Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 20649-20650 [2016-08110]

Download as PDF Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices We base our estimates on our experience with the submission of electronic information to us using the FDA ESG and the number of electronic registration or change requests received between January 1, 2014, and December 31, 2014. Dated: April 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–08075 Filed 4–7–16; 8:45 am] BILLING CODE 4164–01–P 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 Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: 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 OIRA_ submission@omb.eop.gov 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 paperwork@hrsa.gov 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:48 Apr 07, 2016 Jkt 238001 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 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 20649 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: E:\FR\FM\08APN1.SGM 08APN1 20650 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices Number of respondents Form name Number of responses per respondent Total responses Hours per respondent Total burden hours Hospital Enrollment, Additions & Recertifications 340B Program Registrations & Certifications for Hospitals ............. Certifications to Enroll Hospital Outpatient Facilities ....................... Hospital Annual Recertifications ...................................................... 194 697 2134 1 8 6 194 5576 12804 2 0.5 0.25 388 2788 3201 Registrations and Recertifications for Entities Other Than Hospitals 340B Registrations for Community Health Centers ........................ 340B Registrations for STD/TB Clinics ........................................... 340B Registrations for Various Other Eligible Entity Types ............ Community Health Center Annual Recertifications ......................... STD & TB Annual Recertifications .................................................. Annual Recertification for entities other than Hospitals, Community Health Centers, and STD/TB Clinics ..................................... 427 647 405 1204 3123 3 1 1 5 1 1281 647 405 6020 3123 1 1 1 0.25 0.25 1281 647 405 1505 780.75 4899 1 4899 0.25 1224.75 5 8790 1 8790 Contracted Pharmacy Services Registration & Recertifications Contracted Pharmacy Services Registration ................................... 1758 Other Information Collections Submission of Administrative Changes for any Covered Entity ...... Submission of Administrative Changes for any Manufacturer ........ Manufacturer Data Required to Verify 340B Ceiling Price Calculations .............................................................................................. Pharmaceutical Pricing Agreement ................................................. Pharmaceutical Pricing Agreement (PPA) Addendum .................... 9396 350 1 1 9396 350 0.5 0.5 4698 175 600 200 620 4 1 1 2400 200 620 0.5 1 0.5 1200 200 310 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration mstockstill on DSK4VPTVN1PROD with NOTICES National Advisory Council on Nurse Education and Practice; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: National Advisory Council on Nurse Education and Practice (NACNEP). VerDate Sep<11>2014 17:48 Apr 07, 2016 Jkt 238001 Dates and Time: June 7–8, 2016, 8:30 a.m.–5:00 p.m. EST. Place: In-Person Meeting with Webinar/Conference Call Component, U.S. Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 5A02/5A03, Rockville, Maryland 20857. Status: This Advisory Council meeting will be open to the public. Purpose: The purpose of the 133rd NACNEP meeting is to explore strategies to prepare registered nurses (RNs) to address the complex health needs of populations within an evolving health care delivery system. NACNEP members will identify and discuss gaps in population health education, as well as educational competencies in population health for RNs. This meeting will contribute to the development of NACNEP’s mandated 14th Annual Report to the Secretary of the U.S. Department of Health and Human Services and Congress. Agenda: A final agenda will be posted on the NACNEP Web site 3 days prior to the meeting. Agenda items are subject to change as priorities dictate. SUPPLEMENTARY INFORMATION: Further information regarding NACNEP, including the roster of members, reports to Congress, and minutes from previous meetings, is available at the NACNEP Web site. Members of the public and PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 interested parties may request to attend the meeting by contacting Staff Assistant, Jeanne Brown, at jbrown@ hrsa.gov. Access to the meeting will be granted on a first-come, first-served basis and space is limited. Public attendees may submit written statements in advance of the scheduled meeting. In addition, a public comment period is tentatively scheduled for the first day of the meeting after the lunch break. Oral comments will be limited to three minutes per speaker. Written statements and registration for oral comments must be received in advance and should be sent to Erin Fowler by email at: nacnep@hrsa.gov. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the contact person listed above at least 10 days prior to the meeting. Please be advised that council members are given copies of all written statements submitted by the public prior to the meeting. Any further public participation will be at the discretion of the Chair, with approval of the Designated Federal Official in attendance. Any member of the public who wishes to have printed materials distributed to NACNEP should submit materials to the National Advisory Council on Nurse Education and Practice mailbox at nacnep@hrsa.gov, E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20649-20650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08110]


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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 
OIRA_submission@omb.eop.gov 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 paperwork@hrsa.gov 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