Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 49333 

represent a nationwide average of 

consumer purchase prices, net of 

discounts and rebates. The contractor 

shall provide notification when a drug 

product becomes generally available 

and that the contract include such terms 

and conditions as the Secretary shall 

specify, including a requirement that 

the vendor monitor the marketplace. 

CMS has developed a National Average 

Drug Acquisition Cost (NADAC) for 

states to consider when developing 

reimbursement methodology. The 

NADAC is a pricing benchmark that is 

based on the national average costs that 

pharmacies pay to acquire Medicaid 

covered outpatient drugs. This pricing 

benchmark is based on drug acquisition 

costs collected directly from pharmacies 

through a nationwide survey process. 

This survey is conducted on a monthly 

basis to ensure that the NADAC 

reference file remains current and up-todate. Form Number: CMS–10241 (OMB 

control number 0938–1041); Frequency: 

Monthly; Affected Public: Private sector 

(Business or other for-profits); Number 

of Respondents: 72,000; Total Annual 

Responses: 72,000; Total Annual Hours: 

36,000. (For policy questions regarding 

this collection contact: Lisa Shochet at 

410–786–5445.) 

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: August 30, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–19012 Filed 9–1–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Privacy Act of 1974; Matching Program 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services. 

ACTION: Notice of a re-established 

matching program. 

SUMMARY: In accordance with the 

Privacy Act of 1974, as amended, the 

Department of Health and Human 

Services, Administration for Children 

and Families, Office of Planning, 

Research, and Evaluation (HHS/ACF/ 

OPRE), is providing notice of a reestablished matching program between 

the Department of Defense, Defense 

Manpower Data Center (DoD/DMDC) 

and State Public Assistance Agencies 

(SPAAs), ‘‘Verification of Continued 

Eligibility for Benefits Through the 

Public Assistance Reporting Information 

System (PARIS) Program.’’ HHS/ACF/ 

OPRE facilitates the matching program. 

DATES: The deadline for comments on 

this notice is October 4, 2021. The reestablished matching program will 

commence not sooner than 30 days after 

publication of this notice, provided no 

comments are received that warrant a 

change to this notice. The matching 

program will be conducted for an initial 

term of 18 months (from approximately 

September 30, 2021, through March 30, 

2023) and within 3 months of expiration 

may be renewed for 1 additional year if 

the parties make no change to the 

matching program and certify that the 

program has been conducted in 

compliance with the matching 

agreement. 

ADDRESSES: Interested parties may 

submit written comments on this notice, 

by mail or email, to the Director, 

Division of Data and Improvement, 

HHS/ACF Office of Planning, Research, 

and Evaluation, 330 C Street SW, 

Washington, DC 20201, paris@

acf.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

General questions about the matching 

program may be submitted to Alicia 

Gumbs, HHS/ACF Office of Planning, 

Research, and Evaluation, 330 C Street 

SW, Washington, DC 20201 (202) 690– 

8490, paris@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Privacy Act of 1974, as amended (5 

U.S.C. 552a, subsection(e)(12)), provides 

certain protections for individuals 

applying for and receiving Federal 

benefits. The law governs the use of 

computer matching by Federal agencies 

when records in a system of records 

(meaning, Federal agency records about 

individuals retrieved by name or other 

personal identifier) are matched with 

records of other Federal or non-Federal 

agencies. The Privacy Act requires 

agencies involved in a matching 

program to: 

1. Enter into a written agreement, 

which must be prepared in accordance 

with the Privacy Act, approved by the 

Data Integrity Board of each source and 

recipient Federal agency, provided to 

Congress and the Office of Management 

and Budget (OMB), and made available 

to the public, as required by 5 U.S.C. 

552a(o), (u)(3)(A), and (u)(4). 

2. Notify the individuals whose 

information will be used in the 

matching program that the information 

they provide is subject to verification 

through matching, as required by 5 

U.S.C. 552a(o)(1)(D). 

3. Verify match findings before 

suspending, terminating, reducing, or 

making a final denial of an individual’s 

benefits or payments or taking other 

adverse action against the individual, as 

required by 5 U.S.C. 552a(p). 

4. Report the matching program to 

Congress and the OMB, in advance and 

annually, as required by 5 U.S.C. 

552a(o) (2)(A)(i), (r), and (u)(3)(D). 

5. Publish advance notice of the 

matching program in the Federal 

Register as required by 5 U.S.C. 

552a(e)(12). 


lotter on DSK11XQN23PROD with NOTICES1
49334 Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Notices 

This matching program complies with 

these requirements. 

Naomi Goldstein, 

Deputy Assistant Secretary for Planning, 

Research, and Evaluation, ACF. 

Participating Agencies 

Department of Defense, Defense 

Manpower Data Center (DoD/DMDC) is 

the source agency, and each State Public 

Assistance Agency (SPAA) is a nonFederal agency. The Department of 

Health and Human Services, 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation (HHS/ACF/OPRE) 

facilitates the matching program and is 

not a source or recipient of data used in 

the matching program. 

Authority for Conducting the Matching 

Program 

Sections 402, 1137, and 1903(r) of the 

Social Security Act (42 U.S.C. 602, 

1320b–7, and 1396b(r)). 

