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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1OTC drugs that are governed by the provisions 

of section 505G of the FD&C Act are referred to as 

OTC monograph drugs. 

2Section 505G(a)(2) of the FD&C Act provides 

specific requirements for sunscreen drugs in terms 

of conformity with a final monograph, for purposes 

of section 505G(a)(1)(A)(i) of the FD&C Act. 

3Section 505G(a)(1)(A) of the FD&C Act. 

4Section 505G(a)(1)(B) of the FD&C Act. 

monograph drugs.1 Under section 505G 

of the FD&C Act, the rulemaking process 

for establishing, revising, and amending 

OTC monographs was replaced with an 

administrative order process. In 

addition, among other things, section 

505G of the FD&C Act provides a 

baseline status that, as of the date of 

enactment of the CARES Act, a drug that 

satisfies certain requirements described 

in section 505G(a)(1) or (2) is: (1) 

Deemed to be generally recognized as 

safe and effective under section 

201(p)(1) of the FD&C Act (21 U.S.C. 

321(p)(1); (2) not a new drug under 

section 201(p) of the FD&C Act; and (3) 

not subject to section 503(b)(1) of the 

FD&C Act (21 U.S.C. 353(b)(1)). To 

obtain this status, among other things, a 

drug either must be one that is in 

conformity with the requirements for 

nonprescription use of a final 

monograph issued under part 330 

(except as provided in section 

505G(a)(2) of the FD&C Act),2 as well as 

other requirements; 3 or must be one 

that is: (1) Classified in category I for 

safety and effectiveness under a 

tentative final monograph that is the 

most recently applicable proposal or 

determination issued under part 330 

and (2) in conformity with the proposed 

requirements for nonprescription use of 

such tentative final monograph and any 

applicable subsequent determination by 

FDA, as well as other requirements.4

Other applicable requirements in 

section 505G(a)(1) of the FD&C Act 

include conditions or requirements 

under section 505G(b), (c), and (k) of the 

FD&C Act. 

Complementary to the requirements 

for conformity to tentative final or final 

monographs described in section 

505G(a)(1) and (2) of the FD&C Act, 

Congress provided that, under section 

505G(b)(8) of the FD&C Act, a final 

monograph or tentative final monograph 

that establishes conditions of use for a 

drug described in section 505G(a)(1) or 

(2) of the FD&C Act and that represents 

the most recently issued version of the 

conditions of use, including as 

modified, in whole or in part, by any 

proposed or final rule, is deemed to be 

a final order. These deemed final orders 

provide the current OTC drug 

monograph conditions that are in effect 

for each therapeutic category addressed 

by them. Final orders may be amended, 

revoked, or otherwise modified in 

accordance with the procedures of 

section 505G of the FD&C Act. Under 

section 505G(b)(8)(C) of the FD&C Act, 

the deemed establishment of a final 

order is construed to include technical 

amendments necessary to ensure that 

the final order is appropriately 

harmonized, in terms of terminology or 

cross-references, with the applicable 

provisions of the FD&C Act (and 

regulations) and any other final orders 

issued under section 505G. 

Congress also deemed certain 

regulations, as in effect on the day 

before the date of the enactment of the 

CARES Act (i.e., March 26, 2020), to be 

final orders under section 505G(b) of the 

FD&C Act. In particular, section 

505G(k)(2)(A) of the FD&C Act deemed 

the provisions of § 310.545 to be a final 

order under section 505G(b). Also, 

section 505G(k)(2)(B) of the FD&C Act 

deemed regulations establishing 

requirements for specific 

nonprescription drugs marketed 

pursuant to section 505G (including 

such requirements in 21 CFR parts 201 

and 250) to be final orders under section 

505G(b), as they apply to drugs subject 

to section 505G(a)(1) through (4) or 

otherwise subject to an order under 

section 505G. 

