80 FR 22206 - National Advisory Committee on Rural Health and Human Services; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 76 (April 21, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 76 (April 21, 2015)
| Page Range | 22206-22207 | |
| FR Document | 2015-09080 |
[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)] [Notices] [Pages 22206-22207] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09080] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Committee on Rural Health and Human Services; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), announcement is made of the following National Advisory body scheduled to meet during the month of May 2015. The National Advisory Committee on Rural Health and Human Services will convene its seventy seventh meeting in the time and place specified below: Name: National Advisory Committee on Rural Health and Human Services. Dates and Time: May 27, 2015, 8:45 a.m.--5:00 p.m.; May 28, 2015, 8:30 a.m.--5:15 p.m.; May 29, 2015, 8:30 a.m.--11:00 a.m. Place: Natural Bridge State Park, 2135 Natural Bridge Rd, Slade, KY 40376, (606) 663-2214. Status: The meeting will be open to the public. Purpose: The National Advisory Committee on Rural Health and Human Services provides counsel and recommendations to the Secretary with respect to the delivery, research, development, and administration of health and human services in rural areas. Agenda: Wednesday morning, at 8:45 a.m., the meeting will be called to order by the Chairperson of the Committee: The Honorable Ronnie Musgrove. The Committee will examine the issue of an increasing difference between life expectancy among the urban and rural populations of the United States. The day will conclude with a period of public comment at approximately 4:45 p.m. Thursday morning at approximately 8:30 a.m., the Committee will break into Subcommittees and depart for site visits. Subcommittees will visit the Center of Excellence in Rural Health in Hazard, Kentucky, and the Marcum & Wallace Memorial Hospital in Irvine, Kentucky. The day will conclude at the Natural Bridge State Park with a period of public comment at approximately 5:00 p.m. Friday morning at 8:30 a.m., the Committee will meet to summarize key findings and develop a work plan for the next quarter and the following meeting. FOR FURTHER INFORMATION CONTACT: Steve Hirsch, MSLS, Executive Secretary, National Advisory Committee on Rural Health and Human Services, Health Resources and Services Administration, Parklawn Building, 17W29-C, 5600 Fishers Lane, Rockville, MD 20857, Telephone (301) 443-0835, Fax (301) 443-2803. Persons interested in attending any portion of the meeting should contact Catherine Fontenot at the Federal Office of Rural Health Policy (FORHP) via telephone at (301) 945-0897 or by email at cfontenot@hrsa.gov. The Committee [[Page 22207]] meeting agenda will be posted on the Committee's Web site at http://www.hrsa.gov/advisorycommittees/rural/. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-09080 Filed 4-20-15; 8:45 am] BILLING CODE 4165-15-P
![22206 Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices
marketing decision. These challenges IV. Paperwork Reduction Act of 1995 made of the following National
may include differences between the This draft guidance refers to currently Advisory body scheduled to meet
OUS and U.S. clinical conditions, approved collections of information during the month of May 2015.
regulatory requirements (including found in FDA regulations. These The National Advisory Committee on
human subject protections), and/or collections of information are subject to Rural Health and Human Services will
study populations that may be sufficient review by the Office of Management and convene its seventy seventh meeting in
to affect the adequacy of the data for use Budget (OMB) under the Paperwork the time and place specified below:
in establishing the safety and/or Reduction Act of 1995 (44 U.S.C. 3501– Name: National Advisory Committee
effectiveness of the studied device. This 3520). The collections of information in on Rural Health and Human Services.
guidance focuses on considerations 21 CFR parts 50 and 56 have been Dates and Time: May 27, 2015, 8:45
sponsors of device submissions should approved under OMB control number a.m.—5:00 p.m.; May 28, 2015, 8:30
take into account when initiating, or 0910–0755; the collections of a.m.—5:15 p.m.; May 29, 2015, 8:30
relying on previously collected data information in 21 CFR part 601 have a.m.—11:00 a.m.
from, an OUS clinical study to support been approved under OMB control Place: Natural Bridge State Park, 2135
an Investigational Device Exemption, number 0910–0338; the collections of Natural Bridge Rd, Slade, KY 40376,
Premarket Notification (510(k)), De information in 21 CFR parts 801 and (606) 663–2214.
Novo Petition, Humanitarian Device 809 have been approved under OMB Status: The meeting will be open to
Exemption, or Premarket Approval control number 0910–0485; the the public.
