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 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4081 

use of immunizing agents. In addition, 

under 42 U.S.C. 1396s, the committee is 

mandated to establish and periodically 

review and, as appropriate, revise the 

list of vaccines for administration to 

vaccine-eligible children through the 

Vaccines for Children (VFC) program, 

along with schedules regarding dosing 

interval, dosage, and contraindications 

to administration of vaccines. Further, 

under provisions of the Affordable Care 

Act, section 2713 of the Public Health 

Service Act, immunization 

recommendations of the ACIP that have 

been approved by the Director of the 

Centers for Disease Control and 

Prevention and appear on CDC 

immunization schedules must be 

covered by applicable health plans. 

Matters to be Considered: The agenda 

will include discussions on COVID–19 

vaccines. No recommendation vote is 

scheduled for COVID–19 vaccines. 

Agenda items are subject to change as 

priorities dictate. For more information 

on the meeting agenda visit https://

www.cdc.gov/vaccines/acip/meetings/ 

meetings-info.html. 

Meeting Information: The meeting 

will be webcast live via the World Wide 

Web; for more information on ACIP 

please visit the ACIP website: http://

www.cdc.gov/vaccines/acip/index.html. 

Public Participation 

Interested persons or organizations 

are invited to participate by submitting 

written views, recommendations, and 

data. Please note that comments 

received, including attachments and 

other supporting materials are part of 

the public record and are subject to 

public disclosure. Do not include any 

information in your comment or 

supporting materials that you consider 

confidential or inappropriate for public 

disclosure. If you include your name, 

contact information, or other 

information that identifies you in the 

body of your comments, that 

information will be on public display. 

CDC will review all submissions and 

may choose to redact, or withhold, 

submissions containing private or 

proprietary information such as Social 

Security numbers, medical information, 

inappropriate language, or duplicate/ 

near duplicate examples of a mass-mail 

campaign. CDC will carefully consider 

all comments submitted into the docket. 

CDC does not accept comment by email. 

Written Public Comment: Written 

comments must be received on or before 

January 27, 2021. Oral Public Comment: 

This meeting will include time for 

members of the public to make an oral 

comment. Oral public comment will 

occur before any scheduled votes 

including all votes relevant to the 

ACIP’s Affordable Care Act and 

Vaccines for Children Program roles. 

Priority will be given to individuals 

who submit a request to make an oral 

public comment before the meeting 

according to the procedures below. 

Procedure for Oral Public Comment: 

All persons interested in making an oral 

public comment at the January 27, 2021 

ACIP meeting must submit a request at 

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

meetings/ no later than 11:59 p.m., EST, 

January 25, 2021 according to the 

instructions provided. 

If the number of persons requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

time, CDC will conduct a lottery to 

determine the speakers for the 

scheduled public comment session. 

CDC staff will notify individuals 

regarding their request to speak by email 

by January 26, 2021. To accommodate 

the significant interest in participation 

in the oral public comment session of 

ACIP meetings, each speaker will be 

limited to 3 minutes, and each speaker 

may only speak once per meeting. 

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. 2021–00870 Filed 1–12–21; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2306] 

TG United Inc., et al.; Withdrawal of 

Approval of 27 Abbreviated New Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 27 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The applicants 

notified the Agency in writing that the 

drug products were no longer marketed 

and requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

February 16, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 040083 ................................. Phentermine Hydrochloride (HCl) Capsules, 30 milligrams (mg) ......... TG United Inc., 16275 Aviation 

Loop Dr., Brooksville, FL 34604. 

ANDA 040451 ................................. Cyanocobalamin Injection, 1 mg/milliliters (mL) .................................... Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103. 

ANDA 040518 ................................. Bethanechol Chloride Tablets, 50 mg ................................................... Morton Grove Pharmaceuticals 

Inc./Wockhardt USA LLC, 6451 

W. Main St., Morton Grove, IL 

60053. 

ANDA 040532 ................................. Bethanechol Chloride Tablets, 5 mg ..................................................... Do.