Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 52354-52355 [2020-18648]

Download as PDF 52354 Federal Register / Vol. 85, No. 165 / Tuesday, August 25, 2020 / Notices additive prior to its use in food, drugs, cosmetics, or medical devices. Respondents may transmit FAP or CAP regulatory submissions in electronic format or paper format to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition (CFSAN) using Form FDA 3503. Form FDA 3503 helps the respondent organize their submission to focus on the information needed for FDA’s safety review. Form FDA 3503 can also be used to organize information within a master file submitted in support of petitions according to the items listed on the form. Master files can be used as repositories for information that can be referenced in multiple submissions to the Agency, thus minimizing paperwork burden for food and color additive approvals. FDA estimates that the amount of time for respondents to complete Form FDA 3503 will continue to be 1 hour. We are revising the information collection to reflect ongoing modernization efforts. We have augmented our FDA Unified Registration and Listing System (FURLS) with the CFSAN Online Submission Module (COSM). COSM provides a real-time user interface process we believe will assist respondents in preparing and making submissions to Offices in CFSAN. COSM is a web-based tool that supports electronic submissions, thereby eliminating the need for printing and mailing of paper submissions. COSM is available 24 hours a day and seven days a week. Information submitted to COSM is the same information respondents would submit to FURLS. Information about COSM, including user instruction, is available on the internet at: https:// www.fda.gov/food/registration-foodfacilities-and-other-submissions/cfsanonline-submission-module-cosm. Description of Respondents: Respondents are businesses engaged in the manufacture or sale of food, food ingredients, color additives, or substances used in materials that come into contact with food. In the Federal Register of March 17, 2020 (85 FR 15188), we published a 60day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR section; form Average burden per response Total annual responses Total hours Total operating and maintenance costs CAP 70.25, 71.1 ............................................... 2 1 2 1,337 2,674 $5,600 FAPs 171.1 ........................................................ Form FDA 3503 ....................................... 3 6 1 1 3 6 7,093 1 21,279 6 0 0 Total .................................................. ........................ ........................ ........................ ........................ 23,959 5,600 khammond on DSKJM1Z7X2PROD with NOTICES 1 There are no capital costs associated with this collection of information. Our estimate of burden attributable to FAPs or CAPs is based on our experience with the information collection, which has not changed since our last review, and we therefore retain the currently approved burden. This estimate reflects the average number of petitions we have received annually over a period of 10 years. The attendant burden we estimate also reflects an industry average, although burden associated with individual petitions may vary depending on the complexity of the petition, and the amount and type of data needed for scientific analysis. CAPs are subject to fees. The listing fee for a CAP ranges from $1,600 to $3,000, depending on the intended use of the color additive and the scope of the requested amendment. A complete schedule of fees is set forth in § 70.19. An average of one Category A and one Category B color additive petition is expected per year. The maximum CAP fee for a Category A petition is $2,600 and the maximum color additive petition fee for a Category B petition is $3,000. Because an average of 2 CAPs VerDate Sep<11>2014 19:55 Aug 24, 2020 Jkt 250001 are expected per calendar year, the estimated total annual cost burden to petitioners for this startup cost would be less than or equal to $5,600 ((1 × $2,600) + (1 × $3,000) listing fees = $5,600). There are no capital costs associated with CAPs. The labeling requirements for food and color additives were designed to specify the minimum information needed for labeling in order that food and color manufacturers may comply with all applicable provisions of the FD&C Act and other specific labeling acts administered by FDA. Label information does not require any additional information gathering beyond what is already required to assure conformance with all specifications and limitations in any given food or color additive regulation. Label information does not have any specific recordkeeping requirements unique to preparing the label. Therefore, because labeling requirements under § 70.25 for a particular color additive involve information required as part of the CAP safety review process, the estimate for number of respondents is the same for PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 §§ 70.25 and 71.1, and the burden hours for labeling are included in the estimate for § 71.1. Also, because labeling requirements under parts 172, 173, 179, and 180 for particular food additives involve information required as part of the FAP safety review process under § 171.1, the burden hours for labeling are included in the estimate for § 171.1. Dated: August 17, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–18602 Filed 8–24–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0026] Issuance of Priority Review Voucher; Rare Pediatric Disease Product Food and Drug Administration, Health and Human Service (HHS). ACTION: Notice. AGENCY: E:\FR\FM\25AUN1.SGM 25AUN1 Federal Register / Vol. 85, No. 165 / Tuesday, August 25, 2020 / Notices The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. 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 award of the priority review voucher. FDA has determined that EVRYSDI (risdiplam), manufactured by Genentech Inc., meets the criteria for a priority review voucher. SUMMARY: 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. FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that EVRYSDI (risdiplam), manufactured by Genentech Inc., meets the criteria for a priority review voucher. EVRYSDI (risdiplam) is indicated for the treatment of spinal muscular atrophy in pediatric and adult patients. 