Agency Information Collection Activities: Submission for OMB Review; Comment Request, 40821-40822 [E9-19381]
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40821
Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Notices
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Advanced Education
Nursing Traineeship (AENT) and Nurse
Anesthetist Traineeship (NAT) (OMB
No. 0915–0305): Revision
The Health Resources and Services
Administration (HRSA) provides
training grants to educational
institutions to increase the numbers of
advanced education nurses through the
Advanced Education Nursing
Traineeship (AENT) program and the
Nurse Anesthetist Traineeship (NAT)
program.
HRSA developed the AENT and NAT
tables for the application guidances and
the Nurse Traineeship Database for the
two nursing traineeship programs. The
AENT and NAT tables are used
annually by grant applicants that are
applying for AENT and NAT funding.
The funds appropriated for the AENT
and NAT programs are distributed
among eligible institutions based on a
formula. Award amounts are based on
enrollment and graduate data reported
on the tables and two funding factors
(Statutory Funding Preference and
Statutory Special Consideration).
The AENT and NAT tables include
information on program participants
such as the number of enrollees,
projected data on enrollees and
graduates for the following academic
year, number of trainees supported,
number of graduates, number of
graduates supported and the types of
programs they are enrolling into and/or
from which they are graduating. AENT
and NAT applicants will have a single
Number of
respondents
Instrument
Responses
per
respondent
access point to submit their grant
applications including the tables.
Applications are submitted in two
phases: Grants.gov (Phase 1) and the
HRSA Electronic Handbooks (Phase 2).
These tables will be available
electronically through the HRSA
Electronic Handbooks (Phase 2) for
applicants to submit their AENT and/or
NAT grant application(s). The tables are
also used in the Nurse Traineeship
Database which is used by Division of
Nursing staff and not the applicants.
Data from the tables will be used in
the award determination and validation
process. Additionally, the data will be
used to ensure programmatic
compliance, report to Congress and
policymakers on the program
accomplishments, and formulate and
justify future budgets for these activities
submitted to OMB and Congress.
The burden estimate for this project is
as follows:
Total
responses
Hours per
response
Total burden
hours
AENT ....................................................................................
NAT ......................................................................................
500
100
1
1
500
100
1.5
1
750
100
Total ..............................................................................
600
........................
600
........................
850
E-mail comments to
paperwork@hrsa.gov or mail to the
HRSA Reports Clearance Officer, Room
10–33, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857. Written
comments should be received within 60
days of this notice.
Dated: August 5, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–19393 Filed 8–12–09; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
erowe on DSK5CLS3C1PROD with NOTICES
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
VerDate Nov<24>2008
15:29 Aug 12, 2009
Jkt 217001
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
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 [NEW]
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 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
PO 00000
Frm 00015
Fmt 4703
Sfmt 4703
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) 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
E:\FR\FM\13AUN1.SGM
13AUN1
40822
Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Notices
is to determine eligibility for the 340B
program. This information is received
and verified according to 340B
requirements and entered into the 340B
database. Accurate records are critical to
implementation of the 340B legislation
especially to prevent diversion and
duplicate discounts. To maintain
accurate records, the OPA requests
entities to submit modifications to any
administrative information that they
submitted when initially enrolling into
the program. The burden requirement
for these processes is minimal.
Contract Pharmacy Self-Certification
In order to ensure that drug
manufacturers and drug wholesalers
recognize contract pharmacy
Number of
respondents
Reporting requirement
Responses
per
respondent
arrangements, covered entities that elect
to utilize a contract pharmacy are
required to submit to OPA a selfcertification form similar to the
registration form that they have signed
an agreement with the contract
pharmacy.
The Estimates of annualized burden
are as follows:
Total
responses
Hours per
response
Total burden
hours
DSH & Children’s Hospital Enrollment, Additions & Recertifications
340B Program Registrations & Certifications for Disproportionate Share Hospitals ......................................
340B Program Registrations & Certifications for Children’s Hospitals ............................................................
Certifications to Enroll DSH & Children’s Hospitals Outpatient facilities to 340B Program ................................
DSH & Children’s Hospitals’ Annual Recertification ........
70
1
70
.25
17.5
80
1
80
.25
20
180
937
1
1
180
937
.083
.5
14.94
468.5
Registration for Entities Other Than Hospitals & Recertifications
340B Registration Form (Family Planning, STD, TB,
and others) ...................................................................
Family Planning Annual Recertification ...........................
STD & TB Annual Recertification ....................................
Other Entity Annual Recertification for entities other
than DSHs, FP, STD or TB entities .............................
Submission of Administrative Changes for any entity .....
