30-day FRN

Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration

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National Advisory Council on the
National Health Service Corps; Notice
of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: National Advisory Council on
the National Health Service Corps
(NAC).
Date and Time: May 6, 2015 from 2:00
p.m.–3:30 p.m. (EST).
Place: Conference Call Format.
Status: The meeting will be open to
the public.
Purpose: The NAC provides advice to
the Secretary of the Department of
Health and Human Services and the
Administrator of the Health Resources
and Services Administration (HRSA),
with respect to their responsibilities for
designating areas of the United States
with critical health professional
shortages (i.e., Health Professional
Shortage Area) and assigning health care
personnel to improve the delivery of
health services in these areas.
Agenda: The members of the NAC
will discuss: (a) The activities and goals
for fiscal year 2016 for the National
Health Service Corps; (b) their vision
and approaches for future NAC
meetings; and (c) planning for an inperson meeting. The official agenda will
be available 2 days prior to the meeting
on the HRSA Web site at: http://
nhsc.hrsa.gov/corpsexperience/aboutus/
nationaladvisorycouncil/. Agenda items
are subject to change as priorities
dictate.
Public Comment: Requests to make
oral comments or provide written
comments to the NAC should be sent to
CAPT Shari Campbell, Designated
Federal Official, using the address and
phone number below. Individuals who
plan to participate on the conference
call should notify CAPT Campbell at
least 3 days prior to the meeting, using
the address and phone number below.
Members of the public will have the
opportunity to provide comments.

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Interested parties should refer to the
meeting, in the subject line, as the
HRSA National Advisory Council on the
National Health Service Corps. The
conference call-in number is: 888–566–
5974. The passcode is: 4439136.
FOR FURTHER INFORMATION CONTACT:
Anyone requesting information
regarding the NAC should contact CAPT
Shari Campbell, Designated Federal
Official, Bureau of Health Workforce,
HRSA, in one of three ways: (1) Send a
request to the following address: CAPT
Shari Campbell, Designated Federal
Official, Bureau of Health Workforce,
HRSA, Parklawn Building, Room 8C–26,
5600 Fishers Lane, Rockville, Maryland
20857; (2) call (301) 594–4251; or (3)
send an email to scampbell@hrsa.gov.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–09078 Filed 4–20–15; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:

In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than May 21, 2015.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUMMARY:

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SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Enrollment and Re-Certification of
Entities in the 340B Drug Pricing
Program and Collection of Manufacturer
Data to Verify 340B Drug Pricing
Program Ceiling Price Calculations.

OMB No. 0915–0327—Revision
Abstract: Section 602 of Public Law
102–585, the Veterans Health Care Act
of 1992, enacted as Section 340B of the
Public Health Service Act (PHS Act;
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities’’),
provides that a manufacturer who sells
covered outpatient drugs to eligible
entities must sign a Pharmaceutical
Pricing Agreement (PPA) with the
Secretary of Health and Human Services
in which the manufacturer agrees to
charge a price for covered outpatient
drugs that will not exceed an amount
determined under a statutory formula
(‘‘ceiling price’’).
A manufacturer subject to a PPA must
offer all covered outpatient drugs at no
more than the ceiling price to a covered
entity listed in the 340B Program
database. Manufacturers rely on the
information in the 340B database to
determine if a covered entity is
participating in the 340B Program or for
any notifications of changes to
eligibility that may occur within a
quarter. By signing the PPA, the
manufacturer agrees to comply with all
applicable statutory and regulatory
requirements, including any changes
that occur after execution of the PPA.
Covered entities which choose to
participate in the 340B Program must
comply with the requirements of
Section 340B(a)(5) of the PHS Act.
Section 340B(a)(5)(A) prohibits a
covered entity from accepting a
discount for a drug that would also
generate a Medicaid rebate. Further,
Section 340B(a)(5)(B) prohibits a
covered entity from reselling or
otherwise transferring a discounted drug
to a person who is not a patient of the
entity.
Need and Proposed Use of the
Information: Section 340B(d)(1)(B)(i) of
the PHS Act requires the development
of a system to enable the Secretary to
verify the accuracy of ceiling prices
calculated by manufacturers under
subsection (a)(1) and charged to covered
entities, which shall include the
following:
(I) Developing and publishing through
an appropriate policy or regulatory
issuance, precisely defined standards
and methodology for the calculation of
ceiling prices under such subsection.
(II) Comparing regularly the ceiling
prices calculated by the Secretary with

