Notice of Intent To Award a Single-Source Supplement to the National Aging and Disability Networks, 44095-44096 [2020-15280]

Download as PDF Federal Register / Vol. 85, No. 140 / Tuesday, July 21, 2020 / Notices CMS–P–0015A Medicare Current Beneficiary Survey (MCBS) COVID–19 Rapid Response Supplement 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. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public: Submit reports, keep records, or provide information to a third party. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: jbell on DSKJLSW7X2PROD with NOTICES Information Collection 1. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Medicare Current Beneficiary Survey (MCBS) COVID–19 Rapid Response Supplement; Use: CMS is the largest single payer of health care in the United States. The agency plays a direct or indirect role in administering health insurance coverage for more than 120 million people across the Medicare, Medicaid, CHIP, and Exchange populations. A critical aim for CMS is to be an effective steward, major force, and trustworthy partner in supporting innovative approaches to improving quality, accessibility, and affordability in healthcare. CMS also aims to put patients first in the delivery of their health care needs. The Medicare Current Beneficiary Survey (MCBS) is the most comprehensive and complete survey available on the Medicare population and is essential in capturing data not otherwise collected through our operations. The MCBS is a nationallyrepresentative, longitudinal survey of Medicare beneficiaries that we sponsor and is directed by the Office of Enterprise Data and Analytics (OEDA). The survey captures beneficiary information whether aged or disabled, living in the community or facility, or serviced by managed care or fee-forservice. Data produced as part of the MCBS are enhanced with our administrative data (e.g. fee-for-service claims, prescription drug event data, enrollment, etc.) to provide users with more accurate and complete estimates of total health care costs and utilization. The MCBS has been continuously fielded for more than 28 years, encompassing over 1 million interviews and more than 100,000 survey participants. Respondents participate in up to 11 interviews over a four year VerDate Sep<11>2014 17:42 Jul 20, 2020 Jkt 250001 period. This gives a comprehensive picture of health care costs and utilization over a period of time. With the emergence of the COVID–19 pandemic in the U.S., CMS is uniquely positioned to quickly collect vital information on how the pandemic is impacting the Medicare population by utilizing the MCBS. MCBS beneficiaries, by definition, are most at risk for underlying conditions that may lead to more severe COVID–19 complications. This new clearance requests approval to add the Fall COVID–19 Supplement to the MCBS Fall 2020 Round 88 data collection conducted under 0938–0568. Due to the emergence of this public health crisis, a Supplement to the MCBS is especially well-suited to provide CMS critical data on measures of Medicare beneficiary knowledge about telehealth, social distancing and other important preventive health behaviors, along with updated information about COVID–19 testing and the results of those tests. Since the MCBS has a sample size sufficient for estimation, it provides a ready source to obtain high quality data. The MCBS COVID–19 Supplement will be administered to respondents living in the community and to facility staff who answer questions on behalf of the sampled beneficiary. Respondents will participate by telephone to answer the Supplement questions. In accordance with the implementing regulations of the PRA at 5 CFR 1320.13, CMS is requesting emergency processing for this ICR because it cannot reasonably comply with normal clearance procedures. Upon OMB approval of this emergency clearance request, CMS will follow the normal clearance procedures for the MCBS ICR under 0938–0568. Form Number: CMS–P–0015A (OMB control number: 0938–NEW); Frequency: One-time collection; Affected Public: Business or other forprofits and Not-for-profit institutions; Number of Respondents: 11,536; Total Annual Responses: 11,536; Total Annual Hours: 3,229. (For policy questions regarding this collection contact William Long at 410–786–7927.) Dated: July 15, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2020–15677 Filed 7–17–20; 8:45 am] BILLING CODE 4120–01–P PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 44095 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Notice of Intent To Award a SingleSource Supplement to the National Aging and Disability Networks Announcing intent to award a single-source supplement. ACTION: The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by The National Council on Aging for the project Piloting the Remote Delivery of Falls Prevention Programs. The purpose of this supplement is to scale-up research activities for falls prevention interventions delivered remotely/ virtually. SUMMARY: For further information or comments regarding this program supplement, contact Keri Lipperini, U.S. Department of Health and Human Services, Administration for Community Living, Administration on Aging, Office of Nutrition and Health Promotion Programs, 202–795–7422, email keri.lipperini@acl.hhs.gov. SUPPLEMENTARY INFORMATION: This supplement for FY 2020 will be in the amount of $100,000, bringing the total award in FY 2020 to $850,000. The additional funding will be used to enhance existing efforts, not for new efforts. The grantee will continue to work toward their dual