Agency Information Collection Activities: Submission for OMB Review; Comment Request, 42747-42748 [2012-17777]
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42747
Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices
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Dated: July 16, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–17667 Filed 7–19–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1984.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Enrollment and ReCertification of Entities in the 340B
Drug Pricing Program (OMB No. 0915–
0327)—[Revision]
Section 602 of Public Law 102–585,
the Veterans Health Care Act of 1992,
enacted section 340B of the Public
Health Service Act (PHS Act),
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities.’’ Section
340B provides that a manufacturer who
sells covered outpatient drugs to eligible
entities must sign a Pharmaceutical
Pricing Agreement 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. Covered
entities which choose to participate in
the section 340B Drug Pricing 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.
In response to the statutory mandate
of section 340B(a)(9) of the PHS Act to
notify manufacturers of the identities of
covered entities and the mandate of
section 340B(a)(5)(A)(ii) to establish a
mechanism to ensure against duplicate
discounts and the ongoing
responsibility to administer the 340B
Drug Pricing Program while maintaining
efficiency, transparency and integrity,
the HRSA Office of Pharmacy Affairs
(OPA) developed a process of
registration of covered entities to enable
it to address those mandates.
Enrollment/Registration
To enroll and certify the eligible
federally funded grantees and other
safety net health care providers, OPA
Number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Reporting requirement
Responses per
respondent
requires entities to submit
administrative information (e.g.
shipping and billing arrangements,
Medicaid participation), certifying
information and signatures from
appropriate grantee level or entity level
authorizing officials and state/local
government representatives. The
purpose of this registration information
is to determine eligibility for the 340B
Drug Pricing Program. This information
is entered into the 340B database by
entities and verified by OPA staff
according to 340B Drug Pricing Program
requirements. Accurate records are
critical to implementation of the 340B
Drug Pricing Program legislation,
especially to prevent diversion and
duplicate discounts. To maintain
accurate records, 340B statute also
requires that entities recertify eligibility
annually and that they notify the
program of updates to any
administrative information that they
submitted when initially enrolling into
the program. The burden requirement is
low for recertification and for
submitting change requests.
Contract Pharmacy Self-Certification
In order to ensure that drug
manufacturers and drug wholesalers
recognize contract pharmacy
arrangements, covered entities that elect
to utilize one or more contract
pharmacies are also required to submit
general information about the
arrangements and to certify that signed
agreements are in place with those
contract pharmacies.
Pharmaceutical Pricing Agreement
In accordance with the guidance
found in the May 7, 1993, Federal
Register, Section 340B provides that a
manufacturer who sells covered
outpatient drugs to eligible entities must
sign a Pharmaceutical Pricing
Agreement (the ‘‘Agreement’’) with the
Secretary of Health and Human Services
(the ‘‘Secretary’’) in which the
manufacturer agrees to charge a price for
covered outpatient drugs that will not
exceed the average manufacturer price
(‘‘AMP’’) decreased by a rebate
percentage.
The estimates of annualized burden
are as follows:
Total
responses
Hours per
response
Total
burden hours
HOSPITAL ENROLLMENT, ADDITIONS & RECERTIFICATIONS
340B Program Registrations & Certifications for Hospitals .............................................................................
Certifications to Enroll Hospital Outpatient Facilities .......
Hospital Annual Recertification ........................................
VerDate Mar<15>2010
18:18 Jul 19, 2012
Jkt 226001
PO 00000
Frm 00056
546
606
4,842
Fmt 4703
Sfmt 4703
1
1
1
546
606
4,842
E:\FR\FM\20JYN1.SGM
20JYN1
2.0
0.5
0.5
1,092.0
303.0
2,421.0
42748
Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices
Number of
respondents
Reporting requirement
Responses per
respondent
Total
responses
Hours per
response
Total
burden hours
REGISTRATIONS AND RECERTIFICATIONS FOR ENTITIES OTHER THAN HOSPITALS
340B Registrations for Community Health Centers ........
