48428 Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices 

(2) the accuracy of ACL’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used 

to determine burden estimates; 

(3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and 

(4) ways to minimize the burden of 

the collection of information on 

respondents, including through the use 

of automated collection techniques 

when appropriate, and other forms of 

information technology. 

ACL contracts with a national legal 

assistance resource center, the National 

Center on Law and Elder Rights, to 

provide the required services. Through 

the contract, ACL provides aging, 

disability, and related legal 

professionals with training and complex 

case consultations and support for 

demonstration projects regarding 

contractually identified priority legal 

topics. The purpose of the information 

requested is for ACL to ensure that the 

resource center creates and prioritizes 

the training, case consultations and 

technical assistance resources it was 

contracted to provide and to ensure that 

the center targets the contractually 

designated aging network practitioners 

about the priority subject matters. This 

approach enables ACL to make datainformed decisions about the 

deployment of its resource center assets. 

These data are necessary for ACL to 

evaluate contractual compliance with 

established performance indicators. 

These metrics include quantifiable 

increases in uptake by stakeholders of 

training, case consultation and technical 

assistance, and measures of satisfaction 

with and perceived benefit from these 

services. For example, the metrics 

measure successful problem resolution 

as a result of the services provided and 

quantifiable data on fulfillment of 

requests for training, technical 

assistance, and consultation related to 

the contractually designated legal and 

systems development topic areas. The 

information requested by ACL from 

legal and aging/disability professionals 

falls into the following areas: (1) 

Requests for training, case consultation, 

and technical assistance through an 

online, secure Uniform Resource 

Support Request Tool; (2) general 

requests for Legal Training (including 

the volume of Webinar registrations), 

Case Consultation. 

To comment on this information 

collection please visit the ACL website: 

https://www.acl.gov/about-acl/publicinput. 

Estimated Program Burden 

ACL estimates the burden associated 

with this collection of information as 

follows: 

Respondent/data collection activity Number of 

respondents 

Minutes 

per response 

Annual 

burden hours 

Resource Support Requests .................................................................................................... 80 1 min 54 sec ..... 2.53 

Legal Training, Case Consultation, Technical Assistance Requests ....................................... 14,000 1 min 42 sec ..... 397 

Outcome Measurement ............................................................................................................ 3,500 1 min 3 sec ....... 61.25 

Total ................................................................................................................................... 17,580 4 min 39 sec ..... 460.78 

Dated: August 23, 2021. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2021–18590 Filed 8–27–21; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Process Evaluation 

of the Aging Network and Its Return on 

Investment; OMB #0985–New 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living (ACL) is announcing 

an opportunity for the public to 

comment on the proposed collection of 

information listed above. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish a notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a revision to the information collection 

requirements related to the Process 

Evaluation of the Aging Network and its 

Return on Investment. 

DATES: Comments on the collection of 

information submitted electronically by 

11:59 p.m. (EST) or postmarked by 

October 29, 2021. 

ADDRESSES: Submit written comments 

on the collection of information: 

Attention: Caryn Bruyere, 

Caryn.Bruyere@acl.hhs.gov. 

Via U.S. Mail Attention: Caryn 

Bruyere U.S. Department of Health and 

Human Services, Administration for 

Community Living, Washington, DC 

20201. 

FOR FURTHER INFORMATION CONTACT: 

Caryn Bruyere, Office of Performance 

and Evaluation. Administration for 

Community Living Telephone: 202– 

795–7393. 

Email: caryn.bruyere@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: 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. 

‘‘Collection of information’’ is defined 

as agency requests or requirements that 

members of the public submit reports, 

keep records, or provide information to 

a third party. The PRA requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, ACL is publishing a notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, ACL invites 

comments on our burden estimates or 

any other aspect of this collection of 

information, including: 

(1) Whether the proposed collection 

of information is necessary for the 

proper performance of ACL’s functions, 

including whether the information will 

have practical utility; 

(2) the accuracy of ACL’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used 

to determine burden estimates; 

(3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and 

(4) ways to minimize the burden of 

the collection of information on 

respondents, including through the use 

of automated collection techniques 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices 48429 

when appropriate, and other forms of 

information technology. 

Background: Many older adults have 

unmet health care and social service 

needs, which require coordinated care 

across a range of services, including 

access to nutritious meals, 

transportation, preventive health care, 

home and community-based care, social 

interaction, support for family 

caregivers, and advocacy to help 

maintain older adults’ safety, dignity, 

and legal rights. This proposed data 

collection for the Process Evaluation of 

the Aging Network and its Return on 

Investment is intended to provide 

timely information on, (1) how agencies 

in the Aging Network collaborate to 

serve older adults and family caregivers, 

and (2) how agencies measure the 

effectiveness of their efforts with the 

goal of strengthening their reach and 

impact. Through this data collection 

ACL will investigate how states differ in 

their network structure, how agencies 

work together, and potential strategies 

for evaluating return on investments 

(ROI) of ACL programs. 