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Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices

the quarterly pricing data that is
reported by manufacturers to the
Secretary.
(III) Performing spot checks of sales
transactions by covered entities.
(IV) Inquiring into the cause of any
pricing discrepancies that may be
identified and either taking, or requiring
manufacturers to take, such corrective
action as is appropriate in response to
such price discrepancies.
HRSA’s Office of Pharmacy Affairs
(OPA) has previously obtained approval
for information collections in support of
340B covered entity recertification and
registration, as well as registration of
contract pharmacy arrangements and
the PPA itself. OPA is requesting
comments on an additional information
collection in response to the above
pricing verification requirements, as
well as the routine renewal of approval
for the existing information collections.
The previously approved collections are
substantially unchanged, except that
HRSA has transitioned completely to
online versus hardcopy forms.
Pricing data submission, validation
and dissemination: In order to
implement Section 340B(d)(1)(B)(i)(II),

HRSA has already developed a system
to calculate 340B ceiling prices
prospectively from data obtained from
the Centers for Medicare & Medicaid
Services as well as OPA-identified
commercial databases. However, in
order to conduct the comparison
required under the statute,
manufacturers must submit the
quarterly pricing data as required by
section 340B(d)(1)(B)(i)(II).
HRSA is developing a mechanism for
secure manufacturer submissions. This
notice proposes collecting Average
Manufacturer Price, Unit Rebate
Amount, Package Sizes, National Drug
Code (NDC), period of sale (year and
quarter), and manufacturer-determined
340B ceiling price for each NDC
produced by a manufacturer subject to
a PPA. Once any discrepancies between
the manufacturer and OPA-calculated
prices have been resolved, the validated
prices will be made available to
registered covered entities via a secure
Internet-accessible platform as required
by Section 340B(d)(1)(B)(iii).
Accurate and timely pricing data
submissions are critical to successful
implementation of the 340B Program,

ensuring that covered entities have
confidence that the amounts being
charged are in accordance with
statutorily-defined ceiling prices. The
burden imposed on manufacturers by
this requirement is low because the
information requested is readily
available.
Likely Respondents: Drug
Manufacturers.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
responses per
respondent

Number of
respondents

Form name

Total
responses

Hours per
respondent

Total burden
hours

Hospital Enrollment, Additions & Recertifications
340B Program Registrations & Certifications for Hospitals
Certifications to Enroll Hospital Outpatient Facilities .........
Hospital Annual Recertifications ........................................

194
697
2,134

1
8
6

194
5,576
12,804

2
0.5
0.25

388
2,788
3,201

1,281
647

Registrations and Recertifications for Entities Other Than Hospitals
340B Registrations for Community Health Centers ..........
340B Registrations for STD/TB Clinics .............................
340B Registrations for Various Other Eligible Entity
Types ..............................................................................
Community Health Center Annual Recertifications ...........
STD & TB Annual Recertifications ....................................
Annual Recertification for entities other than Hospitals,
Community Health Centers, and STD/TB Clinics ..........

427
647

3
1

1,281
647

1
1

405
1,204
3,123

1
5
1

405
6,020
3,123

1
0.25
0.25

405
1,505
780.75

4,899

1

4,899

0.25

1,224.75

Contracted Pharmacy Services Registration & Recertifications
Contracted Pharmacy Services Registration .....................

1,758

5

8,790

1

8,790

9,396

1

9,396

0.5

4,698

350

1

350

0.5

175

600
200

4
1

2,400
200

0.5
1

1,200
200

26,034

........................

........................

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Other Information Collections
Submission of Administrative Changes for any Covered
Entity ...............................................................................
Submission of Administrative Changes for any Manufacturer ................................................................................
Manufacturer Data Required to Verify 340B Ceiling Price
Calculations ....................................................................
Pharmaceutical Pricing Agreement ...................................
Total ............................................................................

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Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–09079 Filed 4–20–15; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Comments on Deliberation
and Bioethics Education
Department of Health and
Human Services, Office of the Secretary,
Presidential Commission for the Study
of Bioethical Issues.
ACTION: Notice.
AGENCY:

