Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers, 15390-15391 [2018-07256]

Download as PDF 15390 Federal Register / Vol. 83, No. 69 / Tuesday, April 10, 2018 / Notices and associated materials (see ADDRESSES). CMS–10531 Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision (NCD) CMS–R–43 Conditions of Coverage for Portable X-ray Suppliers and Supporting Regulations 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. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. daltland on DSKBBV9HB2PROD with NOTICES Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision (NCD); Use: The data collection is required by the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) entitled, ‘‘Transcatheter Mitral Valve Repair (TMVR)’’. The TMVR device is only covered when specific conditions are met including that the heart team and hospital are submitting data in a prospective, national, audited registry. The data includes patient, practitioner and facility level variables that predict outcomes such as all-cause mortality and quality of life. In order to remove the data collection requirement under this coverage with evidence development (CED) NCD or make any other changes to the existing policy, we must formally reopen and reconsider the policy. We are continuing to review and analyze the data collected since this NCD was effective in 2014. We find that the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, one registry overseen by the National Cardiovascular Data Registry, meets the requirements specified in the NCD on TMVR. The TVT Registry will support a national surveillance system to monitor the VerDate Sep<11>2014 16:56 Apr 09, 2018 Jkt 244001 safety and efficacy of the TMVR technologies for the treatment of mitral regurgitation (MR). The data collected and analyzed in the TVT Registry will be used by CMS to determine if the TMVR is reasonable and necessary (e.g., improves health outcomes) for Medicare beneficiaries under section 1862(a)(1)(A) of the Act. The data will also include the variables on the eight item Kansas City Cardiomyopathy Questionnaire (KCCQ– 10) to assess heath status, functioning and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptoms (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0–100, in which higher scores reflect better health status. The conduct of the STS/ACC TVT Registry and the KCCQ–10 is pursuant to Section 1142 of the Social Security Act (the ACT) that describes the authority of the Agency for Healthcare Research and Quality (AHRQ). Under section 1142, research may be conducted and supported on the outcomes, effectiveness, and appropriateness of health care services and procedures to identify the manner in which disease, disorders, and other health conditions can be prevented, diagnosed, treated, and managed clinically. Section 1862(a)(1)(E) of the Act allows Medicare to cover under coverage with evidence development (CED) certain items or services for which the evidence is not adequate to support coverage under section 1862(a)(1)(A) and where additional data gathered in the context of a clinical setting would further clarify the impact of these items and services on the health of beneficiaries. Form Number: CMS– 10531 (OMB control number: 0938– 1274); Frequency: Annually; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 3,897; Total Annual Responses: 15,588; Total Annual Hours: 5,456. (For policy questions regarding this collection contact Sarah Fulton at 410–786–2749.) 2. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Conditions of Coverage for Portable X-ray Suppliers and Supporting Regulations; Use: The requirements contained in this information collection request are classified as conditions of participation or conditions for coverage. Portable Xrays are basic radiology studies (predominately chest and extremity X- PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 rays) performed on patients in skilled nursing facilities, residents of long-term care facilities and homebound patients. The CoPs are based on criteria described in the law, and are designed to ensure that each portable X-ray supplier has properly trained staff and provides the appropriate type and level of care for patients. We use these conditions to certify suppliers of portable X-ray services wishing to participate in the Medicare program. This is standard medical practice and is necessary in order to help to ensure the well-being, safety and quality professional medical treatment accountability for each patient. There is a significant increase in the burden due to burden that was not accounted for in the previous information collection request. Form Number: CMS–R–43 (OMB Control number: 0938–0338); Frequency: Yearly; Affected Public: Business or other forprofit and Not-for-profit institutions; Number of Respondents: 5,986,509; Total Annual Responses: 5,987,018; Total Annual Hours: 532,959. (For policy questions regarding this collections contact Sonia Swancy at 410–786–8445.) Dated: April 4, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018–07247 Filed 4–9–18; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–1262] Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of several approvals of products redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of vouchers as well as the approval of products redeeming a voucher. SUMMARY: E:\FR\FM\10APN1.SGM 10APN1 Federal Register / Vol. 83, No. 69 / Tuesday, April 10, 2018 / Notices FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–4061, Fax: 301–796–9856, email: althea.cuff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will report the issuance of rare pediatric disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that the following approved drugs meet the redemption criteria: • PRALUENT (alirocumab) approved July 24, 2015, • SOLIQUA (insulin glargine and lixisenatide) approved November 21, 2016, and • JULUCA (dolutegravir and rilpivirine) approved November 21, 2017. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseases Conditions/RarePediatricDiseasePriority VoucherProgram/default.htm. For further information about PRALUENT (alirocumab), SOLIQUA (insulin glargine and lixisenatide), and JULUCA (dolutegravir and rilpivirine), go to the ‘‘Drugs@FDA’’ website at https:// www.accessdata.fda.gov/scripts/cder/ daf/. Dated: April 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–07256 Filed 4–9–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health daltland on DSKBBV9HB2PROD with NOTICES National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning VerDate Sep<11>2014 16:56 Apr 09, 2018 Jkt 244001 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; CRIC Ancillary Study (R01) Date: May 17, 2018. Time: 3:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jason D. Hoffert, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7343, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 496–9010, hoffertj@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Pragmatic Research and Natural Experiments. Date: May 18, 2018. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 Telephone Conference Call). Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 594–8898, barnardm@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR–18–012: NIDDK Program Projects (P01). Date: May 24, 2018. Time: 12:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Dianne Camp, Ph.D., Scientific Review Officer, Review branch, DEA, NIDDK, National Institutes of Health, Room 7013, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 594–7682, campd@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; P01 Application Bladder Physiology. Date: May 31, 2018. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Ryan G. Morris, Ph.D., Scientific Review Officer, review branch, DEA, NIDDK, National Institutes of Health, Room 7015, 6707 Democracy Boulevard, PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 15391 Bethesda, MD 20892–2542, (301) 594–4721, ryan.morris@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: April 4, 2018. David D. Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–07268 Filed 4–9–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Time-Sensitive Obesity Research. Date: May 1, 2018. Time: 1:00 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 594–8898 barnardm@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR–17–270: NIDDK Central Repositories Non-renewable Samples Access (X01). Date: May 2, 2018. Time: 12:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy E:\FR\FM\10APN1.SGM 10APN1

