Federal Register / Vol. 87, No. 77 / Thursday, April 21, 2022 / Notices 23867 

Estimated Total Annual Burden 

Hours: 1,104. 

Authority: 42 U.S.C. 613. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–08495 Filed 4–20–22; 8:45 am] 

BILLING CODE 4184–09–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Availability of Program Application 

Instructions for MIPPA Program Funds 

Title: Medicare Improvements for 

Patients and Providers Act: State 

Applications for Medicare Low-Income 

Benefit Programs Enrollment Outreach 

and Assistance. 

Announcement Type: Initial. 

Funding Opportunity Number: CIP– 

MI–22–001. 

Statutory Authority: The Medicare 

Improvements for Patients and 

Providers Act of 2008, as amended by 

the Patient Protection and Affordable 

Care Act of 2010 and reauthorized by 

the American Taxpayer Relief Act of 

2012 (ATRA), Protecting Access to 

Medicare Act of 2014, Medicare Access 

and CHIP Reauthorization Act of 2015, 

Bipartisan Budget Act of 2018, 

Coronavirus Aid, Relief, and Economic 

Security Act of 2020, and Consolidated 

Appropriations Act of 2021. 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.071. 

Dates: The deadline date for the 

submission of MIPPA Program State 

Plans is 11:59 p.m. ET on June 21, 2022. 

I. Funding Opportunity Description 

The Medicare Improvement for 

Patients and Providers Act (MIPPA) 

program supports states through grants 

to provide outreach and assistance to 

Medicare beneficiaries with limited 

incomes and assets to ensure the 

beneficiaries have access to all Medicare 

related benefits available to them. 

MIPPA state grantees help educate 

Medicare beneficiaries about benefit 

programs that help them pay for 

Medicare including the Low-Income 

Subsidy (LIS) program for Medicare Part 

D and the Medicare Savings Programs 

(MSPs). In addition, MIPPA grantees 

provide education on Medicare 

Preventive Services. MIPPA grantees 

provide education through public 

outreach while also providing one-onone assistance to eligible Medicare 

beneficiaries to help them access and 

apply for benefit programs that help 

lower the costs of their Medicare 

premiums and deductibles. 

MIPPA state funding is limited to 

agencies eligible for MIPPA funding: 

• Priority Area 1—State Health 

Insurance Assistance Program (SHIP): 

SHIP grant recipients or (SHIPdesignated state agencies) 

• Priority Area 2—Area Agencies on 

Aging (AAAs): State Units on Aging 

(SUA) (or SUA-designated state 

agencies) 

• Priority Area 3—Aging and Disability 

Resource Centers (ADRCs): Agencies 

that are established ADRCs who have 

received an ACL ADRC COVID grant 

(or designated state agency serving as 

the No Wrong Door lead) 

ACL will accept only one application 

for each Priority Area per state. If an 

agency is eligible for more than one 

MIPPA Priority Area, the agency may 

combine their responses into one 

comprehensive application. 

These funds will allow agencies to 

provide enhanced outreach to eligible 

Medicare beneficiaries regarding their 

preventive, wellness, and limited 

income benefits; application assistance 

to individuals who may be eligible for 

LIS or MSPs; and outreach activities 

covering LIS, MSP, or aimed at 

preventing disease and promoting 

wellness. Applicant plans should go 

above and beyond those regular 

activities planned in response to other 

funding sources. 

II. Award Information 

1. Funding Instrument Type 

These awards will be made in the 

form of grants to agencies for each 

MIPPA Priority Area: 

Priority Area 1—SHIP: Grants to state 

agencies (State Units on Aging or State 

Departments of Insurance) that 

administer the SHIP to provide 

enhanced outreach to eligible Medicare 

beneficiaries regarding their preventive, 

wellness, and limited income benefits; 

application assistance to individuals 

who may be eligible for LIS or MSPs; 

and outreach activities aimed at 

preventing disease and promoting 

wellness. 

Priority Area 2—AAA: Grants to state 

agencies for AAA programs to provide 

enhanced outreach to eligible Medicare 

beneficiaries regarding their preventive, 

wellness, and limited income benefits; 

application assistance to individuals 

who may be eligible for LIS or MSPs; 

and outreach activities aimed at 

preventing disease and promoting 

wellness. 

