Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Notices 52473 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Form name 

Number of 

respondents/ 

POCs 

Total 

burden hours 

Average 

hourly 

wage rate * 

Total cost 

burden 

Total .......................................................................................................... NA 54 NA 2,509 

* The wage rate in Exhibit 2 is based on May 2019 National Industry-Specific Occupational Employment and Wage Estimates, Bureau of Labor 

Statistics, U.S. Dept. of Labor. Mean hourly wages for nursing home POCs are located at https://www.bls.gov/oes/current/naics3_623000.htm. 

The hourly wage of $46.45 is the weighted mean of $47.32 (General and Operations Managers 11–1021; N=26) and $44.82 (Medical and Health 

Services Managers 11–9111; N=14). 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3520, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ’s health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: September 16, 2021. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2021–20418 Filed 9–20–21; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2021–0104] 

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. A notice 

of the ACIP meeting has also been 

posted on CDC’s ACIP website: http://

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

DATES: The meeting will be held on 

September 22, 2021, from 10:00 a.m. to 

5:00 p.m., EDT, and September 23, 

2021, from 11:00 a.m. to 2:00 p.m., EDT 

(dates and 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 September 21, 2021 

through September 23, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0104 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: September 22–23, 2021 

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. 

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: 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. A notice 

of this ACIP meeting has also been 

posted on CDC’s ACIP website at: http:// 

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

In addition, CDC has sent notice of this 

ACIP meeting by email to those who 

subscribe to receive email updates about 

ACIP. 

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 COVID–19 

vaccine booster doses. Agenda items are 

subject to change as priorities dictate. A 

recommendation vote is scheduled. 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 


lotter on DSK11XQN23PROD with NOTICES1
52474 Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Notices 

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: Written 

comments must be received on or before 

September 22, 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 22– 

23, 2021, ACIP meeting must submit a 

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

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

EDT, September 20, 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 12:00 p.m., EDT, September 21, 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. 2021–20473 Filed 9–17–21; 11:15 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0952] 

Final Administrative Orders for Overthe-Counter Monographs; Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability on its 

website of certain final administrative 

orders (final orders), including for overthe-counter (OTC) drug monographs, 

that were deemed to be final orders by 

the Coronavirus Aid, Relief, and 

Economic Security Act (CARES Act), 

which added a new section to the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). FDA is also announcing the 

process for making these final orders 

available. Finally, FDA is announcing 

its plan for withdrawing regulations that 

established final OTC drug monographs 

prior to the passage of the CARES act, 

and withdrawing or making technical 

changes to the procedures governing the 

OTC drug review. 

DATES: The announcement of the 

availability on FDA’s website of certain 

final orders as deemed by section 505G 

of the FD&C Act and other actions 

related to section 505G is published in 

the Federal Register on September 21, 

2021. 

ADDRESSES: You may view the final 

orders in the OTC Monographs@FDA 

portal at https://

www.accessdata.fda.gov/scripts/cder/ 

omuf/index.cfm. 

• Instructions: For access to the final 

orders, go to https://www.accessdata.

fda.gov/scripts/cder/omuf/index.cfm. 

Under the ‘‘Administrative Orders’’ 

banner, click on the desired link under 

the ‘‘Order ID’’ heading and follow the 

prompts. 

FOR FURTHER INFORMATION CONTACT: 

Helen Lee, Center for Drug Evaluation 

and Research (HFD–600), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–6848. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 27, 2020, the CARES Act 

was signed into law. The CARES Act 

includes provisions that govern the way 

certain OTC drugs are regulated in the 

United States. In particular, the CARES 

Act added section 505G to the FD&C Act 

(21 U.S.C. 355g), which reforms and 

modernizes the OTC drug review 

process that was established in 1972. 

Under the OTC drug review, OTC drug 

monographs (also referred to as OTC 

monographs) for different therapeutic 

categories are established. OTC drugs 

are generally recognized as safe and 

effective (GRASE) if they meet the 

conditions of an OTC monograph, 

including the specified active 

ingredients, uses (indications), doses, 

routes of administration, labeling, and 

testing, along with other applicable 

requirements. 

A. Regulatory Framework for OTC 

Monograph Drugs Prior to the Passage 

of the CARES Act 

Prior to passage of the CARES Act, 

OTC monographs were established, 

revised, and amended using the 

rulemaking process set out by the 

Administrative Procedure Act in 21 

U.S.C. 553. Final OTC monographs 

(final monographs) were codified in 

regulations under title 21 of the CFR. 

The OTC monograph process was set 

forth in 21 CFR part 330 (part 330). Prior 

to establishment of a final monograph, 

GRASE conditions for a therapeutic 

category were set forth in proposed 

rules as tentative final monographs. At 

the time of the passage of the CARES 

Act, certain OTC monographs were still 

at the proposed rulemaking stage, either 

in whole or in part. 

In the course of the OTC drug review, 

FDA also determined when there was 

not sufficient evidence to demonstrate 

certain conditions (e.g., active 

ingredients for specific uses) were 

GRASE. In such cases, FDA often 

expressly codified these determinations 

that certain conditions were not GRASE 

(see, e.g., § 310.545 (21 CFR 310.545)). 

In addition, part 201, subpart G (21 CFR 

part 201, subpart G), includes specific 

labeling requirements for certain drugs, 

including OTC monograph drugs (see, 

e.g., § 201.326, requiring warnings and 

other labeling for OTC drug products 

containing internal analgesic and 

antipyretic active ingredients). 

B. Regulatory Framework for OTC 

Monograph Drugs Under the CARES Act 

The CARES Act added section 505G 

to the FD&C Act, which revised the 

framework for the regulation of OTC 


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