60-day FRN

Federal Register / Vol. 79, No. 189 / Tuesday, September 30, 2014 / Notices
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
HRSA OFAM Grantee Customer
Satisfaction Survey. OMB No. 0915–
xxxx—NEW.
Abstract: The Office of Federal
Assistance Management (OFAM) within
HRSA plans to survey HRSA grant
recipients to better understand their
opinions about HRSA’s grants processes
and to improve the way HRSA conducts
business with them. This survey will
focus on grantee customer satisfaction
areas related to the grants life cycle,
grantee relationships with HRSA staff
(e.g., Project Officers, Grants
Management Officers), technical
assistance received from HRSA bureaus
and offices, availability of grant
resources, and grantee access to
guidance and instructional documents,
etc. The seven (7) grants management
areas, which are directly related to the
grants life cycle, are: Customer Service/

SUPPLEMENTARY INFORMATION:

be used by HRSA to improve the
efficiency, quality, and timeliness of its
grants business processes, as well as to
strengthen its partnership with its
external customers.
Likely Respondents: HRSA Grantees,
specifically individuals who hold
positions as a grantee’s Grant
Administrator, Business Officer, or
Project Director/Principal Investigators,
etc.
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.

Form name

Number of
respondents

Number of
responses per
respondent

Total
responses

HRSA OFAM Grants Management Customer Satisfaction
Survey ..............................................................................

3,000

1

1,500

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.
Dated: September 23, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–23172 Filed 9–29–14; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES

Cooperation; Policies and Procedures;
Pre-Award Phase; Award Phase;
Reporting/Post-Award Administration;
Technical Assistance; and Priorities for
Improvement. The ability to receive this
information from external customers
will provide OFAM with a repository of
information which will be incorporated
into the OFAM’s strategic efforts to
improve grants management services
and customer service overall.
Need and Proposed Use of the
Information: The HRSA OFAM Grantee
Customer Satisfaction Survey will
provide meaningful and relevant results
to agency decision makers about various
customer satisfaction domains (e.g.,
efficiency, timeliness, usefulness,
responsiveness, quality and overall
satisfaction with HRSA project officers,
products, and services). The information
collected will assist HRSA in its efforts
to gauge, understand and effectively
respond to the needs and concerns of its
customers, especially as they relate to
the aforementioned areas. The survey
results will provide HRSA with concrete
indicators regarding the best areas in
which to dedicate time, energy, and
resources to improve customer service.
This information will be used to support
agency-wide continuous quality
improvement (CQI) efforts. It will also

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
ACTION:

Notice.

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

SUMMARY:

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58791

Average
burden per
response
(in hours)

Total
burden
hours

0.25
(15/60)

375

estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than December 1, 2014.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10C–03, 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

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Federal Register / Vol. 79, No. 189 / Tuesday, September 30, 2014 / Notices

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, including any changes
that occur after execution of the PPA.
Covered entities which choose to
participate in the 340B 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.
Need and Proposed Use of the
Information: Section 340B(d)(1)(B)(i) of

the PHS Act requires the development
of a system to enable the Secretary to
verify the accuracy of ceiling prices
calculated by manufacturers under
subsection (a)(1) and charged to covered
entities, which shall include the
following:
(I) Developing and publishing through
an appropriate policy or regulatory
issuance, precisely defined standards
and methodology for the calculation of
ceiling prices under such subsection.
(II) Comparing regularly the ceiling
prices calculated by the Secretary with
the quarterly pricing data that is
reported by manufacturers to the
Secretary.
(III) Performing spot checks of sales
transactions by covered entities.
(IV) Inquiring into the cause of any
pricing discrepancies that may be
identified and either taking, or requiring
manufacturers to take, such corrective
action as is appropriate in response to
such price discrepancies.
HRSA’s Office of Pharmacy Affairs
(OPA) has previously obtained approval
for information collections in support of
340B covered entity recertification and
registration, as well as registration of
contract pharmacy arrangements and
the PPA itself. OPA is requesting
comments on an additional information
collection in response to the above
pricing verification requirements.
Pricing data submission, validation
and dissemination:
In order to implement Section
340B(d)(1)(B)(i)(II), HRSA has already
developed a system to prospectively
calculate 340B ceiling prices from data
obtained from the Centers for Medicare
and Medicaid Services as well as OPAidentified commercial databases.
However, in order to conduct the
comparison, HRSA must require
manufacturers to submit the quarterly
pricing data as referenced.
HRSA has developed a mechanism for
secure manufacturer submissions; the
Agency currently proposes collecting
Number of
respondents

