Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 20649-20650 [2016-08110]
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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_
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.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Enrollment and Re-Certification of
Entities in the 340B Drug Pricing
Program and Collection of Manufacturer
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:48 Apr 07, 2016
Jkt 238001
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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\08APN1.SGM
08APN1
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
mstockstill on DSK4VPTVN1PROD with NOTICES
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).
VerDate Sep<11>2014
17:48 Apr 07, 2016
Jkt 238001
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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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: nacnep@hrsa.gov. 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 nacnep@hrsa.gov,
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20649-20650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08110]
-----------------------------------------------------------------------
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
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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_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.
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 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
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:
[[Page 20650]]
----------------------------------------------------------------------------------------------------------------
Number of Total
Form name Number of responses per Total Hours per burden
respondents respondent responses respondent hours
----------------------------------------------------------------------------------------------------------------
Hospital Enrollment, Additions & Recertifications
----------------------------------------------------------------------------------------------------------------
340B Program Registrations & 194 1 194 2 388
Certifications for Hospitals............
Certifications to Enroll Hospital 697 8 5576 0.5 2788
Outpatient Facilities...................
Hospital Annual Recertifications......... 2134 6 12804 0.25 3201
----------------------------------------------------------------------------------------------------------------
Registrations and Recertifications for Entities Other Than Hospitals
----------------------------------------------------------------------------------------------------------------
340B Registrations for Community Health 427 3 1281 1 1281
Centers.................................
340B Registrations for STD/TB Clinics.... 647 1 647 1 647
340B Registrations for Various Other 405 1 405 1 405
Eligible Entity Types...................
Community Health Center Annual 1204 5 6020 0.25 1505
Recertifications........................
STD & TB Annual Recertifications......... 3123 1 3123 0.25 780.75
Annual Recertification for entities other 4899 1 4899 0.25 1224.75
than Hospitals, Community Health
Centers, and STD/TB Clinics.............
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services Registration & Recertifications
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services Registration 1758 5 8790 1 8790
----------------------------------------------------------------------------------------------------------------
Other Information Collections
----------------------------------------------------------------------------------------------------------------
Submission of Administrative Changes for 9396 1 9396 0.5 4698
any Covered Entity......................
Submission of Administrative Changes for 350 1 350 0.5 175
any Manufacturer........................
Manufacturer Data Required to Verify 340B 600 4 2400 0.5 1200
Ceiling Price Calculations..............
Pharmaceutical Pricing Agreement......... 200 1 200 1 200
Pharmaceutical Pricing Agreement (PPA) 620 1 620 0.5 310
Addendum................................
----------------------------------------------------------------------
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
