Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 30051 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden per 

response 

(in hours) 

Total/annual 

burden 

(in hours) 

Program director recruitment call protocol (Instrument 1) ............................... 6 1 0.50 3.0 

Program staff interview protocol: Program director (Instrument 2) a ............... 6 1 1.0 6.0 

Program staff interview protocol ERSEA staff (Instrument 2) a ....................... 24 1 1.5 36 

Head Start enrolled families focus group guide (Instrument 3) ...................... 60 1 1.5 90 

Community partner recruitment call protocol (Instrument 4) ........................... 24 1 0.17 4.0 

Community partner staff interview protocol (Instrument 5) ............................. 24 1 0.75 18 

Community partner focus group coordination b ............................................... 6 1 2.0 12 

Families not enrolled in Head Start focus group guide (Instrument 6) ........... 60 1 1.5 90 

aThere is one interview protocol for both the program director and the ERSEA staff and the interviewer will tailor it to the respondent(s). bThere is no instrument, only a document of duties associated with this activity. 

Estimated Total Annual Burden 

Hours: 259 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Head Start Act Section 640 [42 

U.S.C. 9835]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–11777 Filed 6–3–21; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Intent To Award 54 Single-Source 

Supplements for Current Senior 

Medicare Patrol (SMP) State Grantee 

ACTION: Notice of single-source 

supplements. 

SUMMARY: The Administration for 

Community Living (ACL) announces the 

intent to award 54 administrative 

supplements in the form of cooperative 

agreements to existing SMP project 

grantees to further support SMP 

activities in each state, the District of 

Columbia, Guam, Puerto Rico, and the 

U.S. Virgin Islands. The purpose of 

existing grantees’ work is to empower 

and assist Medicare beneficiaries, their 

families, and caregivers to prevent, 

detect, and report health care fraud, 

errors, and abuse through outreach, 

counseling, and education with an 

emphasis on reaching Medicare 

beneficiaries with limited income and 

those residing in rural areas. The 

administrative supplements for FY 2021 

will be distributed via formula to the 

existing 54 SMP state grantees, bringing 

the total for the supplement awards to 

$2,002,468. These current SMP grantees 

will use this funding to further enhance 

or expand existing and prior established 

plans to empower and assist Medicare 

beneficiaries, their families, and 

caregivers to prevent, detect, and report 

health care fraud, errors, and abuse 

through outreach, counseling, and 

education. This additional funding will 

be targeted to reach Medicare 

beneficiaries with limited income, and/ 

or those residing in rural areas. 

FOR FURTHER INFORMATION CONTACT: For 

further information or comments 

regarding this program supplement, 

contact Marissa Whitehouse, U.S. 

Department of Health and Human 

Services, Administration for 

Community Living, Center for Integrated 

Programs, Office of Healthcare 

Information and Counseling; telephone 

(202) 795–7425; email 

Marissa.Whitehouse@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Program Name: Senior Medicare 

Patrol (SMP). 

Recipient: 54 current SMP grantees. 

Current grantee State 

FY21 ACL 

recommended 

supplement 

amount 

Alabama Dept of Senior Services ........................................................................................................... Alabama ......................... $41,488 

Alaska Department of Health and Social Services ................................................................................. Alaska ............................ 4,408 

Arizona Department of Economic Security ............................................................................................. Arizona ........................... 32,105 

Arkansas Department of Human Services .............................................................................................. Arkansas ........................ 36,963 

California Health Advocates .................................................................................................................... California ........................ 170,823 

Colorado Division of Insurance ............................................................................................................... Colorado ........................ 22,047 

The Department of Rehabilitation Services ............................................................................................ Connecticut .................... 16,044 

Delaware Division of Social Services ..................................................................................................... Delaware ........................ 4,199 

Legal Counsel For The Elderly ............................................................................................................... District of Columbia ....... 2,658 

Florida Department of Elder Affairs ........................................................................................................ Florida ............................ 116,372 

Eqhealth Solutions, Inc ........................................................................................................................... Georgia .......................... 59,236 

