83_FR_15459 83 FR 15390 - Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers

83 FR 15390 - Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 69 (April 10, 2018)

Page Range15390-15391
FR Document2018-07256

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.

Federal Register, Volume 83 Issue 69 (Tuesday, April 10, 2018) 
[Federal Register Volume 83, Number 69 (Tuesday, April 10, 2018)]
[Notices]
[Pages 15390-15391]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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 
``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

15390 Federal Register / Vol. 83, No. 69 / Tuesday, April 10, 2018 / Notices and associated materials (see safety and efficacy of the TMVR rays) performed on patients in skilled ADDRESSES). technologies for the treatment of mitral nursing facilities, residents of long-term CMS–10531 Transcatheter Mitral regurgitation (MR). care facilities and homebound patients. Valve Repair (TMVR) National The data collected and analyzed in The CoPs are based on criteria described Coverage Decision (NCD) the TVT Registry will be used by CMS in the law, and are designed to ensure CMS–R–43 Conditions of Coverage for to determine if the TMVR is reasonable that each portable X-ray supplier has Portable X-ray Suppliers and and necessary (e.g., improves health properly trained staff and provides the Supporting Regulations outcomes) for Medicare beneficiaries appropriate type and level of care for under section 1862(a)(1)(A) of the Act. patients. We use these conditions to Under the PRA (44 U.S.C. 3501– The data will also include the variables certify suppliers of portable X-ray 3520), federal agencies must obtain on the eight item Kansas City services wishing to participate in the approval from the Office of Management Cardiomyopathy Questionnaire (KCCQ– Medicare program. This is standard and Budget (OMB) for each collection of 10) to assess heath status, functioning medical practice and is necessary in information they conduct or sponsor. and quality of life. In the KCCQ, an order to help to ensure the well-being, The term ‘‘collection of information’’ is overall summary score can be derived safety and quality professional medical defined in 44 U.S.C. 3502(3) and 5 CFR from the physical function, symptoms treatment accountability for each 1320.3(c) and includes agency requests (frequency and severity), social function patient. There is a significant increase in or requirements that members of the and quality of life domains. For each the burden due to burden that was not public submit reports, keep records, or domain, the validity, reproducibility, accounted for in the previous provide information to a third party. responsiveness and interpretability have information collection request. Form Section 3506(c)(2)(A) of the PRA been independently established. Scores Number: CMS–R–43 (OMB Control requires federal agencies to publish a are transformed to a range of 0–100, in number: 0938–0338); Frequency: Yearly; 60-day notice in the Federal Register which higher scores reflect better health Affected Public: Business or other for- concerning each proposed collection of status. profit and Not-for-profit institutions; information, including each proposed The conduct of the STS/ACC TVT Number of Respondents: 5,986,509; extension or reinstatement of an existing Registry and the KCCQ–10 is pursuant Total Annual Responses: 5,987,018; collection of information, before to Section 1142 of the Social Security Total Annual Hours: 532,959. (For submitting the collection to OMB for Act (the ACT) that describes the policy questions regarding this approval. To comply with this authority of the Agency for Healthcare collections contact Sonia Swancy at requirement, CMS is publishing this Research and Quality (AHRQ). Under 410–786–8445.) notice. section 1142, research may be Dated: April 4, 2018. Information Collection conducted and supported on the William N. Parham, III, outcomes, effectiveness, and 1. Type of Information Collection appropriateness of health care services Director, Paperwork Reduction Staff, Office Request: Revision of a currently of Strategic Operations and Regulatory and procedures to identify the manner Affairs. approved collection; Title of in which disease, disorders, and other Information Collection: Transcatheter [FR Doc. 2018–07247 Filed 4–9–18; 8:45 am] health conditions can be prevented, Mitral Valve Repair (TMVR) National diagnosed, treated, and managed BILLING CODE 4120–01–P Coverage Decision (NCD); Use: The data clinically. Section 1862(a)(1)(E) of the collection is required by the Centers for Act allows Medicare to cover under Medicare and Medicaid Services (CMS) DEPARTMENT OF HEALTH AND coverage with evidence development National Coverage Determination (NCD) HUMAN SERVICES (CED) certain items or services for entitled, ‘‘Transcatheter Mitral Valve which the evidence is not adequate to Food and Drug Administration Repair (TMVR)’’. The TMVR device is support coverage under section only covered when specific conditions 1862(a)(1)(A) and where additional data [Docket No. FDA–2018–N–1262] are met including that the heart team gathered in the context of a clinical and hospital are submitting data in a Notice of Approval of Products Under setting would further clarify the impact prospective, national, audited registry. Voucher: Rare Pediatric Disease of these items and services on the health The data includes patient, practitioner of beneficiaries. Form Number: CMS– Priority Review Vouchers and facility level variables that predict 10531 (OMB control number: 0938– AGENCY: Food and Drug Administration, outcomes such as all-cause mortality 1274); Frequency: Annually; Affected HHS. and quality of life. In order to remove Public: Private sector (Business or other ACTION: Notice. the data collection requirement under for-profits); Number of Respondents: this coverage with evidence 3,897; Total Annual Responses: 15,588; SUMMARY: The Food and Drug development (CED) NCD or make any Total Annual Hours: 5,456. (For policy Administration (FDA) is announcing the other changes to the existing policy, we questions regarding this collection issuance of several approvals of must formally reopen and reconsider contact Sarah Fulton at 410–786–2749.) products redeeming a priority review the policy. We are continuing to review 2. Type of Information Collection voucher. The Federal Food, Drug, and and analyze the data collected since this Request: Reinstatement with change of a Cosmetic Act (FD&C Act), as amended NCD was effective in 2014. previously approved collection; Title of by the Food and Drug Administration We find that the Society of Thoracic Information Collection: Conditions of Safety and Innovation Act (FDASIA), Surgery/American College of Cardiology Coverage for Portable X-ray Suppliers authorizes FDA to award priority review daltland on DSKBBV9HB2PROD with NOTICES Transcatheter Valve Therapy (STS/ACC and Supporting Regulations; Use: The vouchers to sponsors of approved rare TVT) Registry, one registry overseen by requirements contained in this pediatric disease product applications the National Cardiovascular Data information collection request are that meet certain criteria. FDA is Registry, meets the requirements classified as conditions of participation required to publish notice of the specified in the NCD on TMVR. The or conditions for coverage. Portable X- issuance of vouchers as well as the TVT Registry will support a national rays are basic radiology studies approval of products redeeming a surveillance system to monitor the (predominately chest and extremity X- voucher. VerDate Sep<11>2014 16:56 Apr 09, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\10APN1.SGM 10APN1

