81 FR 71107 - Advisory Committee on Heritable Disorders in Newborns and Children
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 199 (October 14, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 199 (October 14, 2016)
| Page Range | 71107-71108 | |
| FR Document | 2016-24808 |
[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)] [Notices] [Pages 71107-71108] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24808] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Heritable Disorders in Newborns and Children AGENCY: Health Resources and Service Administration (HRSA), Department of Health and Human Services. ACTION: Notice of meeting. ----------------------------------------------------------------------- SUMMARY: 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 that a meeting is scheduled for the Advisory Committee on Heritable Disorders in Newborns and Children. This meeting will be open to the public but advance registration is required to ensure sufficient webinar capacity. The registration link is https://www.blsmeetings.net/achdncnovember2016/. The registration deadline is Wednesday, November 2, 2016, 11:59 p.m. Eastern Time. DATES AND TIMES: November 3, 2016, 9:00 a.m. to 5:00 p.m. (Meeting time is tentative.) November 4, 2016, 9:00 a.m. to 1:00 p.m. (Meeting time is tentative.) ADDRESSES: This meeting will be held by webinar only. FOR FURTHER INFORMATION CONTACT: Anyone interested in obtaining other relevant information should contact Alaina Harris, Maternal and Child Health Bureau, HRSA, Room 18W66, 5600 Fishers Lane, Rockville, Maryland 20857; email: [email protected]. SUPPLEMENTARY INFORMATION: The Advisory Committee on Heritable Disorders in Newborns and Children (Committee), as authorized by the Public Health Service Act, Title XI, Sec. 1111 (42 U.S.C. 300b-10), 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. In addition, 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 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. The Committee will hear presentations and discussions on topics related to 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. The Committee will also hear updates from the Laboratory Standards and Procedures workgroup, Follow-up and Treatment workgroup, and Education and Training workgroup. Agenda items are subject to changes as priorities indicate. Tentatively, the Committee is expected to review and/or vote on the following: Approving newborn screening surveillance case definitions and whether or not the nominated condition Guanidinoacetate Methyltransferase deficiency should be referred for a full evidence-based review. The Committee will not be voting on a proposed addition of a condition to the Recommended Uniform Screening Panel. The meeting agenda will be available 2 days prior to the meeting on the Committee's Web site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders. Members of the public may submit written and/or present oral comments at the meeting. All comments are part of the official Committee record. Advance registration is required to submit written comments and/or present oral comments. Written comments must be submitted by October 19, 2016, 11:59 p.m. Eastern Time in order to be included in the November 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. Individuals who wish to provide oral comments must register by October 30, 2016, 11:59 p.m. Eastern Time. To ensure that all individuals who have registered to make oral comments can be accommodated, the allocated time may [[Page 71108]] 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. More information on the Advisory Committee is available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016-24808 Filed 10-13-16; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 81, No. 199 / Friday, October 14, 2016 / Notices 71107
Department of Health and Human Dated: October 7, 2016. have been adopted by the Secretary are
Services pursuant to 45 CFR part 11 and Janice M. Soreth, included in the Recommended Uniform
by the General Services Administration, Acting Associate Commissioner, Special Screening Panel and constitute part of
FDA is announcing the renewal of the Medical Programs. the comprehensive guidelines
Antimicrobial Drugs Advisory [FR Doc. 2016–24810 Filed 10–13–16; 8:45 am] supported by HRSA. Pursuant to section
Committee. The committee is a BILLING CODE 4164–01–P 2713 of the Public Health Service Act,
discretionary Federal advisory codified at 42 U.S.C. 300gg–13, non-
committee established to provide advice grandfathered health plans are required
to the Commissioner. The Antimicrobial DEPARTMENT OF HEALTH AND to cover screenings included in the
Drugs Advisory Committee advises the HUMAN SERVICES HRSA-supported comprehensive
Commissioner or designee in guidelines without charging a co-
discharging responsibilities as they Health Resources and Services payment, co-insurance, or deductible for
relate to helping to ensure safe and Administration plan years (i.e., policy years) beginning
effective drugs for human use and, as on or after the date that is 1-year from
Advisory Committee on Heritable the Secretary’s adoption of the
required, any other product for which
Disorders in Newborns and Children condition for screening.
the Food and Drug Administration has
regulatory responsibility. The AGENCY: Health Resources and Service The Committee will hear
Committee reviews and evaluates Administration (HRSA), Department of presentations and discussions on topics
available data concerning the safety and Health and Human Services. related to newborn screening activities,
effectiveness of marketed and ACTION: Notice of meeting.
