12696 Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices 

Altan (2019), ‘‘Cognitive Load in 

Multimedia Learning Environments: A 

Systematic Review.’’ Computers & 

Education, 141, 103618. 

3. Betts, K.R., V. Boudewyns, K.J. Aikin, C. 

Squire, et al. (2018), ‘‘Serious and 

Actionable Risks, Plus Disclosure: 

Investigating an Alternative Approach 

for Presenting Risk Information in 

Prescription Drug Television 

Advertisements.’’ Research in Social and 

Administrative Pharmacy, 14(10), 951– 

963. 

4. Jiang, Y.V., H.J. Lee, A. Asaad, and R. 

Remington (2016), ‘‘Similarity Effects in 

Visual Working Memory.’’ Psychonomic 

Bulletin & Review, 23(2), 476–482. 

5. Oberauer, K. and E.B. Lange (2008), 

‘‘Interference in Verbal Working 

Memory: Distinguishing SimilarityBased Confusion, Feature Overwriting, 

and Feature Migration.’’ Journal of 

Memory and Language, 58(3), 730–745. 

6. Friedman, L.M., C.D. Furberg, and D.L. 

DeMets (1998), Fundamentals of Clinical 

Trials. New York, NY: Spring ScienceBusiness Media, LLC. 

7. Fisher, R.A. (1937), The Design of 

Experiments. Edinburgh, United 

Kingdom: Oliver and Boyd. 

8. Southwell, B.G. and R. Langteau (2008), 

‘‘Age, Memory Changes, and the Varying 

Utility of Recognition as a Media Effects 

Pathway’’. Communication Methods and 

Measures, 2, 100–114. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04472 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–2019–N–2430] 

Request for Nominations on Device 

Good Manufacturing Practice Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting that any industry 

organization interested in participating 

in the selection of a nonvoting industry 

representative to serve on the Device 

Good Manufacturing Practice Advisory 

Committee (DGMPAC) in the Center for 

Devices and Radiological Health notify 

FDA in writing. FDA is also requesting 

nominations for a nonvoting industry 

representative to fill an upcoming 

vacancy on DGMPAC. A nominee may 

either be self-nominated or nominated 

by an organization to serve as a 

nonvoting industry representative. 

Nominations will be accepted for an 

upcoming vacancy effective with this 

notice. 

DATES: Any industry organizations 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by April 5, 2021 (see sections I and 

III of this document for further details). 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA by April 5, 2021. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nominations should be sent to Margaret 

Ames (see FOR FURTHER INFORMATION

CONTACT). All nominations for 

nonvoting industry representatives 

should be submitted electronically by 

accessing FDA’s Advisory Committee 

Membership Nomination Portal at 

https://www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Ames, Office of Management, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5213, Silver Spring, MD 20993– 

0002, 301–796–5960, margaret.ames@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

520 of the Federal Food, Drug and 

Cosmetic Act (21 U.S.C. 360j), as 

amended, provides that DGMPAC shall 

be composed of two representatives of 

interests of the device manufacturing 

industry. The Agency is requesting 

nominations for a nonvoting industry 

representative to fill an upcoming 

vacancy on DGMPAC. FDA is 

publishing a separate document 

announcing the request for notification 

for voting members on DGMPAC. 

I. Function of DGMPAC 

DGMPAC reviews proposed 

regulations issuance regarding good 

manufacturing practices governing the 

methods used in, and the facilities and 

controls used for, the manufacture, 

packaging, storage, installation, and 

servicing of devices, and makes 

recommendations regarding the 

feasibility and reasonableness of those 

proposed regulations. The committee 

also reviews and makes 

recommendations on proposed 

guidelines developed to assist the 

medical device industry in meeting the 

good manufacturing practice 

requirements and provides advice with 

regard to any petition submitted by a 

manufacturer for an exemption or 

variance from good manufacturing 

practice regulations. 

II. Qualifications 

Persons nominated for DGMPAC 

should possess appropriate 

qualifications to understand and 

contribute to the committee’s work as 

described in the committee’s function. 

III. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within 

the subsequent 30 days, FDA will send 

a letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations, 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for the committee. The 

interested organizations are not bound 

by the list of nominees in selecting a 

candidate. However, if no individual is 

selected within the 60 days, the 

Commissioner will select the nonvoting 

member to represent industry interests. 

IV. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Nominations 

must include a current, complete 

re ́sume ́ or curriculum vitae for each 

nominee, including current business 

address, telephone number, email 

address if available, and a signed copy 

of the Acknowledgement and Consent 

form available at the FDA Advisory 

Committee Membership Nomination 

Portal (see ADDRESSES) within 30 days of 

publication of this document (see 

DATES). Nominations must also specify 

the advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 


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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 


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