8850 Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 

5As a part of the plan, CVM established three 

goals, which include: (1) Align antimicrobial drug 

product use with the principles of antimicrobial 

stewardship; (2) foster stewardship of 

antimicrobials in veterinary settings; and (3) 

enhance monitoring of antimicrobial resistance and 

antimicrobial drug use in animals. See the five-year 

action plan at p. 5. 

6CVM intends to initiate the actions outlined in 

the plan in two phases, with Phase 1 activities 

being initiated between FY 2019 and FY 2021 and 

Phase 2 activities being initiated between FY 2022 

and FY 2023. See the five-year action plan at pp. 

5–6. 

objective to engage with our 

stakeholders to develop and implement 

a strategy for promoting antimicrobial 

stewardship in companion animals.5

One of the actions related to this 

objective (Action 1.2.1 under Phase 1 

Actions 6) is to obtain public input 

regarding antimicrobial use practices in 

companion animals and the impact of 

such use practices on the development 

of resistance. 

II. Questions for Consideration 

CVM seeks input on the following 

questions and information requests: 

1. Please describe if antimicrobial use 

practices in companion animals have 

impacted the development of 

antimicrobial resistance in bacterial 

pathogens of companion animals. Please 

provide information, data, and/or 

references to support your response. 

2. Please describe if antimicrobial use 

practices in companion animals, 

including extralabel use, have impacted 

the development of antimicrobial 

resistance in human bacterial 

pathogens. If possible, please describe 

whether the impact was the result of 

direct or indirect contact between 

humans and the treated companion 

animals. Are there specific concerns 

about the development of antimicrobial 

resistance in human bacterial pathogens 

when particular antimicrobial drugs or 

drug classes are used in companion 

animals? Please provide information, 

data, and/or references to support your 

response. 

3. How should the human medical 

importance of particular antimicrobial 

drugs or drug classes be considered 

when deciding whether, or under what 

conditions, to use such drugs in 

companion animals? 

4. How can CVM best engage with our 

stakeholders on promoting 

antimicrobial stewardship for 

companion animals? Examples of 

stakeholders include other government 

agencies, the pharmaceutical industry, 

public health organizations (both public 

and private entities), veterinary 

professional organizations, veterinary 

schools, veterinarians, pet owners, and 

veterinary diagnostic laboratories. 

5. How can CVM encourage the 

development of antimicrobial drugs 

consistent with the principles of 

antimicrobial stewardship for the 

treatment of infectious diseases in 

companion animals for which there are 

no FDA-approved animal drugs? 

a. What bacterial diseases affecting 

companion animals are most in need of 

an FDA-approved animal antimicrobial 

drug? 

b. What safety and effectiveness study 

design considerations present 

challenges for developing antimicrobial 

drugs to address specific infectious 

diseases in companion animals (e.g., 

Lyme disease, sepsis, or osteomyelitis)? 

Are there alternative study designs that 

would address these challenges? If not, 

what role(s) could the stakeholder 

groups identified in question 4 play in 

developing such alternative study 

designs? 

c. Are there specific infectious 

diseases in companion animals for 

which topical formulations of 

antimicrobial drugs (e.g., medicated 

shampoos, rinses, or ointments) may be 

a better alternative than using systemic 

antimicrobial drugs from the 

perspective of antimicrobial 

stewardship? If so, what role(s) could 

the stakeholder groups identified in 

question 4 play toward fostering the use 

of such topical antimicrobial 

formulations? 

6. Labeling: 

a. What information on currently 

approved animal drug labeling helps the 

veterinarian prescribe or use an 

antimicrobial drug in a manner 

consistent with the principles of 

antimicrobial stewardship? 

b. What additional information could 

be added to the approved animal drug 

labeling to improve the veterinarian’s 

ability to prescribe or use an 

antimicrobial drug in a manner 

consistent with the principles of 

antimicrobial stewardship? 

c. Is there a need for materials 

containing labeling information and/or 

information about antimicrobial 

stewardship that veterinarians could 

provide to the client when they 

prescribe an antimicrobial drug (e.g., 

client information sheets or other 

educational handouts)? 

7. With respect to the use of 

antimicrobial drugs in companion 

animals, what other actions should 

CVM consider taking to foster greater 

antimicrobial stewardship? 

Dated: February 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03245 Filed 2–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0008] 

Cellular, Tissue and Gene Therapies 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Cellular, Tissue, and 

Gene Therapies Advisory Committee. 

The general function of the committee is 

to provide advice and recommendations 

to the Agency on FDA’s regulatory 

issues. At least one portion of the 

meeting will be closed to the public. 

