Agency Information Collection Activities: Proposed Collection: Public Comment Request, 63560-63561 [2015-26522]

Download as PDF 63560 Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices the allocated time may be limited. Individuals who are associated with groups or have similar interests may be requested to combine their comments and present them through a single representative. No audiovisual presentations are permitted. For additional information or questions on public comments, please contact Lisa Vasquez, Maternal and Child Health Bureau, Health Resources and Services Administration; email: lvasquez@hrsa.gov. Contact Person: Anyone interested in obtaining other relevant information should contact Debi Sarkar, Maternal and Child Health Bureau, Health Resources and Services Administration, Room 18W68, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; email: dsarkar@hrsa.gov. More information on the Advisory Committee is available at http://www. hrsa.gov/advisorycommittees/mchb advisory/heritabledisorders. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015–26524 Filed 10–19–15; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: 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 paperwork@hrsa.gov or mail the HRSA mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:55 Oct 19, 2015 Jkt 238001 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 paperwork@hrsa.gov 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 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 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. E:\FR\FM\20OCN1.SGM 20OCN1 63561 Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices TOTAL ESTIMATED ANNUALIZED BURDEN HOURS 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 Contracted Pharmacy Services Registration & Recertifications Contracted Pharmacy Services Registration ....................... 1758 5 8790 1 8790 9396 1 9396 0.5 4698 350 1 350 0.5 175 600 200 620 4 1 1 2400 200 620 0.5 1 0.5 1200 200 310 26,554 ........................ 56,705 ........................ 27593.5 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 ........ Total .............................................................................. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES Agency Information Collection Activities; Proposed Collection; Public Comment Request VerDate Sep<11>2014 17:55 Oct 19, 2015 Jkt 238001 When submitting comments or requesting information, please include the document identifier HHS–OS–0945– 0002–60D for reference. Proposed Project: Complaint Forms for Discrimination; Health Information Privacy Complaints. OMB No. 0945–0002—Extension— Office of Civil Rights. Abstract: The Office for Civil Rights is seeking an extension on an approval for a 3-year clearance on a previous collection. Individuals may file written complaints with the Office for Civil Rights when they believe they have been discriminated against by programs or entities that receive Federal financial assistance from the Health and Human Service or if they believe that their right to the privacy of protected health information has been violated. Annual Number of Respondents frequency of submission is record keeping and reporting on occasion. SUPPLEMENTARY INFORMATION: In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0945– 0002, which expires on 12/31/2015. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. SUMMARY: Comments on the ICR must be received on or before December 21, 2015. [Document Identifier: HHS–OS–0945–0002– 60D] Office of the Secretary, HHS. Notice. DATES: Office of the Secretary AGENCY: ACTION: Submit your comments to Information.CollectionClearance@ hhs.gov or by calling (202) 690–6162. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, Information.CollectionClearance@ hhs.gov or (202) 690–6162. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[Federal Register Volume 80, Number 202 (Tuesday, October 20, 2015)]
[Notices]
[Pages 63560-63561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26522]


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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.

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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 paperwork@hrsa.gov 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 paperwork@hrsa.gov 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