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 EVRYSDI (risdiplam), go to the ‘‘Drugs@FDA’’ website at https:// www.accessdata.fda.gov/scripts/cder/ daf/. khammond on DSKJM1Z7X2PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: August 20, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–18648 Filed 8–24–20; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:55 Aug 24, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Infant Mortality Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary’s Advisory Committee on Infant Mortality (ACIM or Committee) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https://www.hrsa.gov/advisorycommittees/infant-mortality/. DATES: September 23, 2020, 11 a.m.–6 p.m. Eastern Time (ET) and September 24, 2020, 11 a.m.–3:30 p.m. ET. ADDRESSES: This meeting will be held via webinar. • The webinar link will be available at ACIM’s website before the meeting: https://www.hrsa.gov/advisorycommittees/infant-mortality/. • The conference call-in number will be available at ACIM’s website before the meeting: https://www.hrsa.gov/ advisory-committees/infant-mortality/ index.html. SUMMARY: FOR FURTHER INFORMATION CONTACT: David S. de la Cruz, Ph.D., MPH, Designated Federal Official, Maternal and Child Health Bureau (MCHB), HRSA, 5600 Fishers Lane, Room 18N25, Rockville, Maryland 20857; 301–443– 0543; or SACIM@hrsa.gov. SUPPLEMENTARY INFORMATION: The ACIM is authorized by section 222 of the Public Health Service Act (42 U.S.C. 217a), as amended. The Committee is governed by provisions of Public Law 92–463, as amended, (5 U.S.C. App. 2), which sets forth standards for the formation and use of Advisory Committees. The ACIM advises the Secretary of HHS on department activities and programs directed at reducing infant mortality and improving the health status of pregnant women and infants. The ACIM represents a public-private partnership at the highest level to provide guidance and focus attention on the policies and resources required to address the reduction of infant mortality and the improvement of the health status of pregnant women and infants. With a focus on life course, the ACIM addresses disparities in maternal health PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 52355 to improve maternal health outcomes, including preventing and reducing maternal mortality and severe maternal morbidity. The ACIM provides advice on how best to coordinate a myriad of federal, state, local, and private programs and efforts that are designed to deal with the health and social problems impacting infant mortality and maternal health, including implementation of the Healthy Start program and maternal and infant health objectives from the National Health Promotion and Disease Prevention Objectives. The agenda for the September 23–24, 2020, meeting is being finalized and may include the following: Updates from HRSA, MCHB, and other federal agencies, continued discussion of the impact of COVID–19 on infant and maternal health, and updates on priority topic areas for ACIM to address (equity, data, access, and quality of care). Agenda items are subject to change as priorities dictate. Refer to the ACIM website above for any updated information concerning the meeting. Members of the public will have the opportunity to provide written or oral comments. Requests to submit a written statement or make oral comments to the ACIM should be sent to David S. de la Cruz, using the email address above at least 3 business days prior to the meeting. Public participants may submit written statements in advance of the scheduled meeting by emailing SACIM@ hrsa.gov. Oral comments will be honored in the order they are requested and may be limited as time allows. Individuals who plan to attend and need special assistance or another reasonable accommodation should notify David S. de la Cruz at the contact information listed above at least 10 business days prior to the meeting. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2020–18565 Filed 8–24–20; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. The meeting will be held as a virtual meeting and is open to the public. E:\FR\FM\25AUN1.SGM 25AUN1

Agencies

[Federal Register Volume 85, Number 165 (Tuesday, August 25, 2020)]
[Notices]
[Pages 52354-52355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18648]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product

AGENCY: Food and Drug Administration, Health and Human Service (HHS).

ACTION: Notice.

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[[Page 52355]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of a priority review voucher to the sponsor of a rare 
pediatric disease product application. 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 award of the priority review voucher. FDA has determined 
that EVRYSDI (risdiplam), manufactured by Genentech Inc., meets the 
criteria for a priority review voucher.

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: FDA is announcing the issuance of a priority 
review voucher to the sponsor of an approved rare pediatric disease 
product application. Under section 529 of the FD&C Act (21 U.S.C. 
360ff), which was added by FDASIA, FDA will award priority review 
vouchers to sponsors of approved rare pediatric disease product 
applications that meet certain criteria. FDA has determined that 
EVRYSDI (risdiplam), manufactured by Genentech Inc., meets the criteria 
for a priority review voucher. EVRYSDI (risdiplam) is indicated for the 
treatment of spinal muscular atrophy in pediatric and adult patients.
    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 EVRYSDI (risdiplam), go to the ``[email protected]'' website 
at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: August 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18648 Filed 8-24-20; 8:45 am]
BILLING CODE 4164-01-P

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