In addition, section 505G(k)(3) of the 

FD&C Act provides that regulations 

establishing final monographs and the 

procedures governing the OTC drug 

review under part 330 and other 

relevant parts of title 21 of the CFR, 

shall be withdrawn or revised to make 

technical changes to ensure conformity 

with appropriate terminology and crossreferences. Section 505G(k)(3) of the 

FD&C Act also provides that any such 

withdrawal or technical changes shall 

be made without public notice and 

comment and shall be effective upon 

publication through notice in the 

Federal Register (or upon such date as 

specified in such notice). 

II. Procedures for Posting Final Orders 

as Deemed by Section 505G of the FD&C 

Act 

The final orders as deemed by section 

505G of the FD&C Act were made 

effective upon enactment of the CARES 

Act on March 27, 2020. By this notice, 

FDA is announcing the availability on 

its website of certain deemed final 

orders and providing the public 

information on the process for making 

available deemed final orders, including 

details on how the public can access 

and view the final orders. FDA is 

posting these final orders to provide the 

public a convenient resource to view 

OTC monographs and non-monograph 

conditions. The process for FDA issuing 

proposed, final, and interim final orders 

under section 505G(b) of the FD&C Act 

to add, modify, or remove OTC 

monograph conditions is generally 

described in section 505G(b) and is not 

addressed in this Notice. Additional 

information, including questions and 

answers on this process, can be found 

on FDA’s OTC monograph web page at 

https://www.fda.gov/drugs/overcounter-otc-nonprescription-drugs/overcounter-otc-drug-review-otc-monographreform-cares-act, and further 

information will be provided when FDA 

issues its first proposed order. 

A. Process for Making Available Final 

Orders as Deemed by Section 505G(b)(8) 

of the FD&C Act 

FDA is announcing its process for 

making available final orders as deemed 

by section 505G(b)(8) of the FD&C Act. 

FDA reviewed all final monographs 

published in the CFR, beginning with 21 

CFR part 331, and the rulemaking 

histories for each OTC monograph 

therapeutic category, to identify all 

relevant final monographs and tentative 

final monographs that established 

conditions of use for a drug described in 

section 505G(a)(1) of the FD&C Act and 

that represented the most recently 

issued version of the conditions of use, 

including as modified, in whole or in 

part, by any proposed or final rule. As 

noted above, the relevant requirements 

for sunscreen drugs subject to section 

505G of the FD&C Act, in terms of 

conformity with a final monograph for 

purposes of section 505G(a)(1)(A)(i), 

were set forth in section 505G(a)(2) and 

consist of the requirements specified in 

21 CFR part 352, as published on May 

21, 1999, except that the applicable 

requirements governing effectiveness 

and labeling are those specified in 

§ 201.327. Altogether, as indicated in 

table 1 below, FDA identified 32 final 

orders created by section 505G(b)(8) of 

the FD&C Act. 

As further discussed below, FDA also 

identified certain regulations that 

established requirements for specific 

nonprescription drugs marketed 

pursuant to section 505G of the FD&C 

Act and, therefore, were deemed final 

orders by section 505G(k)(2)(B), only as 

they apply to drugs subject to section 

505G(a)(1) through (4) or otherwise 

subject to an order under section 505G 

(e.g., § 201.326, which set forth certain 

labeling requirements regarding 

warnings for OTC drug products 

containing internal analgesic and 

antipyretic active ingredients). To the 

extent regulations that were deemed to 

be final orders by section 505G(k)(2)(B) 

of the FD&C Act apply to OTC drugs 

addressed by a final order embodying an 


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OTC monograph, as deemed by section 

505G(b)(8) of the FD&C Act, the relevant 

provisions may be incorporated into the 

final order(s) embodying the OTC 

monograph(s). 

FDA assigned OTC monograph 

numbers to the resulting deemed final 

orders (see table 1). Table 1 provides the 

corresponding OTC monograph number 

and title for each of these OTC 

monographs and identifies the CFR 

citation, if applicable. Additionally, an 

order ID will be assigned in sequential 

order upon posting of all orders, 

including the deemed final orders. 

