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Federal Register/Vol. 81, No. 210/Monday, October 31, 2016 Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices 75411 requires that the beneficiary need at office or Medicare Administrative provide healthcare services under MA least one of the following services as Contractors or CMS. When the CMS– and/or MA–PD plans must complete an certified by a physician in accordance 1490S is used, the beneficiary must application annually, file a bid, and with § 424.22: Intermittent skilled attach to it his/her bills from physicians receive final approval from CMS. The nursing services and the need for skilled or suppliers. The form is, therefore, application process has two options for services which meet the criteria in designed specifically to aid beneficiaries applicants that include: Request for new § 409.32; Physical therapy which meets who cannot get assistance from their MA product or request for expanding the requirements of § 409.44(c), Speech- physicians or suppliers for completing the service area of an existing product. language pathology which meets the claim forms. The form is currently This collection process is the only requirements of § 409.44(c); or have a approved under 0938–1197; however, mechanism for MA and/or MA–PD continuing need for occupational we are submitting for approval as a organizations to complete the required therapy that meets the requirements of standalone information collection application process. CMS utilizes the § 409.44(c), subject to the limitations request. Once a new OMB control application process as the means to described in § 409.42(c)(4). On March number is issued, we will remove the review, assess and determine if 23, 2010, the Affordable Care Act of burden for the CMS–1490S that is applicants are compliant with the 2010 (Pub. L., 111–148) was enacted. currently approved under OMB control current requirements for participation in Section 6407(a) (amended by section number 0938–1197. Form Number: the Medicare Advantage program and to 10605) of the Affordable Care Act CMS–1490 (OMB control number: make a decision related to contract amends the requirements for physician 0938–NEW); Frequency: Occasionally award. Form Number: CMS–10237 certification of home health services Affected Public: Individuals and (OMB control number: 0938–0935); contained in Sections 1814(a)(2)(C) and Households; Number of Respondents: Frequency: Yearly; Affected Public: 1835(a)(2)(A) by requiring that, prior to 167,839; Total Annual Responses: Private sector (Business or other For- certifying a patient as eligible for 167,839; Total Annual Hours: 83,920. profits and Not-for-profit institutions); Medicare’s home health benefit, the (For policy questions regarding this Number of Respondents: 310; Total physician must document that the collection contact Sumita Sen at 410– Annual Responses: 310; Total Annual physician himself or herself or a 786–5755.) Hours: 10,941. (For policy questions permitted non-physician practitioner 8. Type of Information Collection regarding this collection contact has had a face-to-face encounter Request: Revision of a currently Marcella Watts at 410–786–5724.) (including through the use of tele-health approved collection; Title of Dated: October 26, 2016. Information Collection: Solicitation for services, subject to the requirements in William N. Parham, III, section 1834(m) of the Act)’’, with the Applications for Medicare Prescription Drug Plan 2018 Contracts; Use: Coverage Director, Paperwork Reduction Staff, Office patient. The Affordable Care Act of Strategic Operations and Regulatory provision does not amend the statutory for the prescription drug benefit is Affairs. provided through contracted requirement that a physician must [FR Doc. 2016–26242 Filed 10–28–16; 8:45 am] prescription drug (PD) plans or through certify a patient’s eligibility for BILLING CODE 4120–01–P Medicare’s home health benefit, (see Medicare Advantage (MA) plans that Sections 1814(a)(2)(C) and 1835(a)(2)(A) offer integrated prescription drug and of the Act. Form Number: CMS–10311 health care coverage (MA–PD plans). DEPARTMENT OF HEALTH AND Cost Plans that are regulated under (OMB control number: 0938–1083); HUMAN SERVICES Section 1876 of the Social Security Act, Frequency: Yearly; Affected Public: and Employer Group Waiver Plans may Business or other For-profits; Number of Food and Drug Administration also provide a Part D benefit. Respondents: 345,600; Total Annual Organizations wishing to provide [Docket No. FDA–2016–N–3083] Responses: 345,600; Total Annual services under the Prescription Drug Hours: 28,800. (For policy questions Report on the Performance of Drug Benefit Program must complete an regarding this collection contact Hillary and Biologics Firms in Conducting application, negotiate rates, and receive Loeffler at 410–786–0456.) Postmarketing Requirements and final approval from CMS. Existing Part Commitments; Availability 7. Type of Information Collection D Sponsors may also expand their Request: New collection (Request for a contracted service area by