U.S.C. 552b(c)(4), and 5 U.S.C. 

552b(c)(6). The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Agenda items for these meetings are 

subject to change as priorities dictate. 

Dated: January 12, 2021. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2021–00894 Filed 1–14–21; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2021–0003] 

Notice of Availability of a Draft Policy 

Statement for the Biosafety of Large 

Animal Study-Related Activities With 

Brucella abortus and Brucella suis 

Using Outdoor Containment Spaces 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of availability and 

request for comment. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) in the 

Department of Health and Human 

Services (HHS) is opening a public 

docket to obtain comment on a draft 

Brucella policy statement. This draft 

policy statement, when finalized, will 

aid individuals and entities in the 

development of biosafety plans for 

outdoor large animal studies involving 

swine, elk, bison, and cattle to further 

brucellosis research in a manner that 

complies with the HHS and U.S. 

Department of Agriculture (USDA) 

select agent regulations. In a companion 

document published in this issue of the 

Federal Register, USDA has proposed 

the same policy for comment. 

DATES: Submit written or electronic 

comments by March 16, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0003 by either of the methods listed 

below. Do not submit comments by 

email. CDC does not accept acomments 

by email. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Division of Select Agents and 

Toxins, Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, 

Mailstop H21–7, Atlanta, Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket No. CDC–2021–0003 for this 

rulemaking. All relevant comments 

received will be posted without change 

to http://www.regulations.gov, including 

any personal information provided. 

Docket Access: For access to the 

docket to read background documents 

or comments received, or to download 

an electronic version of the draft policy 

statement, go to http://

www.regulations.gov. Please be aware 

that comments and other submissions 

from members of the public are made 

available for public viewing without 

changes. 

FOR FURTHER INFORMATION CONTACT: 

Samuel S. Edwin Ph.D., Director, 

Division of Select Agents and Toxins, 

Centers for Disease Control and