Purpose(s) 

This matching program identifies 

individuals receiving both Federal 

compensation (pay or pension benefits) 

and public assistance benefits under 

Federal benefit programs administered 

by the states and verifies public 

assistance clients’ declarations of 

income circumstances. 

Each participating State Public 

Assistance Agency (SPAA) will provide 

the Department of Defense, Defense 

Manpower Data Center (DMDC) with 

finder files containing identifying and 

other data about public assistance 

applicants or recipients (clients), which 

DMDC will match against DoD military 

and civilian pay files, military retired 

pay files, and survivor pay files (Office 

of Personnel Management (OPM) 

civilian retired and survivor pay files 

will not be used). DMDC will return 

matched data to the SPAA, which the 

SPAA will use to verify clients’ 

continued eligibility to receive public 

assistance benefits under HHS’ 

Medicaid and Temporary Assistance for 

Needy Families (TANF) programs and 

the Department of Agriculture’s 

Supplemental Nutrition Assistance 

Program (SNAP) and, if ineligible, to 

take such action as may be authorized 

by law and regulation to ensure fair and 

equitable treatment in the delivery of 

benefits attributable to funds provided 

by the Federal Government. HHS will 

support each SPAA’s efforts to 

participate in the matching program by 

assisting with finalizing the terms of the 

agreement and coordinating signatures 

on the agreement. 

Categories of Individuals 

The categories of individuals whose 

information is involved in the matching 

program are: 

• Individuals who apply for or 

receive public assistance benefits under 

Federal programs administered by the 

states (i.e., under Medicaid, TANF, and 

SNAP); and 

• Individuals who receive 

compensation from the DoD (i.e., 

military, civilian, survivor, or retirement 

pay or pension benefits). 

Categories of Records 

The categories of records involved in 

the matching program are public 

assistance client identifying information 

and Federal pay and pension data. 

A SPAA will provide the following 

data elements to DMDC about each 

public assistance client: 

• Client social security number 

(SSN), client last name, first name, 

client date of birth, address, gender, 

marital status, information regarding the 

specific public assistance benefit being 

received, file date, state name, state 

optional data, client location code, and 

case number. 

DMDC will provide the SPAA with 

match results containing the following 

data elements about any public 

assistance client who is receiving 

compensation from DoD: 

• SSN; state data; record type; file 

date; date of birth; last name; first name; 

middle name; suffix name; sex; gross 

pay; unit identification (ID) code (UIC); 

agency; pay plan; pay grade; pay step; 

basic salary; state residence; Federal 

taxable wages; Federal tax withheld; 

state taxable wages; state tax withheld; 

employee status code; payroll office 

number; personnel office ID; pay basic 

code; pay period end date 

(YYYYMMDD); disbursing date 

(YYYYMMDD); pay status; category 

code; total base pay all drills; marital 

status code; dependents quantity; off 

duty military code; welfare to work hire 

code; city; state; zip; address lines 1, 2, 

3, 4, 5 and 6; mailing address effective; 

claim number; retired pay entitlement 

effective; comments 1, 2, 3 and 4; and 

member SSN. 

System(s) of Records 

The DoD data used in this matching 

program will be disclosed from the 

following system of records, as 

authorized by routine use 16 published 

March 11, 2019: DMDC 01, titled 

‘‘Defense Manpower Data Center Data 

Base,’’ last published in full at 84 FR 

6383 (Feb. 27, 2019), and modified at 84 

FR 8698 (Mar. 11, 2019) and 84 FR 

15605 (Apr. 16, 2019). 

[FR Doc. 2021–19067 Filed 8–31–21; 11:15 am] 

BILLING CODE 4184–79–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0874] 

Proposal To Refuse To Approve a New 

Drug Application for ITCA 650 

(Exenatide in DUROS Device); 

Opportunity for a Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Director of the Center for 

Drug Evaluation and Research (Center 

Director) at the Food and Drug 

Administration (FDA or Agency) is 

proposing to refuse to approve a new 

drug application (NDA) submitted by 

Intarcia Therapeutics, Inc. (Intarcia), for 

ITCA 650 (exenatide in DUROS device) 

in its present form. This notice 

summarizes the grounds for the Center 

Director’s proposal and offers Intarcia 

an opportunity to request a hearing on 

the matter. 

DATES: Submit either electronic or 

written requests for a hearing by 

October 4, 2021; submit data, 

information, and analyses in support of 

the hearing and any other comments by 

November 1, 2021. 

ADDRESSES: You may submit hearing 

requests, documents in support of the 

hearing, and any other comments as 

follows. Please note that late, untimely 

filed requests and documents will not 

be considered. Electronic requests for a 

hearing must be submitted on or before 

October 4, 2021; electronic documents 

in support of the hearing and any other 

comments must be submitted on or 

before November 1, 2021. The https://

www.regulations.gov electronic filing 

system will accept hearing requests 

until 11:59 p.m. Eastern Time at the end 

of October 4, 2021, and will accept 

documents in support of the hearing 

and any other comments until 11:59 

p.m. Eastern Time at the end of 

November 1, 2021. Documents 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 these 

dates. 

Electronic Submissions 

Submit electronic comments in the 

following way: 


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