80 FR 22207 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 76 (April 21, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 76 (April 21, 2015)
| Page Range | 22207-22209 | |
| FR Document | 2015-09079 |
[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)] [Notices] [Pages 22207-22209] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09079] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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 should be received no later than May 21, 2015. ADDRESSES: Submit your comments, including the Information Collection Request 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 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 and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations. OMB No. 0915-0327--Revision Abstract: Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992, enacted as Section 340B of the Public Health Service Act (PHS Act; ``Limitation on Prices of Drugs Purchased by Covered Entities''), provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a Pharmaceutical Pricing Agreement (PPA) with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula (``ceiling price''). A manufacturer subject to a PPA must offer all covered outpatient drugs at no more than the ceiling price to a covered entity listed in the 340B Program database. Manufacturers rely on the information in the 340B database to determine if a covered entity is participating in the 340B Program or for any notifications of changes to eligibility that may occur within a quarter. By signing the PPA, the manufacturer agrees to comply with all applicable statutory and regulatory requirements, including any changes that occur after execution of the PPA. Covered entities which 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 entity. Need and Proposed Use of the Information: 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, which shall include the following: (I) Developing and publishing through an appropriate policy or regulatory issuance, precisely defined standards and methodology for the calculation of ceiling prices under such subsection. (II) Comparing regularly the ceiling prices calculated by the Secretary with [[Page 22208]] the quarterly pricing data that is reported by manufacturers to the Secretary. (III) Performing spot checks of sales transactions by covered entities. (IV) Inquiring into the cause of any pricing discrepancies that may be identified and either taking, or requiring manufacturers to take, such corrective action as is appropriate in response to such price discrepancies. HRSA's Office of Pharmacy Affairs (OPA) has previously obtained approval for information collections in support of 340B covered entity recertification and registration, as well as registration of contract pharmacy arrangements and the PPA itself. OPA is requesting comments on an additional information collection in response to the above pricing verification requirements, as well as the routine renewal of approval for the existing information collections. The previously approved collections are substantially unchanged, except that HRSA has transitioned completely to online versus hardcopy forms. Pricing data submission, validation and dissemination: In order to implement Section 340B(d)(1)(B)(i)(II), HRSA has already developed a system to calculate 340B ceiling prices prospectively from data obtained from the Centers for Medicare & Medicaid Services as well as OPA-identified commercial databases. However, in order 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). HRSA is developing a mechanism for secure manufacturer submissions. This notice proposes collecting Average Manufacturer Price, Unit Rebate Amount, Package Sizes, National Drug Code (NDC), period of sale (year and quarter), and manufacturer-determined 340B ceiling price for each NDC produced by a manufacturer subject to a PPA. Once any discrepancies between the manufacturer and OPA-calculated prices have been resolved, the validated prices will be made available to registered covered entities via a secure Internet-accessible platform as required by Section 340B(d)(1)(B)(iii). Accurate and timely pricing data submissions are critical to successful implementation of the 340B Program, ensuring that covered entities have confidence that the amounts being charged are in accordance with statutorily-defined ceiling prices. The burden imposed on manufacturers by this requirement is low because the information requested is readily available. Likely Respondents: Drug Manufacturers. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this 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 & 194 1 194 2 388 Certifications for Hospitals... Certifications to Enroll 697 8 5,576 0.5 2,788 Hospital Outpatient Facilities. Hospital Annual Recertifications 2,134 6 12,804 0.25 3,201 ---------------------------------------------------------------------------------------------------------------- Registrations and Recertifications for Entities Other Than Hospitals ---------------------------------------------------------------------------------------------------------------- 340B Registrations for Community 427 3 1,281 1 1,281 Health Centers................. 340B Registrations for STD/TB 647 1 647 1 647 Clinics........................ 