38760 Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Notices 

prevent the potential spread of the 

communicable disease, provided that 

such measures do not affect the 

airworthiness of the aircraft or the safety 

of flight operations. 

(b) The pilot in command of an 

aircraft operated by an airline who 

reports in accordance with paragraph (a) 

of this section shall be deemed to satisfy 

the reporting obligation under 42 CFR 

70.4. 

For the purposes of these regulations, 

ill person means an individual who: 

(1) Has a fever (a measured 

temperature of 100.4 °F [38 °C] or 

greater, or feels warm to the touch, or 

gives a history of feeling feverish) 

accompanied by one or more of the 

following: Skin rash, difficulty 

breathing, persistent cough, decreased 

consciousness or confusion of recent 

onset, new unexplained bruising or 

bleeding (without previous injury), 

persistent diarrhea, persistent vomiting 

(other than air sickness), headache with 

stiff neck, appears obviously unwell; or 

(2) Has a fever that has persisted for 

more than 48 hours; or 

(3) Has symptoms or other indications 

of communicable disease, as the CDC 

may announce through posting of a 

notice in the Federal Register. 

Control of disease transmission 

within the United States is largely 

considered to be the province of State 

and local health authorities, with 

Federal assistance being sought by those 

authorities on a cooperative basis, 

without application of Federal 

regulations. The regulations at 42 CFR 

part 70 were developed to facilitate 

Federal action in the event of large 

outbreaks requiring a coordinated effort 

involving several States, or in the event 

in inadequate local control. While it is 

not known whether, or to what extent, 

situations may arise in which these 

regulations would be invoked, 

contingency planning for domestic 

emergency preparedness is not 

uncommon. If a domestic emergency 

occurs, the reporting and record keeping 

requirements contained in the 

regulations will be used by CDC to carry 

out quarantine responsibilities as 

required by law, specifically, to prevent 

the spread of communicable diseases 

from one State or possession into any 

other State or possession. 

The data collected under 70.4 and 

70.11 is also a critical part of CDC’s 

routine and emergency response 

operations. It involves the collection of 

reports of illnesses that occur aboard 

domestic flights or maritime voyages 

within the U.S. For routine reports of 

illness aboard domestic voyages 

airplane captains will continue to report 

electronically (e.g., verbally via radio to 

Air Traffic Control or the airlines’ points 

of contact [e.g., Operations Center, 

Flight Control, Airline Station 

Manager]). Masters of maritime vessels 

engaged in interstate travel may report 

via email or other electronic method. 

The reporting of required and 

requested signs and symptoms of 

disease outlined above, as well as any 

death, is the minimum necessary to 

meet statutory and regulatory 

obligations, and is consistent with 

International Civil Aviation 

Organization (ICAO) standards for 

aircraft. 

CDC anticipates certain cost burdens 

to respondents and record keepers due 

to the requirements. These costs fall into 

the following categories: 

For reports of death or communicable 

disease made by a pilot in command of 

an aircraft, or a master of a vessel or 

person in charge of a conveyance 

engaged in interstate traffic, the 

requested burden is approximately 186 

hours. This total is estimated from 

approximately 1,600 domestic reports of 

death or communicable disease a year, 

1,400 being from aircrafts, and 

approximately 200 from other 

conveyances (water vessels, buses, or 

trains) with an average burden of seven 

minutes per report. There is no standard 

form for reporting to CDC or the health 

departments and there is no cost to 

respondents other than their time to 

participate. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Pilot in command .................... 42 CFR 70.11 Report of death or illness onboard aircraft 

operated by airline (No Form).

1,400 1 7/60 

Master of vessel or person in 

charge of conveyance.

42 CFR 70.4 Report by the master of a vessel or person in 

charge of conveyance of the incidence of a communicable.

disease occurring while in interstate travel (No form) ...........

200 1 7/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–13889 Filed 6–28–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10691] 

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 

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, 


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Federal Register / Vol. 87, No. 124 / Wednesday, June 29, 2022 / Notices 38761 

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 

August 29, 2022. 

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. 

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–10691 Data Request and 

Attestation for PDP Sponsors 

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: Revision of a currently 

approved collection; Title: Data Request 

and Attestation for PDP Sponsors; Use: 

Section 50354 of the BBA requires that 

the Secretary establish a process for PDP 

sponsors to submit a request for 

standardized extracts of claims data for 

their enrollees. In addition, Section 

50354 of the BBA provides for a number 

of purposes and limitation for the use of 

the claims data and also permits the 

Secretary to establish other limitations 

necessary to protect the identity of 

individuals entitled to or enrolled in 

Medicare, and to protect the security of 

personal health information 

This information collection request 

allows a PDP sponsor to submit a 

request to CMS for claims data for its 

enrollees and to attest that it will adhere 

to the permitted uses and limitations on 

the use of the Medicare claims data that 

are listed in 42 CFR 423.153(g)(3) and 

After requesting claims data for its 

enrollees and attesting to the permitted 

uses and limitations of Medicare claims 

data, PDP sponsors are required to 

complete some basic on-boarding 

activities before gaining access to 

Medicare claims data using the Part A 

and B Claims Data to Part D Sponsors 

(AB2D) API. Form Number: CMS–10691 

(OMB Control Number: 0938–1371); 

Frequency: Annually; Affected Public: 

Private Sector, Business or other forprofit and not-for-profit institutions; 

Number of Respondents: 210; Number 

of Responses: 210 Total Annual Hours: 

39. (For policy questions regarding this 

collection contact Gaare, Kari A. at 410– 

786–8612.) 

Dated: June 23, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–13804 Filed 6–28–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–E–0449] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; DANYELZA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for DANYELZA and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human 

biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by August 29, 2022. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

December 27, 2022. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 29, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 29, 2022. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 


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