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, 38639-38642 [2019-16872]
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Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices
I. Background
Section 506B(c) of the FD&C Act (21
U.S.C. 356b(c)) requires FDA to publish
an annual report on the status of
postmarketing studies that applicants
have committed to, or are required to
conduct, and for which annual status
reports have been submitted.
Under §§ 314.81(b)(2)(vii) and 601.70
(21 CFR 314.81(b)(2)(vii) and 601.70),
applicants of approved drugs and
licensed biologics are required to submit
annually a report on the status of each
clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical
toxicology study or clinical trial either
required by FDA (PMRs) or that they
have committed to conduct (PMCs),
either at the time of approval or after
approval of their new drug application,
abbreviated new drug application, or
biologics license application. The status
of PMCs concerning chemistry,
manufacturing, and production controls
and the status of other studies or
clinical trials conducted on an
applicant’s own initiative are not
required to be reported under
§§ 314.81(b)(2)(vii) and 601.70 and are
not addressed in this report.
Furthermore, section 505(o)(3)(E) of the
FD&C Act (21 U.S.C. 355(o)(3)(E))
requires that applicants report
periodically on the status of each
required study or clinical trial and each
study or clinical trial otherwise
undertaken to investigate a safety issue.
An applicant must report on the
progress of the PMR/PMC on the
anniversary of the drug product’s
approval 1 until the PMR/PMC is
completed or terminated and FDA
determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either
no longer feasible or would no longer
provide useful information.
The report on the status of the studies
and clinical trials that applicants have
agreed to, or are required to, conduct is
on the FDA’s ‘‘Postmarketing
Requirements and Commitments:
Reports’’ web page at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/PostmarketingPhaseIVCommitments/
ucm064436.htm.
II. Fiscal Year 2018 Report
With this notice, FDA is announcing
the availability of the Agency’s annual
report entitled ‘‘Report on the
Performance of Drug and Biologics
Firms in Conducting Postmarketing
Requirements and Commitments.’’
Information in this report covers any
PMR/PMC that was established, in
writing, at the time of approval or after
approval of an application or a
supplement to an application and
summarizes the status of PMRs/PMCs in
fiscal year (FY) 2018 (i.e., as of
September 30, 2018). Information
summarized in the report reflects
combined data from the Center for Drug
Evaluation and Research and the Center
for Biologics Evaluation and Research
and includes the following: (1) The
number of applicants with open PMRs/
PMCs; (2) the number of open PMRs/
PMCs; (3) the timeliness of applicant
submission of the annual status reports
(ASRs); (4) FDA-verified status of open
PMRs/PMCs reported in
§ 314.81(b)(2)(vii) or § 601.70 ASRs; (5)
the status of closed PMRs/PMCs; and (6)
the distribution of the status by fiscal
year of establishment 2 (FY2012 to
FY2018) for PMRs and PMCs open at
the end of FY2018, or those closed
within FY2018. Additional information
about PMRs/PMCs is provided on FDA’s
website at https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Post-marketingPhaseIV
Commitments/default.htm.
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16878 Filed 8–6–19; 8:45 am]
BILLING CODE 4164–01–P
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
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
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SUMMARY:
1 An
applicant must submit an annual status
report on the progress of each open PMR/PMC
within 60 days of the anniversary date of U.S.
approval of the original application or on an
alternate reporting date that was granted by FDA in
writing. Some applicants have requested and been
granted by FDA alternate annual reporting dates to
facilitate harmonized reporting across multiple
applications.
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2 The establishment date is the date of the formal
FDA communication to the applicant that included
the final FDA-required (PMR) or -requested (PMC)
postmarketing study or clinical trial.
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38639
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 September 6,
2019.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
A 60-day notice was published in the
Federal Register on May 9, 2019, vol.
84, No. 90; pp. 20373–75. There were
four public comments received. Some
comments addressed policy issues that
are outside of the scope of this
information collection request. HRSA
responded to technical comments that
pertain to the ICR and revised the draft
instruments based on technical
comments received.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, 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, 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
that comply with section 340B of the
PHS Act if they participate in the
Medicaid Drug Rebate Program. 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
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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 the 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. 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.
In addition, 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
instruments. In doing so, some of the
instruments have been revised to
increase program efficiency and
integrity. Below are descriptions of each
of the instruments and any resulting
revisions captured in both the
registration and pricing component of
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
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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 that they submitted when
initially enrolling into the Program.
