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• Conference proceedings, editorials, letters, white papers, citations that have not been peer-reviewed.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

4080 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

Prevention, 1600 Clifton Road NE, 

Mailstop H21–7, Atlanta, Georgia 30329. 

Telephone: (404) 718–2000. 

SUPPLEMENTARY INFORMATION: 

A. Legal Authority 

HHS/CDC is promulgating this policy 

under the authority of sections 201–204 

and 221 of Title II of Public Law 107– 

188, 116 Stat 637 (42 U.S.C. 262a). 

B. Background 

Under the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (Bioterrorism 

Response Act) (42 U.S.C. 262a(a)(1)), the 

HHS Secretary regulates a list of 

biological agents and toxins that have 

the potential to pose a severe threat to 

public health and safety. The biological 

agents and toxins listed in 42 CFR 73.3 

(HHS select agents and toxins) have the 

potential to pose a severe threat to 

human health and safety and are 

regulated only by HHS/CDC. The 

biological agents listed in § 73.4 

(overlap select agents and toxins) have 

not only the potential to pose a severe 

threat to human health and safety; but 

have been determined by the USDA, 

pursuant to USDA’s authority under the 

Agriculture Bioterrorism Protection Act 

of 2002 (7 U.S.C. 8401), to have the 

potential to pose a severe threat to 

animals and animal products. 

Accordingly, these biological agents are 

jointly regulated by HHS/CDC and 

USDA as ‘‘overlap’’ select agents. The 

Bioterrorism Response Act defines the 

term ‘‘overlap agent or toxin’’ to mean 

a biological agent or toxin that is listed 

pursuant to 42 U.S.C. 262a and is listed 

pursuant to 7 U.S.C. 8401. See 7 U.S.C. 

8411. 

Brucellosis, also known as contagious 

abortion or Bang’s disease, is a 

contagious, costly disease that has 

significant animal health, public health, 

and international trade consequences. 

While most often found in ruminant 

animals (e.g., cattle, bison, cervids and 

swine), brucellosis can affect other 

animals and is transmissible to humans. 

Brucellosis is caused by a group of 

bacteria known scientifically as the 

genus Brucella. Two species of Brucella 

found in the United States: B. abortus, 

principally affecting cattle, bison, and 

cervids, and B. suis, principally 

affecting swine and reindeer, but also 

cattle and bison. 

Brucellosis can be costly to 

agriculture production. In 1952, prior to 

established efforts to eradicate the 

disease, agriculture production losses 

due to brucellosis exceeded $400 

million. A cautionary indicator of the 

need for greater understanding of the 

disease is the expanding range of 

endemic B. abortus in the Greater 

Yellowstone Area and B. suis in feral 

swine populations throughout various 

areas of the United States. This disease 

expansion emphasizes the critical need 

for improved diagnostics, along with 

vaccine development for both Brucella 

species, which could be furthered by 

outdoor research studies. 

Both B. abortus and B. suis are 

currently listed as overlap select agents 

in select agent regulations (42 CFR 73.4 

and 9 CFR 121.4). Accordingly, any 

outdoor research studies must comport 

with the select agent and toxin 

regulations. Therefore, HHS/CDC and 

USDA are issuing a FSAP draft policy 

statement on biosafety for large animal 

outdoor containment studies with B. 

abortus and B. suis to aid individuals 

and entities in the development of 

biosafety plans for such studies that 

meet the requirements of the select 

agent regulations. We are making this 

policy document available to the public 

at the Supporting & Related Materials 

tab of the docket and at https://

www.selectagents.gov/regulations/ 

policy/animalstudy.htm for review and 

comment. 

Copies of the policy document are 

also available for public inspection at 

USDA, room 1620, South Building, 14th 

Street and Independence Avenue SW, 

Washington, DC, between 8 a.m. and 

4:30 p.m., Monday through Friday, 

except holidays. Persons wishing to 

inspect copies are requested to call 

ahead on (202) 799–7039 to facilitate 

entry into the reading room. In addition, 

copies may be obtained by calling or 

writing to the individual listed under 

FOR FURTHER INFORMATION CONTACT. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2021–00877 Filed 1–14–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2021–0002] 

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. Time will be available for public 

comment. The meeting will be webcast 

live via the World Wide Web. 

DATES: The meeting will be held on 

January 27, 2021 from 10:00 a.m. to 5:00 

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

the ACIP website for any updates: 

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

index.html). 

Written comments must be received 

on or before January 27, 2021. 

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–2021–0002 by any 

of the following methods: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

• Mail: Docket No. CDC–2021–0002, 

c/o Attn: January 27, 2021 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. 

Written public comments submitted 

24 hours prior to the ACIP meeting will 

be provided to ACIP members before the 

meeting. 

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 

being given for this meeting due to the 

exceptional circumstances of the 

COVID–19 pandemic and rapidly 

evolving COVID–19 vaccine 

development and regulatory processes. 

The Secretary of Health and Human 

Services has determined that COVID–19 

is a Public Health Emergency. 

Purpose: The committee is charged 

with advising the Director, CDC, on the