Application. This guidance also notes collections of information in 21 CFR Purpose: The National Advisory
other important considerations to take part 807, subpart E, have been approved Committee on Rural Health and Human
into account when initiating or relying under OMB control number 0910–0120; Services provides counsel and
on OUS data. FDA believes that the collections of information in 21 CFR recommendations to the Secretary with
promoting greater clarity concerning part 812 has been approved under OMB respect to the delivery, research,
FDA’s use of foreign study data will control number 0910–0078; the development, and administration of
minimize the possibility for additional collections of information in 21 CFR health and human services in rural
or duplicative U.S. studies, further part 814 have been approved under areas.
efforts to harmonize global clinical trial OMB control number 0910–0231; the Agenda: Wednesday morning, at 8:45
standards, and promote public health collections of information in 21 CFR a.m., the meeting will be called to order
and innovation. part 814, subpart H have been approved by the Chairperson of the Committee:
under OMB control number 0910–0332; The Honorable Ronnie Musgrove. The
II. Significance of Guidance Committee will examine the issue of an
and the collections of information in 21
This draft guidance is being issued CFR part 820 have been approved under increasing difference between life
consistent with FDA’s good guidance OMB control number 0910–0073. expectancy among the urban and rural
practices regulation (21 CFR 10.115). populations of the United States. The
V. Comments day will conclude with a period of
The draft guidance, when finalized, will
represent the Agency’s current thinking Interested persons may submit either public comment at approximately 4:45
on acceptance of clinical data from electronic comments regarding this p.m.
foreign studies conducted OUS. It does document to http://www.regulations.gov Thursday morning at approximately
not create or confer any rights for or on or written comments to the Division of 8:30 a.m., the Committee will break into
any person and does not operate to bind Dockets Management (see ADDRESSES). It Subcommittees and depart for site
FDA or the public. An alternative is only necessary to send one set of visits. Subcommittees will visit the
approach may be used if such approach comments. Identify comments with the Center of Excellence in Rural Health in
satisfies the requirements of the docket number found in brackets in the Hazard, Kentucky, and the Marcum &
applicable statute and regulations. heading of this document. Received Wallace Memorial Hospital in Irvine,
comments may be seen in the Division Kentucky. The day will conclude at the
III. Electronic Access of Dockets Management between 9 a.m. Natural Bridge State Park with a period
and 4 p.m., Monday through Friday, and of public comment at approximately
Persons interested in obtaining a copy
will be posted to the docket at http:// 5:00 p.m.
of the draft guidance may do so by
www.regulations.gov. Friday morning at 8:30 a.m., the
downloading an electronic copy from
the Internet. A search capability for all Dated: April 15, 2015. Committee will meet to summarize key
Centers for Devices and Radiological Leslie Kux, findings and develop a work plan for
Health guidance documents is available Associate Commissioner for Policy. the next quarter and the following
at http://www.fda.gov/MedicalDevices/ [FR Doc. 2015–09176 Filed 4–20–15; 8:45 am]
meeting.
DeviceRegulationandGuidance/ BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT:
GuidanceDocuments/default.htm. Steve Hirsch, MSLS, Executive
Guidance documents are also available Secretary, National Advisory Committee
at http://www.regulations.gov. Persons DEPARTMENT OF HEALTH AND on Rural Health and Human Services,
unable to download an electronic copy HUMAN SERVICES Health Resources and Services
of ‘‘Acceptance of Medical Device Administration, Parklawn Building,
Clinical Data from Studies Conducted Health Resources and Services 17W29–C, 5600 Fishers Lane, Rockville,
Outside the United States; Draft Administration MD 20857, Telephone (301) 443–0835,
tkelley on DSK3SPTVN1PROD with NOTICES
Guidance for Industry and Food and Fax (301) 443–2803.
National Advisory Committee on Rural
Drug Administration Staff’’ may send an Persons interested in attending any
Health and Human Services; Notice of
email request to CDRH-Guidance@ portion of the meeting should contact
Meeting
fda.hhs.gov to receive an electronic Catherine Fontenot at the Federal Office
copy of the document. Please use the In accordance with section 10(a)(2) of of Rural Health Policy (FORHP) via
document number 1741 to identify the the Federal Advisory Committee Act telephone at (301) 945–0897 or by email
guidance you are requesting. (Pub. L. 92–463), announcement is at cfontenot@hrsa.gov. The Committee
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![Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22207
meeting agenda will be posted on the Interested parties should refer to the SUPPLEMENTARY INFORMATION:
Committee’s Web site at http:// meeting, in the subject line, as the Information Collection Request Title:
www.hrsa.gov/advisorycommittees/ HRSA National Advisory Council on the Enrollment and Re-Certification of
rural/. National Health Service Corps. The Entities in the 340B Drug Pricing
conference call-in number is: 888–566– Program and Collection of Manufacturer
Jackie Painter,
5974. The passcode is: 4439136. Data to Verify 340B Drug Pricing
Director, Division of the Executive Secretariat. Program Ceiling Price Calculations.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–09080 Filed 4–20–15; 8:45 am]
Anyone requesting information OMB No. 0915–0327—Revision
BILLING CODE 4165–15–P
regarding the NAC should contact CAPT Abstract: Section 602 of Public Law
Shari Campbell, Designated Federal 102–585, the Veterans Health Care Act
DEPARTMENT OF HEALTH AND Official, Bureau of Health Workforce, of 1992, enacted as Section 340B of the
HUMAN SERVICES HRSA, in one of three ways: (1) Send a Public Health Service Act (PHS Act;
request to the following address: CAPT ‘‘Limitation on Prices of Drugs
Health Resources and Services Shari Campbell, Designated Federal Purchased by Covered Entities’’),
Administration Official, Bureau of Health Workforce, provides that a manufacturer who sells
HRSA, Parklawn Building, Room 8C–26, covered outpatient drugs to eligible
National Advisory Council on the 5600 Fishers Lane, Rockville, Maryland entities must sign a Pharmaceutical
National Health Service Corps; Notice 20857; (2) call (301) 594–4251; or (3) Pricing Agreement (PPA) with the
of Meeting send an email to scampbell@hrsa.gov. Secretary of Health and Human Services
In accordance with section 10(a)(2) of Jackie Painter, in which the manufacturer agrees to
the Federal Advisory Committee Act Director, Division of the Executive Secretariat. charge a price for covered outpatient
(Pub. L. 92–463), notice is hereby given [FR Doc. 2015–09078 Filed 4–20–15; 8:45 am]
drugs that will not exceed an amount
of the following meeting: determined under a statutory formula
BILLING CODE 4165–15–P
Name: National Advisory Council on (‘‘ceiling price’’).