Guam Department of Public Health & Social Services .......................................................................... Guam ............................. 1,318 

Hawaii Department of Health .................................................................................................................. Hawaii ............................ 10,665 

Idaho Commission on Aging ................................................................................................................... Idaho .............................. 12,481 

AgeOptions, Inc ....................................................................................................................................... Illinois ............................. 65,894 

30052 Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 

Current grantee State 

FY21 ACL 

recommended 

supplement 

amount 

IAAAA Education Institute, Inc ................................................................................................................ Indiana ........................... 45,349 

Iowa Department of Commerce .............................................................................................................. Iowa ............................... 26,115 

Kansas Department for Aging and Disability Services ........................................................................... Kansas ........................... 18,494 

Louisville-Jefferson County Metro Government ...................................................................................... Kentucky ........................ 46,755 

Eqhealth Solutions, Inc ........................................................................................................................... Louisiana ........................ 34,011 

Maine Department of Health and Human Services ................................................................................ Maine ............................. 13,962 

Aging, Maryland Department of .............................................................................................................. Maryland ........................ 21,364 

Elder Services of The Merrimack Valley Inc ........................................................................................... Massachusetts ............... 32,656 

MMAP Inc ................................................................................................................................................ Michigan ......................... 63,145 

Minnesota Department of Human Services ............................................................................................ Minnesota ...................... 33,924 

Eqhealth Solutions, Inc ........................................................................................................................... Mississippi ...................... 34,405 

District III Area Agency on Aging ............................................................................................................ Missouri .......................... 45,870 

Missoula Aging Services ......................................................................................................................... Montana ......................... 12,067 

Insurance, Nebraska Department of ....................................................................................................... Nebraska ........................ 13,080 

State of Nevada Aging and Disability Services Division ........................................................................ Nevada ........................... 14,798 

New Hampshire Dept of Health and Human Services ........................................................................... New Hampshire ............. 10,893 

Jewish Family & Vocational Service of Middlesex County, Inc .............................................................. New Jersey .................... 34,929 

Aging & Long-Term Services Department, New Mexico ........................................................................ New Mexico ................... 16,806 

NY Statewide Senior Action Council, Inc ................................................................................................ New York ....................... 122,593 

North Carolina Department of Insurance ................................................................................................ North Carolina ................ 78,824 

Minot State University ............................................................................................................................. North Dakota .................. 5,558 

Pro Seniors Inc ........................................................................................................................................ Ohio ............................... 76,984 

Oklahoma State Insurance Department .................................................................................................. Oklahoma ....................... 29,996 

DHS Office of Financial Services ............................................................................................................ Oregon ........................... 23,257 

Center for Advocacy for the Rights and Interests of the Elderly ............................................................ Pennsylvania .................. 80,868 

Hispanic-American Institute, Inc .............................................................................................................. Puerto Rico .................... 69,909 

Rhode Island Dept of Elderly Affairs ....................................................................................................... Rhode Island .................. 5,334 

South Carolina Department on Aging ..................................................................................................... South Carolina ............... 38,362 

South Dakota Department of Human Services ....................................................................................... South Dakota ................. 7,419 

Upper Cumberland Development District ............................................................................................... Tennessee ..................... 54,777 

Better Business Bureau Educational Foundation ................................................................................... Texas ............................. 134,139 

Legal Services of Virgin Islands Inc ........................................................................................................ U.S. Virgin Islands ......... 1,980 

Human Services, Utah Department of .................................................................................................... Utah ............................... 10,035 

Community of Vermont Elders ................................................................................................................ Vermont ......................... 7,973 

Virginia Association of Area Agencies on Aging .................................................................................... Virginia ........................... 45,083 

Washington State Insurance Commissioner ........................................................................................... Washington .................... 30,651 

Senior Services West Virginia Bureau .................................................................................................... West Virginia .................. 20,356 

Greater Wisconsin Agency on Aging Resources, Inc ............................................................................. Wisconsin ....................... 37,286 

Wyoming Senior Citizens, Inc ................................................................................................................. Wyoming ........................ 5,760 

Period of Performance: The award 

will be issued for the Fiscal Year 2021 

project period of June 1, 2021 through 

May 31, 2022. 

