Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 46958-46959 [2019-19260]

Download as PDF 46958 Federal Register / Vol. 84, No. 173 / Friday, September 6, 2019 / Notices the comments. This guidance supersedes ‘‘Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff; Humanitarian Device Exemption (HDE) Regulation: Questions and Answers,’’ issued July 8, 2010 (available at: https:// www.fda.gov/media/74307/download). II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the Humanitarian Device Exemption Program. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm. Persons unable to download an electronic copy of ‘‘Humanitarian Device Exemption Program’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 17040 and complete title of the guidance in the request. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table: 21 CFR part, guidance, or FD&C Act section Topic 807, 812, 814 ............................................ 814 ............................................................ 814, subparts A through E ....................... 814, subpart H .......................................... 812 ............................................................ ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’. 803 ............................................................ Acceptance of Data from Clinical Investigations for Medical Devices ........................ Pediatric Uses of Devices ............................................................................................ Premarket Approval ..................................................................................................... Humanitarian Device Exemption .................................................................................. Investigational Device Exemption ................................................................................ De Novo classification process .................................................................................... 0910–0741 0910–0748 0910–0231 0910–0332 0910–0078 0910–0844 Medical Devices; Medical Device Reporting; Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements. Protection of Human Subjects: Informed Consent; Institutional Review Boards ........ Institutional Review Boards .......................................................................................... Administrative Practices and Procedures .................................................................... Financial Disclosure by Clinical Investigators .............................................................. 0910–0437 820 ............................................................ 520(m) of the FD&C Act ........................... 50, 56 ........................................................ 56 .............................................................. 10 .............................................................. 54 .............................................................. Dated: September 3, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–19290 Filed 9–5–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: jspears on DSK3GMQ082PROD with NOTICES applicable statutes and regulations. This guidance is not subject to Executive Order 12866. In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has SUMMARY: VerDate Sep<11>2014 16:53 Sep 05, 2019 Jkt 247001 scheduled a public meeting. Information about ACHDNC and the agenda for this meeting can be found on the ACHDNC website at: https://www.hrsa.gov/ advisory-committees/heritabledisorders/. DATES: September 24, 2019, 10:00 a.m.– 1:00 p.m. Eastern Time (ET). ADDRESSES: This meeting will be held via webinar. While this meeting is open to the public, advance registration is required. Please visit the ACHDNC website for information on registration: https://www.hrsa.gov/advisorycommittees/heritable-disorders/ index.html. The deadline for online registration is 12:00 p.m. ET on September 23, 2019. Instructions on how to access the meeting via webcast will be provided upon registration. FOR FURTHER INFORMATION CONTACT: Alaina Harris, Maternal and Child Health Bureau (MCHB), HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; 301–443–0721; or ACHDNC@ hrsa.gov. PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 OMB control No. 0910–0073 0910–0661 0910–0755 0910–0130 0910–0191 0910–0396 ACHDNC provides advice and recommendations to the Secretary of HHS (Secretary) on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. ACHDNC’s recommendations regarding inclusion of additional conditions for screening, following adoption by the Secretary, are evidence-informed preventive health services provided for in the comprehensive guidelines supported by HRSA through the Recommended Uniform Screening Panel (RUSP) pursuant to section 2713 of the Public Health Service Act (42 U.S.C. 300gg– 13). Under this provision, nongrandfathered group health plans and health insurance issuers offering group or individual health insurance are required to provide insurance coverage without cost-sharing (a co-payment, coinsurance, or deductible) for preventive SUPPLEMENTARY INFORMATION: E:\FR\FM\06SEN1.SGM 06SEN1 Federal Register / Vol. 84, No. 173 / Friday, September 6, 2019 / Notices services for plan years (i.e., policy years) beginning on or after the date that is one year from the Secretary’s adoption of the condition for screening. During the September meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include a discussion of the role of health information technology within state newborn screening programs and general updates on ACHDNC projects focused on newborn screening. Agenda items are subject to changes as priorities dictate and the final meeting agenda will be available on ACHDNC’s website: https://www.hrsa.gov/advisorycommittees/heritable-disorders/ index.html. Information about the ACHDNC, a roster of members, as well as past meeting summaries are also available on the ACHDNC website. Members of the public will have the opportunity to provide comments. Requests to offer oral comments will be accepted in the order they are requested and may be limited as time allows. Public participants may also submit written statements. To submit written comments or request time for an oral comment at the meeting, please register online by 12:00 p.m. ET on September 19, 2019. Visit the ACHDNC website for information on registration, https:// www.hrsa.gov/advisory-committees/ heritable-disorders/. Oral comments will be honored in the order they are requested and may be limited as time allows. Individuals associated with groups or who plan to provide comments on similar topics may be asked to combine their comments and present them through a single representative. No audiovisual presentations are permitted. Written comments should identify the individual’s name, address, email, telephone number, professional or organization affiliation, background or area of expertise (i.e., parent, family member, researcher, clinician, public health, etc.) and the topic/subject matter. Maria G. Button, Director, Division of the Executive Secretariat. jspears on DSK3GMQ082PROD with NOTICES [FR Doc. 2019–19260 Filed 9–5–19; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 16:53 Sep 05, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request; Information Request Title: 340B Drug Pricing Program Reporting Requirements, OMB Number 0915–0176—Extension Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection, the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR must be received no later than October 7, 2019. ADDRESSES: Submit your comments, including the ICR title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the ICR title for reference. Information Collection Request Title: Drug Pricing Program Reporting Requirements (OMB No. 0915–0176)— [Extension]. Abstract: Section 602 of Public Law 102–585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act ‘‘Limitation on Prices of Drugs Purchased by Covered Entities’’), which instructs HHS to enter into a Pharmaceutical Pricing Agreement (PPA) with manufacturers of covered outpatient drugs. Manufacturers are required by section 1927(a)(5)(A) of the Social Security Act to enter into agreements with the Secretary of HHS that comply with section 340B of the PHS Act if they participate in the Medicaid Drug Rebate Program. When a SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 46959 drug manufacturer signs a PPA, it is opting into the 340B Drug Pricing Program (340B Program) and it agrees to the statutory requirement that prices charged for covered outpatient drugs to covered entities will not exceed defined 340B ceiling prices, which are based on quarterly pricing data reported by manufacturers to the Centers for Medicare & Medicaid Services. When an eligible covered entity voluntarily decides to enroll and participate in the 340B Program, it accepts responsibility for ensuring compliance with all provisions of the 340B Program, including all associated costs. Covered entities that choose to participate in the 340B Program must comply with the requirements of section 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the covered entity. Section 340B(a)(5)(C) of the PHS Act permits the Secretary of HHS and manufacturers of a covered outpatient drug to conduct audits of covered entities in accordance with by procedures established the Secretary related to the number, duration, and scope of the audits. Manufacturers are permitted to conduct an audit only when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) has occurred. The manufacturer notifies the covered entity in writing when it believes the covered entity has violated these provisions of the 340B Program. If the problem cannot be resolved, the manufacturer will then submit an audit work plan describing the audit and evidence in support of the reasonable cause standard to HRSA, Healthcare Systems Bureau, Office of Pharmacy Affairs (OPA) for review. OPA will review the documentation to determine if reasonable cause exists. Once the audit is completed, the manufacturer will submit copies of the audit report to OPA for review and resolution of the findings, as appropriate. The manufacturer will also submit an informational copy of the audit report to the HHS Office of Inspector General (OIG). In response to the statutory mandate of section 340B(a)(5)(C) to permit the Secretary or manufacturers to conduct audits of covered entities and because of the potential for disputes involving covered entities and participating drug manufacturers, OPA developed an informal voluntary dispute resolution process for manufacturers and covered E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Notices]
[Pages 46958-46959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Meeting of the Advisory Committee on Heritable Disorders in 
Newborns and Children

