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information in 21 CFR 310.305(c) and
21 CFR 314.80(c)(2)(iii) and (e) for
submitting postmarketing safety reports
have been approved under OMB control
number 0910–0230. The collections of
information for submitting
postmarketing safety reports under
MedWatch have been approved under
OMB control number 0910–0291. The
collections of information in 21 CFR
201.56 and 201.57, including 21 CFR
201.57(c)(9)(i)(A) for preparing human
prescription drug labeling to include
pregnancy registries and relevant
contact information under the
subheading Pregnancy Exposure
Registry have been approved under
OMB control number 0910–0572. The
collections of information contained in
the guidance for clinical trial sponsors
entitled ‘‘Establishment and Operation
of Clinical Trial Data Monitoring
Committees’’ (available at https://www.
fda.gov/downloads/Regulatory
Information/Guidances/ucm127073.pdf)
have been approved under OMB control
number 0910–0581. The collections of
information in the ‘‘Content and Format
of Labeling for Human Prescription
Drug and Biological Products;
Requirements for Pregnancy and
Lactation Labeling’’ final rule have been
approved under OMB control number
0910–0624. The collections of
information in 21 CFR 50.25 for the
elements of informed consent have been
approved under OMB control number
0910–0755.
III. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: May 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09527 Filed 5–8–19; 8:45 am]

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Enrollment
and Re-Certification of Entities in the
340B Drug Pricing Program, OMB
Number 0915–0327—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Before 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 ICR should be
received no later than July 8, 2019.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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 [email protected]
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR
title, below, for reference.
Information Collection Request Title:
Enrollment and Re-Certification of
Entities in the 340B Drug Pricing
Program, OMB No. 0915–0327—
Revision.
Abstract: Section 602 of Public Law
102–585, the Veterans Health Care Act
of 1992, enacted section 340B of the
Public Health Service (PHS) Act, which
instructs HHS to enter into a
Pharmaceutical Pricing Agreement
(PPA) with manufacturers of covered
outpatient drugs. Manufacturers are
required by section 1927(a)(5)(A) of the
Social Security Act to enter into
agreements with the Secretary of HHS
(the Secretary) that comply with section
340B of the PHS Act if they participate
in the Medicaid Drug Rebate Program.
SUMMARY:

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When a drug manufacturer signs a PPA,
it is opting into the 340B Drug Pricing
Program (340B Program), and it agrees
to the statutory requirement that prices
charged for covered outpatient drugs to
covered entities will not exceed
statutorily defined 340B ceiling prices.
When an eligible covered entity
voluntarily decides to enroll and
participate in the 340B Program, it
accepts responsibility for ensuring
compliance with all provisions of the
340B Program, including all associated
costs. Covered entities that 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) of the PHS Act prohibits
a covered entity from accepting a
discount for a drug that would also
generate a Medicaid rebate. Further,
section 340B(a)(5)(B) of the PHS Act
prohibits a covered entity from reselling
or otherwise transferring a discounted
drug to a person who is not a patient of
the covered entity.
Need and Proposed Use of the
Information: To ensure its ongoing
responsibility to administer the 340B
Program while maintaining efficiency,
transparency, and integrity, HRSA
developed a process of registration for
covered entities to address specific
statutory mandates. Specifically, section
340B(a)(9) of the PHS Act requires
HRSA to notify manufacturers of the
identities of covered entities and of their
status pertaining to certification and
annual recertification in the 340B
Program pursuant to section 340B(a)(7)
and the establishment of a mechanism
to prevent duplicate discounts as
outlined at section 340B(a)(5)(A)(ii) of
the PHS Act.
Also, section 340B(a)(1) of the PHS
Act requires each participating
manufacturer to enter into an agreement
with the Secretary to offer covered
outpatient drugs to 340B covered
entities.
Finally, 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.
HRSA is requesting approval for
existing information collections. HRSA
notes that the previously approved
collections are mostly unchanged,
except that HRSA has transitioned
completely to online versus hardcopy
forms. In doing so, some of the forms
have been revised to increase program
efficiency and integrity. Below are
descriptions of each of the forms and
any resulting revisions in both the
registration and pricing component of

