Discretionary Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting, 20216-20217 [2014-08079]

Download as PDF 20216 Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Availability of Final Policy Document Health Resources and Services Administration (HRSA), HHS. ACTION: Final Agency guidance and response to public comments. AGENCY: On January 27, 2014, HRSA published Policy Information Notice (PIN) 2014–01 to convey and clarify statutory and regulatory governance requirements for section 330-funded health centers and look-alikes. The PIN, ‘‘Health Center Program Governance,’’ and HRSA’s ‘‘Comments and Response on Draft PIN: Health Center Program Governance’’ are available on the Internet at https://www.bphc.hrsa.gov/ policiesregulations/policies/ pin201401.html, and constitutes final agency guidance. DATES: The effective date of this final agency guidance was January 27, 2014. FOR FURTHER INFORMATION CONTACT: For questions regarding this notice, please contact the Office of Policy and Program Development, Bureau of Primary Health Care, HRSA, at BPHCPolicy@hrsa.gov. SUPPLEMENTARY INFORMATION: HHS’ Health Resources and Services Administration (HRSA) provides grants to eligible health centers under section 330 of the Public Health Service Act to support the delivery of preventive and primary care services to medically underserved communities and vulnerable populations. In 2012, grants helped fund more than 1,200 health center grantees that provided services at nearly 9,000 health care delivery sites and served more than 21 million people. There are also over 100 organizations known as Federally Qualified Health Center (FQHC) look-alikes (look-alikes). As described in section 1861(aa)(4) and section 1905(l)(2)(B) of the Social Security Act, look-alikes do not receive federal funding under section 330 of the PHS Act; however, to receive the lookalike designation and associated FQHC benefits, look-alikes must meet the statutory, regulatory, and policy requirements for health centers under section 330. The purpose of this PIN is to: (a) Convey and clarify statutory and regulatory requirements regarding the structure and functioning of governing boards for all Health Center Program grantees (e.g., section 330(e), (g), (h), and/or (i) grantees) and look-alikes; (b) provide clarification regarding board tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:55 Apr 10, 2014 Jkt 232001 requirements for public centers under co-applicant arrangements, including public centers funded or designated solely under sections 330(g), 330(h), and/or 330(i) to serve special populations; and (c) outline the eligibility and qualifying requirements for HRSA approval of a governance waiver for the 51 percent patient majority governance requirement for eligible section 330 grantees and lookalikes. This PIN also establishes HRSA policy that eliminates the monthly meeting requirement from waiver consideration. On August 20, 2009, HRSA made the draft PIN, ‘‘Health Center Governance Requirements and Expectations,’’ available for public comment. HRSA also published a notice in the Federal Register of September 18, 2009, requesting comments on this draft PIN. Fifty-one parties, including both individuals and groups, submitted a total of 251 comments regarding the draft PIN. After review and careful consideration of all comments received, HRSA has amended the PIN to incorporate certain recommendations from the public. The final PIN reflects these changes. In addition to making the final PIN available on HRSA’s Web site, HRSA is also posting HRSA’s ‘‘Comments and Response on Draft PIN: Health Center Program Governance.’’ The purpose of this document is to summarize the major comments received and describe HRSA’s response, including any corresponding changes made to the PIN. Where comments did not result in a revision to the PIN, explanations are provided. Dated: March 28, 2014. Mary K. Wakefield, Administrator. [FR Doc. 2014–08080 Filed 4–10–14; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Discretionary Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463, codified at 5 U.S.C. App.), notice is hereby given of the following meeting: Name: Discretionary Advisory Committee on Heritable Disorders in Newborns and Children. