80 FR 63560 - Agency Information Collection Activities: Proposed Collection: Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 202 (October 20, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 202 (October 20, 2015)
| Page Range | 63560-63561 | |
| FR Document | 2015-26522 |
[Federal Register Volume 80, Number 202 (Tuesday, October 20, 2015)] [Notices] [Pages 63560-63561] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26522] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (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, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than December 21, 2015. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 10-29, Parklawn Building, 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 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: 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. 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. 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 (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.'' 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. [[Page 63561]] 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 5576 0.5 2788 Hospital Outpatient Facilities. Hospital Annual Recertifications 2134 6 12804 0.25 3201 ---------------------------------------------------------------------------------------------------------------- Registrations and Recertifications for Entities Other Than Hospitals ---------------------------------------------------------------------------------------------------------------- 340B Registrations for Community 427 3 1281 1 1281 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 1204 5 6020 0.25 1505 Recertifications............... STD & TB Annual Recertifications 3123 1 3123 0.25 780.75 Annual Recertification for 4899 1 4899 0.25 1224.75 entities other than Hospitals, Community Health Centers, and STD/TB Clinics................. ---------------------------------------------------------------------------------------------------------------- Contracted Pharmacy Services Registration & Recertifications ---------------------------------------------------------------------------------------------------------------- Contracted Pharmacy Services 1758 5 8790 1 8790 Registration................... ---------------------------------------------------------------------------------------------------------------- Other Information Collections ---------------------------------------------------------------------------------------------------------------- Submission of Administrative 9396 1 9396 0.5 4698 Changes for any Covered Entity. Submission of Administrative 350 1 350 0.5 175 Changes for any Manufacturer... Manufacturer Data Required to 600 4 2400 0.5 1200 Verify 340B Ceiling Price Calculations................... Pharmaceutical Pricing Agreement 200 1 200 1 200 Pharmaceutical Pricing Agreement 620 1 620 0.5 310 (PPA) Addendum................. ------------------------------------------------------------------------------- Total....................... 26,554 .............. 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. 2015-26522 Filed 10-19-15; 8:45 am] BILLING CODE 4165-15-P
![63560 Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices
the allocated time may be limited. Information Collection Clearance implemented in the Affordable Care
Individuals who are associated with Officer, Room 10–29, Parklawn Act. Section 7102(b) of the Affordable
groups or have similar interests may be Building, 5600 Fishers Lane, Rockville, Care Act amends section 340B(a)(1) of
requested to combine their comments MD 20857. the Public Health Service Act (PHSA) to
and present them through a single FOR FURTHER INFORMATION CONTACT: To add two new requirements for inclusion
representative. No audiovisual request more information on the in the PPA with manufacturers of
presentations are permitted. For proposed project or to obtain a copy of covered outpatient drugs:
additional information or questions on the data collection plans and draft I. ‘‘Each such agreement shall require
public comments, please contact Lisa instruments, email paperwork@hrsa.gov that the manufacturer furnish the
Vasquez, Maternal and Child Health or call the HRSA Information Collection Secretary with reports, on a quarterly
Bureau, Health Resources and Services Clearance Officer at (301) 443–1984. basis, of the price for each covered
Administration; email: SUPPLEMENTARY INFORMATION: When outpatient drug subject to the agreement
lvasquez@hrsa.gov. submitting comments or requesting
Contact Person: Anyone interested in that, according to the manufacturer,
information, please include the represents the maximum price that
obtaining other relevant information
information request collection title for covered entities may permissibly be
should contact Debi Sarkar, Maternal
reference. required to pay for the drug (referred to
and Child Health Bureau, Health
Information Collection Request Title: in this section as the ‘‘ceiling price’’)
Resources and Services Administration,
Enrollment and Re-Certification of and
Room 18W68, Parklawn Building, 5600
Entities in the 340B Drug Pricing
Fishers Lane, Rockville, Maryland II. ‘‘. . . shall require that the
Program and Collection of Manufacturer
20857; email: dsarkar@hrsa.gov. manufacturer offer each covered entity
More information on the Advisory Data to Verify 340B Drug Pricing
Program Ceiling Price Calculations. covered outpatient drugs for purchase at
Committee is available at http://www. or below the applicable ceiling price if
hrsa.gov/advisorycommittees/mchb OMB No. 0915–0327—Revision.
Abstract: Section 602 of Public Law such drug is made available to any other
advisory/heritabledisorders. purchaser at any price.’’
102–585, the Veterans Health Care Act
Jackie Painter, of 1992, enacted as Section 340B of the These requirements shall be included
Director, Division of the Executive Secretariat. Public Health Service Act (PHS Act; in the PPA addendum to be signed by
[FR Doc. 2015–26524 Filed 10–19–15; 8:45 am] ‘‘Limitation on Prices of Drugs manufacturers participating in the 340B
BILLING CODE 4165–15–P Purchased by Covered Entities’’), Program to ensure that the provisions of
provides that a manufacturer who sells the 340B statute requiring inclusion in
covered outpatient drugs to eligible the PPA are satisfied. The execution of
DEPARTMENT OF HEALTH AND entities must sign a Pharmaceutical the addendum by manufacturers will
HUMAN SERVICES Pricing Agreement (PPA) with the fulfill the administrative requirement of
Secretary of Health and Human Services the statute that these provisions be
Health Resources and Services in which the manufacturer agrees to included in the PPA. The burden
Administration charge a price for covered outpatient imposed on manufacturers by the
drugs that will not exceed an amount proposed requirement of the PPA is
Agency Information Collection determined under a statutory formula
Activities: Proposed Collection: Public minimal because the addendum does
(‘‘ceiling price’’). A manufacturer not impose requirements beyond review
Comment Request
subject to a PPA must offer all covered and a signature by the manufacturer.