The Presidential Commission
for the Study of Bioethical Issues is
requesting public comment on
deliberation and bioethics education.
DATES: To ensure consideration,
comments must be received by July 20,
2015. Comments received after this date
will be considered only as time permits.
ADDRESSES: Individuals, groups, and
organizations interested in commenting
on this topic may submit comments by
email to info@bioethics.gov or by mail to
the following address: Public
Commentary, Presidential Commission
for the Study of Bioethical Issues, 1425
New York Ave. NW., Suite C–100,
Washington, DC 20005.
FOR FURTHER INFORMATION CONTACT:
Hillary Wicai Viers, Communications
Director, Presidential Commission for
the Study of Bioethical Issues.
Telephone: 202–233–3960. Email:
hillary.viers@bioethics.gov. Additional
information may be obtained at http://
www.bioethics.gov.
SUPPLEMENTARY INFORMATION: On
November 24, 2009, the President
established the Presidential Commission
for the Study of Bioethical Issues
(Bioethics Commission) to advise him
on bioethical issues generated by novel
and emerging research in biomedicine
and related areas of science and
technology. The Commission is charged
with identifying and promoting policies
and practices that ensure ethically
responsible conduct of scientific
research and health care delivery.
Undertaking these duties, the
Commission seeks to identify and
examine specific bioethical, legal, and
social issues related to potential
scientific and technological advances;
examine diverse perspectives and
possibilities for international
collaboration on these issues; and
recommend legal, regulatory, or policy
actions as appropriate.
The Bioethics Commission is
considering two overarching themes of
its work, deliberation and education,

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SUMMARY:

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focusing on their symbiotic relationship
as twin pillars of public bioethics.
Democratic deliberation has been a
guiding ethical principle in the
Commission’s work, informing both its
processes and its recommendations. The
Commission also is committed to
supporting bioethics education at all
levels and across disciplines, through its
own pedagogical materials and its
recommendations for improving and
integrating ethics education in a range
of settings. This new project will
explore the relationship between
deliberation and bioethics education
and the importance of public
engagement in the bioethics
conversation. For example, the
Commission’s deliberations not only
advise the U.S. federal government, but
also play a vital role in civic education.
Bioethics education fosters the scientific
and ethical literacy that supports public
deliberation about science, medicine,
public health, and bioethics, and helps
to prepare students for their role as
citizens in understanding different
perspectives on complex issues that are
often the subject of public policy
debates.
At its meeting on November 6, 2014,
the Commission heard from scholars in
education, medical ethics, and political
philosophy, and began its consideration
of the relationship between deliberation
and bioethics education and its own
role in promoting both of these to
advance public understanding of and
engagement with bioethical debates. For
example, in its most recent report,
Ethics and Ebola: Public Health
Planning and Response, the
Commission made recommendations
regarding the importance of public
education and deliberation in preparing
for public health emergencies. The
ethical challenges that emerged in the
U.S. response to the ongoing Ebola
epidemic in western Africa underscore
the need for appropriate forums for
public engagement and debate on the
ethical dimensions of public health
decision making.
The Commission is interested in
receiving comments from individuals,
groups, and professional communities
regarding deliberation and education in
bioethics. The Commission is
particularly interested in receiving
public commentary regarding:
• The role of deliberation and
deliberative methods to engage the
public and inform debate in bioethics;
• Approaches to integrating public
dialogue into the bioethics conversation;
• Bioethics education as a forum for
fostering deliberative skills and
preparing students to participate in
public dialogue in bioethics;

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• Goals of bioethics education (e.g.,
empirical training, normative
foundations, clinical ethics), and the
competencies and skills bioethics
education seeks to foster;
• Methods and goals of designing
bioethics education and training
programs at different levels (e.g.,
undergraduate foci, master’s degree
programs, terminal degree programs,
and professional certification);
• Potential training in bioethics
across the lifespan at different
educational levels and settings (e.g.,
primary/secondary education,
community education, continuing
professional education), and the role of
education in laying the foundation for
constructive public deliberation and
debate in bioethics;
• The appropriate role of professional
standards for bioethicists, including
core competencies for bioethicists, and
potential accreditation of bioethics
training or education programs;
• Integrating bioethics education
across different professional contexts,
and establishing ‘‘dual competency’’
through reciprocal training in bioethics
and a home or primary discipline (e.g.,
engineering and bioethics, medicine and
bioethics, law and bioethics).
To this end, the Commission is
inviting interested parties to provide
input and advice through written
comments. Comments will be publicly
available, including any personally
identifiable or confidential business
information that they contain. Trade
secrets should not be submitted.
Dated: April 13, 2015.
Lisa M. Lee,
Executive Director, Presidential Commission
for the Study of Bioethical Issues.
[FR Doc. 2015–09172 Filed 4–20–15; 8:45 am]
BILLING CODE 4154–06–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Meeting; Privacy, Security &
Confidentiality Subcommittee
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
Name: National Committee on Vital
and Health Statistics (NCVHS)
Subcommittee on Privacy,
Confidentiality & Security.
Time And Date: May 6, 2015 9:00
a.m.–5:00 p.m. EST, May 7, 2015 9:00
a.m.–12:00 p.m. EST.
Place: U.S. Department of Health and
Human Services, Centers for Disease

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