80 FR 63559 - Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 202 (October 20, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 202 (October 20, 2015)
| Page Range | 63559-63560 | |
| FR Document | 2015-26524 |
[Federal Register Volume 80, Number 202 (Tuesday, October 20, 2015)] [Notices] [Pages 63559-63560] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26524] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration 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: Advisory Committee on Heritable Disorders in Newborns and Children. Dates and Times: November 3, 2015, 9:00 a.m. to 4:00 p.m. Place: Webinar. Status: The meeting will be open to the public. Please register at https://www.blsmeetings.net/ACHDNCNovember2015/. The registration deadline is Friday, October 30, 2015, 11:59 p.m. Eastern Time. Purpose: The Advisory Committee on Heritable Disorders in Newborns and Children (Committee), as authorized by the Public Health Service Act (PHS), 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 (RUSP) and constitute part of the comprehensive guidelines supported by the Health Resources and Services Administration. Pursuant to section 2713 of the Public Health Service Act, codified at 42 U.S.C. 300gg-13, non-grandfathered health plans and group and individual health insurance issuers 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 one year from the Secretary's adoption of the condition for screening. Agenda: The meeting will include: (1) Discussion and vote on the statutory Committee's proposed bylaws, (2) a discussion of nomination process for prospective organizational representatives, (3) a presentation on the Notice of Proposed Rulemaking on Federal Policy for the Protection of Human Subjects and the potential impact on newborn screening research, (4) updates from the Pilot Study Workgroup, Cost Analysis Workgroup, and Timeliness Workgroup, (5) a presentation on transition models from pediatric to adult health care using innovative strategies, and (6) a presentation on current education activities within newborn screening and impact on families and children. There are no votes that involve proposed additions of a condition to the RUSP scheduled for this meeting. Agenda items are subject to change as necessary or appropriate. The agenda, webinar information, Committee Roster, Charter, presentations, and other meeting materials will be located on the Advisory Committee's Web site at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders. Registration: Registration information will be on the Committee Web site at https://www.blsmeetings.net/ACHDNCNovember2015/. The registration deadline is Friday, October 30, 11:59 p.m. Eastern Time. Public Comments: Members of the public may present oral comments and/or submit written comments. Comments are part of the official Committee record. Advance registration is required to present oral comments and/or submit written comments. Oral public comments are tentatively scheduled for November 3, 2015. Individuals who wish to present oral public comments must indicate this when registering. Written comments may be uploaded on the registration Web site and must be received by the registration deadline (October 30, 11:59 p.m. Eastern Time), as this will allow them to be included in the November meeting briefing book. Individuals who wish to present oral comments and/or provide written comments should identify on the registration Web site 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, [[Page 63560]] 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. Contact Person: Anyone interested in obtaining other relevant information should contact Debi Sarkar, Maternal and Child Health Bureau, Health Resources and Services Administration, Room 18W68, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; email: dsarkar@hrsa.gov. More information on the Advisory Committee is available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-26524 Filed 10-19-15; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices 63559
The draft meeting agenda will be Administration, 5600 Fishers Lane, the date that is one year from the
posted on www.acotmeetings.net (but Room 17W65, Rockville, MD 20857; Secretary’s adoption of the condition for
the timing of events may be subject to telephone 301–443–1127. screening.
change). Those participating at this Agenda: The meeting will include: (1)
Jackie Painter,
meeting should register by visiting Discussion and vote on the statutory
Director, Division of the Executive Secretariat. Committee’s proposed bylaws, (2) a
www.acotmeetings.net. The deadline to
[FR Doc. 2015–26523 Filed 10–19–15; 8:45 am] discussion of nomination process for
register for this meeting is Monday,
November 16, 2015. For all logistical BILLING CODE 4165–15–P prospective organizational
questions and concerns, please contact representatives, (3) a presentation on the
Susie Gingrich, Leonard Resource Notice of Proposed Rulemaking on
DEPARTMENT OF HEALTH AND Federal Policy for the Protection of
Group, at 202–289–8322 or send an
HUMAN SERVICES Human Subjects and the potential
email to sgingrich@lriginc.com.
The public can join the meeting by: impact on newborn screening research,
Health Resources and Services
1. (Audio Portion) Calling the (4) updates from the Pilot Study
Administration
Conference Phone Number (1–800–832– Workgroup, Cost Analysis Workgroup,
0736) and providing the Participant Advisory Committee on Heritable and Timeliness Workgroup, (5) a
Code (1337210); and Disorders in Newborns and Children; presentation on transition models from
2. (Visual Portion) Connecting to the Notice of Meeting pediatric to adult health care using
ACOT Adobe Connect Pro Meeting innovative strategies, and (6) a
using the following URL https://lrg. In accordance with section 10(a)(2) of presentation on current education
adobeconnect.com/acot1115 (copy and the Federal Advisory Committee Act activities within newborn screening and
paste the link into your browser if it (Pub. L. 92–463, codified at 5 U.S.C. impact on families and children. There
does not work directly). App.), notice is hereby given of the are no votes that involve proposed
Participants should call and connect following meeting: additions of a condition to the RUSP
Name: Advisory Committee on scheduled for this meeting.