Each OTC monograph embodied by a 

deemed final order is accompanied by a 

summary and a background section. In 

the background section, FDA describes 

the relevant proposed and final rules 

that constitute the deemed final order. 

Additionally, pursuant to section 

505G(b)(8)(C) of the FD&C Act, OTC 

monographs embodied by deemed final 

orders include any technical 

amendments that are determined to be 

necessary to ensure that they are 

appropriately harmonized, in terms of 

terminology and cross-references, with 

applicable provisions of the FD&C Act, 

FDA regulations, and any other orders 

issued under section 505G. The 

background section generally describes 

any differences between the deemed 

final order and the proposed and final 

rules that constitute the order. 

Some OTC monographs incorporate 

by reference specified material, 

published by an entity other than the 

United States government (e.g., an ISO 

standard). This incorporated material is 

available for inspection at FDA. For 

further information about inspecting 

incorporated materials, see https://

www.fda.gov/drugs/over-counter-otcnonprescription-drugs/over-counter-otcdrug-review-otc-monograph-reformcares-act. Copies of incorporated 

material may also be available from its 

publisher. 

TABLE 1—OTC MONOGRAPHS AS REPRESENTED BY FINAL ORDERS DEEMED BY SECTION 505G(B)(8) OF THE FD&C ACT

OTC monograph 

number CFR citation in title 21 OTC monograph title 

M001 .................. Part 331 .................................. Antacid Products for OTC Human Use. 

M002 .................. Part 332 .................................. Antiflatulent Products for OTC Human Use. 

M003 .................. N/A1 ........................................ First Aid Antiseptic Drug products for OTC Human Use. 

M004 .................. Part 333, subpart B ................ First Aid Antibiotic Drug Products for OTC Human Use. 

M005 .................. Part 333, subpart C ................ Topical Antifungal Drug Products for OTC Human Use. 

M006 .................. Part 333, subpart D ................ Topical Acne Drug Products for OTC Human Use. 

M007 .................. N/A1 ........................................ Laxative Drug Products for OTC Human Use. 

M008 .................. Part 335 .................................. Antidiarrheal Drug Products for OTC Human Use. 

M009 .................. Part 336 .................................. Antiemetic Drug Products for OTC Human Use. 

M010 .................. Part 338 .................................. Nighttime Sleep Aid Drug Products for OTC Human Use. 

M011 .................. Part 340 .................................. Stimulant Drug Products for OTC Human Use. 

M012 .................. Part 341 .................................. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Human 

Use. 

M013 .................. Part 343 .................................. Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human Use. 

M014 .................. Part 344 .................................. Topical Otic Drug Products for OTC Human Use. 

M015 .................. Part 346 .................................. Anorectal Drug Product for OTC Human Use. 

M016 .................. Part 347 .................................. Skin Protectant Drug Products for OTC Human Use. 

M017 .................. Part 348 .................................. External Analgesic Drug Product for OTC Human Use. 

M018 .................. Part 349 .................................. Ophthalmic Drug Products for OTC Human Use. 

M019 .................. Part 350 .................................. Antiperspirant Drug Products for OTC Human Use. 

M020 .................. Part 352 .................................. Sunscreen Drug Products for OTC Human Use. 

M021 .................. Part 355 .................................. Anticaries Drug Products for OTC Human Use. 

M022 .................. N/A1 ........................................ Oral Health Care Drug Products for OTC Human Use. 

M023 .................. N/A1 ........................................ Poison Treatment Drug Products for OTC Human Use. 

M024 .................. Part 357, subpart B ................ Anthelminic Drug Products for OTC Human Use. 

M025 .................. Part 357, subpart C ................ Cholecystokinetic Drug Products for OTC Human Use. 

M026 .................. Part 357, subpart I .................. Deodorant Drug Products for Internal Use for OTC Human Use. 

M027 .................. N/A1 ........................................ Orally Administered Menstrual Drug Products for OTC Human Use. 

M028 .................. Part 358, subpart B ................ Wart Remover Drug Products for OTC Human Use. 