DATES: The meeting will be held 

virtually on March 10, 2022, from 10 

a.m. to 1:30 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of the COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. The online web 

conference meeting will be available at 

the following link on the day of the 

meeting: https://youtu.be/silb2C_Ro8I. 

FOR FURTHER INFORMATION CONTACT: 

Christina Vert or Tonica Burke, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

1244, Silver Spring, MD 20993–0002, 

240–402–8054, ctgtac@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before joining the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On March 10, 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 8851 

2022, for Topic I, the committee will 

meet in open session to hear an 

overview of the research programs in 

the Gene Transfer and Immunogencity 

Branch, Division of Cellular and Gene 

Therapies, Office of Tissues and 

Advanced Therapies, Center for 

Biologics Research. After the Topic I 

open session, the meeting will be closed 

to the public for committee 

deliberations. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: On March 10, 2022, from 

10 a.m. to 12:40 p.m. Eastern Time, the 

meeting is open to the public for Topic 

I. Interested persons may present data, 

information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before 

March 3, 2022. Oral presentations from 

the public will be scheduled between 

approximately 11:40 a.m. and 12:40 

p.m. Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

23, 2022. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 24, 2022. 

Closed Committee Deliberations: On 

March 10, 2022, from 12:40 p.m. to 1:30 

p.m. Eastern Time for Topic I, the 

meeting will be closed to permit 

discussion where disclosure would 

constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The recommendations of the 

advisory committee regarding the 

progress of the individual investigators’ 

research programs, along with other 

information, will be discussed during 

this session. We believe that public 

discussion of these recommendations on 

individual scientists would constitute 

an unwarranted invasion of personal 

privacy. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Christina Vert 

at ctgtac@fda.hhs.gov (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03366 Filed 2–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Presidential Advisory 

Council on HIV/AIDS 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice of a virtual meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Service is hereby giving notice that the 

Presidential Advisory Council on HIV/ 

AIDS (PACHA or the Council) will be 

holding the 73rd full Council meeting 

utilizing virtual technology on Monday, 

March 14 and Tuesday, March 15, 2022 

from approximately 10:00–4:30 p.m. 

(ET) on both days. The meeting will be 

open to the public and there will be an 

interactive community engagement 

session during the first day of the 

meeting. Additionally, there will be a 

public comment session during the 

meeting; pre-registration is required to 

provide public comment. To pre-register 

to provide public comment, please send 

an email to PACHA@hhs.gov and 

include your name, organization, and 

title by close of business Monday, 

March 7, 2022. If you decide you would 

like to provide public comment but do 

not pre-register, you may submit your 

written statement by emailing PACHA@

hhs.gov by close of business Tuesday, 

March, 22, 2022. The meeting agenda 

will be posted on the PACHA page on 

HIV.gov at https://www.hiv.gov/federalresponse/pacha/about-pacha prior to 

the meeting. 

DATES: The meeting will be held on 

Monday, March 14 and Tuesday March 

15, 2022 from approximately 10:00–4:30 

p.m. (ET) on both days. This meeting 

will be conducted utilizing virtual 

technology. 

ADDRESSES: Instructions on attending 

this meeting virtually will be posted 

prior to the meeting at: https://

www.hiv.gov/federal-response/pacha/ 

about-pacha. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Caroline Talev, MPA, Management 

Analyst, Presidential Advisory Council 

on HIV/AIDS, 330 C Street SW, Room 

L609A, Washington, DC 20024; (202) 

795–7622 or PACHA@hhs.gov. 

Additional information can be obtained 

by accessing the Council’s page on the 

HIV.gov site at www.hiv.gov/pacha. 

SUPPLEMENTARY INFORMATION: PACHA 

was established by Executive Order 

12963, dated June 14, 1995, as amended 

by Executive Order 13009, dated June 

14, 1996 and is currently operating 

under the authority given in Executive 

Order 14048, dated September 30, 2021. 

The Council was established to provide 

advice, information, and 

recommendations to the Secretary 

regarding programs and policies 

intended to promote effective HIV 

diagnosis, treatment, prevention, and 

quality care services. The functions of 

the Council are solely advisory in 

nature. 

The Council consists of not more than 

35 members. Council members are 

selected from prominent community 

leaders with particular expertise in, or 

knowledge of, matters concerning HIV 

and AIDS, public health, global health, 

population health, philanthropy, 

marketing or business, as well as other 

national leaders held in high esteem 

from other sectors of society. PACHA 

selections also include persons with 

lived HIV experience and racial/ethnic 

and sexual and gender minority persons 

disproportionately affected by HIV. 


jspears on DSK121TN23PROD with NOTICES1