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Dates and Times: May 29, 2014, 9:30 a.m. to 4:30 p.m. May 30, 2014, 9:30 a.m. to 3:00 p.m. Place: Webinar and In-Person, U.S. Pharmacopeial Convention (USP) Headquarters, 12601 Twinbrook Parkway, Rockville, Maryland 20852. Status: The meeting will be open to the public with attendance limited to space availability. Participants also have the option of viewing the meeting via webinar. Whether attending in-person or via webinar, all participants must register for the meeting at https://www.blsmeetings.net/ ACHDNCMay2014. The registration deadline is Friday, May 2, 2014, 11:59 p.m. Eastern Time. If there are technical problems gaining access to the Web site, please contact Anthony Rodell, Director of Client Relations, at arodell@SeamonCorporation.com. Purpose: The Discretionary Advisory Committee on Heritable Disorders in Newborns and Children (Committee), as authorized by Public Health Service Act (PHS), 42 U.S.C. 217a: Advisory councils or committees, was established to advise the Secretary of the Department of Health and Human Services about 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. Note: the Committee’s recommendations regarding additional conditions/inherited disorders for screening that have been adopted by the Secretary are included in the Recommended Uniform Screening Panel and constitute part of the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA). Pursuant to section 2713 of the Public Health Service Act, codified at 42 U.S.C. 300gg–13, nongrandfathered health plans are required to cover screenings included in the HRSAsupported comprehensive guidelines without charging a co-payment, co-insurance, or deductible for plan years (i.e., policy years) beginning on or after the date that is 1 year from the Secretary’s adoption of the condition for screening. Agenda: The meeting will include: (1) A discussion and vote on a systematic approach to evaluate the impact of adding newborn screening conditions on state public health systems; (2) a presentation on the impact of the rapid implementation of electronic health records on the Early Hearing Detection and Intervention State programs; (3) a discussion on a potential national infrastructure to conduct research on population-based screening; (4) a presentation on the impact of new CPT codes for molecular diagnostics on laboratories; and (5) updates from the Committee’s Laboratory Standards and Procedures, Follow-up and Treatment, and Education and Training subcommittees. Tentatively, the Committee is expected to review and/or vote on a systematic approach to evaluate the impact of adding newborn screening conditions on state public health systems. This tentative vote does not involve any proposed addition of a condition to the Recommended Uniform Screening Panel. Agenda items are subject to change as necessary or appropriate. The agenda, E:\FR\FM\11APN1.SGM 11APN1 Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Notices webinar information, Committee Roster, Charter, presentations, and other meeting materials are located on the Advisory Committee’s Web site at https:// www.hrsa.gov/advisorycommittees/ mchbadvisory/heritabledisorders. Public Comments: Members of the public may present oral comments and/or submit written comments. Comments are part of the official Committee record. Public comment periods are tentatively scheduled for both May 29 and May 30, 2014. Advance registration is required to present oral comments and/or submit written comments at https://www.blsmeetings.net/ ACHDNCMay2014. The registration deadline is Friday, May 2, 2014, 11:59 p.m. Eastern Time. Written comments must be received by the deadline in order to be included in the May meeting briefing book. Written comments should identify the individual’s name, address, email, telephone number, professional or business affiliation, type of expertise (i.e., parent, researcher, clinician, public health, etc.), and the topic/subject matter of comments. To ensure that all individuals who have registered to make oral comments can be accommodated, the allocated time may be limited. Individuals who are associated with groups or have similar interests may be requested to combine their comments and present them through a single representative. No audiovisual presentations are permitted. For additional information or questions on public comments, please contact Lisa Vasquez, Maternal and Child Health Bureau, Health Resources and Services Administration; email: lvasquez@hrsa.gov. For Further Information Contact: Anyone interested in obtaining other relevant information should contact Debi Sarkar, Maternal and Child Health Bureau, Health Resources and Services Administration, Room 18A–19, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; email: dsarkar@hrsa.gov. More information on the Advisory Committee is available at https:// www.hrsa.gov/advisorycommittees/ mchbadvisory/heritabledisorders. Dated: April 3, 2014. Jackie Painter, Deputy Director, Division of Policy and Information Coordination. [FR Doc. 2014–08079 Filed 4–10–14; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES tkelley on DSK3SPTVN1PROD with NOTICES National Institutes of Health Collaborative Workshop on Aquatic Models and 21st Century Toxicology; Notice of Public Meeting and Registration Information The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces a ‘‘Collaborative Workshop SUMMARY: VerDate Mar<15>2010 18:55 Apr 10, 2014 Jkt 232001 on Aquatic Models and 21st Century Toxicology.’’ The workshop proposes to explore and discuss how small aquarium fish species may be used as model organisms to screen and prioritize compounds for further in vivo testing and assess mechanisms of chemical toxicity. Discussions will focus on the application of these models to the field of environmental health while leveraging the techniques and knowledge of broad-based, interdisciplinary research. DATES: Meeting: May 5–6, 2014, from 8:00 a.m. to approximately 5:00 p.m. Eastern Daylight Time (EDT) on May 5 and 8:00 a.m. to approximately 4:15 p.m. EDT on May 6. A poster session will be held on May 5. Meeting Registration: Registration is open through April 25, 2014. ADDRESSES: Meeting Location: James B. Hunt Jr. Library, Centennial Campus, North Carolina State University (NCSU), 1070 Partners Way, Raleigh, NC 27606. Meeting Web page: The preliminary agenda, registration, and other meeting materials are at https://ntp.niehs.nih.gov/ go/41308. FOR FURTHER INFORMATION CONTACT: Dr. Warren S. Casey, Director, NICEATM; email: warren.casey@nih.gov; telephone: (919) 316–4729. SUPPLEMENTARY INFORMATION: Background: The need to screen thousands of environmental chemicals for their potential effects on human health has propelled the use of highthroughput cell-based screens to the forefront of toxicology. Key to the use of these screens is the availability of model organisms that recapitulate human development, physiology, and disease processes while avoiding the limitations of current rodent-based models. Incorporating small aquarium fish models into modern toxicological investigations could yield significant scientific and economic benefits. This workshop highlights the potential of these organisms in toxicological research and enables scientists to discuss strategies for leveraging aquatic models in understanding the role of environmental exposures on human health. The workshop is cosponsored by the NTP and NCSU; the organizing committee includes members from the NTP, NCSU, the National Institute of Environmental Health Sciences, the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and Duke University. Preliminary Agenda and Other Meeting Information: A preliminary agenda and additional information are PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 20217 available at https://ntp.niehs.nih.gov/go/ 41308. Meeting and Registration: This meeting is open to the public, free of charge, with attendance limited only by the space available. Individuals who plan to attend should register on the NTP Web site (https://ntp.niehs.nih.gov/ go/41308) by April 25, 2014, to facilitate meeting planning. Interested individuals are encouraged to visit this Web page to stay abreast of the most current information about the meeting. Information for visitors to the Hunt Library is available at https:// www.lib.ncsu.edu/huntlibrary. Individuals with disabilities who need accommodation to participate in this event should contact Dr. Elizabeth Maull at phone: (919) 316–4668 or email: maull@niehs.nih.gov. TTY users should contact the Federal TTY Relay Service at 800–877–8339. Requests should be made at least five business days in advance of the event. Background Information on NICEATM: NICEATM conducts data analyses, workshops, independent validation studies, and other activities to assess new, revised, and alternative test methods and strategies and provides support for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3) provides authority for ICCVAM and NICEATM in the development of alternative test methods. Information about NICEATM and ICCVAM is found at https:// ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam. Dated: April 3, 2014. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2014–08082 Filed 4–10–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting 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 E:\FR\FM\11APN1.SGM 11APN1

