81 FR 20649 - 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 81, Issue 68 (April 8, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 68 (April 8, 2016)
| Page Range | 20649-20650 | |
| FR Document | 2016-08110 |
[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)] [Notices] [Pages 20649-20650] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08110] ----------------------------------------------------------------------- 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 9, 2016. 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 the Secretary of Health and Human Services will enter into a Pharmaceutical Pricing Agreement (PPA) with each manufacturer of covered outpatient drugs in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed the average manufacturer price decreased by a rebate percentage. Under this PPA, a manufacturer agrees not to charge a price for covered outpatient drugs that exceeds 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 if such drug is made available to any other purchaser at any price. The manufacturer shall rely on the information in the 340B database to determine if the 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. In response to comments submitted during the first public review of this ICR, the language has been revised in this notice and in the draft instruments in order to align with the applicable statutory language regarding the obligation to sign the PPA, the circumstances under which participating manufacturers must offer covered outpatient drugs to covered entities, and the description of the ceiling price data required to be provided. The purpose of this revision is to include an addendum to the PPA to incorporate the administrative requirement for manufacturer integrity provisions directly addressed in the Affordable Care Act. Need and Proposed Use of the Information: HRSA is proposing revisions to the current PPA to include an addendum in response to manufacturer integrity provisions implemented in the Affordable Care Act. Section 7102(b) of the Affordable Care Act amends section 340B(a)(1) of the Public Health Service Act (PHSA) to add two new requirements for inclusion in the PPA with manufacturers of covered outpatient drugs: 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 . . .'' 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.'' These requirements shall be included in the PPA addendum to be signed by manufacturers participating in the 340B Program to ensure that the provisions of the 340B statute requiring inclusion in the PPA are satisfied. The execution of the addendum by manufacturers will fulfill the administrative requirement of the statute that these provisions be included in the PPA. The burden imposed on manufacturers by the proposed requirement of the PPA is minimal because the addendum does not impose requirements beyond review and a signature by the manufacturer. 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 Information Collection Request are summarized in the table below. Total Estimated Annualized Burden Hours: [[Page 20650]] ---------------------------------------------------------------------------------------------------------------- Number of Total Form name Number of responses per Total Hours per burden respondents respondent responses respondent hours ---------------------------------------------------------------------------------------------------------------- Hospital Enrollment, Additions & Recertifications ---------------------------------------------------------------------------------------------------------------- 340B Program Registrations & 194 1 194 2 388 Certifications for Hospitals............ Certifications to Enroll Hospital 697 8 5576 0.5 2788 Outpatient Facilities................... Hospital Annual Recertifications......... 2134 6 12804 0.25 3201 ---------------------------------------------------------------------------------------------------------------- Registrations and Recertifications for Entities Other Than Hospitals ---------------------------------------------------------------------------------------------------------------- 340B Registrations for Community Health 427 3 1281 1 1281 Centers................................. 340B Registrations for STD/TB Clinics.... 647 1 647 1 647 340B Registrations for Various Other 405 1 405 1 405 Eligible Entity Types................... Community Health Center Annual 1204 5 6020 0.25 1505 Recertifications........................ STD & TB Annual Recertifications......... 3123 1 3123 0.25 780.75 Annual Recertification for entities other 4899 1 4899 0.25 1224.75 than Hospitals, Community Health Centers, and STD/TB Clinics............. ---------------------------------------------------------------------------------------------------------------- Contracted Pharmacy Services Registration & Recertifications ---------------------------------------------------------------------------------------------------------------- Contracted Pharmacy Services Registration 1758 5 8790 1 8790 ---------------------------------------------------------------------------------------------------------------- Other Information Collections ---------------------------------------------------------------------------------------------------------------- Submission of Administrative Changes for 9396 1 9396 0.5 4698 any Covered Entity...................... Submission of Administrative Changes for 350 1 350 0.5 175 any Manufacturer........................ Manufacturer Data Required to Verify 340B 600 4 2400 0.5 1200 Ceiling Price Calculations.............. Pharmaceutical Pricing Agreement......... 200 1 200 1 200 Pharmaceutical Pricing Agreement (PPA) 620 1 620 0.5 310 Addendum................................ ---------------------------------------------------------------------- Total................................ 26,654 .............. 56,705 ........... 27593.5 ---------------------------------------------------------------------------------------------------------------- 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. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2016-08110 Filed 4-7-16; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices 20649
We base our estimates on our Data to Verify 340B Drug Pricing Act. Section 7102(b) of the Affordable
experience with the submission of Program Ceiling Price Calculations. Care Act amends section 340B(a)(1) of
electronic information to us using the the Public Health Service Act (PHSA) to
OMB No. 0915–0327—Revision
FDA ESG and the number of electronic add two new requirements for inclusion
registration or change requests received Abstract: Section 602 of Public Law in the PPA with manufacturers of
between January 1, 2014, and December 102–585, the Veterans Health Care Act covered outpatient drugs:
31, 2014. of 1992, enacted as Section 340B of the I. ‘‘Each such agreement shall require
Public Health Service Act (PHS Act; that the manufacturer furnish the
Dated: April 1, 2016.