170
85
111
1
47
11
170
3995
1221
.083
.083
.083
14.11
331.59
101.34
400
460
10
1
4000
460
.083
.083
332
38.18
.083
..........................
166
1504.16
Contracted Pharmacy Services Registration & Recertifications
Contracted Pharmacy Services Registration ...................
Total ..........................................................................
2000
* 4493
1
........................
2000
13,313
* The total number of respondents may be overestimated since we are unable to avoid duplication of respondents who submit information to
the OPA over the course of participation in the 340B Drug Pricing Program, via the initial registration process to any updates/modifications and
enrolling contract pharmacies, if applicable, to the recertification process.
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: August 5, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–19381 Filed 8–12–09; 8:45 am]
erowe on DSK5CLS3C1PROD with NOTICES
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Health
Promotion and Disease Prevention
Research Centers, Special Interest
Project Competitive Supplements
(SIPS) (U48 Panels N, O and P), RFA–
DP09–101SUPP09, Initial Review
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting.
Time and Dates:
9 a.m.–5 p.m., August 5, 2009 (closed).
9 a.m.–5 p.m., August 6, 2009 (closed).
9 a.m.–5 p.m., August 7, 2009 (closed).
Place: Westin Hotel, 3377 Peachtree Road,
NE., Atlanta, GA, 30326, Telephone (678)
500–3100.
Status: The meeting will be closed to the
public in accordance with provisions set
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Fmt 4703
Sfmt 4703
forth in section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of the application received in
response to ‘‘Health Promotion and Disease
Prevention Research Centers, Special Interest
Project Competitive Supplements (SIPS) (U48
Panels N, O and P), RFA–DP09–101SUPP09,
initial review.’’
Contact Person for More Information:
Brenda Colley-Gilbert, Ph.D., Director,
Extramural Research Program Office, CCH,
47770 Buford Highway, MS K–92, Atlanta,
GA 30341, Telephone (770) 488–8390.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–19293 Filed 8–12–09; 8:45 am]
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]]>Agencies
[Federal Register Volume 74, Number 155 (Thursday, August 13, 2009)]
[Notices]
[Pages 40821-40822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19381]
-----------------------------------------------------------------------
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, e-mail
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1129.
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 [NEW]
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 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) 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
[[Page 40822]]
is to determine eligibility for the 340B program. This information is
received and verified according to 340B requirements and entered into
the 340B database. Accurate records are critical to implementation of
the 340B legislation especially to prevent diversion and duplicate
discounts. To maintain accurate records, the OPA requests entities to
submit modifications to any administrative information that they
submitted when initially enrolling into the program. The burden
requirement for these processes is minimal.
Contract Pharmacy Self-Certification
In order to ensure that drug manufacturers and drug wholesalers
recognize contract pharmacy arrangements, covered entities that elect
to utilize a contract pharmacy are required to submit to OPA a self-
certification form similar to the registration form that they have
signed an agreement with the contract pharmacy.
The Estimates of annualized burden are as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Reporting requirement respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
DSH & Children's Hospital Enrollment, Additions & Recertifications
----------------------------------------------------------------------------------------------------------------
340B Program Registrations & 70 1 70 .25 17.5
Certifications for
Disproportionate Share
Hospitals......................
340B Program Registrations & 80 1 80 .25 20
Certifications for Children's
Hospitals......................
Certifications to Enroll DSH & 180 1 180 .083 14.94
Children's Hospitals Outpatient
facilities to 340B Program.....
DSH & Children's Hospitals' 937 1 937 .5 468.5
Annual Recertification.........
----------------------------------------------------------------------------------------------------------------
Registration for Entities Other Than Hospitals & Recertifications
----------------------------------------------------------------------------------------------------------------
340B Registration Form (Family 170 1 170 .083 14.11
Planning, STD, TB, and others).
Family Planning Annual 85 47 3995 .083 331.59
Recertification................
STD & TB Annual Recertification. 111 11 1221 .083 101.34
Other Entity Annual 400 10 4000 .083 332
Recertification for entities
other than DSHs, FP, STD or TB
entities.......................
Submission of Administrative 460 1 460 .083 38.18
Changes for any entity.........
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services Registration & Recertifications
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services 2000 1 2000 .083 166
Registration...................
Total....................... * 4493 .............. 13,313 .............. 1504.16
----------------------------------------------------------------------------------------------------------------
* The total number of respondents may be overestimated since we are unable to avoid duplication of respondents
who submit information to the OPA over the course of participation in the 340B Drug Pricing Program, via the
initial registration process to any updates/modifications and enrolling contract pharmacies, if applicable, to
the recertification process.
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 e-mail 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: August 5, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-19381 Filed 8-12-09; 8:45 am]
BILLING CODE 4165-15-P