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: In accordance with the Federal Advisory Committee Act, this 
notice announces that the Advisory Committee on Heritable Disorders in 
Newborns and Children (ACHDNC) has scheduled a public meeting. 
Information about ACHDNC and the agenda for this meeting can be found 
on the ACHDNC website at: https://www.hrsa.gov/advisory-committees/heritable-disorders/.

DATES: September 24, 2019, 10:00 a.m.-1:00 p.m. Eastern Time (ET).

ADDRESSES: This meeting will be held via webinar. While this meeting is 
open to the public, advance registration is required. Please visit the 
ACHDNC website for information on registration: https://www.hrsa.gov/advisory-committees/heritable-disorders/. The deadline for 
online registration is 12:00 p.m. ET on September 23, 2019. 
Instructions on how to access the meeting via webcast will be provided 
upon registration.

FOR FURTHER INFORMATION CONTACT: Alaina Harris, Maternal and Child 
Health Bureau (MCHB), HRSA, 5600 Fishers Lane, Rockville, Maryland 
20857; 301-443-0721; or [email protected].

SUPPLEMENTARY INFORMATION: ACHDNC provides advice and recommendations 
to the Secretary of HHS (Secretary) on the development of newborn 
screening activities, technologies, policies, guidelines, and programs 
for effectively reducing morbidity and mortality in newborns and 
children having, or at risk for, heritable disorders. ACHDNC's 
recommendations regarding inclusion of additional conditions for 
screening, following adoption by the Secretary, are evidence-informed 
preventive health services provided for in the comprehensive guidelines 
supported by HRSA through the Recommended Uniform Screening Panel 
(RUSP) pursuant to section 2713 of the Public Health Service Act (42 
U.S.C. 300gg-13). Under this provision, non-grandfathered group health 
plans and health insurance issuers offering group or individual health 
insurance are required to provide insurance coverage without cost-
sharing (a co-payment, co-insurance, or deductible) for preventive

[[Page 46959]]

services for plan years (i.e., policy years) beginning on or after the 
date that is one year from the Secretary's adoption of the condition 
for screening.
    During the September meeting, ACHDNC will hear from experts in the 
fields of public health, medicine, heritable disorders, rare disorders, 
and newborn screening. Agenda items include a discussion of the role of 
health information technology within state newborn screening programs 
and general updates on ACHDNC projects focused on newborn screening. 
Agenda items are subject to changes as priorities dictate and the final 
meeting agenda will be available on ACHDNC's website: https://www.hrsa.gov/advisory-committees/heritable-disorders/. 
Information about the ACHDNC, a roster of members, as well as past 
meeting summaries are also available on the ACHDNC website.
    Members of the public will have the opportunity to provide 
comments. Requests to offer oral comments will be accepted in the order 
they are requested and may be limited as time allows. Public 
participants may also submit written statements. To submit written 
comments or request time for an oral comment at the meeting, please 
register online by 12:00 p.m. ET on September 19, 2019. Visit the 
ACHDNC website for information on registration, https://www.hrsa.gov/advisory-committees/heritable-disorders/. Oral comments will 
be honored in the order they are requested and may be limited as time 
allows. Individuals associated with groups or who plan to provide 
comments on similar topics may be asked to combine their comments and 
present them through a single representative. No audiovisual 
presentations are permitted. Written comments should identify the 
individual's name, address, email, telephone number, professional or 
organization affiliation, background or area of expertise (i.e., 
parent, family member, researcher, clinician, public health, etc.) and 
the topic/subject matter.

Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-19260 Filed 9-5-19; 8:45 am]
BILLING CODE 4165-15-P
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