Federal Register / Vol. 83, No. 69 / Tuesday, April 10, 2018 / Notices 15391 FOR FURTHER INFORMATION CONTACT: individuals associated with the grant Bethesda, MD 20892–2542, (301) 594–4721, Althea Cuff, Center for Drug Evaluation applications, the disclosure of which ryan.morris@nih.gov. and Research, Food and Drug would constitute a clearly unwarranted (Catalogue of Federal Domestic Assistance Administration, 10903 New Hampshire invasion of personal privacy. Program Nos. 93.847, Diabetes, Ave., Silver Spring, MD 20993–0002, Endocrinology and Metabolic Research; Name of Committee: National Institute of 93.848, Digestive Diseases and Nutrition 301–796–4061, Fax: 301–796–9856, Diabetes and Digestive and Kidney Diseases Research; 93.849, Kidney Diseases, Urology email: althea.cuff@fda.hhs.gov. Special Emphasis Panel; CRIC Ancillary and Hematology Research, National Institutes SUPPLEMENTARY INFORMATION: Under Study (R01) of Health, HHS) section 529 of the FD&C Act (21 U.S.C. Date: May 17, 2018. Time: 3:00 p.m. to 4:00 p.m. Dated: April 4, 2018. 360ff), which was added by FDASIA, Agenda: To review and evaluate grant David D. Clary, FDA will report the issuance of rare applications. Program Analyst, Office of Federal Advisory pediatric disease priority review Place: National Institutes of Health, Two Committee Policy. vouchers and the approval of products Democracy Plaza, 6707 Democracy [FR Doc. 2018–07268 Filed 4–9–18; 8:45 am] for which a voucher was redeemed. Boulevard, Bethesda, MD 20892 (Telephone FDA has determined that the Conference Call). BILLING CODE 4140–01–P following approved drugs meet the Contact Person: Jason D. Hoffert, Ph.D., redemption criteria: Scientific Review Officer, Review Branch, • PRALUENT (alirocumab) approved DEA, NIDDK, National Institutes of Health, DEPARTMENT OF HEALTH AND July 24, 2015, Room 7343, 6707 Democracy Boulevard, HUMAN SERVICES • SOLIQUA (insulin glargine and Bethesda, MD 20892–2542, (301) 496–9010, lixisenatide) approved November 21, hoffertj@niddk.nih.gov. National Institutes of Health 2016, and Name of Committee: National Institute of National Institute of Diabetes and • JULUCA (dolutegravir and Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Pragmatic Research Digestive and Kidney Diseases; Notice rilpivirine) approved November 21, and Natural Experiments. of Closed Meetings 2017. For further information about the Rare Date: May 18, 2018. Pursuant to section 10(d) of the Pediatric Disease Priority Review Time: 10:00 a.m. to 4:00 p.m. Federal Advisory Committee Act, as Agenda: To review and evaluate grant Voucher Program and for a link to the amended, notice is hereby given of the applications. full text of section 529 of the FD&C Act, Place: National Institutes of Health, Two following meetings. go to https://www.fda.gov/ForIndustry/ Democracy Plaza, 6707 Democracy The meetings will be closed to the DevelopingProductsforRareDiseases Boulevard, Bethesda, MD 20892 Telephone public in accordance with the Conditions/RarePediatricDiseasePriority Conference Call). provisions set forth in sections VoucherProgram/default.htm. For Contact Person: Michele L. Barnard, Ph.D., 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., further information about PRALUENT Scientific Review Officer, Review Branch, as amended. The grant applications and (alirocumab), SOLIQUA (insulin DEA, NIDDK, National Institutes of Health, the discussions could disclose glargine and lixisenatide), and JULUCA Room 7353, 6707 Democracy Boulevard, confidential trade secrets or commercial Bethesda, MD 20892–2542, (301) 594–8898, (dolutegravir and rilpivirine), go