340B Registrations for Various 405 1 405 1 405 Other Eligible Entity Types.... Community Health Center Annual 1,204 5 6,020 0.25 1,505 Recertifications............... STD & TB Annual Recertifications 3,123 1 3,123 0.25 780.75 Annual Recertification for 4,899 1 4,899 0.25 1,224.75 entities other than Hospitals, Community Health Centers, and STD/TB Clinics................. ---------------------------------------------------------------------------------------------------------------- Contracted Pharmacy Services Registration & Recertifications ---------------------------------------------------------------------------------------------------------------- Contracted Pharmacy Services 1,758 5 8,790 1 8,790 Registration................... ---------------------------------------------------------------------------------------------------------------- Other Information Collections ---------------------------------------------------------------------------------------------------------------- Submission of Administrative 9,396 1 9,396 0.5 4,698 Changes for any Covered Entity. Submission of Administrative 350 1 350 0.5 175 Changes for any Manufacturer... Manufacturer Data Required to 600 4 2,400 0.5 1,200 Verify 340B Ceiling Price Calculations................... Pharmaceutical Pricing Agreement 200 1 200 1 200 ------------------------------------------------------------------------------- Total....................... 26,034 .............. .............. .............. 27,283.5 ---------------------------------------------------------------------------------------------------------------- [[Page 22209]] Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-09079 Filed 4-20-15; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22207
meeting agenda will be posted on the Interested parties should refer to the SUPPLEMENTARY INFORMATION:
Committee’s Web site at http:// meeting, in the subject line, as the Information Collection Request Title:
www.hrsa.gov/advisorycommittees/ HRSA National Advisory Council on the Enrollment and Re-Certification of
rural/. National Health Service Corps. The Entities in the 340B Drug Pricing
conference call-in number is: 888–566– Program and Collection of Manufacturer
Jackie Painter,
5974. The passcode is: 4439136. Data to Verify 340B Drug Pricing
Director, Division of the Executive Secretariat. Program Ceiling Price Calculations.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–09080 Filed 4–20–15; 8:45 am]
Anyone requesting information OMB No. 0915–0327—Revision
BILLING CODE 4165–15–P
regarding the NAC should contact CAPT Abstract: Section 602 of Public Law
Shari Campbell, Designated Federal 102–585, the Veterans Health Care Act
DEPARTMENT OF HEALTH AND Official, Bureau of Health Workforce, of 1992, enacted as Section 340B of the
HUMAN SERVICES HRSA, in one of three ways: (1) Send a Public Health Service Act (PHS Act;
request to the following address: CAPT ‘‘Limitation on Prices of Drugs
Health Resources and Services Shari Campbell, Designated Federal Purchased by Covered Entities’’),
Administration Official, Bureau of Health Workforce, provides that a manufacturer who sells
HRSA, Parklawn Building, Room 8C–26, covered outpatient drugs to eligible
National Advisory Council on the 5600 Fishers Lane, Rockville, Maryland entities must sign a Pharmaceutical
National Health Service Corps; Notice 20857; (2) call (301) 594–4251; or (3) Pricing Agreement (PPA) with the
of Meeting send an email to scampbell@hrsa.gov. Secretary of Health and Human Services
In accordance with section 10(a)(2) of Jackie Painter, in which the manufacturer agrees to
the Federal Advisory Committee Act Director, Division of the Executive Secretariat. charge a price for covered outpatient
(Pub. L. 92–463), notice is hereby given [FR Doc. 2015–09078 Filed 4–20–15; 8:45 am]
drugs that will not exceed an amount
of the following meeting: determined under a statutory formula
BILLING CODE 4165–15–P
Name: National Advisory Council on (‘‘ceiling price’’).
the National Health Service Corps A manufacturer subject to a PPA must
(NAC). DEPARTMENT OF HEALTH AND offer all covered outpatient drugs at no
Date and Time: May 6, 2015 from 2:00 HUMAN SERVICES more than the ceiling price to a covered
p.m.–3:30 p.m. (EST). entity listed in the 340B Program
Place: Conference Call Format. Health Resources and Services database. Manufacturers rely on the
Status: The meeting will be open to Administration information in the 340B database to
the public. determine if a covered entity is
Purpose: The NAC provides advice to Agency Information Collection participating in the 340B Program or for
the Secretary of the Department of Activities: Submission to OMB for any notifications of changes to
Health and Human Services and the Review and Approval; Public Comment eligibility that may occur within a
Administrator of the Health Resources Request quarter. By signing the PPA, the
and Services Administration (HRSA), manufacturer agrees to comply with all
with respect to their responsibilities for AGENCY: Health Resources and Services applicable statutory and regulatory
designating areas of the United States Administration, HHS. requirements, including any changes
with critical health professional ACTION: Notice. that occur after execution of the PPA.
shortages (i.e., Health Professional Covered entities which choose to
Shortage Area) and assigning health care SUMMARY: In compliance with Section participate in the 340B Program must
personnel to improve the delivery of 3507(a)(1)(D) of the Paperwork comply with the requirements of
health services in these areas. Reduction Act of 1995, the Health Section 340B(a)(5) of the PHS Act.