340B Registrations for Family Planning Programs, STD/
TB Clinics and Various Other Eligible Entity Types ....
Community Health Center Annual Recertification ...........
Family Planning Annual Recertification ...........................
STD & TB Annual Recertification ....................................
Annual Recertification for entities other than Hospitals,
Community Health Centers, Family Planning, STD or
TB Clinics .....................................................................
253
1
253
1.0
253.0
353
4,507
3,879
2,754
1
1
1
1
353
4,507
3,879
2,754
1.0
0.5
0.5
0.5
353.0
2,253.5
1,939.5
1,377.0
1,174
1
1,174
0.5
587.0
2500
1.0
2500.0
CONTRACTED PHARMACY SERVICES REGISTRATIONS
Contracted Pharmacy Services Registration ...................
2500
1
OTHER INFORMATION COLLECTIONS
Submission of Administrative Changes for any Covered
Entity .............................................................................
Submission of Administrative Changes for any Manufacturer ..............................................................................
Pharmaceutical Pricing Agreement .................................
2,500
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Dated: July 16, 2012.
Jennifer Riggle,
Deputy Director, Office of Management.
[FR Doc. 2012–17777 Filed 7–19–12; 8:45 am]
BILLING CODE 4165–15–P
2,500
0.5
1,250.0
350
200
1
1
350
200
0.5
1.0
175.0
200.0
24,464
Total ..........................................................................
1
............................
24,464
........................
14,704.0
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
and Budget for review under the
Paperwork Reduction Act of 1995:
Health Resources and Services
Administration
Proposed Project: Faculty Loan
Repayment Program (OMB No. 0915–
0150)—[Revision]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Under the Health Resources and
Services Administration (HRSA) Faculty
Loan Repayment Program, degreetrained health professionals from
disadvantaged backgrounds may enter
into a contract under which the
Department of Health and Human
Services will make payments on eligible
educational loans in exchange for a
minimum of 2 years of service as a fulltime or part-time faculty member of an
accredited health professions college or
university. Applicants must complete
an application and provide all other
required documentation, including
information on all eligible educational
loans.
The annual estimate of burden is as
follows:
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1984.
The following request has been
submitted to the Office of Management
Number of
respondents
Instrument
Responses per
respondent
Total
responses
Hours per
response
Total burden
hours
304
* 304
304
1
*1
1
304
304
304
1
1
.25
304
304
76
Total ..........................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Online Application ............................................................
Institution/Loan Repayment Employment Form ..............
Authorization to Release Information Form .....................
912
............................
........................
........................
684
*Respondent for this form is the institution for the applicant.
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
VerDate Mar<15>2010
18:18 Jul 19, 2012
Jkt 226001
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. Please direct all
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
E:\FR\FM\20JYN1.SGM
20JYN1
]]>Agencies
[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Notices]
[Pages 42747-42748]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17777]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, email
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1984.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: Enrollment and Re-Certification of Entities in the
340B Drug Pricing Program (OMB No. 0915-0327)--[Revision]
Section 602 of Public Law 102-585, the Veterans Health Care Act of
1992, enacted section 340B of the Public Health Service Act (PHS Act),
``Limitation on Prices of Drugs Purchased by Covered Entities.''
Section 340B provides that a manufacturer who sells covered outpatient
drugs to eligible entities must sign a Pharmaceutical Pricing Agreement
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. Covered
entities which choose to participate in the section 340B Drug Pricing
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.
In response to the statutory mandate of section 340B(a)(9) of the
PHS Act to notify manufacturers of the identities of covered entities
and the mandate of section 340B(a)(5)(A)(ii) to establish a mechanism
to ensure against duplicate discounts and the ongoing responsibility to
administer the 340B Drug Pricing Program while maintaining efficiency,
transparency and integrity, the HRSA Office of Pharmacy Affairs (OPA)
developed a process of registration of covered entities to enable it to
address those mandates.