M029 .................. Part 358, subpart D ................ Ingrown Toenail Relief Drug Products for OTC Human Use. 

M030 .................. Part 358, subpart F ................. Corn and Callus Remover Drug Products for OTC Human Use. 

M031 .................. Part 358, subpart G ................ Pediculicide Drug Products for OTC Human Use. 

M032 .................. Part 358, subpart H ................ Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for OTC 

Human Use. 

1 Not applicable as there is no relevant CFR citation (i.e., there were no final monographs at the time of enactment of the CARES Act). 

B. Process for Making Available Final 

Orders as Deemed by Section 505G(k)(2) 

of the FD&C Act 

Under section 505G(k)(2)(A) of the 

FD&C Act, the non-monograph 

conditions in § 310.545 in effect on the 

day before the date of enactment of the 

CARES Act (i.e., March 26, 2020) were 

deemed to be a final order under section 

505G(b). The provisions of § 310.545 list 

active ingredients for which there is not 

sufficient data to establish general 

recognition of the safety and 

effectiveness for the specified use in 

OTC drug products. Before posting the 

deemed final order containing these 

provisions, FDA intends to remove the 

compliance dates found in the 

regulation because the dates are no 

longer relevant, since any current 

product would have been introduced or 

delivered for introduction into interstate 

commerce well after the compliance 

date. FDA also intends to rearrange the 

listed active ingredients within each 

provision regarding a particular 

therapeutic category so that they 

generally appear in alphabetical order. 

When posting this final order, FDA will 

assign a final order ID and OTC nonmonograph conditions number. 

In addition, under section 

505G(k)(2)(B) of the FD&C Act, 

regulations in effect on March 26, 2020, 

establishing requirements for specific 


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nonprescription drugs marketed 

pursuant to section 505G of the FD&C 

Act were deemed final orders under 

section 505G(b), only as they apply to 

drugs subject to section 505G(a)(1) 

through (4) of the FD&C Act or 

otherwise subject to a final order under 

section 505G. As discussed above, 

provisions from a regulation that was 

deemed to be a final order by section 

505G(k)(2)(B) of the FD&C Act may be 

incorporated into a relevant final order 

embodying an OTC monograph under 

section 505G(b)(8). A deemed final 

order under section 505G(k)(2)(B) of the 

FD&C Act may also be posted as a 

separate, standalone final order. In the 

latter case, FDA intends to issue an 

accompanying notice in the Federal 

Register announcing its availability on 

our website. Regulations deemed to be 

final orders by section 505G(k)(2)(B) of 

the FD&C Act will remain in the CFR to 

the extent they also apply to drugs that 

are not subject to section 505G(a)(1) 

through (4) or otherwise subject to an 

order under section 505G. 

C. Availability of Final Orders Including 

Those Deemed by Section 505G of the 

FD&C Act 

FDA has established a new IT system 

with a web portal, OTC Monographs@

FDA, which can be accessed through 

FDA’s website. The portal will provide 

access to a repository of final orders 

under section 505G of the FD&C Act and 

is available at https://www.accessdata.

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

To access the final orders, go to the OTC 

Monographs@FDA portal at 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 ease of reference, FDA also is 

posting in the OTC Monographs@FDA 

portal the individual OTC monographs 

embodied by final orders under section 

505G(b) of the FD&C Act, without any 

sections that accompany the 

monograph, such as the background 

section. To access just the OTC 

monographs, under the ‘‘OTC 

Monographs’’ banner, click on the 

desired link under the ‘‘OTC 

Monograph ID’’ heading and follow the 

prompts. 

FDA will make available deemed final 

orders embodying OTC monographs in 

batches on a rolling basis until all 32 

such orders, discussed above in section 

II.A (see also table 1), are available in 

the repository. FDA will also make 

available in the repository the final 

order that reflects the provisions of 

§ 310.545, as deemed by section 

505G(k)(2)(A) of the FD&C Act, and final 

orders regarding requirements for 

specific nonprescription drugs, as 

deemed by section 505G(k)(2)(B). 

