77466 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Living Systematic Review 

on Plant-Based Treatment for Chronic 

Pain 

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 Living 

Systematic Review on Plant-Based 

Treatment for Chronic Pain, 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published and unpublished pertinent 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 January 4, 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 a Living Systematic Review 

on Plant-Based Treatment for Chronic 

Pain. 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 Plant-Based Treatment for 

Chronic Pain, including those that 

describe adverse events. The entire 

research protocol is available online at: 

https://effectivehealthcare.ahrq.gov/ 

products/plant-based-chronic-paintreatment/protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Plant-Based Treatment 

for 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 

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.effectivehealthcare 

.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) 

1. In adults with chronic pain, what 

are the benefits of cannabinoids? 

2. In adults with chronic pain, what 

are the harms of cannabinoids? 

3. In adults with chronic pain, what 

are the benefits of kratom or other plantbased substances for treatment of 

chronic pain? 

4. In adults with chronic pain, what 

are the harms of kratom or other plantbased substances for treatment of 

chronic pain? 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) 

PICOTS element Inclusion criteria Exclusion criteria 

Population ................ All KQs: Adults (including pregnant or breastfeeding 

women) 18 years and older with chronic pain (≤12 weeks 

or pain persisting past the time for normal tissue healing). See categorization of specifically included pain populations below.

All KQs: Children and adolescents <18 years old; adults 

with acute or subacute pain; patients at end of life or in 

palliative care (e.g., with late stage cancer-related pain). 

Interventions ............ KQs 1 and 2: Cannabinoids (including synthetics) using different delivery mechanisms such as oral, buccal, inhalational, topical, or other administration routes.All KQs: Non-plant-based interventions, capsaicin, herbal 

supplements. 

KQs 3 and 4: Kratom or other plant-based substances; couse of kratom or other plant-based substances and 

opioids. 

All KQs: Co-use of other drugs for pain. 

Comparators ............ All KQs: Any comparator, or usual care ............................... All KQs: No comparison. 

Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 77467 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)—Continued 

PICOTS element Inclusion criteria Exclusion criteria 

Outcomes ................ All KQs: Primary efficacy outcomes (i.e., pain, function, disability, pain interference); harms and adverse effects 

(e.g., dizziness, nausea, sedation, development of cannabis use disorder); secondary outcomes (i.e., psychological distress including depression and anxiety, quality 

of life, opioid use, sleep quality, sleep disturbance, health 

care utilization).

All KQs: Other outcomes. 

Time of follow-up ..... All KQs: short term (1 to <6 months), intermediate term (6 

to <12 months), long term (≥1 year).

All KQs: studies with <1-month of treatment or followup 

after treatment. 

Setting ..................... All KQs: Any nonhospital setting or setting of self-directed 

care.

All KQs: Hospital care, hospice care, emergency department care. 

Study design ............ All KQs: RCTs; observational studies with a concurrent 

control group for harms, and to fill gaps in the evidence 

for benefits.

All KQs: Other study designs. 

Abbreviations: RCT = randomized controlled trial. 

Dated: November 27, 2020. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2020–26570 Filed 12–1–20; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended, and the Determination of 

the Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, CDC, pursuant to 

Public Law 92–463. 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. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)- 

RFA–PS–21–003, PrEP Choice: 

Increasing the Use of HIV Pre-exposure 

Prophylaxis in an Era of Choices; and 

RFA–PS–21–004, Implementing and 

Evaluating a Data-to-Care Rx Strategy. 

Date: February 23–24, 2021. 

Time: 10:00 a.m.–5:00 p.m., EST. 

Place: Teleconference, Centers for 

Disease Control and Prevention, Room 

1080, 8 Corporate Square Boulevard, 

Atlanta, Georgia 30329–4027. 

Agenda: To review and evaluate grant 

applications. 

FOR FURTHER INFORMATION CONTACT: 

Gregory Anderson, M.S., M.P.H., 

Scientific Review Officer, CDC, 1600 

Clifton Road NE, Mailstop US8–1, 

Atlanta, Georgia 30329–4027, (404) 718– 

8833, GAnderson@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2020–26558 Filed 12–1–20; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2020–0121] 

Advisory Committee on Immunization 

Practices (ACIP) 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of meeting and request 

for comment. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, the 

Centers for Disease Control and 

Prevention (CDC), announces the 

following meeting of the Advisory 

Committee on Immunization Practices 

(ACIP). This meeting is open to the 

public. The meeting will be webcast live 

via the World Wide Web. 

DATES: The meeting will be held on 

December 1, 2020 from 2:00 p.m. to 5:00 

p.m., EST (times subject to change). 

Written comments must be received 

on or before December 3, 2020. 

ADDRESSES: For more information on 

ACIP please visit the ACIP website: 

http://www.cdc.gov/vaccines/acip/ 

index.html. 

You may submit comments, identified 

by Docket No. CDC–2020–0121 by any 

of the following methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Docket No. CDC–2020–0121, 

c/o Attn: November 23, 2020 ACIP 

Meeting, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE, 

MS H24–8, Atlanta, GA 30329–4027. 

Instructions: All submissions received 

must include the Agency name and 

Docket Number. All relevant comments 

received in conformance with the 

https://www.regulations.gov suitability 

policy will be posted without change to 

https://www.regulations.gov, including 

any personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie Thomas, ACIP Committee 

Management Specialist, Centers for 

Disease Control and Prevention, 

National Center for Immunization and 

Respiratory Diseases, 1600 Clifton Road 

NE, MS–H24–8, Atlanta, GA 30329– 

4027; Telephone: 404–639–8367; Email: 

ACIP@cdc.gov. 

SUPPLEMENTARY INFORMATION: In 

accordance with 41 CFR 102–3.150(b), 

less than 15 calendar days’ notice is