to the property such as patentable material, barnardm@extra.niddk.nih.gov. ‘‘Drugs@FDA’’ website at https:// and personal information concerning Name of Committee: National Institute of www.accessdata.fda.gov/scripts/cder/ individuals associated with the grant Diabetes and Digestive and Kidney Diseases daf/. Special Emphasis Panel; PAR–18–012: applications, the disclosure of which Dated: April 4, 2018. NIDDK Program Projects (P01). would constitute a clearly unwarranted Leslie Kux, Date: May 24, 2018. invasion of personal privacy. Associate Commissioner for Policy. Time: 12:00 p.m. to 3:00 p.m. Name of Committee: Agenda: To review and evaluate grant National Institute of Diabetes and Digestive [FR Doc. 2018–07256 Filed 4–9–18; 8:45 am] applications. and Kidney Diseases Special Emphasis Panel; BILLING CODE 4164–01–P Place: National Institutes of Health, Two Time-Sensitive Obesity Research. Democracy Plaza, 6707 Democracy Date: May 1, 2018. Boulevard, Bethesda, MD 20892 (Telephone Time: 1:00 p.m. to 2:30 p.m. DEPARTMENT OF HEALTH AND Conference Call). Agenda: To review and evaluate grant HUMAN SERVICES Contact Person: Dianne Camp, Ph.D., applications. Scientific Review Officer, Review branch, Place: National Institutes of Health, Two National Institutes of Health DEA, NIDDK, National Institutes of Health, Democracy Plaza, 6707 Democracy Room 7013, 6707 Democracy Boulevard, Boulevard, Bethesda, MD 20892 (Telephone National Institute of Diabetes and Bethesda, MD 20892–2542, (301) 594–7682, Conference Call). Digestive and Kidney Diseases; Notice campd@extra.niddk.nih.gov. Contact Person: Michele L. Barnard, Ph.D., of Closed Meetings Name of Committee: National Institute of Scientific Review Officer, Review Branch, Diabetes and Digestive and Kidney Diseases DEA, NIDDK, National Institutes of Health Pursuant to section 10(d) of the Special Emphasis Panel; P01 Application Room 7353, 6707 Democracy Boulevard, Federal Advisory Committee Act, as Bladder Physiology. Bethesda, MD 20892–2542, (301) 594–8898 amended, notice is hereby given of the Date: May 31, 2018. barnardm@extra.niddk.nih.gov. following meetings. Time: 2:00 p.m. to 5:00 p.m. Name of Committee: National Institute of The meetings will be closed to the Agenda: To review and evaluate grant Diabetes and Digestive and Kidney Diseases public in accordance with the applications. Special Emphasis Panel; PAR–17–270: daltland on DSKBBV9HB2PROD with NOTICES provisions set forth in sections Place: National Institutes of Health, Two NIDDK Central Repositories Non-renewable Democracy Plaza, 6707 Democracy Samples Access (X01). 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Boulevard, Bethesda, MD 20892 (Telephone Date: May 2, 2018. as amended. The grant applications and Conference Call). Time: 12:00 p.m. to 2:00 p.m. the discussions could disclose Contact Person: Ryan G. Morris, Ph.D., Agenda: To review and evaluate grant confidential trade secrets or commercial Scientific Review Officer, review branch, applications. property such as patentable material, DEA, NIDDK, National Institutes of Health, Place: National Institutes of Health, Two and personal information concerning Room 7015, 6707 Democracy Boulevard, Democracy Plaza, 6707 Democracy VerDate Sep<11>2014 16:56 Apr 09, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\10APN1.SGM 10APN1


Document Created: 2018-04-09 23:51:42
Document Modified: 2018-04-09 23:51:42
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactAlthea 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]
FR Citation83 FR 15390 
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