15 minutes prior to the meeting for
Heritable Disorders in Newborns and Agenda items are subject to change as
logistics to be set up. If you have never
Children. necessary or appropriate. The agenda,
attended an Adobe Connect meeting, Dates and Times: November 3, 2015,
please test your connection using the webinar information, Committee Roster,
9:00 a.m. to 4:00 p.m. Charter, presentations, and other
following URL: https://hrsa.connect Place: Webinar.
solutions.com/common/help/en/ meeting materials will be located on the
Status: The meeting will be open to Advisory Committee’s Web site at
support/meeting_test.htm and get a the public. Please register at https:// http://www.hrsa.gov/advisory
quick overview by following URL: www.blsmeetings.net/ACHDNC committees/mchbadvisory/heritable
http://www.adobe.com/go/connectpro_ November2015/. The registration disorders.
overview. deadline is Friday, October 30, 2015, Registration: Registration information
Call 202–289–8322 or send an email 11:59 p.m. Eastern Time. will be on the Committee Web site at
to sgringrich@lrginc.com if you are Purpose: The Advisory Committee on https://www.blsmeetings.net/ACHDNC
having trouble connecting to the Heritable Disorders in Newborns and November2015/. The registration
meeting site. Children (Committee), as authorized by deadline is Friday, October 30, 11:59
Public Comment: It is preferred that the Public Health Service Act (PHS), p.m. Eastern Time.
persons interested in providing an oral Title XI, § 1111 (42 U.S.C. 300b–10), Public Comments: Members of the
presentation email a written request, was established to advise the Secretary public may present oral comments and/
along with a copy of their presentation of the Department of Health and Human or submit written comments. Comments
to Patricia Stroup, MBA, MPA, Services about the development of are part of the official Committee record.
Executive Secretary, Healthcare Systems newborn screening activities, Advance registration is required to
Bureau, Health Resources and Services technologies, policies, guidelines, and present oral comments and/or submit
Administration, at pstroup@hrsa.gov. programs for effectively reducing written comments. Oral public
Requests should contain the name, morbidity and mortality in newborns comments are tentatively scheduled for
address, telephone number, email and children having, or at risk for, November 3, 2015. Individuals who
address, and any business or heritable disorders. In addition, the wish to present oral public comments
professional affiliation of the person Committee’s recommendations must indicate this when registering.
desiring to make an oral presentation. regarding additional conditions/ Written comments may be uploaded on
Groups having similar interests are inherited disorders for screening that the registration Web site and must be
requested to combine their comments have been adopted by the Secretary are received by the registration deadline
and present them through a single included in the Recommended Uniform (October 30, 11:59 p.m. Eastern Time),
representative. Screening Panel (RUSP) and constitute as this will allow them to be included
The allocation of time may be part of the comprehensive guidelines in the November meeting briefing book.
adjusted to accommodate the level of supported by the Health Resources and Individuals who wish to present oral
expressed interest. Persons who do not Services Administration. Pursuant to comments and/or provide written
file an advance request for a section 2713 of the Public Health comments should identify on the
presentation, but desire to make an oral Service Act, codified at 42 U.S.C. registration Web site the individual’s
statement, may request it during the
mstockstill on DSK4VPTVN1PROD with NOTICES
300gg–13, non-grandfathered health name, address, email, telephone
public comment period. Public plans and group and individual health number, professional or business
participation and ability to comment insurance issuers are required to cover affiliation, type of expertise (i.e., parent,
will be limited to time as it permits. screenings included in the HRSA- researcher, clinician, public health,
FOR FURTHER INFORMATION CONTACT: supported comprehensive guidelines etc.), and the topic/subject matter of
Patricia Stroup, MBA, MPA, Executive without charging a co-payment, co- comments. To ensure that all
Secretary, Healthcare Systems Bureau, insurance, or deductible for plan years individuals who have registered to make
Health Resources and Services (i.e., policy years) beginning on or after oral comments can be accommodated,
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![63560 Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices
the allocated time may be limited. Information Collection Clearance implemented in the Affordable Care
Individuals who are associated with Officer, Room 10–29, Parklawn Act. Section 7102(b) of the Affordable
groups or have similar interests may be Building, 5600 Fishers Lane, Rockville, Care Act amends section 340B(a)(1) of
requested to combine their comments MD 20857. the Public Health Service Act (PHSA) to
and present them through a single FOR FURTHER INFORMATION CONTACT: To add two new requirements for inclusion
representative. No audiovisual request more information on the in the PPA with manufacturers of
presentations are permitted. For proposed project or to obtain a copy of covered outpatient drugs:
additional information or questions on the data collection plans and draft I. ‘‘Each such agreement shall require
public comments, please contact Lisa instruments, email paperwork@hrsa.gov that the manufacturer furnish the
Vasquez, Maternal and Child Health or call the HRSA Information Collection Secretary with reports, on a quarterly
Bureau, Health Resources and Services Clearance Officer at (301) 443–1984. basis, of the price for each covered
Administration; email: SUPPLEMENTARY INFORMATION: When outpatient drug subject to the agreement
lvasquez@hrsa.gov. submitting comments or requesting
Contact Person: Anyone interested in that, according to the manufacturer,
information, please include the represents the maximum price that
obtaining other relevant information
information request collection title for covered entities may permissibly be
should contact Debi Sarkar, Maternal
reference. required to pay for the drug (referred to
and Child Health Bureau, Health
Information Collection Request Title: in this section as the ‘‘ceiling price’’)
Resources and Services Administration,
Enrollment and Re-Certification of and
Room 18W68, Parklawn Building, 5600
Entities in the 340B Drug Pricing
Fishers Lane, Rockville, Maryland II. ‘‘. . . shall require that the
Program and Collection of Manufacturer
20857; email: dsarkar@hrsa.gov. manufacturer offer each covered entity
More information on the Advisory Data to Verify 340B Drug Pricing
Program Ceiling Price Calculations. covered outpatient drugs for purchase at
Committee is available at http://www. or below the applicable ceiling price if
hrsa.gov/advisorycommittees/mchb OMB No. 0915–0327—Revision.