technologies, policies, guidelines, and
investigational human drug products for programs for effectively reducing
use in the treatment of infectious SUMMARY: In accordance with section morbidity and mortality in newborns
diseases and disorders and makes 10(a)(2) of the Federal Advisory and children having, or at risk for,
appropriate recommendations to the Committee Act (Pub. L. 92–463, codified heritable disorders. The Committee will
Commissioner of Food and Drugs. at 5 U.S.C. App.), notice is hereby given also hear updates from the Laboratory
The Committee shall consist of a core that a meeting is scheduled for the Standards and Procedures workgroup,
of 13 voting members including the Advisory Committee on Heritable Follow-up and Treatment workgroup,
Chair. Members and the Chair are Disorders in Newborns and Children. and Education and Training workgroup.
selected by the Commissioner or This meeting will be open to the public Agenda items are subject to changes as
designee from among authorities but advance registration is required to priorities indicate. Tentatively, the
knowledgeable in the fields of infectious ensure sufficient webinar capacity. The Committee is expected to review and/or
disease, internal medicine, registration link is https:// vote on the following: Approving
www.blsmeetings.net/ newborn screening surveillance case
microbiology, pediatrics, epidemiology
achdncnovember2016/. The registration definitions and whether or not the
or statistics, and related specialties.
deadline is Wednesday, November 2, nominated condition Guanidinoacetate
Members will be invited to serve for
2016, 11:59 p.m. Eastern Time. Methyltransferase deficiency should be
overlapping terms of up to four years.
DATES AND TIMES: November 3, 2016, referred for a full evidence-based
Almost all non-Federal members of this
9:00 a.m. to 5:00 p.m. (Meeting time is review. The Committee will not be
committee serve as Special Government
tentative.) voting on a proposed addition of a
Employees. The core of voting members
November 4, 2016, 9:00 a.m. to 1:00 condition to the Recommended Uniform
may include one technically qualified
p.m. (Meeting time is tentative.) Screening Panel. The meeting agenda
member, selected by the Commissioner
ADDRESSES: This meeting will be held
will be available 2 days prior to the
or designee, who is identified with meeting on the Committee’s Web site:
consumer interests and is recommended by webinar only.
http://www.hrsa.gov/
by either a consortium of consumer- FOR FURTHER INFORMATION CONTACT:
advisorycommittees/mchbadvisory/
oriented organizations or other Anyone interested in obtaining other heritabledisorders.
interested persons. In addition to the relevant information should contact Members of the public may submit
voting members, the Committee may Alaina Harris, Maternal and Child written and/or present oral comments at
include one non-voting member who is Health Bureau, HRSA, Room 18W66, the meeting. All comments are part of
identified with industry interests. 5600 Fishers Lane, Rockville, Maryland the official Committee record. Advance
Further information regarding the 20857; email: aharris@hrsa.gov. registration is required to submit written
most recent charter and other SUPPLEMENTARY INFORMATION: The comments and/or present oral
information can be found at http:// Advisory Committee on Heritable comments. Written comments must be
www.fda.gov/AdvisoryCommittees/ Disorders in Newborns and Children submitted by October 19, 2016, 11:59
CommitteesMeetingMaterials/Drugs/ (Committee), as authorized by the p.m. Eastern Time in order to be
Anti-InfectiveDrugsAdvisoryCommittee/ Public Health Service Act, Title XI, included in the November meeting
ucm094132.htm or by contacting the § 1111 (42 U.S.C. 300b–10), was briefing book. Written comments should
Designated Federal Officer (see FOR established to advise the Secretary of identify the individual’s name, address,
FURTHER INFORMATION CONTACT). In light the Department of Health and Human email, telephone number, professional
of the fact that no change has been made Services about the development of or business affiliation, type of expertise
to the committee name or description of newborn screening activities, (i.e., parent, researcher, clinician, public
duties, no amendment will be made to technologies, policies, guidelines, and health, etc.), and the topic/subject
rmajette on DSK2TPTVN1PROD with NOTICES
21 CFR 14.100. programs for effectively reducing matter of comments.
This document is issued under the morbidity and mortality in newborns Individuals who wish to provide oral
Federal Advisory Committee Act (5 and children having, or at risk for, comments must register by October 30,
U.S.C. app.). For general information heritable disorders. In addition, the 2016, 11:59 p.m. Eastern Time. To
related to FDA advisory committees, Committee’s recommendations ensure that all individuals who have
please visit us at http://www.fda.gov/ regarding additional conditions/ registered to make oral comments can be
AdvisoryCommittees/default.htm. inherited disorders for screening that accommodated, the allocated time may
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![71108 Federal Register / Vol. 81, No. 199 / Friday, October 14, 2016 / Notices
be limited. Individuals who are FOR FURTHER INFORMATION CONTACT: To information on career plans. The alumni
associated with groups or have similar request more information on the questionnaire collects information on
interests may be requested to combine proposed project or to obtain a copy of career outcomes (including practice in
their comments and present them the data collection plans and draft primary care and in underserved
through a single representative. No instruments, email paperwork@hrsa.gov settings) following graduation as well as
audiovisual presentations are permitted. or call the HRSA Information Collection feedback on the quality of training.