The Process Evaluation of the Aging 

Network and its Return on Investment 

will include: (1) A census of agencies in 

the Aging Network, and (2) key 

informant interviews with agencies that 

are evaluating ROI. The survey seeks to 

collect data from all State Units on 

Aging (SUAs), Area Agencies on Aging 

(AAAs) (including some Aging and 

Disability Resource Centers), and Older 

Americans Act Title VI Native American 

tribal organizations. Surveying these 

organizations will help ACL understand 

how and with whom agencies in the 

network collaborate to address the 

needs of older adults and family 

caregivers, partnerships that have 

formed or expanded because of COVID– 

19, and how agencies measure the 

effectiveness and ROI of their various 

programs. 

The study will also include key 

informant interviews with a subset of 10 

agencies that responded to the survey 

whose responses indicate that their 

agency is evaluating ROI. The data 

collection team will ask in-depth 

questions about the costs and benefits 

included in ROI calculations, successes 

and challenges to evaluating ROI, and 

lessons learned that could benefit other 

agencies seeking to conduct their own 

assessment of ROI. 

To comment on this information 

collection please visit the ACL website: 

https://www.acl.gov/about-acl/publicinput. 

Estimated Program Burden 

ACL estimates the burden associated 

with this collection of information as 

follows: The proposed data collection 

estimates the average burden per 

response to be 0.17 hours for the Aging 

Network survey. The average burden per 

response for the key informant 

interviews estimated as 1 hour. 

TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS

Data collection activity 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Total 

number of 

responses 

Average 

burden per 

response 

(in hours) 

Annual 

estimated 

burden hours 

Aging Network survey ......................................... 864 1 ..................... 864 0.17 ................................ 144 

Key informant interview guide ............................. 10 1 ..................... 10 1 ..................................... 10 

Total ............................................................. 874 Varies ............. 874 0.18 (weighted mean) .... 154 

Dated: August 24, 2021. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2021–18588 Filed 8–27–21; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0790] 

Breckenridge Pharmaceutical, Inc.; 

Withdrawal of Approval of Abbreviated 

New Drug Application for Solifenacin 

Succinate Tablets, 5 Milligrams and 10 

Milligrams 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of the abbreviated new drug 

application (ANDA) for solifenacin 

succinate tablets, 5 milligrams (mg) and 

10 mg, held by Breckenridge 

Pharmaceutical, Inc., 15 Massirio Dr., 

Berlin, CT 06037 (Breckenridge). 

Breckenridge requested withdrawal of 

this application and has waived its 

opportunity for a hearing. 

DATES: Approval is withdrawn as of 

August 30, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On May 

20, 2019, FDA approved ANDA 209818 

for solifenacin succinate tablets, 5 mg 

and 10 mg, for the treatment of 

overactive bladder with symptoms of 

urge urinary incontinence, urgency, and 

urinary frequency. On January 23, 2020, 

Breckenridge issued a field alert report 

that solifenacin succinate tablets, 5 mg 

and 10 mg, may convert to solifenacin 

tartrate tablets during manufacturing 

due to an interaction between 

solifenacin succinate and tartartic acid, 

which is an inactive ingredient in this 

drug product’s formulation. On January 

24, 2020, Breckenridge executed a Class 

II Recall (Retail-Level) of all solifenacin 

succinate tablet product lots that were 

distributed to market. Breckenridge 

cannot market its solifenacin succinate 

tablet product under the current 

approval conditions for ANDA 209818. 

To the extent that its active ingredient 

has converted from solifenacin 

succinate to solifenacin tartrate, the 

product Breckenridge has distributed 

under ANDA 209818 is misbranded. 

After discussions with FDA, on April 

21, 2020, Breckenridge requested that 

FDA withdraw approval of ANDA 

209818 for solifenacin succinate tablets 

under § 314.150(d) (21 CFR 314.150(d)) 

and waived its opportunity for a 

hearing. For the reasons discussed 

above, and in accordance with the 

applicant’s request, approval of ANDA 

209818 solifenacin succinate tablets, 

and all amendments and supplements 

thereto, is withdrawn under 

§ 314.150(d). Distribution of solifenacin 

succinate tablets into interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 


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