Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices 42843 

and adjust results based on those 

factors. 

The mode experiment is designed to 

examine the effects of the shortened 

survey on response rates and scores and 

to provide precise adjustment estimates 

for survey items and composites on the 

shortened survey instrument. 

Information from this mode experiment 

will help CMS determine whether an 

additional mode of administration (i.e., 

Web data collection) should be included 

and a shortened survey instrument 

should be used in the current national 

implementation of the HHCAHPS 

Survey. Form Number: CMS–10784 

(OMB control number: 0938–New); 

Frequency: Annually; Affected Public: 

Individuals or Households; Number of 

Respondents: 6,280; Total Annual 

Responses: 6,280; Total Annual Hours: 

1,049. (For policy questions regarding 

this collection contact Lori E. Teichman 

at 410–786–6684). 

Dated: August 2, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–16755 Filed 8–4–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0271] 

Determination That VOTRIENT 

(Pazopanib Hydrochloride) Tablets, 

400 Milligrams, Were Not Withdrawn 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 or Agency) has 

determined that VOTRIENT (pazopanib 

hydrochloride) tablets, 400 milligrams 

(mg), were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for pazopanib 

hydrochloride tablets, 400 mg, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Sungjoon Chi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6212, 

Silver Spring, MD 20993–0002, 240– 

402–9674, Sungjoon.Chi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which 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. 

VOTRIENT (pazopanib 

hydrochloride) tablets, 400 mg, are the 

subject of NDA 022465, held by 

Novartis Pharmaceuticals Corp., and 

initially approved on October 19, 2009. 

VOTRIENT is a kinase inhibitor 

indicated for the treatment of patients 

with advanced renal cell carcinoma. 

VOTRIENT (pazopanib hydrochloride) 

tablets, 400 mg, are currently listed in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Hyman, Phelps & McNamara, P.C., 

submitted a citizen petition dated 

March 5, 2021 (Docket No. FDA–2021– 

P–0271), under 21 CFR 10.30, 

requesting that the Agency determine 

whether VOTRIENT (pazopanib 

hydrochloride) tablets, 400 mg, were 

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 VOTRIENT (pazopanib 

hydrochloride) tablets, 400 mg, were not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that VOTRIENT (pazopanib 

hydrochloride) tablets, 400 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

VOTRIENT (pazopanib hydrochloride) 

tablets, 400 mg, 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 VOTRIENT (pazopanib 

hydrochloride) tablets, 400 mg, 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. ANDAs that refer 

to VOTRIENT (pazopanib 

hydrochloride) tablets, 400 mg, may 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: July 29, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16692 Filed 8–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3741] 

Remanufacturing of Medical Devices; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability; extension 

of comment period. 


khammond on DSKJM1Z7X2PROD with NOTICES