More information on the Advisory Clearance Officer at (301) 443–1984.
Committee is available at http:// Statute requires that THCGME
SUPPLEMENTARY INFORMATION: When
www.hrsa.gov/advisorycommittees/ program award recipients report
submitting comments or requesting
mchbadvisory/heritabledisorders. information, please include the annually on the types of primary care
information request collection title for resident approved training programs
Jason E. Bennett, that the THCs provided for residents,
Director, Division of the Executive Secretariat. reference.
Information Collection Request Title: the number of approved training
[FR Doc. 2016–24808 Filed 10–13–16; 8:45 am] positions for residents, the number of
Evaluation and Initial Assessment of
BILLING CODE 4165–15–P
HRSA Teaching Health Centers. residents who completed their
OMB No.: 0915–0376—Extension. residency training at the end of the
Abstract: Section 5508 of the academic year and care for vulnerable
DEPARTMENT OF HEALTH AND Affordable Care Act of 2010 amended populations, and any other information
HUMAN SERVICES section 340H of the Public Health as deemed appropriate by the Secretary.
Health Resources and Services Service Act to establish the Teaching The described data collection activities
Administration Health Center Graduate Medical have served to meet this statutory
Education (THCGME) program to requirement for the THCGME program
Agency Information Collection support new and the expansion of award recipients in a uniform and
Activities: Proposed Collection: Public existing primary care residency training consistent manner and have allowed
Comment Request; Evaluation and programs in community-based settings. comparisons of this group to other
Initial Assessment of HRSA Teaching The primary goals of this program are to trainees in non-THC programs. GW
Health Centers increase the production of primary care
seeks renewal of these measures with no
providers who are well prepared to
AGENCY: Health Resources and Services changes.
practice in community settings,
Administration (HRSA), Department of particularly with underserved Likely Respondents: Respondents are
Health and Human Services. populations, and to improve the overall medical and dental residents as well as
ACTION: Notice. number and geographic distribution of graduates of Teaching Health Centers.
primary care providers. Burden Statement: Burden in this
SUMMARY: In compliance with the Need and Proposed Use of the
requirement for opportunity for public context means the time expended by
Information: To ensure these goals are persons to generate, maintain, retain,
comment on proposed data collection achieved, the George Washington
projects (Section 3506(c)(2)(A) of the disclose or provide the information
University (GW) is conducting an
Paperwork Reduction Act of 1995), requested. This includes the time
evaluation of the training,
HRSA announces plans to submit an needed to review instructions; to
administrative and organizational
Information Collection Request (ICR), structures, clinical service, challenges, develop, acquire, install and utilize
described below, to the Office of innovations, costs associated with technology and systems for the purpose
Management and Budget (OMB). Prior training, and outcomes of Teaching of collecting, validating and verifying
to submitting the ICR to OMB, HRSA Health Centers (THCs). GW has information, processing and
seeks comments from the public developed questionnaires for maintaining information, and disclosing
regarding the burden estimate, below, or implementation with all THC and providing information; to train
any other aspect of the ICR. matriculating residents, graduating personnel and to be able to respond to
DATES: Comments on this ICR must be residents, and graduated residents at 1 a collection of information; to search
received no later than December 13, year post-graduation. The matriculation data sources; to complete and review
2016. questionnaire aims to collect the collection of information; and to
ADDRESSES: Submit your comments to background information on THC transmit or otherwise disclose the
paperwork@hrsa.gov or mail the HRSA residents to better understand the information. The total annual burden
Information Collection Clearance characteristics of individuals who apply hours estimated for this Information
Officer, Room 14N–39, 5600 Fishers and are accepted to THC programs. The Collection Request are summarized in
Lane, Rockville, MD 20857. graduation questionnaire collects the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
THC Graduate Survey ......................................................... 300 1 300 0.33 99
rmajette on DSK2TPTVN1PROD with NOTICES
THC Matriculant Survey ....................................................... 300 1 300 0.25 75
THC Graduation Survey ...................................................... 300 1 300 0.25 75
Total .............................................................................. 900 ........................ 900 ........................ 249
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Document Created: 2016-10-14 00:00:33
Document Modified: 2016-10-14 00:00:33
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of meeting. | |
| Contact | Anyone interested in obtaining other relevant information should contact Alaina Harris, Maternal and Child Health Bureau, HRSA, Room 18W66, 5600 Fishers Lane, Rockville, Maryland 20857; email: [email protected] | |
| FR Citation | 81 FR 71107 |
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