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

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
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 1ESTIMATED ANNUALIZED BURDEN HOURS
Annual number of respondents
Data collection activity
Average burden per response in hours
Total number of responses
Annual estimated burden hours
Aging Network survey
Key informant interview guide

864
10

1
1

864
10

0.17
1

144
10

Total

874

Varies

874

0.18 weighted mean

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Dated: August 24, 2021.
Alison Barkoff, Acting Administrator and Assistant Secretary for Aging.
FR Doc. 202118588 Filed 82721; 8:45 am BILLING CODE 415401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0790

Breckenridge Pharmaceutical, Inc.;
Withdrawal of Approval of Abbreviated New Drug Application for Solifenacin Succinate Tablets, 5 Milligrams and 10
Milligrams AGENCY:
khammond on DSKJM1Z7X2PROD with NOTICES

Number of responses per respondent
Food and Drug Administration,
HHS.
ACTION:

Notice.

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
SUMMARY:

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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 209930002, 301
7963137, Kimberly.Lehrfeld@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:

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drug products 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 314.150d 21 CFR 314.150d and waived its opportunity for a hearing. For the reasons discussed above, and in accordance with the applicants request, approval of ANDA
209818 solifenacin succinate tablets, and all amendments and supplements thereto, is withdrawn under 314.150d. Distribution of solifenacin succinate tablets into interstate commerce without an approved application is illegal and subject to regulatory action see sections 505a
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