goals of providing public education on the risk of falls and how to prevent them and supporting the implementation and dissemination of evidence-based falls prevention programs. Program Name: National Falls Prevention Resource Center. Recipient: The National Council on Aging. Period of Performance: The supplement award will be issued for the fifth year of a five year project period of August 1, 2016 to July 31, 2021. Total Award Amount: $850,000 in FY 2020. Award Type: Cooperative Agreement, Supplement. Statutory Authority: The Older Americans Act (OAA) of 1965, as amended, Public Law 116–131. FOR FURTHER INFORMATION CONTACT: Basis for Award The National Council on Aging (NCOA) is currently funded to carry out the objectives of the National Falls Prevention Resource Center grant for the period of August 1, 2016 to July 31, E:\FR\FM\21JYN1.SGM 21JYN1 44096 Federal Register / Vol. 85, No. 140 / Tuesday, July 21, 2020 / Notices 2021. Since the project’s implementation, the grantee has made satisfactory progress toward its approved work plan. This supplemental funding is intended to enhance NCOA’s existing work—enabling them to provide responsive support for communitybased organizations during the COVID– 19 pandemic by piloting the remote/ virtual delivery of falls prevention interventions. As a well-established and trusted organization in the aging and disability networks, NCOA is uniquely positioned to complete the work called for under this project. Their current grant has two primary goals: (1) To provide public education on the risk of falls and how to prevent them; and (2) support the implementation and dissemination of evidence-based falls prevention programs. To accomplish these goals, NCOA serves as the national leader in falls prevention, reaching millions of professionals, older adults, individuals with disabilities, and their families each year through Falls Prevention Awareness Day and other public awareness activities and events. They also provide technical assistance for organizations implementing falls prevention programs, including one-onone consultation, national conferences, and webinars. They have a comprehensive, interactive website with tools and resources, including—but not limited to—issues briefs, tip sheets, Dated: July 8, 2020. Mary Lazare, Principal Deputy Administrator. [FR Doc. 2020–15280 Filed 7–20–20; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1227] Roerig Division of Pfizer Inc., et.al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. SUMMARY: Approval is withdrawn as of August 20, 2020. DATES: FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: Application No. Drug Applicant ANDA 060709 ......... Oleandomycin Injection ......................................................... ANDA 061087 ......... ANDA 061943 ......... Benzocaine, Oxytetracycline Hydrochloride (HCl), and Polymyxin B Sulfate Otic Solution. Tetracycline HCl Capsules, 250 milligrams (mg) and 500 mg. Chloramphenicol Ophthalmic Solution, 0.5% ........................ ANDA 062175 ......... ANDA 062215 ......... ANDA 076203 ......... Tetracycline HCl Capsules, 250 mg ...................................... Oxytetracycline HCl Capsules ............................................... Ribavirin Capsules, 200 mg .................................................. ANDA 077456 ......... ANDA 084669 ......... Ribavirin Tablets, 200 mg, 400 mg, and 600 mg ................. Chlorpropamide Tablets, 250 mg .......................................... ANDA 201750 ......... Articaine HCI and Epinephrine Bitartrate for Injection, 4%; Equivalent to (EQ) 0.017 mg base/1.7 milliliters (mL); (4%; EQ 0.01 mg base/mL). Roerig Division of Pfizer Inc., 235 East 42nd St., New York, NY 10017. Pfizer Laboratories, Division of Pfizer Inc., 235 East 42nd St., New York, NY 10017. Warner Chilcott Division of Warner Lambert-Pfizer, Inc., 235 East 42nd St., New York, NY 10017. Lederle Laboratories, Division of American Cyanamid Co., 1 Cyanamid Plaza, Wayne, NJ 07470. Warner Chilcott Division of Warner Lambert-Pfizer, Inc. Lederle Laboratories, Division of American Cyanamid Co. Kadmon Pharmaceuticals, LLC, 119 Commonwealth Dr., Warrendale, PA 15086. Do. Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038. Hansamed Ltd., 4761 Tara Ct., West Bloomfield, MI 48323. ANDA 061725 ......... jbell on DSKJLSW7X2PROD with NOTICES policy and practice models, and toolkits. They have also presented to the aging and disability networks locally and on a national level, and have developed substantive partnerships with program developers, organizations, universities. Establishing an entirely new grant project at this time would be potentially disruptive to the work needed to ensure the continued availability of falls prevention programs. If this supplement were not provided, ACL grantees and the hundreds community-based organizations across the nation who provide many of these falls prevention interventions would be unable to do so due to the COVID–19 pandemic. Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 20, 2020. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction VerDate Sep<11>2014 17:42 Jul 20, 2020 Jkt 250001 into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on August 20, 2020 may continue to be dispensed until the inventories have been depleted or the PO 00000 Frm 00058 Fmt 4703 Sfmt 9990 drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: July 15, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–15727 Filed 7–20–20; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\21JYN1.SGM 21JYN1