Priority Area 3—ADRC: Aging and 

Disability Resource Center Programs 

(ADRC): Grants to agencies that are 

established ADRCs to provide outreach 

regarding Medicare Part D benefits 

related to LIS and MSPs, and conduct 

outreach activities aimed at preventing 

disease and promoting wellness. 

2. Anticipated Total Priority Area 

Funding per Budget Period 

ACL intends to make available, under 

this program announcement, grant 

awards for the three MIPPA priority 

areas. Funding will be distributed 

through a formula as identified in 

statute. The amounts allocated are based 

upon factors defined in statute and will 

be distributed to each priority area 

based on the formula. ACL will fund 

total project periods of up to two (2) 

years contingent upon availability of 

federal funds. 

Priority Area 1—SHIP: $15.8 million 

in FY 2022 for state agencies that 

administer the SHIP Program. 

Priority Area 2—AAA: $13.4 million 

in FY 2022 for State Units on Aging for 

Area Agencies on Aging. 

Priority Area 3—ADRC: $4.6 million 

in FY 2022 for agencies that are 

established ADRCs who have received 

an ACL ADRC COVID grant. 

III. Eligibility Criteria and Other 

Requirements 

1. Eligible Applicants for MIPPA State 

Grants: 

Priority Area 1—SHIP: Only existing 

SHIP grant recipients or (SHIPdesignated state agencies) are eligible to 

apply. 

Priority Area 2—AAA: Only State 

Units on Aging (SUA) (or SUAdesignated state agencies) are eligible to 

apply. 

Priority Area 3—ADRC: Only agencies 

that are established ADRCs who have 

received an ACL ADRC COVID grant (or 

designated state agency serving as the 

No Wrong Door lead) are eligible to 

apply. 

Eligibility may change if future 

funding is available. 

2. Cost Sharing or Matching is not 

required. 

3. Unique Entity ID: All grant 

applicants must obtain and keep current 

a Unique Entity ID (UEI). On April 4, 

2022, the unique entity identifier used 

across the federal government changed 

from the DUNS Number to the Unique 

Entity ID (generated by SAM.gov). The 

Unique Entity ID is a 12-character 

alphanumeric ID assigned to an entity 

by SAM.gov. The UEI is viewable in 

your SAM.gov entity registration record. 

4. Intergovernmental Review: 

Executive Order 12372, 

Intergovernmental Review of Federal 

Programs, is not applicable to these 

grant applications. 


jspears on DSK121TN23PROD with NOTICES1
23868 Federal Register / Vol. 87, No. 77 / Thursday, April 21, 2022 / Notices 

1An applicant must submit an annual status 

report on the progress of each open PMR/PMC 

within 60 days of the anniversary date of U.S. 

approval of the original application or on an 

alternate reporting date that was granted by FDA in 

writing. Some applicants have requested and been 

granted by FDA alternate annual reporting dates to 

facilitate harmonized reporting across multiple 

applications. 

2The ‘‘Report on the Performance of Drug and 

Biologics Firms in Conducting Postmarketing 

Requirements and Commitments’’ can be found on 

the FDA’s Postmarketing Requirements and 

Commitments: Reports web page: https://

www.fda.gov/drugs/postmarket-requirements-andcommitments/postmarketing-requirements-andcommitments-reports. 

3The establishment date is the date of the formal 

FDA communication to the applicant that included 

the final FDA-required (PMR) or requested (PMC) 

postmarketing study or clinical trial. 

IV. Submission Information 

1. Application Kit 

Application Kit/Program Instructions 

are available at www.grantsolutions.gov. 

Instructions for completing the 

application kit will be available on the 

site. 

2. Submission Dates and Times 

To receive consideration, applications 

must be submitted by 11:59 p.m. Eastern 

Time on June 21, 2022, through 

www.GrantSolutions.gov. 

VII. Agency Contacts 

Direct inquiries regarding 

programmatic issues to: Margaret 

Flowers, Phone: 202.795.7315, Email: 

Margaret.Flowers@acl.hhs.gov. 

