Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices 12697 

nominee is aware of the nomination 

unless self-nominated. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the committee. (Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process.) 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and, therefore, encourages 

nominations of appropriately qualified 

candidates from these groups. 

Specifically, nominations for nonvoting 

representatives of industry interests are 

encouraged from the device 

manufacturing industry. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04450 Filed 3–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0030] 

Determination That BELVIQ 

(Lorcaserin Hydrochloride) Tablets, 10 

Milligrams, and BELVIQ XR (Lorcaserin 

Hydrochloride) Extended-Release 

Tablets, 20 Milligrams, Were 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that BELVIQ (lorcaserin 

hydrochloride) tablets, 10 milligrams 

(mg), and BELVIQ XR (lorcaserin 

hydrochloride) extended-release tablets, 

20 mg, were withdrawn from sale for 

reasons of safety or effectiveness. The 

Agency will not accept or approve 

abbreviated new drug applications 

(ANDAs) for lorcaserin hydrochloride 

tablets, 10 mg and 20 mg. 

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 seek approval to market a 

generic version of a previously 

approved drug product. In general, to 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product has the same 

active ingredient(s); dosage form; route 

of administration; strength; conditions 

of use; and, with certain exceptions, 

labeling as the listed drug. In addition, 

the ANDA applicant must show that the 

generic drug product is bioequivalent to 

the listed drug. 

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 new 

drug application (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. 

BELVIQ (lorcaserin hydrochloride) 

tablets, 10 mg, is the subject of NDA 

022529, and BELVIQ XR (lorcaserin 

hydrochloride) extended-release tablets, 

20 mg, is the subject of NDA 208524, 

both held by Eisai Inc. (Eisai), and 

initially approved on June 27, 2012, and 

July 15, 2016, respectively. BELVIQ and 

BELVIQ XR are indicated as an adjunct 

to a reduced-calorie diet and increased 

physical activity for chronic weight 

management in adults with an initial 

body mass index of: 

• 30 kilograms per square meter (kg/ 

m2) or greater (obese); or 

• 27 kg/m2 or greater (overweight) in 

the presence of at least one weightrelated comorbid condition (e.g., 

hypertension, dyslipidemia, type 2 

diabetes). 

After reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that BELVIQ (lorcaserin 

hydrochloride) tablets, 10 mg, and 

BELVIQ XR (lorcaserin hydrochloride) 

extended-release tablets, 20 mg, were 

withdrawn for reasons of safety or 

effectiveness. 

In 2012, the Agency required the drug 

manufacturer to conduct a randomized, 

double-blind, placebo-controlled 

clinical trial to evaluate the risk of 

cardiovascular problems. The 

Cardiovascular and Metabolic Effects of 

Lorcaserin in Overweight and Obese 

Patients—Thrombolysis in Myocardial 

Infarction 61 (CAMELLIA–TIMI 61) 

clinical trial was conducted to fulfill 

this requirement. An analysis of the 

CAMELLIA–TIMI 61 trial results 

suggests an imbalance in cancer in 

humans. Although chance effect cannot 

be ruled out, the imbalance persisted 

throughout multiple analysis 

approaches. The clinical findings 

corroborated by the evidence from the 

animal models informed the Agency’s 

assessment that the risk outweighs any 

potential benefits for the current 

indications. These findings were 

considered clinically meaningful and 

could not be adequately addressed 

through labeling. Additional evidence 

would be necessary to investigate this 

signal; however, the Agency has 

determined that it is unlikely that the 

necessary safety endpoints (i.e., cancer 

and reproductive safety) can be readily 

or ethically investigated in a clinical 

trial. Because preclinical or clinical 

studies would first need to be 

conducted to address these concerns, 

the Agency has determined that this 

drug product would not be considered 

safe and effective if it were reintroduced 

to the market. 

FDA issued a Drug Safety 

Communication on January 14, 2020, 

alerting the public that results from a 

clinical trial assessing the risk of heartrelated problems show a possible 

increased risk of cancer with BELVIQ 

and BELVIQ XR (see https://

www.fda.gov/drugs/drug-safety-andavailability/safety-clinical-trial-showspossible-increased-risk-cancer-weightloss-medicine-belviq-belviq-xr). On 

February 13, 2020, FDA announced it 

had asked Eisai to voluntarily withdraw 

BELVIQ and BELVIQ XR from the U.S. 

market (see https://www.fda.gov/drugs/ 

drug-safety-and-availability/fdarequests-withdrawal-weight-loss-drugbelviq-belviq-xr-lorcaserin-market). On 

February 13, 2020, Eisai submitted a 

request to FDA to withdraw approval of 

NDA 022529 for BELVIQ and NDA 

208524 for BELVIQ XR under 21 CFR 

314.150(d) and waived its opportunity 

for a hearing. As requested by Eisai, the 

Agency issued a Federal Register notice 

on September 17, 2020 (85 FR 58063), 

withdrawing approval of the 


jbell on DSKJLSW7X2PROD with NOTICES
12698 Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices 

applications for BELVIQ (lorcaserin 

hydrochloride) tablets, 10 mg, and 

BELVIQ XR (lorcaserin hydrochloride) 

extended-release tablets, 20 mg, 

effective September 17, 2020. 