Agencies

[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Notices]
[Pages 44095-44096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15280]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Community Living


Notice of Intent To Award a Single-Source Supplement to the 
National Aging and Disability Networks

ACTION: Announcing intent to award a single-source supplement.

-----------------------------------------------------------------------

SUMMARY: The Administration for Community Living (ACL) announces the 
intent to award a single-source supplement to the current cooperative 
agreement held by The National Council on Aging for the project 
Piloting the Remote Delivery of Falls Prevention Programs. The purpose 
of this supplement is to scale-up research activities for falls 
prevention interventions delivered remotely/virtually.

FOR FURTHER INFORMATION CONTACT: For further information or comments 
regarding this program supplement, contact Keri Lipperini, U.S. 
Department of Health and Human Services, Administration for Community 
Living, Administration on Aging, Office of Nutrition and Health 
Promotion Programs, 202-795-7422, email [email protected].

SUPPLEMENTARY INFORMATION: This supplement for FY 2020 will be in the 
amount of $100,000, bringing the total award in FY 2020 to $850,000.
    The additional funding will be used to enhance existing efforts, 
not for new efforts. The grantee will continue to work toward their 
dual goals of providing public education on the risk of falls and how 
to prevent them and supporting the implementation and dissemination of 
evidence-based falls prevention programs.
    Program Name: National Falls Prevention Resource Center.
    Recipient: The National Council on Aging.
    Period of Performance: The supplement award will be issued for the 
fifth year of a five year project period of August 1, 2016 to July 31, 
2021.
    Total Award Amount: $850,000 in FY 2020.
    Award Type: Cooperative Agreement, Supplement.
    Statutory Authority: The Older Americans Act (OAA) of 1965, as 
amended, Public Law 116-131.

Basis for Award

    The National Council on Aging (NCOA) is currently funded to carry 
out the objectives of the National Falls Prevention Resource Center 
grant for the period of August 1, 2016 to July 31,

[[Page 44096]]

2021. Since the project's implementation, the grantee has made 
satisfactory progress toward its approved work plan.
    This supplemental funding is intended to enhance NCOA's existing 
work--enabling them to provide responsive support for community-based 
organizations during the COVID-19 pandemic by piloting the remote/
virtual delivery of falls prevention interventions.
    As a well-established and trusted organization in the aging and 
disability networks, NCOA is uniquely positioned to complete the work 
called for under this project. Their current grant has two primary 
goals: (1) To provide public education on the risk of falls and how to 
prevent them; and (2) support the implementation and dissemination of 
evidence-based falls prevention programs. To accomplish these goals, 
NCOA serves as the national leader in falls prevention, reaching 
millions of professionals, older adults, individuals with disabilities, 
and their families each year through Falls Prevention Awareness Day and 
other public awareness activities and events. They also provide 
technical assistance for organizations implementing falls prevention 
programs, including one-on-one consultation, national conferences, and 
webinars. They have a comprehensive, interactive website with tools and 
resources, including--but not limited to--issues briefs, tip sheets, 
policy and practice models, and toolkits. They have also presented to 
the aging and disability networks locally and on a national level, and 
have developed substantive partnerships with program developers, 
organizations, universities.
    Establishing an entirely new grant project at this time would be 
potentially disruptive to the work needed to ensure the continued 
availability of falls prevention programs. If this supplement were not 
provided, ACL grantees and the hundreds community-based organizations 
across the nation who provide many of these falls prevention 
interventions would be unable to do so due to the COVID-19 pandemic.

    Dated: July 8, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020-15280 Filed 7-20-20; 8:45 am]
BILLING CODE 4154-01-P
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