Agency Information Collection Activities: Proposed Collection: Comment Request; Information Request Title: 340B Drug Pricing Program Reporting Requirements, OMB Number 0915-0176-Extension

Federal Register, Volume 84 Issue 173 (Friday, September 6, 2019)
[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Pages 46959-46960]
From the Federal Register Online via the Government Publishing Office []
[FR Doc No: 2019-19244]
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request; Information Request Title: 340B Drug Pricing Program
Reporting Requirements, OMB Number 0915-0176--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection, the Paperwork Reduction Act of
1995, 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 must be received no later than October 7,
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.
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: When submitting comments or requesting
information, please include the ICR title for reference.
    Information Collection Request Title: Drug Pricing Program
Reporting Requirements (OMB No. 0915-0176)--[Extension].
    Abstract: Section 602 of Public Law 102-585, the Veterans Health
Care Act of 1992, enacted section 340B of the Public Health Service Act
(PHS Act ``Limitation on Prices of Drugs Purchased by Covered
Entities''), 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 defined 340B
ceiling prices, which are based on quarterly pricing data reported by
manufacturers to the Centers for Medicare & Medicaid Services. 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) prohibits a covered entity from accepting a
discount for a drug that would also generate a Medicaid rebate.
Further, section 340B(a)(5)(B) prohibits a covered entity from
reselling or otherwise transferring a discounted drug to a person who
is not a patient of the covered entity.
    Section 340B(a)(5)(C) of the PHS Act permits the Secretary of HHS
and manufacturers of a covered outpatient drug to conduct audits of
covered entities in accordance with by procedures established the
Secretary related to the number, duration, and scope of the audits.
Manufacturers are permitted to conduct an audit only when there is
reasonable cause to believe a violation of section 340B(a)(5)(A) or (B)
has occurred. The manufacturer notifies the covered entity in writing
when it believes the covered entity has violated these provisions of
the 340B Program. If the problem cannot be resolved, the manufacturer
will then submit an audit work plan describing the audit and evidence
in support of the reasonable cause standard to HRSA, Healthcare Systems
Bureau, Office of Pharmacy Affairs (OPA) for review. OPA will review
the documentation to determine if reasonable cause exists. Once the
audit is completed, the manufacturer will submit copies of the audit
report to OPA for review and resolution of the findings, as
appropriate. The manufacturer will also submit an informational copy of
the audit report to the HHS Office of Inspector General (OIG).
    In response to the statutory mandate of section 340B(a)(5)(C) to
permit the Secretary or manufacturers to conduct audits of covered
entities and because of the potential for disputes involving covered
entities and participating drug manufacturers, OPA developed an
informal voluntary dispute resolution process for manufacturers and
[[Page 46960]]
entities. Prior to filing a request for resolution of a dispute with
OPA, the parties involved should attempt in good faith to resolve the
dispute. All parties involved in the dispute should maintain written
documentation as evidence of a good faith attempt to resolve the
dispute. To request voluntary dispute resolution of an unresolved
dispute, a party submits a written request for a review of the dispute
to OPA. A committee appointed to review the documentation will send a
letter to the party alleged to have committed a violation. The party
will be asked to provide a response to or a rebuttal of the
    HRSA published a notice in 1996 and a policy release in 2011 on
manufacturer audit guidelines and the informal dispute resolution
process (61 FR 65406 (December 12, 1996) and ``Clarification of
Manufacturer Audits of 340B Covered Entities,'' Release No. 2011-3).
    Need and Proposed Use of the Information: HRSA is proposing the
collection of information related to the manufacturer audit guidelines.
These guidelines contain the following reporting/notification elements:
    1. Manufacturers should notify the covered entity in writing when
it believes a violation has occurred;
    2. manufacturers should submit documentation to OPA as evidence of
good faith in attempts to resolve a dispute;
    3. manufacturers must submit an audit work plan to OPA;
    4. manufacturers should submit the audit report to the OPA and
informational copies to the HHS OIG; and
    5. the covered entity should provide a written response to the
audit report.
    This information is necessary to ensure the orderly conduct of
manufacturer audits. Also, the informal dispute resolution process
requires the participating manufacturer or covered entity requesting
dispute resolution to provide OPA with a written request. The party
alleged to have committed a 340B Program violation may provide a
response or rebuttal to OPA. This information is necessary to ensure
that the dispute will be resolved in a fair and equitable manner.
    A 60-day notice was published in the Federal Register on June 18,
2019, vol. 84, No. 117; pp. 28308-09. There was one public comment
received. The comment received addressed a policy issue that is beyond
the scope of this information collection request; therefore, HRSA will
not be addressing the comment in this notice.
    Likely Respondents: Drug manufacturers and 340B covered entities.
    Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested during an audit. 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 for both covered entities and
manufacturers. The total annual burden hours estimated for this ICR are
summarized in the table below.
                                    Total Estimated Annualized Burden Hours *
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
    Good faith Resolution \1\...              10               1              10              60             600
    Audit Notification to Entity              14               1              14               6              84
    Audit Workplan \1\..........              45               1              45              12             540
    Audit Report \1\............              14               1              14              12             168
    Entity Response.............              14               1              14              12             168
Dispute Resolution:
    Mediation Request...........              10               4              40              15             600
    Rebuttal....................              10               1              10              28             280
        Total...................             117  ..............             147  ..............           2,440
\1\ Prepared by the manufacturer.
* Since the first public review of the ICR, HRSA has received several audit work plans from manufacturers. HRSA
  has decided to update its proposed burden hours to reflect the increase in submissions.
                                              Recordkeeping Burden
                                                                  Number of         Hours of
                  Recordkeeping requirement                     recordkeepers    recordkeeping     Total burden
Dispute Records..............................................              50                1               50
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-19244 Filed 9-5-19; 8:45 am]