340B covered entities have an ongoing
responsibility to immediately notify
HRSA in the event 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 is entered into the 340B
OPAIS by entities and verified by HRSA
staff according to 340B Program
requirements. In response to the
comments received, HRSA has made
technical revisions to the draft
instruments and explains the revisions
below.
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. In response to
comments, HRSA notes that the 340B
Program Hospital Registration
Instructions lists examples of the types
of documentation that supports the
hospital’s classification. The
instructions are located at https://
www.hrsa.gov/sites/default/files/hrsa/
opa/340b-hospital-registrationinstructions.pdf.
2. 340B Program Registrations for
STD/TB Clinics: HRSA is requesting
that any STD and TB 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 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
number correlates to the Federal Grant
Number, which is already required
during registration.
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In response to comments submitted
during the first public review of this
ICR, HRSA continues to believe there
will be no additional burden associated
with providing what type of in-kind
funding they receive as it is expected to
be provided as part of an audit of a
covered entity. The draft instruments
explain that in-kind contributions may
be in the form of real property,
equipment, supplies and other
expendable property, and goods and
services directly benefiting and
specifically identifiable to the project or
program.
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 period of assistance. This
will assist HRSA in accurately
determining 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. In response to
comments received, HRSA has made
general technical and editorial revisions
to this instrument.
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 into
the program. HRSA expects that the
burden imposed 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 utilize 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. In response to
comments, HRSA has made several
technical corrections to this instrument.
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
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outpatient drugs to eligible entities must
sign a PPA with the Secretary of HHS
in which the manufacturer agrees to
charge a price for covered outpatient
drugs that will not exceed the average
manufacturer price (‘‘AMP’’) decreased
by a rebate percentage. In addition,
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
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. One
commenter suggested that HRSA list
FDA ‘‘ingredient names’’ in the 340B
OPAIS to simplify the search process for
covered entities. HRSA will consider
this for future collections due to system
changes that would need to occur to
operationalize this suggestion.
The burden imposed on
manufacturers is low because the
information requested is readily
available and utilized 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
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
1,008
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
1
1
350
200
0.50
1
175
200
600
4
2,400
0.50
1,200
36,983
........................
94,629
........................
43,433
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Other Information Collections
Submission of Administrative Changes for any Covered
Entity .................................................................................
Submission of Administrative Changes for any Manufacturer ..................................................................................
Pharmaceutical Pricing Agreement and PPA Addendum ...
Manufacturer Data Required to Verify the 340B Ceiling
Price .................................................................................
Total ..............................................................................
* Revised since last OMB submission, but burden was not affected.
** Burden changed from .50 to .25 due to the 340B OPAIS improvement.
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During the first public review of the
ICR, HRSA inadvertently omitted the
burden estimate for the instrument
pertaining to manufacturer data
required to verify the 340B ceiling price.
The estimate for that instrument has
been included here and HRSA invites
comments to be submitted to OMB for
consideration during the review and
approval period.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–16872 Filed 8–6–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review Advisory
Council: Notice of Charter Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Center for
Scientific Review Advisory Council was
renewed for an additional two-year
period on March 31, 2019.
It is determined that the Center for
Scientific Review Advisory Council is
in the public interest in connection with
the performance of duties imposed on
the National Institutes of Health by law,
and that these duties can best be
performed through the advice and
counsel of this group.
Inquiries may be directed to Claire
Harris, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or harriscl@mail.nih.gov.
Dated: August 1, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–16825 Filed 8–6–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jspears on DSK3GMQ082PROD with NOTICES
Substance Abuse and Mental Health
Services Administration
Advisory Committee for Women’s
Services (ACWS); Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given of a meeting of
the Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
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Advisory Committee for Women’s
Services (ACWS) on August 20, 2019.
The meeting will include discussions
on assessing SAMHSA’s current
strategies, including the mental health
and substance use needs of the women
and girls population. Additionally, the
ACWS will be speaking with the
Assistant Secretary of Mental Health
and Substance Use regarding priorities
and directions around behavioral health
services and access for women and
children.
The meeting is open to the public and
will be held at SAMHSA, 5600 Fishers
Lane, Rockville, MD 20857. Interested
persons may present data, information,
or views, orally or in writing, on issues
pending before the committee. Written
submissions should be forwarded to the
contact person by August 13, 2019. Oral
presentations from the public will be
scheduled at the conclusion of the
meeting. Individuals interested in
making oral presentations are
encouraged to notify the contact person
on or before August 13, 2019. Five
minutes will be allotted for each
presentation.
