National Committee on Vital and Health Statistics: Visioning Session, 20153-20154 [2019-09460]

Download as PDF Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices December 29, 2015 (80 FR 81335). Specific questions were posed to solicit input into the content of the draft guidance and comments were collected through Docket No. FDA–2012–N–1021. FDA also considered comments received on the draft guidance that appeared in the Federal Register of September 15, 2017 (82 FR 43390). FDA revised the guidance as appropriate in response to the comments. 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 ‘‘Utilizing Animal Studies to Evaluate Organ Preservation Devices.’’ 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 applicable statutes and regulations. This guidance is not subject to Executive Order 12866. 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 CDRH guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Utilizing Animal Studies to Evaluate 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 and the Federal Food, Drug, and Cosmetic Act (FD&C Act) have been approved by OMB as listed in the following table: Topic 807, subpart E .............................................................................................................. 814, subparts A through E ........................................................................................... 814, subpart H .............................................................................................................. 812 ................................................................................................................................ ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ ... ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. Premarket notification ............................... Premarket approval .................................. Humanitarian Device Exemption .............. Investigational Device Exemption ............. De Novo classification process ................ Q-submissions .......................................... [FR Doc. 2019–09402 Filed 5–7–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration FOR FURTHER INFORMATION CONTACT: Robert Walsh, Designated Federal Officer, at the Healthcare Systems Bureau, Division of Transplantation, HRSA, 5600 Fishers Lane, 8W60, Rockville, Maryland 20857; 301–443– 6839; or RWalsh@hrsa.gov. New meeting date: Tuesday, July 2, 2019, rather than May 7, 2019, as previously announced. Amy P. McNulty, Acting Director, Division of the Executive Secretariat. Meeting of the Advisory Council on Blood Stem Cell Transplantation [FR Doc. 2019–09434 Filed 5–7–19; 8:45 am] BILLING CODE 4165–15–P Health Resources and Services Administration (HRSA), HHS. AGENCY: ACTION: Notice; correction. The Advisory Council on Blood Stem Cell Transplantation (ACBSCT) meeting has been rescheduled due to unforeseen circumstances and will now be held on Tuesday, July 2, 2019, from 10:00 a.m.– 4:00 p.m. Eastern Time. The meeting will be held by webinar and conference call. The webinar link, conference callin number, agenda, and instructions for registration will be posted 15 business days before the meeting on the ACBSCT website at https:// bloodcell.transplant.hrsa.gov/about/ advisory_council/meetings/. SUMMARY: khammond on DSKBBV9HB2PROD with NOTICES Organ Preservation Devices’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500083 to identify the guidance you are requesting. 21 CFR Part; guidance; or FD&C act section Dated: May 2, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. VerDate Sep<11>2014 16:57 May 07, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Visioning Session Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee program. Name: National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Standards. Date and Times: Wednesday, July 10, 2019: 9:00 a.m.–5:00 p.m. (EDT), Thursday, July 11, 2019: 8:30 a.m.–5:00 p.m. (EDT). PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 20153 OMB Control No. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 0910–0756 Place: U.S. Department of Health and Human Services, Hubert H. Humphrey Building, 200 Independence Avenue SW, Rm. 505–A, Washington, DC 20201. Status: Open. There will be a public comment period during the final 15 minutes of the first day of the meeting. Purpose: Health Insurance Portability and Accountability Act (HIPAA) legislation from 1996, as amended,1 established a regulatory framework to support the exchange of electronic information between covered entities, and directed the Secretary of Health and Human Services (HHS) to publish regulations adopting standards, code sets, and unique identifiers. The administrative simplification provisions of HIPAA pertain to retail pharmacy and medical transactions, such as eligibility, claims, payment, enrollment, and authorizations. NCVHS advises the HHS Secretary on health data, statistics, privacy, national health information policy, and is mandated to report to Congress on the implementation status of HIPAA. Since mid-2017, the Subcommittee on Standards has been focused on developing a ‘‘predictability roadmap’’ through collaboration with industry to identify and evaluate barriers to the efficient and timely update and 1 Along with Section 1104 (c) of the Patient Protection and Affordable Care Act (ACA) of 2010. E:\FR\FM\08MYN1.SGM 08MYN1 khammond on DSKBBV9HB2PROD with NOTICES 20154 Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices adoption of standards and operating rules. NCVHS sought to identify and understand the challenges under the current standards development and regulatory processes. Based on feedback the Committee obtained from stakeholders over an eighteen-month period, in February 2019 the Committee delivered five recommendations to the HHS Secretary supporting the industry’s need for trusted cadence to improve the updates, adoption and implementation of transaction standards and operating rules to keep pace with innovative business needs and technology changes. The five recommendations represented actionable steps for adopting, implementing, and enforcing the administrative simplification provisions of HIPAA. One recommendation was specific to certain entities and processes related to the maintenance, modification, and recommendations to the Secretary for updated and new standards or transactions. Regarding this process, NCVHS urged HHS ‘‘to re-evaluate the function and purpose of the Designated Standards Maintenance Organizations (DSMO).’’ In the HIPAA Transaction and Code Sets final rule of August 2000 (65 FR 50312), the Secretary named the six DSMOs. After the publication of the final rule, the six organizations and the Secretary of HHS signed a Memorandum of Understanding (MOU) establishing a steering committee and formalizing the processes for reviewing updated or new standards in advance of a recommendation to NCVHS and the Secretary. Between 2001 and 2004, the DSMO steering committee received more than 150 change requests. Today, the DSMO receives fewer than 10 change requests per year. The DSMO appears to have accomplished the purposes for which it was established. To support future work the HHS Secretary may undertake regarding the NCVHS recommendation to re-evaluate the DSMO, the Subcommittee will conduct a facilitated visioning session with a group of industry stakeholders. The goal of this session is to develop a set of viable options for a nextgeneration DSMO. Following the meeting, the Subcommittee plans to draft additional recommendations for the full Committee to consider for submission to the HHS Secretary. These recommendations will take into account the input received during the facilitated visioning session. The times and topic for this meeting are subject to change. Participation in the visioning session will be by invitation in order to maximize VerDate Sep<11>2014 16:57 May 07, 2019 Jkt 247001 effectiveness. Members of the public are welcome to submit comments and suggestions through August 20, 2019, to ncvhsmail@cdc.gov. Please refer to the posted agenda at www.ncvhs.hhs.gov for updates. Contact Persons for More Information: Substantive program information may be obtained from Rebecca Hines, MHS, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, telephone (301) 458–4715. To obtain information pertaining to meeting content, contact Geanelle G. Herring, MSW, (410) 786–4466; Centers for Medicare & Medicaid Services, Office of Information Technology, Division of National Standards, 7500 Security Boulevard, Baltimore, Maryland, 21244 and/or Lorraine Doo, MSWA, MPH, (410) 786–6597. Summaries of past meetings and a roster of Committee members are available on the NCVHS website: www.ncvhs.hhs.gov where further information, including an agenda and instructions to access the live audio broadcast of the meeting, will also be posted. Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (770) 488–3210 as soon as possible. Dated: May 2, 2019. Sharon Arnold, Associate Deputy Assistant Secretary for Planning and Evaluation, Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 2019–09460 Filed 5–7–19; 8:45 am] BILLING CODE 4151–05–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Statement of Organization, Functions, and Delegations of Authority: Office of the Assistant Secretary for Financial Resources Office of the Secretary, HHS. Notice. AGENCY: ACTION: The Department of Health and Human Services (HHS) is updating a portion of one office, the Office of the Assistant Secretary for Financial Resources (ASFR), which is located within the Office of the Secretary (OS). ASFR is modifying its structure to streamline and improve operational functionality by replacing the Office of Grants and Acquisition Policy and Accountability (AMT) and establishing SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 in its place the Office of Acquisitions (AMV), and the Office of Grants (AMU). FOR FURTHER INFORMATION CONTACT: Jen Moughalian, Acting Assistant Secretary for Financial Resources, 200 Independence Ave. SW, Washington, DC 20201, (202) 690–6061. Part A, Office of the Secretary, Statement of Organization, Functions and Delegations of Authority for the Department of Health and Human Services (HHS) is being amended at Chapter AM, Office of Financial Resources, as last amended at 76 FR 69741–42, dated November 9, 2011, 74 FR 57679–82, dated November 9, 2009, and 74 FR 18238–39, dated April 21, 2009. This reorganization will eliminate the Office of Grants and Acquisition Policy and Accountability (AMT) within the Office of Financial Resources (ASFR) and establish the Office of Grants (AMU) and Office of Acquisitions (AMV). This reorganization will make the following changes under Chapter AM, Office of Financial Resources: I. Under Section AM.10 Organization, delete in its entirety and replace with the following: Section AM.10 Organization: The Office of Financial Resources is headed by the Assistant Secretary for Financial Resources (ASFR). The Assistant Secretary for Financial Resources is the Departmental Chief Financial Officer (CFO), Chief Acquisition Officer (CAO) and Performance Improvement Officer (PIO), and reports to the Secretary. The office consists of the following components: D Immediate Office of the Assistant Secretary (AM). D Office of Budget (AML). D Office of Finance (AMS). D Office of Grants (AMU). D Office of Acquisitions (AMV). II. Under Chapter AM, ‘‘Office of the Assistant Secretary for Financial Resources,’’ delete Chapter AMT, ‘‘Office of Grants and Acquisition Policy and Accountability,’’ in its entirety and replace with the following: Chapter AMU, Office of Grants (AMU) Section AMU.00 Mission The Office of Grants (OG) provides Department-wide leadership, guidance, and oversight to constituent organizations, and coordinates long and short-range planning for HHS’ grants management policies, practices, systems and workforce. OG provides technical assistance to the Department’s OPDIVs and STAFFDIVs, evaluates effectiveness of the grants programs and processes; develops pertinent HHS-wide regulatory guidance, policies, and performance standards; maintains and reports E:\FR\FM\08MYN1.SGM 08MYN1