Agencies

[Federal Register Volume 83, Number 69 (Tuesday, April 10, 2018)]
[Notices]
[Pages 15390-15391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07256]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]


Notice of Approval of Products Under Voucher: Rare Pediatric 
Disease Priority Review Vouchers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of several approvals of products redeeming a priority review 
voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as 
amended by the Food and Drug Administration Safety and Innovation Act 
(FDASIA), authorizes FDA to award priority review vouchers to sponsors 
of approved rare pediatric disease product applications that meet 
certain criteria. FDA is required to publish notice of the issuance of 
vouchers as well as the approval of products redeeming a voucher.

[[Page 15391]]


FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-
796-9856, email: [email protected].

SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C. 
360ff), which was added by FDASIA, FDA will report the issuance of rare 
pediatric disease priority review vouchers and the approval of products 
for which a voucher was redeemed.
    FDA has determined that the following approved drugs meet the 
redemption criteria:
     PRALUENT (alirocumab) approved July 24, 2015,
     SOLIQUA (insulin glargine and lixisenatide) approved 
November 21, 2016, and
     JULUCA (dolutegravir and rilpivirine) approved November 
21, 2017.
    For further information about the Rare Pediatric Disease Priority 
Review Voucher Program and for a link to the full text of section 529 
of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further 
information about PRALUENT (alirocumab), SOLIQUA (insulin glargine and 
lixisenatide), and JULUCA (dolutegravir and rilpivirine), go to the 
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: April 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07256 Filed 4-9-18; 8:45 am]
BILLING CODE 4164-01-P

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