The meeting may be accessed via
telephone or web meeting. To obtain the
call-in number and access code, submit
written or brief oral comments, or
request special accommodations for
persons with disabilities, please register
on-line at https://
snacregister.samhsa.gov/
MeetingList.aspx, or communicate with
SAMHSA’s Designated Federal Officer,
Ms. Valerie Kolick.
Substantive meeting information and
a roster of ACWS members may be
obtained either by accessing the
SAMHSA Committees’ Web https://
www.samhsa.gov/about-us/advisorycouncils/meetings, or by contacting Ms.
Kolick.
Committee Name: Substance Abuse
and Mental Health Services
Administration, Advisory Committee for
Women’s Services (ACWS).
Date/Time/Type: Tuesday, August 20,
2019, from: 9:00 a.m. to 3:00 p.m. EDT
(OPEN).
Place: SAMHSA, 5600 Fishers Lane,
Rockville, MD 20857.
Contact: Valerie Kolick, Designated
Federal Officer, SAMHSA’s Advisory
Committee for Women’s Services, 5600
Fishers Lane, Rockville, MD 20857,
Telephone: (240) 276–1738, Email:
Valerie.kolick@samhsa.hhs.gov.
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Dated: August 1, 2019.
Carlos Castillo,
CAPT, USPHS, Committee Management
Officer, Substance Abuse and Mental Health,
Services Administration.
[FR Doc. 2019–16831 Filed 8–6–19; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF THE INTERIOR
Bureau of Land Management
[LLORW00000.10200000.
DF0000.LXSSH1080000.19X.HAG 19–0096]
Notice of Public Meetings for the San
Juan Islands National Monument
Advisory Committee
Bureau of Land Management,
Interior.
ACTION: Notice of public meeting.
AGENCY:
In accordance with the
Federal Land Policy and Management
Act and the Federal Advisory
Committee Act of 1972, the U.S.
Department of the Interior, Bureau of
Land Management’s (BLM), San Juan
Islands National Monument Advisory
Committee (MAC) will meet as
indicated below:
DATES: The MAC will hold a public
meeting on Tuesday, Sept. 24, 2019.
This meeting will run from 10 a.m. to
3:30 p.m. The public comment period is
scheduled for 2 p.m.
ADDRESSES: The meeting will be held at
the Lopez Community Center for the
Arts, 204 Village Rd, Lopez Island, WA
98261. The public may send written
comments to the MAC at BLM Spokane
District, Attn. MAC, 1103 N Fancher,
Spokane Valley, WA 99212.
FOR FURTHER INFORMATION CONTACT: Jeff
Clark, Spokane District Public Affairs
Officer, 1103 N Fancher, Spokane
Valley, WA 99212, (509) 536–1297, or
jeffclark@blm.gov. Persons who use a
telecommunications device for the deaf
(TDD) may call the Federal Relay
Service at 1(800) 877–8339 to contact
the above individual during normal
business hours. This service is available
24 hours a day, 7 days a week, to leave
a message or question with the above
individual. You will receive a reply
during normal business hours.
SUPPLEMENTARY INFORMATION: The San
Juan Islands MAC is comprised of 12
members representing a wide array of
interests, including recreation, tribal
interests, education, environmental
organizations, and landowners. The
MAC advises the Secretary of the
Interior with respect to the preparation
and implementation of the San Juan
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38639-38642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16872]
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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
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
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 September
6, 2019.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to 202-395-5806.
A 60-day notice was published in the Federal Register on May 9,
2019, vol. 84, No. 90; pp. 20373-75. There were four public comments
received. Some comments addressed policy issues that are outside of the
scope of this information collection request. HRSA responded to
technical comments that pertain to the ICR and revised the draft
instruments based on technical comments received.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, 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, 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 that
comply with section 340B of the PHS Act if they participate in the
Medicaid Drug Rebate Program. 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
[[Page 38640]]
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 the 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. 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.
In addition, 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 instruments. In doing so, some of the instruments have
been revised to increase program efficiency and integrity. Below are
descriptions of each of the instruments and any resulting revisions
captured in both the registration and pricing component of 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 that they submitted when initially enrolling into the
Program. 340B covered entities have an ongoing responsibility to
immediately notify HRSA in the event 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 is entered into
the 340B OPAIS by entities and verified by HRSA staff according to 340B
Program requirements. In response to the comments received, HRSA has
made technical revisions to the draft instruments and explains the
revisions below.