‘‘Limitation on Prices of Drugs Secretary with reports, on a quarterly
Leslie Kux, Purchased by Covered Entities’’),
Associate Commissioner for Policy. basis, of the price for each covered
provides that the Secretary of Health outpatient drug subject to the agreement
[FR Doc. 2016–08075 Filed 4–7–16; 8:45 am] and Human Services will enter into a
that, according to the manufacturer,
BILLING CODE 4164–01–P Pharmaceutical Pricing Agreement
represents the maximum price that
(PPA) with each manufacturer of
covered entities may permissibly be
covered outpatient drugs in which the
DEPARTMENT OF HEALTH AND required to pay for the drug . . .’’ and
manufacturer agrees to charge a price for
HUMAN SERVICES covered outpatient drugs that will not II. ‘‘. . . shall require that the
exceed the average manufacturer price manufacturer offer each covered entity
Health Resources and Services decreased by a rebate percentage. Under covered outpatient drugs for purchase at
Administration this PPA, a manufacturer agrees not to or below the applicable ceiling price if
charge a price for covered outpatient such drug is made available to any other
Agency Information Collection purchaser at any price.’’
drugs that exceeds an amount
Activities: Submission to OMB for These requirements shall be included
determined under a statutory formula
Review and Approval; Public Comment in the PPA addendum to be signed by
(ceiling price). A manufacturer subject
Request manufacturers participating in the 340B
to a PPA must offer all covered
AGENCY: Health Resources and Services outpatient drugs at no more than the Program to ensure that the provisions of
Administration, HHS. ceiling price to a covered entity listed in the 340B statute requiring inclusion in
the 340B Program database if such drug the PPA are satisfied. The execution of
ACTION: Notice.
is made available to any other purchaser the addendum by manufacturers will
SUMMARY: In compliance with Section at any price. The manufacturer shall fulfill the administrative requirement of
3507(a)(1)(D) of the Paperwork rely on the information in the 340B the statute that these provisions be
Reduction Act of 1995, the Health database to determine if the covered included in the PPA. The burden
Resources and Services Administration entity is participating in the 340B imposed on manufacturers by the
(HRSA) has submitted an Information Program or for any notifications of proposed requirement of the PPA is
Collection Request (ICR) to the Office of changes to eligibility that may occur minimal because the addendum does
Management and Budget (OMB) for within a quarter. By signing the PPA, not impose requirements beyond review
review and approval. Comments the manufacturer agrees to comply with and a signature by the manufacturer.
submitted during the first public review all applicable statutory and regulatory Likely Respondents: Drug
of this ICR will be provided to OMB. requirements. In response to comments Manufacturers.
submitted during the first public review
OMB will accept further comments from Burden Statement: Burden in this
of this ICR, the language has been
the public during the review and context means the time expended by
revised in this notice and in the draft
approval period. persons to generate, maintain, retain,
instruments in order to align with the
DATES: Comments on this ICR should be disclose or provide the information
applicable statutory language regarding
received no later than May 9, 2016. requested. This includes the time
the obligation to sign the PPA, the
needed to review instructions; to
ADDRESSES: Submit your comments, circumstances under which
develop, acquire, install and utilize
including the Information Collection participating manufacturers must offer
technology and systems for the purpose
Request Title, to the desk officer for covered outpatient drugs to covered
of collecting, validating and verifying
HRSA, either by email to OIRA_ entities, and the description of the
ceiling price data required to be information, processing and
submission@omb.eop.gov or by fax to maintaining information, and disclosing
202–395–5806. provided.
The purpose of this revision is to and providing information; to train
FOR FURTHER INFORMATION CONTACT: To personnel and to be able to respond to
include an addendum to the PPA to
request a copy of the clearance requests a collection of information; to search
incorporate the administrative
submitted to OMB for review, email the data sources; to complete and review
requirement for manufacturer integrity
HRSA Information Collection Clearance the collection of information; and to
provisions directly addressed in the
Officer at paperwork@hrsa.gov or call transmit or otherwise disclose the
Affordable Care Act.
(301) 443–1984. Need and Proposed Use of the information. The total annual burden
SUPPLEMENTARY INFORMATION: Information: HRSA is proposing hours estimated for this Information
Information Collection Request Title: revisions to the current PPA to include Collection Request are summarized in
Enrollment and Re-Certification of an addendum in response to the table below.
