Agency Information Collection Activities: Proposed Collection: Comment Request Information Request Title: 340B Drug Pricing Program Reporting Requirements, OMB Number 0915-0176-Extension, 28308-28310 [2019-12894]

Download as PDF 28308 Federal Register / Vol. 84, No. 117 / Tuesday, June 18, 2019 / Notices pertaining to ACF programs, key stakeholder groups involved in ACF projects and programs, individuals engaged in program re-design or demonstration development for evaluation, state or local government officials, or others involved in or prospectively involved in ACF programs. ANNUAL BURDEN ESTIMATES Estimated number of responses per respondent Estimated total number of respondents Instrument type Average burden hours per response Estimated total burden hours Semi-Structured Discussions and Focus Groups ............................................ Interviews ......................................................................................................... Questionnaires/Surveys ................................................................................... Templates and Open-ended requests ............................................................. 2,000 1,000 1,000 250 1 1 * 1.5 1 2 1 .5 10 4,000 1,000 750 2,500 Total .......................................................................................................... ........................ ........................ ........................ 8,250 * We have estimated 1.5 responses to account for rapid cycle testing, which will require multiple responses. Authority: Social Security Act, Sec. 1110. [42 U.S.C. 1310]. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–12801 Filed 6–17–19; 8:45 am] BILLING CODE 4184–79–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. jbell on DSK3GLQ082PROD with NOTICES AGENCY: SUMMARY: 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). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate or any other aspect of the ICR. DATES: Comments on this ICR must be received no later than August 19, 2019. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 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 VerDate Sep<11>2014 17:23 Jun 17, 2019 Jkt 247001 instruments, email paperwork@hrsa.gov 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 information request collection title for reference. Information Collection Request Title: Drug Pricing Program Reporting Requirements OMB No. 0915–0176— [Extension]. Abstract: Section 340B of the Public Health Service Act (PHS Act ‘‘Limitation on Prices of Drugs Purchased by Covered Entities’’) 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 to 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 (CMS). 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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 procedures established by 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 the 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 covered entities who, prior to filing a request for resolution of a dispute with OPA, E:\FR\FM\18JNN1.SGM 18JNN1 28309 Federal Register / Vol. 84, No. 117 / Tuesday, June 18, 2019 / Notices 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 allegations. 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 of 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. 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 respondents Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Audits Good faith Resolution 1 ........................................................ Audit Notification to Entity 1 ................................................. Audit Workplan 1 .................................................................. Audit Report 1 ....................................................................... Entity Response ................................................................... 10 10 43 14 14 1 1 1 1 1 10 10 43 14 14 60 6 12 12 12 600 60 516 168 168 Dispute Resolution Mediation Request ............................................................... Rebuttal ................................................................................ 10 10 4 1 40 10 15 28 600 280 Total .............................................................................. 111 ........................ 120 ........................ 2,392 Recordkeeping requirement Number of recordkeepers Hours of recordkeeping Total burden Dispute Records .......................................................................................................................... 50 1 50 1 Prepared by the manufacturer. jbell on DSK3GLQ082PROD with NOTICES Recordkeeping Burden: 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. Maria G. Button, Director, Division of the Executive Secretariat. [FR Doc. 2019–12894 Filed 6–17–19; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 18:40 Jun 17, 2019 Jkt 247001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\18JNN1.SGM 18JNN1 28310 Federal Register / Vol. 84, No. 117 / Tuesday, June 18, 2019 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Substance Abuse and Mental Health Services Administration, HHS Senior Executive Service Performance Review Board Meeting of the the Substance Abuse and Mental Health Services Administration’s National Advisory Council Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: jbell on DSK3GLQ082PROD with NOTICES SUMMARY: HRSA, an Operating Division of HHS, is publishing a list of persons appointed to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA for the Fiscal Year 2019 and 2020 review period. FOR FURTHER INFORMATION CONTACT: Georgia Lyons, Executive Resources, Office of Human Resources, 5600 Fishers Lane, Rm. 12N06C, Rockville, Maryland 20857, Telephone (301) 443– 4618. SUPPLEMENTARY INFORMATION: Title 5, U.S.C. 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95–454, requires that the appointment of Performance Review Board Members be published in the Federal Register. The following are persons appointed to serve on the HRSA Performance Review Board: Leslie Atkinson Tonya Bowers Adriane Burton Tina Cheatham Laura Cheever Natasha Coulouris Cheryl Dammons Elizabeth DeVoss Diana Espinosa Catherine Ganey Alexandra Garcia Heather Hauck Laura Kavanagh Martin Kramer Rimas Liogys Torey Mack James Macrae Susan Monarez Thomas Morris Kerry Nesseler Luis Padilla Wendy Ponton Michael Warren George Sigounas, Administrator. [FR Doc. 2019–12819 Filed 6–17–19; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 18:40 Jun 17, 2019 Jkt 247001 Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: Notice is hereby given of the meeting on July 1, 2019, of the Substance Abuse and Mental Health Services Administration’s (SAMHSA) National Advisory Council (SAMHSA NAC). This notice may publish with less than 15 days prior to the meeting due to a change in schedule for the committee chair and unexpected calendar changes. The meeting is open to the public and can be accessed via telephone only. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/ advisory-councils/meetings. The meeting will include remarks and dialogue from the Assistant Secretary for Mental Health and Substance Use; updates from the SAMHSA Centers Directors, and a council discussion with SAMHSA NAC members. DATES: July 1, 2019, 9:00 a.m. to 12:00 p.m. (EDT)/Open. ADDRESSES: The meeting will be held (virtually) at SAMHSA Headquarters, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: Carlos Castillo, Committee Management Officer and Designated Federal Official, SAMHSA National Advisory Council, Room 18E05C, 5600 Fishers Lane, Rockville, Maryland 20857 (mail), Telephone: (240) 276–2787, Email: carlos.castillo@samhsa.hhs.gov. SUPPLEMENTARY INFORMATION: The SAMHSA NAC was established to advise the Secretary, Department of Health and Human Services (HHS), and the Assistant Secretary for Mental Health and Substance Use, SAMHSA, to improve the provision of treatments and related services to individuals with respect to substance use and to improve prevention services, promote mental health, and protect legal rights of individuals with mental illness and individuals who are substance users. SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Interested persons may present data, information, or views orally or in writing, on issues pending before the Council. Written submissions must be forwarded to the contact person by June 26, 2019. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations must notify the contact person by June 26, 2019. Up to 3 minutes will be allotted for each presentation. To obtain the call-in number, access code, and/or web access link; submit written or brief oral comments; or request special accommodations for persons with disabilities, please register on-line at: http://nac.samhsa.gov/ Registration/meetingsRegistration.aspx, or communicate with SAMHSA’s Committee Management Officer, CAPT Carlos Castillo. Meeting information and a roster of Council members may be obtained either by accessing the SAMHSA Council’s website at http:// www.samhsa.gov/about-us/advisorycouncils/ or by contacting Carlos Castillo. Council Name: Substance Abuse and Mental Health Services Administration National Advisory Council. Dated: June 12, 2019. Carlos Castillo, Committee Management Officer, SAMHSA. [FR Doc. 2019–12797 Filed 6–17–19; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA–4421– DR; Docket ID FEMA–2019–0001] Iowa; Amendment No. 5 to Notice of a Major Disaster Declaration Federal Emergency Management Agency, DHS. AGENCY: ACTION: Notice. SUMMARY: This notice amends the notice of a major disaster declaration for the State of Iowa (FEMA–4421–DR), dated E:\FR\FM\18JNN1.SGM 18JNN1

