Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices 32935 

GA 30341, Telephone: (770) 488–3953; 

Email: NCIPCBSC@cdc.gov. 

SUPPLEMENTARY INFORMATION: Portions 

of the meeting as designated above will 

be closed to the public in accordance 

with provisions set forth in Section 

552b(c)(4) and (6), Title 5 U.S.C., and 

the Determination of the Director, 

Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, 

CDC, pursuant to Public Law 92–463 (5 

U.S.C. App.). 

Purpose: The Board will: (1) Conduct, 

encourage, cooperate with, and assist 

other appropriate public health 

authorities, scientific institutions, and 

scientists in the conduct of research, 

investigations, experiments, 

demonstrations, and studies relating to 

the causes, diagnosis, treatment, control, 

and prevention of physical and mental 

diseases, and other impairments; (2) 

assist States and their political 

subdivisions in preventing and 

suppressing communicable and noncommunicable diseases and other 

preventable conditions and in 

promoting health and well-being; and 

(3) conduct and assist in research and 

control activities related to injury. The 

BSC, NCIPC makes recommendations 

regarding policies, strategies, objectives, 

and priorities; reviews progress toward 

injury prevention goals; and provides 

evidence in injury prevention-related 

research and programs. The Board also 

provides advice on the appropriate 

balance of intramural and extramural 

research, and the structure, progress, 

and performance of intramural 

programs. The Board is designed to 

provide guidance on extramural 

scientific program matters, including 

the: (1) Review of extramural research 

concepts for funding opportunity 

announcements; (2) conduct of 

Secondary Peer Review of extramural 

research grants, cooperative agreements, 

and contracts applications received in 

response to funding opportunity 

announcements as they relate to the 

Center’s programmatic balance and 

mission; (3) submission of secondary 

review recommendations to the Center 

Director of applications to be considered 

for funding support; (4) review of 

research portfolios, and (5) review of 

program proposals. 

Matters To Be Considered: The open 

portion of the agenda will include 

discussion on NCIPC Research Priorities 

for Addressing Adverse Childhood 

Experiences. The closed portion of the 

agenda will focus on the Secondary Peer 

Review of extramural research grant 

applications received in response to 

three Notice of Funding Opportunities 

(NOFOs): (1) RFA–CE–21–001— 

‘‘Rigorous Evaluation of Policies for 

their Impacts on the Primary Prevention 

of Multiple Forms of Violence’’; (2) 

RFA–CE–21–003—‘‘Grants to Support 

New Investigators in Conducting 

Research Related to Preventing 

Interpersonal Violence Impacting 

Children and Youth’’; and (3) RFA–CE– 

21–004—‘‘Research Grants for 

Preventing Violence and ViolenceRelated Injury (R01)’’; as well as PHS 

2020 Omnibus Solicitation of the NIH, 

CDC and FDA for Small Business 

Innovation Research Grant Applications 

(Parent SBIR [R43/R44] Clinical Trial 

Not Allowed). Agenda items are subject 

to change as priorities dictate. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–13119 Filed 6–22–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10137 and CMS– 

10174] 

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, 

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 23, 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–10137 Solicitation for 

Applications for Medicare 

Prescription Drug Plan 2023 Contracts 

CMS–10174 Collection of Prescription 

Drug Data from MA–PD, PDP and 

Fallout Plans/Sponsors for Medicare 

Part D Payments 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 


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32936 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices 

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 of 

Information Collection: Solicitation for 

Applications for Medicare Prescription 

Drug Plan 2023 Contracts; Use: Coverage 

for the prescription drug benefit is 

provided through contracted 

prescription drug plans (PDPs) or 

through Medicare Advantage (MA) 

plans that offer integrated prescription 

drug and health care coverage (MA–PD 

plans). Cost Plans that are regulated 

under Section 1876 of the Social 

Security Act, and Employer Group 

Waiver Plans (EGWP) may also provide 

a Part D benefit. Organizations wishing 

to provide services under the 

Prescription Drug Benefit Program must 

complete an application, negotiate rates, 

and receive final approval from CMS. 

Existing Part D Sponsors may also 

expand their contracted service area by 

completing the Service Area Expansion 

(SAE) application. 

Collection of this information is 

mandated in Part D of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) in 

Subpart 3. The application requirements 

are codified in Subpart K of 42 CFR 423 

entitled ‘‘Application Procedures and 

Contracts with PDP Sponsors.’’ 

The information will be collected 

under the solicitation of proposals from 

PDP, MA–PD, Cost Plan, Program of All 

Inclusive Care for the Elderly (PACE), 

and EGWP applicants. The collected 

information will be used by CMS to: (1) 

Ensure that applicants meet CMS 

requirements for offering Part D plans 

(including network adequacy, 

contracting requirements, and 

compliance program requirements, as 

described in the application), (2) 

support the determination of contract 

awards. Form Number: CMS–10137 

(OMB control number: 0938–0936); 

Frequency: Yearly; Affected Public: 

Businesses or other for-profits, Not-forprofit institutions; Number of 

Respondents: 716; Total Annual 

Responses: 382; Total Annual Hours: 

1,716. (For policy questions regarding 

this collection contact Arianne 

Spaccarelli at 410–786–5715.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Collection of 

Prescription Drug Event Data From 

Contracted Part D Providers for 

Payment; Use: The PDE data is used in 

the Payment Reconciliation System to 

perform the annual Part D payment 

reconciliation, any PDE data within the 

Coverage Gap Phase of the Part D benefit 

is used for invoicing in the CGDP, and 

the data are part of the report provided 

to the Secretary of the Treasury for 

Section 9008. 

CMS has used PDE data to create 

summarized dashboards and tools, 

including the Medicare Part D Drug 

Spending Dashboard & Data, the Part D 

Manufacturer Rebate Summary Report, 

and the Medicare Part D Opioid 

Prescribing Mapping Tool. The data are 

also used in the Medicare Trustees 

Report. Due to the market sensitive 

nature of PDE data, external uses of the 

data are subject to significant 

limitations. However, CMS does analyze 

the data on a regular basis to determine 

drug cost and utilization patterns in 

order to inform programmatic patterns 

and to develop informed policy in the 

Part D program. 

The information users will be 

Pharmacy Benefit Managers (PBMs), 

third party administrators and 

pharmacies, and the PDPs, MA–PDs, 

Fallbacks and other plans that offer 

coverage of outpatient prescription 

drugs under the Medicare Part D benefit 

to Medicare beneficiaries. The 

statutorily required data is used 

primarily for payment and is used for 

claim validation as well as for other 

legislated functions such as quality 

monitoring, program integrity and 

oversight. Form Number: CMS–10174 

(OMB control number: 0938–0982); 

Frequency: Yearly; Affected Public: 

Businesses or other for-profits, Not-forprofit institutions; Number of 

Respondents: 739; Total Annual 

Responses: 1,499,238,090; Total Annual 

Hours: 2,998. (For policy questions 

regarding this collection contact Ivan 

Iveljic at 410–786–3312.) 

Dated: June 17, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–13194 Filed 6–22–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–E–1642] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; GIVLAARI 

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 GIVLAARI 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 drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by August 23, 2021. 

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 20, 2021. 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 23, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 23, 2021. 

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: 


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