Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices 42841 

107 42 CFR 71.40(f). 

108 42 CFR 71.40(e)(1) and (3). 

109As excepted pursuant to the Public Health 

Determination Regarding an Exception for 

Unaccompanied Noncitizen Children from Order 

Suspending the Right to Introduce Certain Persons 

from Countries Where a Quarantinable 

Communicable Disease Exists. 86 FR 38717 (July 

22, 2021). 

110 42 U.S.C. 268; 42 CFR 71.40(d). 

111CDC relies on the Department of Defense, 

other federal agencies, and state and local 

governments to provide both logistical support and 

facilities for federal quarantines. CDC lacks the 

resources, manpower, and facilities to quarantine 

covered noncitizens. 

112 5 U.S.C. 553(a)(1). 

A. Covered Noncitizens 

This Order applies to persons 

traveling from Canada or Mexico 

(regardless of their country of origin) 

who would otherwise be introduced 

into a congregate setting in a POE or 

U.S. Border Patrol station at or near the 

U.S. land and adjacent coastal borders 

subject to certain exceptions detailed 

below; this includes noncitizens who do 

not have proper travel documents, 

noncitizens whose entry is otherwise 

contrary to law, and noncitizens who 

are apprehended at or near the border 

seeking to unlawfully enter the United 

States between POE. For purposes of 

this Order, I refer to persons covered by 

the Order as ‘‘covered noncitizens.’’ 

B. Exceptions 

This Order does not apply to the 

following: 

• U.S. citizens, U.S. nationals, and 

lawful permanent residents; 107

• Members of the armed forces of the 

United States and associated personnel, 

U.S. government employees or 

contractors on orders abroad, or their 

accompanying family members who are 

on their orders or are members of their 

household, subject to required 

assurances; 108

• Noncitizens who hold valid travel 

documents and arrive at a POE; 

• Noncitizens in the visa waiver 

program who are not otherwise subject 

to travel restrictions and arrive at a POE; 

• Unaccompanied Noncitizen 

Children; 109

• Noncitizens who would otherwise 

be subject to this Order, who are 

permitted to enter the U.S. as part of a 

DHS-approved process, where the 

process approved by DHS has been 

documented and shared with CDC, and 

includes appropriate COVID–19 

mitigation protocols, per CDC guidance; 

and 

• Persons whom customs officers 

determine, with approval from a 

supervisor, should be excepted from 

this Order based on the totality of the 

circumstances, including consideration 

of significant law enforcement, officer 

and public safety, humanitarian, and 

public health interests. DHS will 

consult with CDC regarding the 

standards for such exceptions to help 

ensure consistency with current CDC 

guidance and public health 

recommendations. 

C. APA, Review, and Termination 

This Order shall be immediately 

effective. I consulted with DHS and 

other federal departments as needed 

before I issued this Order and requested 

that DHS continue to aid in the 

enforcement of this Order because CDC 

does not have the capability, resources, 

or personnel needed to do so.110 As part 

of the consultation, DHS developed 

operational plans for implementing this 

Order. CDC has reviewed these plans 

and finds them to be consistent with the 

language of this Order directing that 

covered noncitizens spend as little time 

in congregate settings as practicable 

under the circumstances. In my view, 

DHS’s assistance with implementing the 

Order is necessary, as CDC’s other 

public health tools are not viable 

mechanisms given CDC resource and 

personnel constraints, the large numbers 

of covered noncitizens involved, and 

the likelihood that covered noncitizens 

do not have homes in the United 

States.111

This Order is not a rule subject to 

notice and comment under the 

Administrative Procedure Act (APA). 

Even if it were, notice and comment and 

a delay in effective date are not required 

because there is good cause to dispense 

with prior public notice and the 

opportunity to comment on this Order 

and a delayed effective date. Given the 

public health emergency caused by 

COVID–19, it would be impracticable 

and contrary to public health practices 

and the public interest to delay the 

issuing and effective date of this Order 

with respect to all covered noncitizens. 

In addition, this Order concerns ongoing 

discussions with Canada and Mexico on 

how best to control COVID–19 

transmission over our shared borders 

and therefore directly ‘‘involve[s] . . . a 

. . . foreign affairs function of the 

United States;’’ 112 thus, notice and 

comment and a delay in effective date 

are not required. 

This Order shall remain effective until 

either the expiration of the Secretary of 

HHS’ declaration that COVID–19 

constitutes a public health emergency, 

or I determine that the danger of further 

introduction, transmission, or spread of 

COVID–19 into the United States has 

ceased to be a serious danger to the 

public health and continuation of this 

Order is no longer necessary to protect 

public health, whichever occurs first. At 

least every 60 days, the CDC shall 

review the latest information regarding 

the status of the COVID–19 public 

health emergency and associated public 

health risks, including migration 

patterns, sanitation concerns, and any 

improvement or deterioration of 

conditions at the U.S. border, to 

determine whether the Order remains 

necessary to protect public health. Upon 

determining that the further 

introduction of COVID–19 into the 

United States is no longer a serious 

danger to the public health necessitating 

the continuation of this Order, I will 

publish a notice in the Federal Register 

terminating this Order. I retain the 

authority to modify or terminate the 

Order, or its implementation, at any 

time as needed to protect public health. 