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[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Notices]
[Pages 28308-28310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12894]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 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). Prior to submitting the ICR to OMB, HRSA seeks comments from the 
public regarding the burden estimate or any other aspect of the ICR.

DATES: Comments on this ICR must be received no later than August 19, 
2019.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 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 [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 information request collection title 
for reference.
    Information Collection Request Title: Drug Pricing Program 
Reporting Requirements OMB No. 0915-0176--[Extension].
    Abstract: Section 340B of the Public Health Service Act (PHS Act 
``Limitation on Prices of Drugs Purchased by Covered Entities'') 
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 to 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 (CMS). 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 procedures established by 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 the 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 
covered entities who, prior to filing a request for resolution of a 
dispute with OPA,

[[Page 28309]]

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 allegations.
    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 of 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.
    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
----------------------------------------------------------------------------------------------------------------
                                                     Audits
----------------------------------------------------------------------------------------------------------------
Good faith Resolution \1\.......              10               1              10              60             600
Audit Notification to Entity \1\              10               1              10               6              60
Audit Workplan \1\..............              43               1              43              12             516
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.......................             111  ..............             120  ..............           2,392
----------------------------------------------------------------------------------------------------------------
\1\ Prepared by the manufacturer.

    Recordkeeping Burden:

----------------------------------------------------------------------------------------------------------------
                                                                  Number of         Hours of
                  Recordkeeping requirement                     recordkeepers    recordkeeping     Total burden
----------------------------------------------------------------------------------------------------------------
Dispute Records..............................................              50                1               50
----------------------------------------------------------------------------------------------------------------

    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.

Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-12894 Filed 6-17-19; 8:45 am]
BILLING CODE 4165-15-P