FDA is announcing that the OTC 

Monographs@FDA portal currently 

includes an initial batch of four deemed 

final orders embodying OTC 

monographs (see table 2). The posting of 

the remainder of these 32 deemed final 

orders, as well as the deemed final order 

under section 505G(k)(2)(A) of the FD&C 

Act, will not be announced in the 

Federal Register but will be announced 

on FDA’s OTC monograph web page, 

https://www.fda.gov/drugs/overcounter-otc-nonprescription-drugs/overcounter-otc-drug-review-otc-monographreform-cares-act. FDA plans to issue a 

notice of availability in the Federal 

Register when posting in the repository 

final orders deemed by section 

505G(k)(2)(B) of the FD&C Act. 

TABLE 2—INITIAL BATCH OF POSTED FINAL ORDERS DEEMED BY SECTION 505G OF THE FD&C ACT

Order ID OTC monograph 

number 

CFR 

citation in 

Title 21 

OTC monograph title 

OTC000001 ...... M002 ................ Part 332 ......... Antiflatulent Products for OTC Human Use. 

OTC000002 ...... M010 ................ Part 338 ......... Nighttime Sleep-Aid Drug Products for OTC Human Use. 

OTC000003 ...... M014 ................ Part 344 ......... Topical Otic Drug Products for OTC Human Use. 

OTC000004 ...... M030 ................ Part 358, Subpart F.Corn and Callus Remover Drug Products for OTC Human Use. 

FDA encourages the public to 

frequently view our website at https:// 

www.fda.gov/drugs/over-counter-otcnonprescription-drugs/over-counter-otcdrug-review-otc-monograph-reformcares-act and the OTC Monographs@

FDA portal for the most up-to-date 

information about the status of posted 

final orders as deemed by section 505G 

of the FD&C Act. Questions regarding 

these final orders can be submitted to 

FDA at druginfo@fda.hhs.gov. 

In the future, the repository will also 

include proposed orders, final orders, 

and interim final orders to add, amend, 

or remove OTC monograph conditions 

that are issued by FDA either on its own 

initiative or pursuant to an OTC 

monograph order request under section 

505G(b)(5) of the FD&C Act. Information 

on the process for FDA issuing 

proposed, final, and interim final orders 

is provided in section 505G(b) of the 

FD&C Act. Additional information, 

including questions and answers on this 

process, can be found on FDA’s OTC 

monograph web page (https://

www.fda.gov/drugs/over-counter-otcnonprescription-drugs/over-counter-otcdrug-review-otc-monograph-reformcares-act), which will continue to be 

updated as FDA issues new orders. 

III. Procedures for Withdrawing 

Regulations for Final Monographs and 

the Procedures Governing the OTC 

Drug Review, and Withdrawing and 

Making Technical Changes to 

Regulations in Part 330 and Other 

Relevant Parts of Title 21 of the CFR 

Under section 505G(k)(3) of the FD&C 

Act, regulations establishing final 

monographs and the procedures 

governing the OTC drug review under 

part 330 and other relevant parts of title 

21 of the CFR (as in effect on March 26, 

2020) shall be withdrawn or revised to 

make technical changes to ensure 

conformity with appropriate 

terminology and cross-references. 

Section 505G(k)(3) of the FD&C Act also 

provides that any such withdrawal or 

technical changes shall be made without 

public notice and comment and shall be 

effective upon publication through 

notice in the Federal Register (or upon 

such date as specified in such notice). 

FDA intends to issue a notice to 

withdraw the regulations establishing 

final monographs in title 21 of the CFR 

at a later date once all the relevant 

deemed final orders have been posted 

on FDA’s OTC monographs@FDA web 

portal (i.e., 21 CFR parts 331, 332, 333, 

335, 336, 338, 340, 341, 343, 344, 346, 

347, 348, 349, 350, 352, 355, 357, and 

358). Prior to the withdrawal of such 

regulations, the public should reference 

the OTC monographs posted in the OTC 


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Monographs@FDA portal at https://

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

omuf/index.cfm, to the extent the 

corresponding deemed final order has 

been added to the portal. Additionally, 

in either the same notice or a separate 

notice in the Federal Register, pursuant 

to section 505G(k)(3) of the FD&C Act, 

FDA intends to withdraw certain 

portions of the regulations governing the 

OTC drug review, and to make certain 

technical changes. 

