30-day FRN

Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
We base our estimates on our
experience with the submission of
electronic information to us using the
FDA ESG and the number of electronic
registration or change requests received
between January 1, 2014, and December
31, 2014.
Dated: April 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08075 Filed 4–7–16; 8:45 am]
BILLING CODE 4164–01–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 9, 2016.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
[email protected] 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 [email protected] or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Enrollment and Re-Certification of
Entities in the 340B Drug Pricing
Program and Collection of Manufacturer

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SUMMARY:

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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 the Secretary of Health
and Human Services will enter into a
Pharmaceutical Pricing Agreement
(PPA) with each manufacturer of
covered outpatient drugs in which the
manufacturer agrees to charge a price for
covered outpatient drugs that will not
exceed the average manufacturer price
decreased by a rebate percentage. Under
this PPA, a manufacturer agrees not to
charge a price for covered outpatient
drugs that exceeds 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 if such drug
is made available to any other purchaser
at any price. The manufacturer shall
rely on the information in the 340B
database to determine if the 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. In response to comments
submitted during the first public review
of this ICR, the language has been
revised in this notice and in the draft
instruments in order to align with the
applicable statutory language regarding
the obligation to sign the PPA, the
circumstances under which
participating manufacturers must offer
covered outpatient drugs to covered
entities, and the description of the
ceiling price data required to be
provided.
The purpose of this revision is to
include an addendum to the PPA to
incorporate the administrative
requirement for manufacturer integrity
provisions directly addressed in the
Affordable Care Act.
Need and Proposed Use of the
Information: HRSA is proposing
revisions to the current PPA to include
an addendum in response to
manufacturer integrity provisions
implemented in the Affordable Care

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20649

Act. Section 7102(b) of the Affordable
Care Act amends section 340B(a)(1) of
the Public Health Service Act (PHSA) to
add two new requirements for inclusion
in the PPA with manufacturers of
covered outpatient drugs:
I. ‘‘Each such agreement shall require
that the manufacturer furnish the
Secretary with reports, on a quarterly
basis, of the price for each covered
outpatient drug subject to the agreement
that, according to the manufacturer,
represents the maximum price that
covered entities may permissibly be
required to pay for the drug . . .’’ and
II. ‘‘. . . shall require that the
manufacturer offer each covered entity
covered outpatient drugs for purchase at
or below the applicable ceiling price if
such drug is made available to any other
purchaser at any price.’’
These requirements shall be included
in the PPA addendum to be signed by
manufacturers participating in the 340B
Program to ensure that the provisions of
the 340B statute requiring inclusion in
the PPA are satisfied. The execution of
the addendum by manufacturers will
fulfill the administrative requirement of
the statute that these provisions be
included in the PPA. The burden
imposed on manufacturers by the
proposed requirement of the PPA is
minimal because the addendum does
not impose requirements beyond review
and a signature by the manufacturer.
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 Information
Collection Request are summarized in
the table below.
Total Estimated Annualized Burden
Hours:

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20650

Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
Number of
respondents

Form name

Number of
responses per
respondent

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
2134

1
8
6

194
5576
12804

2
0.5
0.25

388
2788
3201

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
405
1204
3123

3
1
1
5
1

1281
647
405
6020
3123

1
1
1
0.25
0.25

1281
647
405
1505
780.75

4899

1

4899

0.25

1224.75

5

8790

1

8790

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

1758

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 .................................................
Pharmaceutical Pricing Agreement (PPA) Addendum ....................

9396
350

1
1

9396
350

0.5
0.5

4698
175

600
200
620

4
1
1

2400
200
620

0.5
1
0.5

1200
200
310

Total ..........................................................................................

26,654

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

56,705

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

27593.5

HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–08110 Filed 4–7–16; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration

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National Advisory Council on Nurse
Education and Practice; 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
Nurse Education and Practice
(NACNEP).

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Dates and Time: June 7–8, 2016, 8:30
a.m.–5:00 p.m. EST.
Place: In-Person Meeting with
Webinar/Conference Call Component,
U.S. Department of Health and Human
Services, Health Resources and Services
Administration, 5600 Fishers Lane,
Room 5A02/5A03, Rockville, Maryland
20857.
Status: This Advisory Council
meeting will be open to the public.
Purpose: The purpose of the 133rd
NACNEP meeting is to explore strategies
to prepare registered nurses (RNs) to
address the complex health needs of
populations within an evolving health
care delivery system. NACNEP members
will identify and discuss gaps in
population health education, as well as
educational competencies in population
health for RNs. This meeting will
contribute to the development of
NACNEP’s mandated 14th Annual
Report to the Secretary of the U.S.
Department of Health and Human
Services and Congress.
Agenda: A final agenda will be posted
on the NACNEP Web site 3 days prior
to the meeting. Agenda items are subject
to change as priorities dictate.
SUPPLEMENTARY INFORMATION: Further
information regarding NACNEP,
including the roster of members, reports
to Congress, and minutes from previous
meetings, is available at the NACNEP
Web site. Members of the public and

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interested parties may request to attend
the meeting by contacting Staff
Assistant, Jeanne Brown, at jbrown@
hrsa.gov. Access to the meeting will be
granted on a first-come, first-served
basis and space is limited. Public
attendees may submit written
statements in advance of the scheduled
meeting. In addition, a public comment
period is tentatively scheduled for the
first day of the meeting after the lunch
break. Oral comments will be limited to
three minutes per speaker. Written
statements and registration for oral
comments must be received in advance
and should be sent to Erin Fowler by
email at: [email protected]. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
contact person listed above at least 10
days prior to the meeting.
Please be advised that council
members are given copies of all written
statements submitted by the public prior
to the meeting. Any further public
participation will be at the discretion of
the Chair, with approval of the
Designated Federal Official in
attendance. Any member of the public
who wishes to have printed materials
distributed to NACNEP should submit
materials to the National Advisory
Council on Nurse Education and
Practice mailbox at [email protected],

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