Authority 

The authority for this Order is 

Sections 362 and 365 of the Public 

Health Service Act (42 U.S.C. 265, 268) 

and 42 CFR 71.40. 

Dated: August 3, 2021. 

Sherri Berger, 

Chief of Staff, Centers for Disease Control 

and Prevention. 

[FR Doc. 2021–16856 Filed 8–3–21; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10148 and CMS– 

10784] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 


khammond on DSKJM1Z7X2PROD with NOTICES
42842 Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

October 4, 2021. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10148 HIPAA Administrative 

Simplification (Non-Privacy/Security) 

Complaint Form 

CMS–10784 The Home Health Care 

CAHPS® Survey (HHCAHPS) Mode 

Experiment 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: HIPAA 

Administrative Simplification (NonPrivacy/Security) Complaint Form; Use: 

The Secretary of Health and Human 

Services (HHS), hereafter known as 

‘‘The Secretary,’’ codified 45 CFR parts 

160 and 164 Administrative 

Simplification provisions that apply to 

the enforcement of the Health Insurance 

Portability and Accountability Act of 

1996 Public Law 104–191 (HIPAA). The 

provisions address rules relating to the 

investigation of non-compliance of the 

HIPAA Administrative Simplification 

code sets, unique identifiers, operating 

rules, and transactions. 45 CFR 160.306, 

Complaints to the Secretary, provides 

for investigations of covered entities by 

the Secretary. Further, it outlines the 

procedures and requirements for filing a 

complaint against a covered entity. 

Anyone can file a complaint if he or 

she suspects a potential violation. 

Persons believing that a covered entity 

is not utilizing the adopted 

Administrative Simplification 

provisions of HIPAA are voluntarily 

requested to file a complaint with CMS 

via the Administrative Simplification 

Enforcement and Testing Tool (ASETT) 

online system, by mail, or by sending an 

email to the HIPAA mailbox at 

hipaacomplaint@cms.hhs.gov. 

Information provided on the standard 

form will be used during the 

investigation process to validate noncompliance of HIPAA Administrative 

Simplification provisions. 

This standard form collects 

identifying and contact information of 

the complainant, as well as the 

identifying and contact information of 

the filed against entity (FAE). This 

information enables CMS to respond to 

the complainant and gather more 

information if necessary, and to contact 

the FAE to discuss the complaint and 

CMS’ findings. Form Number: CMS– 

10148 (OMB control number: 0938– 

0948); Frequency: Occasionally; 

Affected Public: Private sector, Business 

or Not-for-profit institutions, State, 

Local, or Tribal Governments, Federal 

Government, Not-for-profits institutions; 

Number of Respondents: 21; Total 

Annual Responses: 21; Total Annual 

Hours: 12. (For policy questions 

regarding this collection contact Kevin 

Stewart at 410–786–6149). 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control); Title of Information 

Collection: The Home Health Care 

CAHPS® Survey (HHCAHPS) Mode 

Experiment; Use: The reporting of 

quality data by HHAs is mandated by 

Section 1895(b)(3)(B)(v)(II) of the Social 

Security Act (‘‘the Act’’). This statute 

requires that ‘‘each home health agency 

shall submit to the Secretary such data 

that the Secretary determines are 

appropriate for the measurement of 

health care quality. Such data shall be 

submitted in a form and manner, and at 

a time, specified by the Secretary for 

purposes of this clause.’’ HHCAHPS 

data are mandated in the Medicare 

regulations at 42 CFR 484.250(a), which 

requires HHAs to submit HHCAHPS 

data to meet the quality reporting 

requirements of section 1895(b)(3)(B)(v) 

of the Act. This collection of 

information is necessary to be able to 

test updates to the HHCAHPS survey 

and administration protocols. 

CMS proposes to conduct a mode 

experiment with the main goal of testing 

the effects of a web-based mode on 

response rates and scores as an addition 

to the three currently approved modes 

(OMB Control Number: 0938–1370). The 

addition of a web mode will give HHAs 

an alternative or an addition to the use 

of mail and telephone modes. CMS is 

also interested in testing a revised, 

shorter version of the HHCAHPS survey, 

based on feedback from patients and 

stakeholders. 

The data collected from the 

HHCAHPS Survey mode experiment 

will be used for the following purposes: 

• Test the shortened survey 

instrument, including several new 

items; 

• Compare survey responses across 

the four proposed modes to determine if 

adjustments are needed to ensure that 

data collection mode does not influence 

results; and 

• Determine if and by how much 

patient characteristics affect the 

patients’ rating of the care they receive 


khammond on DSKJM1Z7X2PROD with NOTICES
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