Agenda: The members of the NAC Resources and Services Administration Section 340B(a)(5)(A) prohibits a
will discuss: (a) The activities and goals (HRSA) has submitted an Information covered entity from accepting a
for fiscal year 2016 for the National Collection Request (ICR) to the Office of discount for a drug that would also
Health Service Corps; (b) their vision Management and Budget (OMB) for generate a Medicaid rebate. Further,
and approaches for future NAC review and approval. Comments Section 340B(a)(5)(B) prohibits a
meetings; and (c) planning for an in- submitted during the first public review covered entity from reselling or
person meeting. The official agenda will of this ICR will be provided to OMB. otherwise transferring a discounted drug
be available 2 days prior to the meeting OMB will accept further comments from to a person who is not a patient of the
on the HRSA Web site at: http:// the public during the review and entity.
nhsc.hrsa.gov/corpsexperience/aboutus/ approval period. Need and Proposed Use of the
nationaladvisorycouncil/. Agenda items DATES: Comments on this ICR should be Information: Section 340B(d)(1)(B)(i) of
are subject to change as priorities received no later than May 21, 2015. the PHS Act requires the development
dictate. of a system to enable the Secretary to
Public Comment: Requests to make ADDRESSES: Submit your comments,
verify the accuracy of ceiling prices
oral comments or provide written including the Information Collection calculated by manufacturers under
comments to the NAC should be sent to Request Title, to the desk officer for subsection (a)(1) and charged to covered
CAPT Shari Campbell, Designated HRSA, either by email to OIRA_ entities, which shall include the
Federal Official, using the address and submission@omb.eop.gov or by fax to following:
202–395–5806.
tkelley on DSK3SPTVN1PROD with NOTICES
phone number below. Individuals who (I) Developing and publishing through
plan to participate on the conference FOR FURTHER INFORMATION CONTACT: To an appropriate policy or regulatory
call should notify CAPT Campbell at request a copy of the clearance requests issuance, precisely defined standards
least 3 days prior to the meeting, using submitted to OMB for review, email the and methodology for the calculation of
the address and phone number below. HRSA Information Collection Clearance ceiling prices under such subsection.
Members of the public will have the Officer at paperwork@hrsa.gov or call (II) Comparing regularly the ceiling
opportunity to provide comments. (301) 443–1984. prices calculated by the Secretary with
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![Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22209
Jackie Painter, focusing on their symbiotic relationship • Goals of bioethics education (e.g.,
Director, Division of the Executive Secretariat. as twin pillars of public bioethics. empirical training, normative
[FR Doc. 2015–09079 Filed 4–20–15; 8:45 am] Democratic deliberation has been a foundations, clinical ethics), and the
BILLING CODE 4165–15–P guiding ethical principle in the competencies and skills bioethics
Commission’s work, informing both its education seeks to foster;
processes and its recommendations. The • Methods and goals of designing
DEPARTMENT OF HEALTH AND Commission also is committed to bioethics education and training
HUMAN SERVICES supporting bioethics education at all programs at different levels (e.g.,
levels and across disciplines, through its undergraduate foci, master’s degree
Request for Comments on Deliberation own pedagogical materials and its programs, terminal degree programs,
and Bioethics Education recommendations for improving and and professional certification);
AGENCY: Department of Health and integrating ethics education in a range • Potential training in bioethics
Human Services, Office of the Secretary, of settings. This new project will across the lifespan at different
Presidential Commission for the Study explore the relationship between educational levels and settings (e.g.,
of Bioethical Issues. deliberation and bioethics education primary/secondary education,
and the importance of public community education, continuing
ACTION: Notice.
