Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Notices 20875 

2https://wayback.archive-it.org/7993/ 

20201222110245/https://www.fda.gov/medicaldevices/workshops-conferences-medical-devices/ public-workshop-content-premarket-submissionsmanagement-cybersecurity-medical-devicesjanuary-29-30. 

https://www.govinfo.gov/content/pkg/ 

FR-2018-10-18/pdf/2018-22697.pdf) and 

input gained from the public workshop 

entitled, ‘‘Content of Premarket 

Submissions for Management of 

Cybersecurity in Medical devices’’ held 

on January 29–30, 2019.2 Several 

changes were made in this draft 

guidance, including a change in title to 

better capture the scope of the current 

draft guidance, document structure 

change to align with use of a Secure 

Product Framework, removal of risk 

tiers, replacement of the Cybersecurity 

Bill of Materials with Software Bill of 

Materials, additional clarification 

regarding premarket submission 

document requests throughout the draft 

guidance, and addition of 

Investigational Device Exemptions to 

the scope. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Cybersecurity in Medical Devices: 

Quality System Considerations and 

Content of Premarket Submissions.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This draft 

guidance is also available at https://

www.regulations.gov and at https:// 

www.fda.gov/regulatory-information/

search-fda-guidance-documents or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/

biologics-guidances. Persons unable to 

download an electronic copy of 

‘‘Cybersecurity in Medical Devices: 

Quality System Considerations and 

Content of Premarket Submissions’’ may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1825–R1 and 

complete title to identify the guidance 

you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations, guidance, and forms have 

been approved by OMB as listed in the 

following table: 

21 CFR part or guidance Topic OMB control 

No. 

807, subpart E ............................................................................ Premarket notification ................................................................ 0910–0120 

814, subparts A through E .......................................................... Premarket approval .................................................................... 0910–0231 

814, subpart H ............................................................................ Humanitarian Device Exemption ............................................... 0910–0332 

812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078 

860, subpart D ............................................................................ De Novo classification process .................................................. 0910–0844 

‘‘Requests for Feedback on Medical Device Submissions: The 

Pre-Submission Program and Meetings with Food and Drug 

Administration Staff’’.

Q-submissions ........................................................................... 0910–0756 

800, 801, and 809 ....................................................................... Medical Device Labeling Regulations ........................................ 0910–0485 

820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 

Dated: April 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07614 Filed 4–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–P–0077] 

Determination That NASONEX 

(Mometasone Furoate) Nasal Spray, 

0.05 Milligram/Spray (50 Microgram), 

Was Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that NASONEX 

(mometasone furoate) nasal spray, 0.05 

milligram (mg)/spray (50 microgram 

(mcg)), was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Sungjoon Chi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6216, 

Silver Spring, MD 20993–0002, 240– 

402–9674, Sungjoon.Chi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) Has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 


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20876 Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Notices 

1Toxic Wastes and Race at Twenty 1987—2007. 

A Report Prepared for the United Church of Christ 

Justice & Witness Ministries. Principal Authors: 

Bullard R, Mohai P, Saha R, Wright B. 2007. 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

NASONEX (mometasone furoate) 

nasal spray, 0.05 mg/spray 50 (mcg), is 

the subject of NDA 020762, held by 

Organon LLC, and initially approved on 

October 1, 1997. NASONEX 

(mometasone furoate) nasal spray, 0.05 

mg/spray 50 (mcg) is a corticosteroid 

indicated for: 

• Treatment of nasal symptoms of 

allergic rhinitis in patients 2 years of age 

and older; 

• treatment of nasal congestion 

associated with seasonal allergic rhinitis 

in patients 2 years of age or older; 

• prophylaxis of seasonal allergic 

rhinitis in patients 12 years of age or 

older; and 

• treatment of nasal polyps in 

patients 18 years of age or older. 

In a letter dated December 4, 2020, 

Merck Sharp and Dohme Corp., a 

subsidiary of Merck and Co., Inc., 

notified FDA that NASONEX 

(mometasone furoate) nasal spray, 0.05 

mg/spray 50 (mcg) was being 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Aurobindo Pharma Ltd. submitted a 

citizen petition dated January 14, 2022 

(Docket No. FDA–2022–P–0077), under 

21 CFR 10.30, requesting that the 

Agency determine whether NASONEX 

(mometasone furoate) nasal spray, 0.05 

mg/spray 50 (mcg), was withdrawn from 

sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that NASONEX (mometasone 

furoate) nasal spray, 0.05 mg/spray 50 

(mcg) was not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that NASONEX 

(mometasone furoate) nasal spray, 0.05 

mg/spray 50 (mcg) was withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

NASONEX (mometasone furoate) nasal 

spray, 0.05 mg/spray 50 (mcg) from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list NASONEX (mometasone 

furoate) nasal spray, 0.05 mg/spray 50 

(mcg), in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. FDA 

will not begin procedures to withdraw 

approval of approved ANDAs that refer 

to this drug product. Additional ANDAs 

for this drug product may also be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: April 4, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07563 Filed 4–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Information (RFI): 2022 

HHS Environmental Justice Strategy 

and Implementation Plan Draft Outline 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services (HHS). 

ACTION: Notice of request for 

information. 

SUMMARY: The Department of Health and 

Human Services (HHS) is issuing this 

Request for Information (RFI) to receive 

input from the public on HHS’ draft 

outline to further the development of 

the 2022 Environmental Justice Strategy 

and Implementation Plan. Consistent 

with the policy of this administration 

directing HHS to make achieving 

environmental justice part of its 

mission, HHS would like to identify 

priority actions and strategies to best 

address environmental injustices and 

health inequities for people of color, 

disadvantaged, vulnerable, low-income, 

marginalized, and indigenous 

populations. With the engagement of 

and input from the public, the 2022 

Environmental Justice Strategy and 

Implementation Plan will serve as a 

guide to confront environmental and 

health disparities and implement a 

multifaceted approach that will serve 

vulnerable populations and 

communities disproportionately 

impacted by environmental burdens. 

DATES: To be assured consideration, 

comments must be received at the email 

address provided below, no later than 

midnight Eastern Time (ET) on May 19, 

2022. HHS will not reply individually to 

responders but will consider all 

comments submitted by the deadline. 

Do not provide confidential information 

as comments may be published or 

otherwise used for agency purposes. 

ADDRESSES: Please submit all responses 

via email to OASHcomments@hhs.gov 

as a Word document or in the body of 

an email. 

FOR FURTHER INFORMATION CONTACT: Dr. 

LaToria Whitehead, Senior Public 

Health Analyst, email: ceq6@cdc.gov, 

phone: (770) 488–3633. 

SUPPLEMENTARY INFORMATION: The 

mission of the U.S. Department of 

Health and Human Services is to 

enhance the health and well-being of 

Americans, by providing for effective 

health and human services and by 

fostering sound, sustained advances in 

the sciences underlying medicine, 

public health, and social services. For 

years studies have demonstrated that 

people of color and disadvantaged, 

vulnerable, low-income, marginalized, 

and indigenous populations are 

disproportionately burdened by 

environmental hazards.1 These 

populations are often exposed to 

unhealthy land uses, poor air and water 

quality, dilapidated housing, lead 

exposure, and other environmental 

threats that drive health disparities. 

Many of these communities are 

underserved and surrounded by social 

inequities such as job insecurity, 

underemployment, linguistic isolation, 

underperforming schools, noise, 

crowded homes, lack of access to 


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