the National Health Service Corps A manufacturer subject to a PPA must
(NAC). DEPARTMENT OF HEALTH AND offer all covered outpatient drugs at no
Date and Time: May 6, 2015 from 2:00 HUMAN SERVICES more than the ceiling price to a covered
p.m.–3:30 p.m. (EST). entity listed in the 340B Program
Place: Conference Call Format. Health Resources and Services database. Manufacturers rely on the
Status: The meeting will be open to Administration information in the 340B database to
the public. determine if a covered entity is
Purpose: The NAC provides advice to Agency Information Collection participating in the 340B Program or for
the Secretary of the Department of Activities: Submission to OMB for any notifications of changes to
Health and Human Services and the Review and Approval; Public Comment eligibility that may occur within a
Administrator of the Health Resources Request quarter. By signing the PPA, the
and Services Administration (HRSA), manufacturer agrees to comply with all
with respect to their responsibilities for AGENCY: Health Resources and Services applicable statutory and regulatory
designating areas of the United States Administration, HHS. requirements, including any changes
with critical health professional ACTION: Notice. that occur after execution of the PPA.
shortages (i.e., Health Professional Covered entities which choose to
Shortage Area) and assigning health care SUMMARY: In compliance with Section participate in the 340B Program must
personnel to improve the delivery of 3507(a)(1)(D) of the Paperwork comply with the requirements of
health services in these areas. Reduction Act of 1995, the Health Section 340B(a)(5) of the PHS Act.
Agenda: The members of the NAC Resources and Services Administration Section 340B(a)(5)(A) prohibits a
will discuss: (a) The activities and goals (HRSA) has submitted an Information covered entity from accepting a
for fiscal year 2016 for the National Collection Request (ICR) to the Office of discount for a drug that would also
Health Service Corps; (b) their vision Management and Budget (OMB) for generate a Medicaid rebate. Further,
and approaches for future NAC review and approval. Comments Section 340B(a)(5)(B) prohibits a
meetings; and (c) planning for an in- submitted during the first public review covered entity from reselling or
person meeting. The official agenda will of this ICR will be provided to OMB. otherwise transferring a discounted drug
be available 2 days prior to the meeting OMB will accept further comments from to a person who is not a patient of the
on the HRSA Web site at: http:// the public during the review and entity.
nhsc.hrsa.gov/corpsexperience/aboutus/ approval period. Need and Proposed Use of the
nationaladvisorycouncil/. Agenda items DATES: Comments on this ICR should be Information: Section 340B(d)(1)(B)(i) of
are subject to change as priorities received no later than May 21, 2015. the PHS Act requires the development
dictate. of a system to enable the Secretary to
Public Comment: Requests to make ADDRESSES: Submit your comments,
verify the accuracy of ceiling prices
oral comments or provide written including the Information Collection calculated by manufacturers under
comments to the NAC should be sent to Request Title, to the desk officer for subsection (a)(1) and charged to covered
CAPT Shari Campbell, Designated HRSA, either by email to OIRA_ entities, which shall include the
Federal Official, using the address and submission@omb.eop.gov or by fax to following:
202–395–5806.
tkelley on DSK3SPTVN1PROD with NOTICES
phone number below. Individuals who (I) Developing and publishing through
plan to participate on the conference FOR FURTHER INFORMATION CONTACT: To an appropriate policy or regulatory
call should notify CAPT Campbell at request a copy of the clearance requests issuance, precisely defined standards
least 3 days prior to the meeting, using submitted to OMB for review, email the and methodology for the calculation of
the address and phone number below. HRSA Information Collection Clearance ceiling prices under such subsection.
Members of the public will have the Officer at paperwork@hrsa.gov or call (II) Comparing regularly the ceiling
opportunity to provide comments. (301) 443–1984. prices calculated by the Secretary with
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Document Created: 2015-12-16 08:33:54
Document Modified: 2015-12-16 08:33:54
| 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 | |
| Contact | Steve Hirsch, MSLS, Executive Secretary, National Advisory Committee on Rural Health and Human Services, Health Resources and Services Administration, Parklawn Building, 17W29-C, 5600 Fishers Lane, Rockville, MD 20857, Telephone (301) 443-0835, Fax (301) 443-2803. | |
| FR Citation | 80 FR 22206 |
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