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the 340B Office of Pharmacy Affairs
Information System (OPAIS).
Enrollment/Registration
To enroll and certify the eligible
federally funded grantees and other
safety net health care providers, HRSA
requires entities to submit
administrative information (e.g.,
shipping and billing arrangements,
Medicaid participation), certifying
information (e.g., Medicare Cost Report
information, documentation supporting
the hospital’s selected classification),
and attestation from appropriate grantee
level or entity level authorizing officials
and primary contacts. The purpose of
this registration information is to
determine eligibility for the 340B
Program. To maintain accurate records,
HRSA requests entities to submit
modifications to any administrative
information they submitted when
initially enrolling in the Program. 340B
covered entities have an ongoing
responsibility to immediately notify
HRSA of any change in eligibility for the
340B Program. No less than on an
annual basis, entities must certify the
accuracy of the information provided
and continued maintenance of their
eligibility and comply with statutory
mandates of the Program.
Registration and annual recertification
information are entered into the 340B
OPAIS by entities and verified by HRSA
staff according to 340B Program
requirements. The following forms are
being revised:
1. 340B Program Registrations &
Certifications for Hospitals (applies to
all hospital types): With the launch of
340B OPAIS in September 2017, HRSA
removed the requirement for a
Government Official to attest to the
hospital classification of a parent
hospital. HRSA would like to require
parent hospitals to attach documents
supporting the hospital classification
that they select during registration. This
is a more accurate and efficient way to
determine the eligibility of parent
hospital registrations, without
increasing the burden, since the
Government Official attestation has
been removed.
2. 340B Program Registrations for
STD/TB Clinics: HRSA is requesting
that any STD entity provide its Notice
of Funding Opportunity (NOFO)
number at the time of registration.
HRSA is also requesting that an entity
describe the type of in-kind funding it
receives, as well as the time period of
the funding. This will assist HRSA in
accurately determining the eligibility of
the covered entity registration. This
requirement would impose minimal
burden on the public, as the NOFO

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number correlates to the Federal Grant
Number, which is already required
during registration.
3. 340B Registrations for Ryan White
Entities: HRSA is requesting that any
Ryan White entity provide its NOFO
number at the time of registration.
HRSA is also requesting that an entity
provide the time period of the
assistance. This will assist HRSA to
accurately determine the eligibility of
the registration. This requirement would
impose minimal burden on the public,
as the NOFO number correlates to the
Federal Grant Number, which is already
required during registration.
4. Medicaid Billing: HRSA is making
a minor change to clarify the question
about Medicaid billing.
Accurate records are critical to the
prevention of drug diversion to noneligible individuals as well as duplicate
discounts in the 340B Program. To
maintain accurate records, HRSA also
requires that covered entities recertify
eligibility annually, and that they notify
the program of updates to any
administrative information that they
submitted when initially enrolling in
the program. HRSA expects that the
burden imposed by these processes is
low for recertification and minimal for
submitting change requests.
Contract Pharmacy Self-Certification
To ensure that drug manufacturers
and drug wholesalers recognize contract
pharmacy arrangements, covered
entities that elect to use one or more
contract pharmacies are required to
submit general information about the
arrangements and certify that signed
agreements are in place with those
contract pharmacies.
Pharmaceutical Pricing Agreement and
Addendum
In accordance with the 340B Program
guidance issued in the May 7, 1993,
Federal Register, section 340B(a)(1) of
the PHS Act provides that a
manufacturer who sells covered
outpatient drugs to eligible entities must
sign a Pharmaceutical Pricing
Agreement (the ‘‘Agreement’’) with the
Secretary of HHS (the ‘‘Secretary’’) 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. Also, section
340B(a)(1) of the PHS Act includes
specific required components of the
PPA with manufacturers of covered
outpatient drugs. In particular, section
340B(a)(1) includes the following
requirements:
I. ‘‘Each such agreement shall require
that the manufacturer furnish the