AGENCY: Health Resources and Services outpatient drugs at no more than the
Likely Respondents: Drug
Administration, HHS. ceiling price to a covered entity listed in
Manufacturers.
ACTION: Notice. the 340B Program database. The
manufacturer shall rely on the Burden Statement: Burden in this
SUMMARY: In compliance with the information in the 340B database to context means the time expended by
requirement for opportunity for public determine if the covered entity is persons to generate, maintain, retain,
comment on proposed data collection participating in the 340B Program or for disclose or provide the information
projects (Section 3506(c)(2)(A) of the any notifications of changes to requested. This includes the time
Paperwork Reduction Act of 1995), the eligibility that may occur within a needed to review instructions; to
Health Resources and Services quarter. By signing the PPA, the develop, acquire, install and utilize
Administration (HRSA) announces manufacturer agrees to comply with all technology and systems for the purpose
plans to submit an Information applicable statutory and regulatory of collecting, validating and verifying
Collection Request (ICR), described requirements. information, processing and
below, to the Office of Management and The purpose of this revision is to maintaining information, and disclosing
Budget (OMB). Prior to submitting the include an addendum to the PPA to and providing information; to train
ICR to OMB, HRSA seeks comments incorporate the administrative personnel and to be able to respond to
from the public regarding the burden requirement for manufacturer integrity a collection of information; to search
estimate, below, or any other aspect of provisions directly addressed in the data sources; to complete and review
the ICR. Affordable Care Act. the collection of information; and to
DATES: Comments on this Information Need and Proposed Use of the transmit or otherwise disclose the
Collection Request must be received no Information: HRSA is proposing information. The total annual burden
mstockstill on DSK4VPTVN1PROD with NOTICES
later than December 21, 2015. revisions to the current PPA to include hours estimated for this Information
ADDRESSES: Submit your comments to an addendum in response to Collection Request are summarized in
paperwork@hrsa.gov or mail the HRSA manufacturer integrity provisions the table below.
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![Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices 63561
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
Number of Total Hours per Total burden
Form name responses per
respondents responses respondent 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,
Community 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 Manufac-
turer .................................................................................. 350 1 350 0.5 175
Manufacturer Data Required to Verify 340B Ceiling Price
Calculations ...................................................................... 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 .............................................................................. 26,554 ........................ 56,705 ........................ 27593.5
HRSA specifically requests comments ACTION: Notice. SUPPLEMENTARY INFORMATION: When
on (1) the necessity and utility of the submitting comments or requesting
proposed information collection for the SUMMARY: In compliance with section information, please include the
proper performance of the agency’s 3506(c)(2)(A) of the Paperwork document identifier HHS–OS–0945–
functions, (2) the accuracy of the Reduction Act of 1995, the Office of the 0002–60D for reference.
estimated burden, (3) ways to enhance Secretary (OS), Department of Health Proposed Project: Complaint Forms
the quality, utility, and clarity of the and Human Services, announces plans
information to be collected, and (4) the for Discrimination; Health Information
to submit an Information Collection
use of automated collection techniques Privacy Complaints.
Request (ICR), described below, to the
or other forms of information Office of Management and Budget OMB No. 0945–0002—Extension—
technology to minimize the information (OMB). The ICR is for extending the use Office of Civil Rights.
collection burden. of the approved information collection Abstract: The Office for Civil Rights is
Jackie Painter, assigned OMB control number 0945– seeking an extension on an approval for
Director, Division of the Executive Secretariat. 0002, which expires on 12/31/2015. a 3-year clearance on a previous
Prior to submitting the ICR to OMB, OS collection. Individuals may file written
[FR Doc. 2015–26522 Filed 10–19–15; 8:45 am]
seeks comments from the public complaints with the Office for Civil
BILLING CODE 4165–15–P
regarding the burden estimate, below, or Rights when they believe they have
any other aspect of the ICR. been discriminated against by programs
DEPARTMENT OF HEALTH AND DATES: Comments on the ICR must be or entities that receive Federal financial
HUMAN SERVICES received on or before December 21, assistance from the Health and Human
2015. Service or if they believe that their right
Office of the Secretary to the privacy of protected health
[Document Identifier: HHS–OS–0945–0002– ADDRESSES: Submit your comments to information has been violated. Annual
60D] Information.CollectionClearance@ Number of Respondents frequency of
mstockstill on DSK4VPTVN1PROD with NOTICES
hhs.gov or by calling (202) 690–6162.
submission is record keeping and
Agency Information Collection
FOR FURTHER INFORMATION CONTACT: reporting on occasion.
Activities; Proposed Collection; Public
Information Collection Clearance staff,
Comment Request
Information.CollectionClearance@
AGENCY: Office of the Secretary, HHS. hhs.gov or (202) 690–6162.
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Document Created: 2015-12-14 15:25:42
Document Modified: 2015-12-14 15:25:42
| 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 Information Collection Request must be received no later than December 21, 2015. | |
| 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 the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 80 FR 63560 |
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