completing AGENCY: Food and Drug Administration, new OMB control number); Title of the Service Area Expansion application. HHS. Information Collection: Patient’s Form Number: CMS–10137 (OMB ACTION: Notice of availability. Request for Medicare Payment; Use: The control number: 0938–0936); Frequency: Form CMS–1490S form provides Yearly; Affected Public: Private sector SUMMARY: Under the Federal Food, beneficiaries with a relatively easy form (Business or other For-profits and Not- Drug, and Cosmetic Act (the FD&C Act), to use when filing their claims. Without for-profit institutions); Number of the Food and Drug Administration (FDA the collection of this information, Respondents: 463; Total Annual or Agency) is required to report claims for reimbursement relating to the Responses: 160; Total Annual Hours: annually in the Federal Register on the provision of Part B medical services/ 1,565. (For policy questions regarding status of postmarketing requirements supplies could not be acted upon. This this collection contact Arianne (PMRs) and postmarketing would result in a nationwide paralysis Spaccarelli at 410–786–5715.) commitments (PMCs) required of, or of the operation of the Federal 9. Type of Information Collection agreed upon by, holders of approved Government’s Part B Medicare program, Request: Revision of a currently drug and biological products. This and major problems for the patients/ approved collection; Title of notice is the Agency’s report on the beneficiaries inflicting severe physical Information Collection: Applications for status of the studies and clinical trials and financial hardship on beneficiaries. Part C Medicare Advantage, 1876 Cost that applicants have agreed to, or are This form was explicitly developed for Plans, and Employer Group Waiver required to, conduct. A supplemental easy use by beneficiaries who file their Plans to Provide Part C Benefits; Use: report entitled ‘‘Supplementary Report: own claims. The CMS–1490S form can This information collection includes the Performance of Drug and Biologics be obtained from any Social Security process for organizations wishing to Firms in Conducting Postmarketing VerDate Sep<11>2014 17:53 Oct 28, 2016 Jkt 241001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\31OCN1.SGM 31OCN1 sradovich on DSK3GMQ082PROD with NOTICES 75412 Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Notices Requirements (PMRs) and approved in accordance with the provide useful information. The annual Postmarketing Commitments (PMCs) accelerated approval provisions in status report (ASR) must include a (FY 2013 and FY 2014),’’ containing section 506(c)(2)(A) of the FD&C Act (21 description of the PMR/PMC, a schedule additional information and analyses on CFR 314.510 and 601.41). for completing the PMR/PMC, and a the status of PMRs and PMCs as of • For a drug that was approved on the characterization of the current status of September 30, 2013, and September 30, basis of animal efficacy data because the PMR/PMC. The report must also 2014, is available on FDA’s Web site at human efficacy trials are not ethical or provide an explanation of the PMR/PMC http://www.fda.gov/Drugs/Guidance feasible (21 CFR 314.610(b)(1) and status by describing briefly the progress ComplianceRegulatoryInformation/Post- 601.91(b)(1)). PMRs for drug products of the PMR/PMC. A PMR/PMC schedule marketingPhaseIVCommitments/ approved under the animal efficacy is expected to include the actual or ucm064436.htm. rule 2 can be conducted only when the projected dates for the following: (1) drug product is used for its indication Submission of the final protocol to FDA; FOR FURTHER INFORMATION CONTACT: and when an exigency (or event or need) Cathryn C. Lee, Center for Drug (2) completion of the study or clinical arises. In the absence of a public health trial; and (3) submission of the final Evaluation and Research, Food and emergency, these studies or clinical report to FDA. Drug Administration, 10903 New trials will remain pending indefinitely. Hampshire Ave., Bldg. 22, Rm. 6484, C. PMR/PMC Status Categories Silver Spring, MD 20993–0002, 301– B. Reporting Requirements The status of the PMR/PMC must be 796–0700; or Stephen Ripley, Center for Under the regulations (21 CFR described in the ASR according to the Biologics Evaluation and Research, 314.81(b)(2)(vii) and 601.70), applicants terms and definitions provided in 21 Food and Drug Administration, 10903 of approved drugs are required to CFR 314.81 and 601.70. For its own New Hampshire Ave., Bldg. 71, Rm. submit annually a report on the status reporting purposes, FDA has also 3128, Silver Spring, MD 20993–0002, of each clinical safety, clinical efficacy, established terms to describe when the 240–402–7911. clinical pharmacology, and nonclinical conditions of the PMR/PMC have been SUPPLEMENTARY INFORMATION: toxicology study or clinical trial either met, and when it has been determined I. Background required by FDA or that they have that a PMR/PMC is no longer committed to conduct, either at the time necessary.4 The PMR/PMC status A.
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