Agency Information Collection Activities: Proposed Collection: Public Comment Request, 63560-63561 [2015-26522]
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63560
Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices
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 https://www.
hrsa.gov/advisorycommittees/mchb
advisory/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than December 21, 2015.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:55 Oct 19, 2015
Jkt 238001
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
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. 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.
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
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
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 (referred to
in this section as the ‘‘ceiling price’’)
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.
E:\FR\FM\20OCN1.SGM
20OCN1
63561
Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
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
Contracted Pharmacy Services Registration & Recertifications
Contracted Pharmacy Services Registration .......................
1758
5
8790
1
8790
9396
1
9396
0.5
4698
350
1
350
0.5
175
600
200
620
4
1
1
2400
200
620
0.5
1
0.5
1200
200
310
26,554
........................
56,705
........................
27593.5
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 ........
Total ..............................................................................
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. 2015–26522 Filed 10–19–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
VerDate Sep<11>2014
17:55 Oct 19, 2015
Jkt 238001
When
submitting comments or requesting
information, please include the
document identifier HHS–OS–0945–
0002–60D for reference.
Proposed Project: Complaint Forms
for Discrimination; Health Information
Privacy Complaints.
OMB No. 0945–0002—Extension—
Office of Civil Rights.
Abstract: The Office for Civil Rights is
seeking an extension on an approval for
a 3-year clearance on a previous
collection. Individuals may file written
complaints with the Office for Civil
Rights when they believe they have
been discriminated against by programs
or entities that receive Federal financial
assistance from the Health and Human
Service or if they believe that their right
to the privacy of protected health
information has been violated. Annual
Number of Respondents frequency of
submission is record keeping and
reporting on occasion.
SUPPLEMENTARY INFORMATION:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). The ICR is for extending the use
of the approved information collection
assigned OMB control number 0945–
0002, which expires on 12/31/2015.
Prior to submitting the ICR to OMB, OS
seeks comments from the public
regarding the burden estimate, below, or
any other aspect of the ICR.
SUMMARY:
Comments on the ICR must be
received on or before December 21,
2015.
[Document Identifier: HHS–OS–0945–0002–
60D]
Office of the Secretary, HHS.
Notice.
DATES:
Office of the Secretary
AGENCY:
ACTION:
Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
E:\FR\FM\20OCN1.SGM
20OCN1
]]>Agencies
[Federal Register Volume 80, Number 202 (Tuesday, October 20, 2015)]
[Notices]
[Pages 63560-63561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26522]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
no later than December 21, 2015.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10-29, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
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. 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.
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
(referred to in this section as the ``ceiling price'') 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.
[[Page 63561]]
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Total Hours per Total burden
respondents respondent responses respondent hours
----------------------------------------------------------------------------------------------------------------
Hospital Enrollment, Additions & Recertifications
----------------------------------------------------------------------------------------------------------------
340B Program Registrations & 194 1 194 2 388
Certifications for Hospitals...
Certifications to Enroll 697 8 5576 0.5 2788
Hospital Outpatient Facilities.
Hospital Annual Recertifications 2134 6 12804 0.25 3201
----------------------------------------------------------------------------------------------------------------
Registrations and Recertifications for Entities Other Than Hospitals
----------------------------------------------------------------------------------------------------------------
340B Registrations for Community 427 3 1281 1 1281
Health Centers.................
340B Registrations for STD/TB 647 1 647 1 647
Clinics........................
340B Registrations for Various 405 1 405 1 405
Other 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 4899 1 4899 0.25 1224.75
entities other than Hospitals,
Community Health Centers, and
STD/TB Clinics.................
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services Registration & Recertifications
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services 1758 5 8790 1 8790
Registration...................
----------------------------------------------------------------------------------------------------------------
Other Information Collections
----------------------------------------------------------------------------------------------------------------
Submission of Administrative 9396 1 9396 0.5 4698
Changes for any Covered Entity.
Submission of Administrative 350 1 350 0.5 175
Changes for any Manufacturer...
Manufacturer Data Required to 600 4 2400 0.5 1200
Verify 340B Ceiling Price
Calculations...................
Pharmaceutical Pricing Agreement 200 1 200 1 200
Pharmaceutical Pricing Agreement 620 1 620 0.5 310
(PPA) Addendum.................
-------------------------------------------------------------------------------
Total....................... 26,554 .............. 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. 2015-26522 Filed 10-19-15; 8:45 am]
BILLING CODE 4165-15-P