Accordingly, the Agency will remove 

BELVIQ (lorcaserin hydrochloride) 

tablets, 10 mg, and BELVIQ XR 

(lorcaserin hydrochloride) extendedrelease tablets, 20 mg, from the list of 

drug products published in the Orange 

Book. FDA will not accept or approve 

ANDAs that refer to this drug product. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04449 Filed 3–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

‘‘Low Income Levels’’ Used for Various 

Health Professions and Nursing 

Programs Authorized in Titles III, VII, 

and VIII of the Public Health Service 

Act 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is updating income 

levels used to identify a ‘‘low income 

family’’ for the purpose of determining 

eligibility for programs that provide 

health professions and nursing training 

to individuals from disadvantaged 

backgrounds. These various programs 

are authorized in Titles III, VII, and VIII 

of the Public Health Service Act. 

SUPPLEMENTARY INFORMATION: HHS 

periodically publishes in the Federal 

Register low-income levels to be used 

by institutions receiving grants and 

cooperative agreements to determine 

eligibility for programs providing 

training for (1) disadvantaged 

individuals, (2) individuals from 

disadvantaged backgrounds, or (3) 

individuals from low-income families. 

Many health professions and nursing 

grant and cooperative agreement 

awardees use the low-income levels to 

determine whether potential program 

participants are from an economically 

disadvantaged background and would 

be eligible to participate in the program, 

as well as to determine the amount of 

funding the individual receives. Awards 

are generally made to accredited schools 

of medicine, osteopathic medicine, 

public health, dentistry, veterinary 

medicine, optometry, pharmacy, allied 

health, podiatric medicine, nursing, and 

chiropractic; public or private nonprofit 

schools which offer graduate programs 

in behavioral health and mental health 

practice; and other public or private 

nonprofit health or educational entities 

to assist individuals from disadvantaged 

backgrounds to enter and graduate from 

health professions and nursing schools. 

Some programs provide for the 

repayment of health professions or 

nursing education loans for students 

from disadvantaged backgrounds. 

A ‘‘low-income family/household’’ for 

programs included in Titles III, VII, and 

VIII of the Public Health Service Act is 

defined as having an annual income that 

does not exceed 200 percent of the 

Department’s poverty guidelines. A 

family is a group of two or more 

individuals related by birth, marriage, or 

adoption who live together. 

Most HRSA programs use the income 

of a student’s parent(s) to compute low 

income status. However, a ‘‘household’’ 

may potentially be only one person. 

Other HRSA programs, depending upon 

the legislative intent of the program, the 

programmatic purpose related to income 

level, as well as the age and 

circumstances of the participant, will 

apply these low income standards to the 

individual student to determine 

eligibility, as long as he or she is not 

listed as a dependent on the tax form of 

his or her parent(s). Each program 

announces the rationale and choice of 

methodology for determining low 

income levels in program funding 

opportunities or applications. 

Low-income levels are adjusted 

annually based on HHS’s poverty 

guidelines. HHS’s poverty guidelines 

are based on poverty thresholds 

published by the U.S. Census Bureau, 

adjusted annually for changes in the 

Consumer Price Index. The income 

figures below have been updated to 

reflect the Department’s 2021 poverty 

guidelines as published in 86 FR 19 

(February 1, 2021). 

LOW INCOME LEVELS BASED ON THE

2021 POVERTY GUIDELINES FOR THE

48 CONTIGUOUS STATES AND THE

DISTRICT OF COLUMBIA

Persons in family/household * Income level ** 

1 ............................................ $25,760 

2 ............................................ 34,840 

3 ............................................ 43,920 

4 ............................................ 53,000 

5 ............................................ 62,080 

6 ............................................ 71,160 

7 ............................................ 80,240 

LOW INCOME LEVELS BASED ON THE

2021 POVERTY GUIDELINES FOR THE

48 CONTIGUOUS STATES AND THE

DISTRICT OF COLUMBIA—Continued 

Persons in family/household * Income level ** 

8 ............................................ 89,320 

For families with more than 8 persons, add 

$9,080 for each additional person. 

* Includes only dependents listed on federal 

income tax forms. 

** Adjusted gross income for calendar year 

2020. 

LOW INCOME LEVELS BASED ON THE

2021 POVERTY GUIDELINES FOR

ALASKA

Persons in family/household * Income level ** 

1 ............................................ $32,180 

2 ............................................ 43,540 

3 ............................................ 54,900 

4 ............................................ 66,260 

5 ............................................ 77,620 

6 ............................................ 88,980 

7 ............................................ 100,340 

8 ............................................ 111,700 

For families with more than 8 persons, add 

$11,360 for each additional person. 

* Includes only dependents listed on federal 

income tax forms. 

** Adjusted gross income for calendar year 

2020. 

LOW INCOME LEVELS BASED ON THE

2021 POVERTY GUIDELINES FOR HAWAII

Persons in family/household * Income level ** 

1 ............................................ $29,640 

2 ............................................ 40,080 

3 ............................................ 50,520 

4 ............................................ 60,960 

5 ............................................ 71,400 

6 ............................................ 81,840 

7 ............................................ 92,280 

8 ............................................ 102,720 

For families with more than 8 persons, add 

$10,440 for each additional person. 

* Includes only dependents listed on federal 

income tax forms. 

** Adjusted gross income for calendar year 

2020. 

Separate poverty guidelines figures 

for Alaska and Hawaii reflect Office of 

Economic Opportunity administrative 

practice beginning in the 1966–1970 

period since the U.S. Census Bureau 

poverty thresholds do not have separate 

figures for Alaska and Hawaii. The 

poverty guidelines are not defined for 

Puerto Rico or other outlying 

jurisdictions. Puerto Rico and other 

outlying jurisdictions shall use income 


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