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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48430 Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices 

and 301(d) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(a) and 

331(d)). 

Dated: August 17, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18586 Filed 8–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2021–D–0603 and FDA– 

2021–D–0604] 

Safety and Performance Based 

Pathway Device-Specific Guidances; 

Draft Guidances for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of two draft 

device-specific guidance documents for 

the Safety and Performance Based 

Pathway—specifically, ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; Draft 

Guidance for Industry and Food and 

Drug Administration Staff’’ and ‘‘Facet 

Screw Systems—Performance Criteria 

for Safety and Performance Based 

Pathway; Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ The device-specific guidances 

identified in this notice were developed 

in accordance with the finalized 

guidance entitled ‘‘Safety and 

Performance Based Pathway.’’ These 

draft guidance documents are not final 

nor are they in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 29, 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– 

2021–D–0603 for ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; Draft 

Guidance for Industry and Food and 

Drug Administration Staff’’ and Docket 

No. FDA–2021–D–0604 for ‘‘Facet 

Screw Systems—Performance Criteria 

for Safety and Performance Based 

Pathway; Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ Received comments will be 

placed in the dockets 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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Denture Base 

Resins—Performance Criteria for Safety 

and Performance Based Pathway; Draft 

Guidance for Industry and Food and 

Drug Administration Staff’’ or ‘‘Facet 

Screw Systems—Performance Criteria 

for Safety and Performance Based 

Pathway; Draft Guidance for Industry 

and Food and Drug Administration 

Staff’’ to the Office of Policy, Guidance 

and Policy Development, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Jason Ryans, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 


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