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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.’’
The burden imposed on manufacturers
by submission of the PPA and PPA
Addendum is low as the information is
readily available.
Pricing Data Submission, Validation
and Dissemination
To implement section
340B(d)(1)(B)(i)(II) of the PHS Act,
HRSA developed a system to calculate
340B ceiling prices prospectively from
data obtained from the Centers for
Medicare & Medicaid Services as well as
a third party commercial database.
However, 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). The 340B
OPAIS securely collects the following
data from manufacturers on a quarterly
basis: Average manufacturer price, unit
rebate amount, package size, case pack
size, unit type, national drug code,
labeler code, product code, period of
sale (year and quarter), FDA product
name, labeler name, wholesale
acquisition cost, and the manufacturer
determined ceiling price for each
covered outpatient drug produced by a
manufacturer subject to a PPA. The
burden imposed on manufacturers is
low because the information requested
is readily available and used by
manufacturers in other areas.
Likely Respondents: Drug
manufacturers and covered entities.
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

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information. The total annual burden

hours estimated for this ICR are
summarized in the table below.

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

248
665
2,481

1
8
10

248
5,320
24,810

2.00
0.50
0.25

496
2,660
6,202

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

360
535

3
1

1,080
535

1.00
1.00

1,080
535

392
1,277
4,033

1
7
1

392
8,939
4,033

1.00
0.25
0.25

392
2,235
1,008

4,472

1

4,472

0.25

1,118

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

2,048

11

22,528

1.00

22,528

19,322

1

19,322

** 0.25

4,831

350
200
36,383

1
1
........................

350
200
92,229

0.50
1.00
........................

175
200
43,460

Other Information Collections
Submission of Administrative Changes for any Covered
Entity .................................................................................
Submission of Administrative Changes for any Manufacturer ..................................................................................
Pharmaceutical Pricing Agreement and PPA Addendum ...
Total ..............................................................................

* Revised since last OMB submission, but burden was not affected.
** Burden changed from .5 to .25 due to the 340B OPAIS improvement.

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.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2019–09601 Filed 5–8–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Tick-Borne Disease
Working Group
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:

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As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the Tick-Borne Disease Working
Group (Working Group) will hold a
meeting. The meeting will be open to
the public. For this meeting, Working
Group members will focus on plans to
develop the next report to the HHS
Secretary and Congress on federal tickborne activities and research, taking into
consideration the 2018 report. The 2020
report will also address a wide range of
federal activities and research related to
tick-borne diseases, such as,
surveillance, prevention, diagnosis,
diagnostics, and treatment; identify gaps
in tick-borne disease research; and
provide recommendations to the HHS
Secretary regarding changes or
improvements to such activities and
research. In developing the report, the
Working Group will solicit stakeholder
input.

SUMMARY:

The meeting will be held on June
4, 2019, from 8:30 a.m. to 5:00 p.m. ET
(times are tentative and subject to
change). The confirmed times and
agenda items for the meeting will be

DATES:

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posted on the website for the Working
Group at https://www.hhs.gov/ash/
advisory-committees/tickbornedisease/
meetings/2019-6-4/index.html when
this information becomes available.
ADDRESSES: The meeting will be held at
the Holiday Inn Washington-Capitol,
550 C Street SW, Washington, DC
20024. Members of the public may also
attend the meeting via webcast.
Instructions for attending via webcast
will be posted one week prior to the
meeting at https://www.hhs.gov/ash/
advisory-committees/tickbornedisease/
meetings/2019-6-4/index.html.
FOR FURTHER INFORMATION CONTACT:
James Berger, Designated Federal Officer
for the Working Group; Office of HIV/
AIDS and Infectious Disease Policy,
Office of the Assistant Secretary for
Health, Department of Health and
Human Services, Mary E Switzer
Building, 330 C Street SW, Suite L100,
Washington, DC 20024. Email: tickborne
[email protected]; Phone: 202–795–7697.
SUPPLEMENTARY INFORMATION: In-person
attendance at the meeting is limited to
space available; therefore,
preregistration for public members is
advisable and can be accomplished by

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