Abstract: Section 602 of Public Law such drug is made available to any other
advisory/heritabledisorders. purchaser at any price.’’
102–585, the Veterans Health Care Act
Jackie Painter, of 1992, enacted as Section 340B of the These requirements shall be included
Director, Division of the Executive Secretariat. Public Health Service Act (PHS Act; in the PPA addendum to be signed by
[FR Doc. 2015–26524 Filed 10–19–15; 8:45 am] ‘‘Limitation on Prices of Drugs manufacturers participating in the 340B
BILLING CODE 4165–15–P Purchased by Covered Entities’’), Program to ensure that the provisions of
provides that a manufacturer who sells the 340B statute requiring inclusion in
covered outpatient drugs to eligible the PPA are satisfied. The execution of
DEPARTMENT OF HEALTH AND entities must sign a Pharmaceutical the addendum by manufacturers will
HUMAN SERVICES Pricing Agreement (PPA) with the fulfill the administrative requirement of
Secretary of Health and Human Services the statute that these provisions be
Health Resources and Services in which the manufacturer agrees to included in the PPA. The burden
Administration charge a price for covered outpatient imposed on manufacturers by the
drugs that will not exceed an amount proposed requirement of the PPA is
Agency Information Collection determined under a statutory formula
Activities: Proposed Collection: Public minimal because the addendum does
(‘‘ceiling price’’). A manufacturer not impose requirements beyond review
Comment Request
subject to a PPA must offer all covered and a signature by the manufacturer.
AGENCY: Health Resources and Services outpatient drugs at no more than the
Likely Respondents: Drug
Administration, HHS. ceiling price to a covered entity listed in
Manufacturers.
ACTION: Notice. the 340B Program database. The
manufacturer shall rely on the Burden Statement: Burden in this
SUMMARY: In compliance with the information in the 340B database to context means the time expended by
requirement for opportunity for public determine if the covered entity is persons to generate, maintain, retain,
comment on proposed data collection participating in the 340B Program or for disclose or provide the information
projects (Section 3506(c)(2)(A) of the any notifications of changes to requested. This includes the time
Paperwork Reduction Act of 1995), the eligibility that may occur within a needed to review instructions; to
Health Resources and Services quarter. By signing the PPA, the develop, acquire, install and utilize
Administration (HRSA) announces manufacturer agrees to comply with all technology and systems for the purpose
plans to submit an Information applicable statutory and regulatory of collecting, validating and verifying
Collection Request (ICR), described requirements. information, processing and
below, to the Office of Management and The purpose of this revision is to maintaining information, and disclosing
Budget (OMB). Prior to submitting the include an addendum to the PPA to and providing information; to train
ICR to OMB, HRSA seeks comments incorporate the administrative personnel and to be able to respond to
from the public regarding the burden requirement for manufacturer integrity a collection of information; to search
estimate, below, or any other aspect of provisions directly addressed in the data sources; to complete and review
the ICR. Affordable Care Act. the collection of information; and to
DATES: Comments on this Information Need and Proposed Use of the transmit or otherwise disclose the
Collection Request must be received no Information: HRSA is proposing information. The total annual burden
mstockstill on DSK4VPTVN1PROD with NOTICES
later than December 21, 2015. revisions to the current PPA to include hours estimated for this Information
ADDRESSES: Submit your comments to an addendum in response to Collection Request are summarized in
paperwork@hrsa.gov or mail the HRSA manufacturer integrity provisions the table below.
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Document Created: 2015-12-14 15:25:01
Document Modified: 2015-12-14 15:25:01
| 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 | |
| FR Citation | 80 FR 63559 |
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