engagement in the bioethics professional education), and the role of
SUMMARY: The Presidential Commission conversation. For example, the education in laying the foundation for
for the Study of Bioethical Issues is Commission’s deliberations not only constructive public deliberation and
requesting public comment on advise the U.S. federal government, but debate in bioethics;
deliberation and bioethics education. also play a vital role in civic education. • The appropriate role of professional
DATES: To ensure consideration, Bioethics education fosters the scientific standards for bioethicists, including
comments must be received by July 20, and ethical literacy that supports public core competencies for bioethicists, and
2015. Comments received after this date deliberation about science, medicine, potential accreditation of bioethics
will be considered only as time permits. public health, and bioethics, and helps training or education programs;
ADDRESSES: Individuals, groups, and
to prepare students for their role as • Integrating bioethics education
organizations interested in commenting citizens in understanding different across different professional contexts,
on this topic may submit comments by perspectives on complex issues that are and establishing ‘‘dual competency’’
email to info@bioethics.gov or by mail to often the subject of public policy through reciprocal training in bioethics
the following address: Public debates. and a home or primary discipline (e.g.,
At its meeting on November 6, 2014, engineering and bioethics, medicine and
Commentary, Presidential Commission
the Commission heard from scholars in bioethics, law and bioethics).
for the Study of Bioethical Issues, 1425
education, medical ethics, and political To this end, the Commission is
New York Ave. NW., Suite C–100,
philosophy, and began its consideration inviting interested parties to provide
Washington, DC 20005.
of the relationship between deliberation input and advice through written
FOR FURTHER INFORMATION CONTACT:
and bioethics education and its own comments. Comments will be publicly
Hillary Wicai Viers, Communications role in promoting both of these to available, including any personally
Director, Presidential Commission for advance public understanding of and identifiable or confidential business
the Study of Bioethical Issues. engagement with bioethical debates. For information that they contain. Trade
Telephone: 202–233–3960. Email: example, in its most recent report, secrets should not be submitted.
hillary.viers@bioethics.gov. Additional Ethics and Ebola: Public Health
information may be obtained at http:// Dated: April 13, 2015.
Planning and Response, the
www.bioethics.gov. Lisa M. Lee,
Commission made recommendations
SUPPLEMENTARY INFORMATION: On regarding the importance of public Executive Director, Presidential Commission
November 24, 2009, the President for the Study of Bioethical Issues.
education and deliberation in preparing
established the Presidential Commission for public health emergencies. The [FR Doc. 2015–09172 Filed 4–20–15; 8:45 am]
for the Study of Bioethical Issues ethical challenges that emerged in the BILLING CODE 4154–06–P
(Bioethics Commission) to advise him U.S. response to the ongoing Ebola
on bioethical issues generated by novel epidemic in western Africa underscore
and emerging research in biomedicine the need for appropriate forums for DEPARTMENT OF HEALTH AND
and related areas of science and public engagement and debate on the HUMAN SERVICES
technology. The Commission is charged ethical dimensions of public health
with identifying and promoting policies National Committee on Vital and Health
decision making. Statistics: Meeting; Privacy, Security &
and practices that ensure ethically The Commission is interested in
responsible conduct of scientific Confidentiality Subcommittee
receiving comments from individuals,
research and health care delivery. groups, and professional communities Pursuant to the Federal Advisory
Undertaking these duties, the regarding deliberation and education in Committee Act, the Department of
Commission seeks to identify and bioethics. The Commission is Health and Human Services (HHS)
examine specific bioethical, legal, and particularly interested in receiving announces the following advisory
social issues related to potential public commentary regarding: committee meeting.
scientific and technological advances; • The role of deliberation and Name: National Committee on Vital
examine diverse perspectives and deliberative methods to engage the and Health Statistics (NCVHS)
tkelley on DSK3SPTVN1PROD with NOTICES
possibilities for international public and inform debate in bioethics; Subcommittee on Privacy,
collaboration on these issues; and • Approaches to integrating public Confidentiality & Security.
recommend legal, regulatory, or policy dialogue into the bioethics conversation; Time And Date: May 6, 2015 9:00
actions as appropriate. • Bioethics education as a forum for a.m.–5:00 p.m. EST, May 7, 2015 9:00
The Bioethics Commission is fostering deliberative skills and a.m.–12:00 p.m. EST.
considering two overarching themes of preparing students to participate in Place: U.S. Department of Health and
its work, deliberation and education, public dialogue in bioethics; Human Services, Centers for Disease
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Document Created: 2015-12-16 08:34:11
Document Modified: 2015-12-16 08:34:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than May 21, 2015. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 80 FR 22207 |
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