40058 Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 

password protected platforms. 

Respondents will include educational 

developers requesting accreditation for 

their trainings and public health and 

healthcare professionals who seek 

training. No statistical methods will be 

used to analyze the information 

collected. CDC will use identifiable 

information in TCEO to track 

participant completion of educational 

activities to facilitate required reporting 

to earn continuing education credits, 

hours, or units. Aggregate and nonaggregate data from the evaluations in 

TCEO and CDC TRAIN will be used to 

improve educational activities and 

assess learning outcomes. 

CDC requests approval for an 

estimated 412,600 annual burden hours. 

There are no costs to respondents other 

than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden time 

per response 

(in hours) 

Total 

Response 

Burden 

(in hours) 

Educational Developers (Health Educators).TCEO Proposal ................................ 120 1 5 600 

Public Health and Health Care Professionals (Learners).TCEO New Participant Registration 300,000 1 5/60 25,000 

Public Health and Health Care Professionals (Learners).TCEO Post-Course Evaluation ........ 300,000 3 10/60 150,000 

Public Health and Health Care Professionals (Learners).TCEO Follow-Up Evaluation ............ 30,000 3 3/60 4,500 

TCEO Sub-Total ........................ ........................................................... ........................ ........................ ........................ 180,100 

Public Health and Health Care Professionals (Learners).CDC TRAIN Immediate Post-Course 

Evaluation Tool.

300,000 3 15/60 225,000 

Public Health and Health Care Professionals (Learners).CDC TRAIN Delayed Follow-Up 

Evaluation Tool.

30,000 3 5/60 7,500 

0.33TRAIN Sub-Total ................ ........................................................... ........................ ........................ ........................ 232,500 

Total .................................... ........................................................... ........................ ........................ ........................ 412,600 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–15794 Filed 7–23–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2021–0075] 

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. For more 

information on ACIP please visit the 

ACIP website: http://www.cdc.gov/ 

vaccines/acip/index.html. 

DATES: The meeting will be held on 

September 29, 2021, from 10:00 a.m. to 

5:05 p.m., EDT, and September 30, 

2021, from 10:00 a.m. to 1:10 p.m., EDT 

(times subject to change), see the ACIP 

website for updates: http:// 

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

The public may submit written 

comments from July 26, 2021 through 

September 30, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0075 by any of the following methods: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

• Mail: Centers for Disease Control 

and Prevention, 1600 Clifton Road NE, 

MS H24–8, Atlanta, Georgia 30329– 

4027, Attn: ACIP Meeting. 

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 72 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, Georgia 30329– 

4027; Telephone: (404) 639–8367; 

Email: ACIP@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Purpose: The committee is charged 

with advising the Director, CDC, on the 

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 cholera 

vaccine, hepatitis vaccines, herpes 

zoster vaccines, orthopoxvirus vaccine, 

pneumococcal vaccine, and tickborne 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 40059 

encephalitis vaccine. No 

recommendation votes are scheduled. 

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. Comments will be 

posted on https://www.regulations.gov. 

Therefore, 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. 

Written Public Comment: The docket 

will be opened to receive written 

comments on September 1, 2021. 

Written comments must be received on 

or before September 30, 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 September 29– 

30, 2021, ACIP meeting must submit a 

request at http://www.cdc.gov/vaccines/ 

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

EDT, September 24, 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 

September 28, 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. 2021–15799 Filed 7–23–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0651] 

Cellular, Tissue and Gene Therapies 

Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of public 

docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Cellular, Tissue and Gene Therapies 

Advisory Committee (CTGTAC). The 

general function of the committee is to 

provide advice and recommendations to 

FDA on regulatory issues. Matters 

considered at the meeting will include 

discussion of the toxicity risks of adenoassociated virus (AAV) vector-based 

gene therapy products. The discussion 

topics include oncogenicity risks due to 

vector genome integration and safety 

issues identified during preclinical and/ 

or clinical evaluation. The meeting will 

be open to the public on both days. FDA 

is establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

September 2 and 3, 2021, from 10 a.m. 

to 6 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/advisory-committees/ 

about-advisory-committees/commonquestions-and-answers-about-fdaadvisory-committee-meetings. The 

online web conference meeting will be 

available at the following links on the 

day of the meeting: Day 1 https://

youtu.be/58KjL9_p9Tw and Day 2 

https://youtu.be/yLggQF0XUUY. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0651. 

The docket will close on September 1, 

2021. Submit either electronic or 

written comments on this public 

meeting on or before September 1, 2021. 

Please note that late, untimely filed 

comments will not be considered. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of September 1, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Comments received on or before 

August 26, 2021, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 


jbell on DSKJLSW7X2PROD with NOTICES