Entities in the 340B Drug Pricing manufacturer integrity provisions Total Estimated Annualized Burden
mstockstill on DSK4VPTVN1PROD with NOTICES
Program and Collection of Manufacturer implemented in the Affordable Care Hours:
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![20650 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
Number of
Number of Total Hours per Total bur-
Form name responses per
respondents responses respondent den hours
respondent
Hospital Enrollment, Additions & Recertifications
340B Program Registrations & Certifications for Hospitals ............. 194 1 194 2 388
Certifications to Enroll Hospital Outpatient Facilities ....................... 697 8 5576 0.5 2788
Hospital Annual Recertifications ...................................................... 2134 6 12804 0.25 3201
Registrations and Recertifications for Entities Other Than Hospitals
340B Registrations for Community Health Centers ........................ 427 3 1281 1 1281
340B Registrations for STD/TB Clinics ........................................... 647 1 647 1 647
340B Registrations for Various Other Eligible Entity Types ............ 405 1 405 1 405
Community Health Center Annual Recertifications ......................... 1204 5 6020 0.25 1505
STD & TB Annual Recertifications .................................................. 3123 1 3123 0.25 780.75
Annual Recertification for entities other than Hospitals, Commu-
nity Health Centers, and STD/TB Clinics ..................................... 4899 1 4899 0.25 1224.75
Contracted Pharmacy Services Registration & Recertifications
Contracted Pharmacy Services Registration ................................... 1758 5 8790 1 8790
Other Information Collections
Submission of Administrative Changes for any Covered Entity ...... 9396 1 9396 0.5 4698
Submission of Administrative Changes for any Manufacturer ........ 350 1 350 0.5 175
Manufacturer Data Required to Verify 340B Ceiling Price Calcula-
tions .............................................................................................. 600 4 2400 0.5 1200
Pharmaceutical Pricing Agreement ................................................. 200 1 200 1 200
Pharmaceutical Pricing Agreement (PPA) Addendum .................... 620 1 620 0.5 310
Total .......................................................................................... 26,654 ........................ 56,705 .................... 27593.5
HRSA specifically requests comments Dates and Time: June 7–8, 2016, 8:30 interested parties may request to attend
on (1) the necessity and utility of the a.m.–5:00 p.m. EST. the meeting by contacting Staff
proposed information collection for the Place: In-Person Meeting with Assistant, Jeanne Brown, at jbrown@
proper performance of the agency’s Webinar/Conference Call Component, hrsa.gov. Access to the meeting will be
functions, (2) the accuracy of the U.S. Department of Health and Human granted on a first-come, first-served
estimated burden, (3) ways to enhance Services, Health Resources and Services basis and space is limited. Public
the quality, utility, and clarity of the Administration, 5600 Fishers Lane, attendees may submit written
information to be collected, and (4) the Room 5A02/5A03, Rockville, Maryland statements in advance of the scheduled
use of automated collection techniques 20857. meeting. In addition, a public comment
or other forms of information Status: This Advisory Council period is tentatively scheduled for the
technology to minimize the information meeting will be open to the public. first day of the meeting after the lunch
collection burden. Purpose: The purpose of the 133rd break. Oral comments will be limited to
NACNEP meeting is to explore strategies three minutes per speaker. Written
Jackie Painter, to prepare registered nurses (RNs) to statements and registration for oral
Director, Division of the Executive Secretariat. address the complex health needs of comments must be received in advance
[FR Doc. 2016–08110 Filed 4–7–16; 8:45 am] populations within an evolving health and should be sent to Erin Fowler by
BILLING CODE 4165–15–P care delivery system. NACNEP members email at: nacnep@hrsa.gov. Individuals
will identify and discuss gaps in who plan to attend and need special
population health education, as well as assistance, such as sign language
DEPARTMENT OF HEALTH AND educational competencies in population interpretation or other reasonable
HUMAN SERVICES health for RNs. This meeting will accommodations, should notify the
contribute to the development of contact person listed above at least 10
Health Resources and Services NACNEP’s mandated 14th Annual days prior to the meeting.
Administration Report to the Secretary of the U.S. Please be advised that council
Department of Health and Human members are given copies of all written
National Advisory Council on Nurse Services and Congress. statements submitted by the public prior
Education and Practice; Notice of Agenda: A final agenda will be posted to the meeting. Any further public
Meeting on the NACNEP Web site 3 days prior participation will be at the discretion of
to the meeting. Agenda items are subject
mstockstill on DSK4VPTVN1PROD with NOTICES
the Chair, with approval of the
In accordance with section 10(a)(2) of to change as priorities dictate. Designated Federal Official in
the Federal Advisory Committee Act SUPPLEMENTARY INFORMATION: Further attendance. Any member of the public
(Pub. L. 92–463), notice is hereby given information regarding NACNEP, who wishes to have printed materials
of the following meeting: including the roster of members, reports distributed to NACNEP should submit
Name: National Advisory Council on to Congress, and minutes from previous materials to the National Advisory
Nurse Education and Practice meetings, is available at the NACNEP Council on Nurse Education and
(NACNEP). Web site. Members of the public and Practice mailbox at nacnep@hrsa.gov,
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Document Created: 2018-02-07 13:49:55
Document Modified: 2018-02-07 13:49:55
| 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 9, 2016. | |
| 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 | 81 FR 20649 |
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