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[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20153-20154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09460]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Committee on Vital and Health Statistics: Visioning 
Session

    Pursuant to the Federal Advisory Committee Act, the Department of 
Health and Human Services (HHS) announces the following advisory 
committee program.
    Name: National Committee on Vital and Health Statistics (NCVHS), 
Subcommittee on Standards.
    Date and Times: Wednesday, July 10, 2019: 9:00 a.m.-5:00 p.m. 
(EDT), Thursday, July 11, 2019: 8:30 a.m.-5:00 p.m. (EDT).
    Place: U.S. Department of Health and Human Services, Hubert H. 
Humphrey Building, 200 Independence Avenue SW, Rm. 505-A, Washington, 
DC 20201.
    Status: Open. There will be a public comment period during the 
final 15 minutes of the first day of the meeting.
    Purpose: Health Insurance Portability and Accountability Act 
(HIPAA) legislation from 1996, as amended,\1\ established a regulatory 
framework to support the exchange of electronic information between 
covered entities, and directed the Secretary of Health and Human 
Services (HHS) to publish regulations adopting standards, code sets, 
and unique identifiers. The administrative simplification provisions of 
HIPAA pertain to retail pharmacy and medical transactions, such as 
eligibility, claims, payment, enrollment, and authorizations.
---------------------------------------------------------------------------

    \1\ Along with Section 1104 (c) of the Patient Protection and 
Affordable Care Act (ACA) of 2010.
---------------------------------------------------------------------------

    NCVHS advises the HHS Secretary on health data, statistics, 
privacy, national health information policy, and is mandated to report 
to Congress on the implementation status of HIPAA. Since mid-2017, the 
Subcommittee on Standards has been focused on developing a 
``predictability roadmap'' through collaboration with industry to 
identify and evaluate barriers to the efficient and timely update and

[[Page 20154]]

adoption of standards and operating rules. NCVHS sought to identify and 
understand the challenges under the current standards development and 
regulatory processes. Based on feedback the Committee obtained from 
stakeholders over an eighteen-month period, in February 2019 the 
Committee delivered five recommendations to the HHS Secretary 
supporting the industry's need for trusted cadence to improve the 
updates, adoption and implementation of transaction standards and 
operating rules to keep pace with innovative business needs and 
technology changes. The five recommendations represented actionable 
steps for adopting, implementing, and enforcing the administrative 
simplification provisions of HIPAA.
    One recommendation was specific to certain entities and processes 
related to the maintenance, modification, and recommendations to the 
Secretary for updated and new standards or transactions. Regarding this 
process, NCVHS urged HHS ``to re-evaluate the function and purpose of 
the Designated Standards Maintenance Organizations (DSMO).''
    In the HIPAA Transaction and Code Sets final rule of August 2000 
(65 FR 50312), the Secretary named the six DSMOs. After the publication 
of the final rule, the six organizations and the Secretary of HHS 
signed a Memorandum of Understanding (MOU) establishing a steering 
committee and formalizing the processes for reviewing updated or new 
standards in advance of a recommendation to NCVHS and the Secretary.
    Between 2001 and 2004, the DSMO steering committee received more 
than 150 change requests. Today, the DSMO receives fewer than 10 change 
requests per year. The DSMO appears to have accomplished the purposes 
for which it was established.
    To support future work the HHS Secretary may undertake regarding 
the NCVHS recommendation to re-evaluate the DSMO, the Subcommittee will 
conduct a facilitated visioning session with a group of industry 
stakeholders. The goal of this session is to develop a set of viable 
options for a next-generation DSMO.
    Following the meeting, the Subcommittee plans to draft additional 
recommendations for the full Committee to consider for submission to 
the HHS Secretary. These recommendations will take into account the 
input received during the facilitated visioning session.
    The times and topic for this meeting are subject to change. 
Participation in the visioning session will be by invitation in order 
to maximize effectiveness. Members of the public are welcome to submit 
comments and suggestions through August 20, 2019, to [email protected]. 
Please refer to the posted agenda at www.ncvhs.hhs.gov for updates.
    Contact Persons for More Information: Substantive program 
information may be obtained from Rebecca Hines, MHS, Executive 
Secretary, NCVHS, National Center for Health Statistics, Centers for 
Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 
20782, telephone (301) 458-4715. To obtain information pertaining to 
meeting content, contact Geanelle G. Herring, MSW, (410) 786-4466; 
Centers for Medicare & Medicaid Services, Office of Information 
Technology, Division of National Standards, 7500 Security Boulevard, 
Baltimore, Maryland, 21244 and/or Lorraine Doo, MSWA, MPH, (410) 786-
6597. Summaries of past meetings and a roster of Committee members are 
available on the NCVHS website: www.ncvhs.hhs.gov where further 
information, including an agenda and instructions to access the live 
audio broadcast of the meeting, will also be posted.
    Should you require reasonable accommodation, please contact the CDC 
Office of Equal Employment Opportunity on (770) 488-3210 as soon as 
possible.

    Dated: May 2, 2019.
Sharon Arnold,
Associate Deputy Assistant Secretary for Planning and Evaluation, 
Science and Data Policy, Office of the Assistant Secretary for Planning 
and Evaluation.
[FR Doc. 2019-09460 Filed 5-7-19; 8:45 am]
 BILLING CODE 4151-05-P
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