Dated: April 15, 2022. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2022–08511 Filed 4–20–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3771] 

Report on the Performance of Drug 

and Biologics Firms in Conducting 

Postmarketing Requirements and 

Commitments; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the 

Agency’s annual report entitled ‘‘Report 

on the Performance of Drug and 

Biologics Firms in Conducting 

Postmarketing Requirements and 

Commitments.’’ Under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), FDA is required to report annually 

on the status of postmarketing 

requirements (PMRs) and postmarketing 

commitments (PMCs) required of, or 

agreed upon by, application holders of 

approved drug and biological products. 

The report on the status of the studies 

and clinical trials that applicants have 

agreed, or are required, to conduct is on 

FDA’s ‘‘Postmarketing Requirements 

and Commitments: Reports’’ web page 

(https://www.fda.gov/drugs/postmarketrequirements-and-commitments/ 

postmarketing-requirements-andcommitments-reports). 

FOR FURTHER INFORMATION CONTACT: 

Kathy Weil, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5367, Silver Spring, 

MD 20993–0002, 301–796–0700; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 506B(c) of the FD&C Act (21 

U.S.C. 356b(c)) requires FDA to publish 

an annual report on the status of 

postmarketing studies that applicants 

have committed to, or are required to 

conduct, and for which annual status 

reports have been submitted. 

Under §§ 314.81(b)(2)(vii) and 601.70 

(21 CFR 314.81(b)(2)(vii) and 601.70), 

applicants of approved drugs and 

licensed biological products are 

required to submit annually a report on 

the status of each clinical safety, clinical 

efficacy, clinical pharmacology, and 

nonclinical toxicology study or clinical 

trial either required by FDA (PMRs) or 

that they have committed to conduct 

(PMCs), either at the time of approval or 

after approval of their new drug 

application, abbreviated new drug 

application, or biologics license 

application. The status of PMCs 

concerning chemistry, manufacturing, 

and production controls and the status 

of other studies or clinical trials 

conducted on an applicant’s own 

initiative are not required to be reported 

under §§ 314.81(b)(2)(vii) and 601.70 

and are not addressed in this report. 

Furthermore, section 505(o)(3)(E) of the 

FD&C Act (21 U.S.C. 355(o)(3)(E)) 

requires that applicants report 

periodically on the status of each 

required study or clinical trial and each 

study or clinical trial ‘‘otherwise 

undertaken . . . to investigate a safety 

issue . . .’’ 

An applicant must report on the 

progress of the PMR/PMC on the 

anniversary of the drug product’s 

approval 1 until the PMR/PMC is 

completed or terminated and FDA 

determines that the PMR/PMC has been 

fulfilled or that the PMR/PMC is either 

no longer feasible or would no longer 

provide useful information. 

II. Fiscal Year 2020 Report 

With this notice, FDA is announcing 

the availability of the Agency’s annual 

report entitled ‘‘Report on the 

Performance of Drug and Biologics 

Firms in Conducting Postmarketing 

Requirements and Commitments.’’ 2

Information in this report covers any 

PMR/PMC that was established, in 

writing, at the time of approval or after 

approval of an application or a 

supplement to an application and 

summarizes the status of PMRs/PMCs in 

fiscal year (FY) 2020 (i.e., as of 

September 30, 2020). Information 

summarized in the report reflects 

combined data from the Center for Drug 

Evaluation and Research and the Center 

for Biologics Evaluation and Research 

and includes the following: (1) The 

number of applicants with open PMRs/ 

PMCs; (2) the number of open PMRs/ 

PMCs; (3) the timeliness of applicant 

submission of the annual status reports 

(ASRs); (4) FDA-verified status of open 

PMRs/PMCs reported in 

§ 314.81(b)(2)(vii) or § 601.70 ASRs; (5) 

the status of closed PMRs/PMCs; and (6) 

the distribution of the status by fiscal 

year of establishment 3 (FY2014 to 

FY2020) for PMRs and PMCs open at 

the end of FY2020, or those closed 

within FY2020. Additional information 

about PMRs/PMCs is provided on FDA’s 

website at https://www.fda.gov/drugs/ 

guidance-compliance-regulatoryinformation/postmarket-requirementsand-commitments. 

Dated: April 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08499 Filed 4–20–22; 8:45 am] 

BILLING CODE 4164–01–P 


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