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. In response to
comments, HRSA notes that the 340B Program Hospital Registration
Instructions lists examples of the types of documentation that supports
the hospital's classification. The instructions are located at https://www.hrsa.gov/sites/default/files/hrsa/opa/340b-hospital-registration-instructions.pdf.
2. 340B Program Registrations for STD/TB Clinics: HRSA is
requesting that any STD and TB 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 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 number correlates to the Federal Grant Number,
which is already required during registration.
In response to comments submitted during the first public review of
this ICR, HRSA continues to believe there will be no additional burden
associated with providing what type of in-kind funding they receive as
it is expected to be provided as part of an audit of a covered entity.
The draft instruments explain that in-kind contributions may be in the
form of real property, equipment, supplies and other expendable
property, and goods and services directly benefiting and specifically
identifiable to the project or program.
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 period
of assistance. This will assist HRSA in accurately determining 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. In response to comments received, HRSA
has made general technical and editorial revisions to this instrument.
Accurate records are critical to the prevention of drug diversion
to non-eligible 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 into the program. HRSA expects that
the burden imposed 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 utilize
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. In response to comments,
HRSA has made several technical corrections to this instrument.
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
[[Page 38641]]
outpatient drugs to eligible entities must sign a PPA with the
Secretary of HHS in which the manufacturer agrees to charge a price for
covered outpatient drugs that will not exceed the average manufacturer
price (``AMP'') decreased by a rebate percentage. In addition, 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 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. One commenter suggested that HRSA list
FDA ``ingredient names'' in the 340B OPAIS to simplify the search
process for covered entities. HRSA will consider this for future
collections due to system changes that would need to occur to
operationalize this suggestion.
The burden imposed on manufacturers is low because the information
requested is readily available and utilized 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 information. The total annual burden hours estimated for
this ICR are summarized in the table below.
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 & 248 1 248 2.00 496
Certifications for Hospitals *.
Certifications to Enroll 665 8 5,320 0.50 2,660
Hospital Outpatient Facilities.
Hospital Annual Recertifications 2,481 10 24,810 0.25 6,202
----------------------------------------------------------------------------------------------------------------
Registrations and Recertifications for Entities Other Than Hospitals
----------------------------------------------------------------------------------------------------------------
340B Registrations for Community 360 3 1,080 1.00 1,080
Health Centers *...............
340B Registrations for STD/TB 535 1 535 1.00 535
Clinics *......................
340B Registrations for Various 392 1 392 1.00 392
Other Eligible Entity Types *..
Community Health Center Annual 1,277 7 8,939 0.25 1,008
Recertifications...............
STD & TB Annual Recertifications 4,033 1 4,033 0.25 1,008
Annual Recertification for 4,472 1 4,472 0.25 1,118
entities other than Hospitals,
Community Health Centers, and
STD/TB Clinics.................
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services Registration & Recertifications
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services 2,048 11 22,528 1.00 22,528
Registration...................
----------------------------------------------------------------------------------------------------------------
Other Information Collections
----------------------------------------------------------------------------------------------------------------
Submission of Administrative 19,322 1 19,322 ** 0.25 4,831
Changes for any Covered Entity.
Submission of Administrative 350 1 350 0.50 175
Changes for any Manufacturer...
Pharmaceutical Pricing Agreement 200 1 200 1 200
and PPA Addendum...............
Manufacturer Data Required to 600 4 2,400 0.50 1,200
Verify the 340B Ceiling Price..
-------------------------------------------------------------------------------
Total....................... 36,983 .............. 94,629 .............. 43,433
----------------------------------------------------------------------------------------------------------------
* Revised since last OMB submission, but burden was not affected.
** Burden changed from .50 to .25 due to the 340B OPAIS improvement.
[[Page 38642]]
During the first public review of the ICR, HRSA inadvertently
omitted the burden estimate for the instrument pertaining to
manufacturer data required to verify the 340B ceiling price. The
estimate for that instrument has been included here and HRSA invites
comments to be submitted to OMB for consideration during the review and
approval period.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-16872 Filed 8-6-19; 8:45 am]
BILLING CODE 4165-15-P