Total Award Amount: $2,002,468 

total in FY 2021. 

Award Type: Cooperative Agreement. 

Statutory Authority: The statutory 

authority is contained in the HIPAA of 

1996 (Pub. L. 104–191). 

Basis for Award: With the final FY 

2021 appropriation, Congress 

established the new baseline for the 

SMP program, setting the minimum 

ACL will receive to support this 

program to $20 million annually. This is 

an increase of $2 million over the 

amount ACL received for SMP 

historically. The additional funding is 

intended to expand and enhance current 

SMP activities with the purpose of 

reaching more Medicare beneficiaries. 

As such, OHIC is proposing to distribute 

the additional funding to the existing 

SMP state grantees to establish new 

baseline funding amounts for each of 

the state projects. 

The current SMP state grantees are 

funded to carry out the SMP Project 

mission for the period of June 1, 2018 

through May 31, 2023. Much work has 

already been completed and further 

tasks are currently being accomplished. 

It would be unnecessarily time 

consuming and disruptive to the SMP 

program, and the beneficiaries being 

served, for ACL to establish new 

grantees at this time. The current 

grantees are providing critical services 

in an efficient and successful manner. 

These administrative supplements will 

allow the SMP state grantees to expand 

their current work in empowering 

Medicare beneficiaries, their families, 

and caregivers to prevent, detect, and 

report health care fraud, errors, and 

abuse through outreach, counseling, and 

education with a particular emphasis on 

reaching Medicare beneficiaries with 

limited income and those residing in 

rural areas. The existing SMP state 

grantees are uniquely placed to continue 

and expand this work. Since 2018, and 

for years before for many repeat 

grantees, current grantees have been the 

proven state and community presence 

for preventing, detecting, and reporting 

Medicare fraud. There is one SMP state 

grantee project in each of the 50 States, 

the District of Columbia, Puerto Rico, 

Guam, and the U.S. Virgin Islands. In 

2019, the most up-to-date complete year 

of data, the 54 SMP projects had a total 

of 6,875 active team members who 

conducted a total of 28,146 group 

outreach and education events, reaching 

an estimated 1.6 million people. In 

addition, the projects had 320,590 

individual interactions with, or on 

behalf of, a Medicare beneficiary. For 

2019, the SMP projects reported $2.4 

million in expected Medicare 

recoveries. This program has 

successfully operated since its inception 

23 years ago. Current grantees are 

closely monitored and are successfully 

Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 30053 

meeting all programmatic goals under 

the current SMP grant. 

Dated: May 26, 2021. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2021–11779 Filed 6–3–21; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2024] 

Enhanced Drug Distribution Security at 

the Package Level Under the Drug 

Supply Chain Security Act; Draft 

Guidance for Industry; 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 a draft 

guidance for industry entitled 

‘‘Enhanced Drug Distribution Security at 

the Package Level Under the Drug 

Supply Chain Security Act.’’ The Drug 

Supply Chain Security Act (DSCSA) 

outlines critical enhanced drug 

distribution security requirements for 

building an electronic, interoperable 

system by November 27, 2023, that will 

identify and trace certain prescription 

drugs at the package level as they are 

distributed within the United States. 

This draft guidance clarifies these 

requirements and provides 

recommendations on the system 

attributes necessary to enable the secure 

tracing of product at the package level, 

including allowing for the use of 

verification, inference, and aggregation, 

as necessary. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 3, 2021 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2020–D–2024 for ‘‘Enhanced Drug 

Distribution Security at the Package 

Level Under the Drug Supply Chain 

Security Act.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Abha Kundi, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3130, drugtrackandtrace@

fda.hhs.gov 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 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Enhanced Drug Distribution Security at 

the Package Level Under the Drug 

Supply Chain Security Act.’’