Enrollment/Registration
To enroll and certify the eligible federally funded grantees and
other safety net health care providers, OPA requires entities to submit
administrative information (e.g. shipping and billing arrangements,
Medicaid participation), certifying information and signatures from
appropriate grantee level or entity level authorizing officials and
state/local government representatives. The purpose of this
registration information is to determine eligibility for the 340B Drug
Pricing Program. This information is entered into the 340B database by
entities and verified by OPA staff according to 340B Drug Pricing
Program requirements. Accurate records are critical to implementation
of the 340B Drug Pricing Program legislation, especially to prevent
diversion and duplicate discounts. To maintain accurate records, 340B
statute also requires that entities recertify eligibility annually and
that they notify the program of updates to any administrative
information that they submitted when initially enrolling into the
program. The burden requirement is low for recertification and for
submitting change requests.
Contract Pharmacy Self-Certification
In order to ensure that drug manufacturers and drug wholesalers
recognize contract pharmacy arrangements, covered entities that elect
to utilize one or more contract pharmacies are also required to submit
general information about the arrangements and to certify that signed
agreements are in place with those contract pharmacies.
Pharmaceutical Pricing Agreement
In accordance with the guidance found in the May 7, 1993, Federal
Register, Section 340B provides that a manufacturer who sells covered
outpatient drugs to eligible entities must sign a Pharmaceutical
Pricing Agreement (the ``Agreement'') with the Secretary of Health and
Human Services (the ``Secretary'') in which the manufacturer agrees to
charge a price for covered outpatient drugs that will not exceed the
average manufacturer price (``AMP'') decreased by a rebate percentage.
The estimates of annualized burden are as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Reporting requirement respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
HOSPITAL ENROLLMENT, ADDITIONS & RECERTIFICATIONS
----------------------------------------------------------------------------------------------------------------
340B Program Registrations & 546 1 546 2.0 1,092.0
Certifications for Hospitals.
Certifications to Enroll 606 1 606 0.5 303.0
Hospital Outpatient
Facilities...................
Hospital Annual 4,842 1 4,842 0.5 2,421.0
Recertification..............
----------------------------------------------------------------------------------------------------------------
[[Page 42748]]
REGISTRATIONS AND RECERTIFICATIONS FOR ENTITIES OTHER THAN HOSPITALS
----------------------------------------------------------------------------------------------------------------
340B Registrations for 253 1 253 1.0 253.0
Community Health Centers.....
340B Registrations for Family 353 1 353 1.0 353.0
Planning Programs, STD/TB
Clinics and Various Other
Eligible Entity Types........
Community Health Center Annual 4,507 1 4,507 0.5 2,253.5
Recertification..............
Family Planning Annual 3,879 1 3,879 0.5 1,939.5
Recertification..............
STD & TB Annual 2,754 1 2,754 0.5 1,377.0
Recertification..............
Annual Recertification for 1,174 1 1,174 0.5 587.0
entities other than
Hospitals, Community Health
Centers, Family Planning, STD
or TB Clinics................
----------------------------------------------------------------------------------------------------------------
CONTRACTED PHARMACY SERVICES REGISTRATIONS
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services 2500 1 2500 1.0 2500.0
Registration.................
----------------------------------------------------------------------------------------------------------------
OTHER INFORMATION COLLECTIONS
----------------------------------------------------------------------------------------------------------------
Submission of Administrative 2,500 1 2,500 0.5 1,250.0
Changes for any Covered
Entity.......................
Submission of Administrative 350 1 350 0.5 175.0
Changes for any Manufacturer.
Pharmaceutical Pricing 200 1 200 1.0 200.0
Agreement....................
---------------------------------------------------------------------------------
Total..................... 24,464 ................ 24,464 .............. 14,704.0
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: July 16, 2012.
Jennifer Riggle,
Deputy Director, Office of Management.
[FR Doc. 2012-17777 Filed 7-19-12; 8:45 am]
BILLING CODE 4165-15-P