IV. Paperwork Reduction Act of 1995 

Under section 505G(o) of the FD&C 

Act, the Paperwork Reduction Act of 

1995 (Chapter 35 of title 44, United 

States Code) does not apply to 

collections of information made under 

section 505G of the FD&C Act. 

Therefore, clearance by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 is not 

required for collections of information, 

if any, in orders deemed to be final 

orders by section 505G of the FD&C Act. 

Dated: September 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20393 Filed 9–20–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0281] 

Agency Father Generic Information 

Collection Request; 30-Day Public 

Comment Request 

AGENCY: Office of the Secretary, Health 

and Human Service, HHS. 

ACTION: Notice and request for 

comments. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before October 21, 2021. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When requesting 

information, please include the 

document identifier 0990–0281–30D 

and project title for reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Prevention 

Communication Formative Research. 

Type of Collection: Extension. 

OMB No.: 0990–0281—Office of 

Disease Prevention and Health 

Promotion. 

Abstract: The Office of Disease 

Prevention and Health Promotion 

(ODPHP) is focused on developing and 

disseminating health information to the 

public. ODPHP faces an increasingly 

urgent interest in finding effective ways 

to communicate health information to 

America’s diverse population. ODPHP 

strives to be responsive to the needs of 

America’s diverse audiences while 

simultaneously serving all Americans 

across a range of channels, from print to 

new communication technologies. To 

carry out prevention information efforts, 

ODPHP is committed to conducting 

formative and usability research to 

provide guidance on the development 

and implementation of their 

communication and education efforts. 

The information collected will be used 

to improve communication, products, 

and services that support key office 

activities including: Healthy People, 

Dietary Guidelines for Americans, 

Physical Activity Guidelines for 

Americans, MyHealthfinder, the Move 

Your Way® Campaign, the President’s 

Council on Sports, Fitness & Nutrition, 

health literacy and healthy aging. 

ODPHP communicates through its 

websites (www.health.gov) and through 

other channels including social media, 

print materials, interactive training 

modules, and reports. This request 

builds on previous formative research 

approaches to place more emphasis on 

Web-based data collection to allow 

greater geographical diversity among 

respondents, to decrease respondent 

burden, and to save government costs. 

Data collection will be qualitative and 

quantitative and may include in-depth 

interviews, focus groups, web-based 

surveys, omnibus surveys, card sorting, 

and various forms of usability testing of 

materials and interactive tools to assess 

the public’s understanding of disease 

prevention and health promotion 

content, responses to prototype 

materials, and barriers to effective use. 

The program is requesting a 3-year 

clearance. The type of respondents are 

consumers and health professionals 

which will be surveyed on an annual 

basis. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

Consumers (screening & omnibus survey) ..................................................... 7725 1 10/60 1287.5 

Consumers (qualitative testing) ....................................................................... 1250 1 1 1250 

Consumers (focus groups) .............................................................................. 575 1 1.5 862.5 

Consumers (screening & intercepts) ............................................................... 35250 1 5/60 2937.5 

Consumers (survey) ........................................................................................ 10000 1 15/60 2500 

Consumers (gatekeeper reviews) .................................................................... 325 1 30/60 162.5 

Consumers (cognitive tests) ............................................................................ 50 1 2 100 

Health care professionals (screening) ............................................................. 1350 1 10/60 225 

Health care professionals (interview) .............................................................. 50 1 1 50 

Health care professionals (focus group) .......................................................... 400 1 1.5 600 

Total .......................................................................................................... ........................ ........................ ........................ 9,975 


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