Agencies

[Federal Register Volume 79, Number 70 (Friday, April 11, 2014)]
[Notices]
[Pages 20216-20217]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08079]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Discretionary Advisory Committee on Heritable Disorders in 
Newborns and Children; Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463, codified at 5 U.S.C. App.), notice is 
hereby given of the following meeting:

    Name: Discretionary Advisory Committee on Heritable Disorders in 
Newborns and Children.
    Dates and Times: May 29, 2014, 9:30 a.m. to 4:30 p.m. May 30, 
2014, 9:30 a.m. to 3:00 p.m.
    Place: Webinar and In-Person, U.S. Pharmacopeial Convention 
(USP) Headquarters, 12601 Twinbrook Parkway, Rockville, Maryland 
20852.
    Status: The meeting will be open to the public with attendance 
limited to space availability. Participants also have the option of 
viewing the meeting via webinar. Whether attending in-person or via 
webinar, all participants must register for the meeting at https://www.blsmeetings.net/ACHDNCMay2014. The registration deadline is 
Friday, May 2, 2014, 11:59 p.m. Eastern Time. If there are technical 
problems gaining access to the Web site, please contact Anthony 
Rodell, Director of Client Relations, at 
arodell@SeamonCorporation.com.
    Purpose: The Discretionary Advisory Committee on Heritable 
Disorders in Newborns and Children (Committee), as authorized by 
Public Health Service Act (PHS), 42 U.S.C. 217a: Advisory councils 
or committees, was established to advise the Secretary of the 
Department of Health and Human Services about 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. 
Note: the Committee's recommendations regarding additional 
conditions/inherited disorders for screening that have been adopted 
by the Secretary are included in the Recommended Uniform Screening 
Panel and constitute part of the comprehensive guidelines supported 
by the Health Resources and Services Administration (HRSA). Pursuant 
to section 2713 of the Public Health Service Act, codified at 42 
U.S.C. 300gg-13, non-grandfathered health plans are required to 
cover screenings included in the HRSA-supported comprehensive 
guidelines without charging a co-payment, co-insurance, or 
deductible for plan years (i.e., policy years) beginning on or after 
the date that is 1 year from the Secretary's adoption of the 
condition for screening.
    Agenda: The meeting will include: (1) A discussion and vote on a 
systematic approach to evaluate the impact of adding newborn 
screening conditions on state public health systems; (2) a 
presentation on the impact of the rapid implementation of electronic 
health records on the Early Hearing Detection and Intervention State 
programs; (3) a discussion on a potential national infrastructure to 
conduct research on population-based screening; (4) a presentation 
on the impact of new CPT codes for molecular diagnostics on 
laboratories; and (5) updates from the Committee's Laboratory 
Standards and Procedures, Follow-up and Treatment, and Education and 
Training subcommittees. Tentatively, the Committee is expected to 
review and/or vote on a systematic approach to evaluate the impact 
of adding newborn screening conditions on state public health 
systems. This tentative vote does not involve any proposed addition 
of a condition to the Recommended Uniform Screening Panel.
    Agenda items are subject to change as necessary or appropriate. 
The agenda,

[[Page 20217]]

webinar information, Committee Roster, Charter, presentations, and 
other meeting materials are located on the Advisory Committee's Web 
site at https://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
    Public Comments: Members of the public may present oral comments 
and/or submit written comments. Comments are part of the official 
Committee record. Public comment periods are tentatively scheduled 
for both May 29 and May 30, 2014. Advance registration is required 
to present oral comments and/or submit written comments at https://www.blsmeetings.net/ACHDNCMay2014. The registration deadline is 
Friday, May 2, 2014, 11:59 p.m. Eastern Time. Written comments must 
be received by the deadline in order to be included in the May 
meeting briefing book. Written comments should identify the 
individual's name, address, email, telephone number, professional or 
business affiliation, type of expertise (i.e., parent, researcher, 
clinician, public health, etc.), and the topic/subject matter of 
comments. To ensure that all individuals who have registered to make 
oral comments can be accommodated, the allocated time may be 
limited. Individuals who are associated with groups or have similar 
interests may be requested to combine their comments and present 
them through a single representative. No audiovisual presentations 
are permitted. For additional information or questions on public 
comments, please contact Lisa Vasquez, Maternal and Child Health 
Bureau, Health Resources and Services Administration; email: 
lvasquez@hrsa.gov.
    For Further Information Contact: Anyone interested in obtaining 
other relevant information should contact Debi Sarkar, Maternal and 
Child Health Bureau, Health Resources and Services Administration, 
Room 18A-19, Parklawn Building, 5600 Fishers Lane, Rockville, 
Maryland 20857; email: dsarkar@hrsa.gov.
    More information on the Advisory Committee is available at 
https://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.

    Dated: April 3, 2014.
Jackie Painter,
Deputy Director, Division of Policy and Information Coordination.
[FR Doc. 2014-08079 Filed 4-10-14; 8:45 am]
BILLING CODE 4165-15-P