Reporting requirement

Responses
per
respondent

Average Manufacturer Price, Unit
Rebate Amount, Package Sizes, National
Drug Code and manufacturerdetermined 340B ceiling price for each
product subject to a PPA. Once any
discrepancies between the manufacturer
and OPA-calculated prices have been
resolved, the validated prices will be
made available to registered covered
entities via a secure Internet-accessible
platform as required by Section
340B(d)(1)(B)(iii).
Accurate and timely pricing data
submissions are critical to successful
implementation of the 340B Program,
ensuring that covered entities have
confidence that the amounts being
charged are in accordance with
statutorily-defined ceiling prices. The
burden imposed on manufacturers by
this requirement is low because the
information requested is readily
available.
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.
The annual estimate of burden is as
follows:

Total
responses

Hours per
response

Total burden
hours

Hospital Enrollment, Additions & Recertifications

tkelley on DSK3SPTVN1PROD with NOTICES

340B Program Registrations & Certifications for Hospitals .............................................................................
Certifications to Enroll Hospital Outpatient Facilities .......
Hospital Annual Recertifications ......................................

546
606
4842

1
1
1

546
606
4842

2.00
.50
.50

1092
303
2421

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 Recertifications .........
Family Planning Annual Recertifications .........................
STD & TB Annual Recertifications ..................................

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253

1

253

1.0

253

353
4507
3879
2754

1
1
1
1

353
4507
3879
2754

1.0
.50
.50
.50

353
2253.5
1939.5
1377

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Federal Register / Vol. 79, No. 189 / Tuesday, September 30, 2014 / Notices
Number of
respondents

Reporting requirement
Annual Recertification for entities other than Hospitals,
Community Health Centers, Family Planning, STD or
TB Clinics .....................................................................

Responses
per
respondent

1174

Total
responses

Hours per
response

Total burden
hours

1

1174

.50

587

2500

1

2500

.50

1250

350

1

350

.50

175

600

4

2400

.50

1200

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 .........................................................

Contracted Pharmacy Services Registration & Recertifications
Contracted Pharmacy Services Registration ...................

2500

1

2500

Total ..........................................................................

24,664

........................

26,464

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.
Dated: September 23, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.

Dated: September 23, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–23178 Filed 9–29–14; 8:45 am]

[FR Doc. 2014–23183 Filed 9–29–14; 8:45 am]

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HOMELAND
SECURITY

Health Resources and Services
Administration

Coast Guard

National Advisory Council on the
National Health Service Corps; 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:

tkelley on DSK3SPTVN1PROD with NOTICES

specified above using the following
information: Dial-in number: 1–800–619–
8528; Passcode: 2240736.
Public Comment: There will be an
opportunity for the public to comment
towards the end of the call.
For Further Information Contact: Ed
Mekeel, Bureau of Health Workforce, Health
Resources and Services Administration,
Parklawn Building, Room 13–64, 5600
Fishers Lane, Rockville, Maryland 20857,
email: emekeel@hrsa.gov, or telephone: 301–
443–6156.

Name: National Advisory Council on the
National Health Service Corps (NHSC).
Date And Time: October 23, 2014 from 1:00
p.m.–2:30 p.m. EST.
Place: The meeting will be via audio
conference call.
Status: The meeting will be open to the
public.
Agenda: The Council is holding a meeting
via conference call to discuss the
accomplishments of the NHSC in fiscal year
(FY) 2014 and activities and goals for FY
2015. The public can join the meeting via
audio conference call on the date and time

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[USCG–2014–0107; OMB Control Number
1625–0011]

Collection of Information Under
Review by Office of Management and
Budget
Coast Guard, DHS.
Thirty-Day Notice Requesting
Comments.

AGENCY:
ACTION:

In compliance with the
Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding
Information Collection Requests (ICRs),
abstracted below, to the Office of
Management and Budget (OMB), Office
of Information and Regulatory Affairs
(OIRA), requesting approval of a
Reinstatement, with change, of a
previously approved collection for
which approval has expired for the
following collection of information:

SUMMARY:

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1.0
..........................

2500
15,704

1625–0011, Applications for Private
Aids to Navigation and for Class I
Private Aids to Navigation on Artificial
Islands and Fixed Structures. Review
and comments by OIRA ensure we only
impose paperwork burdens
commensurate with our performance of
duties.
DATES: Comments must reach the Coast
Guard and OIRA on or before October
30, 2014.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2014–0107] to the
Docket Management Facility (DMF) at
the U.S. Department of Transportation
(DOT) and/or to OIRA. To avoid
duplicate submissions, please use only
one of the following means:
(1) Online: (a) To Coast Guard docket
at http://www.regulations.gov. (b) To
OIRA by email via: OIRA-submission@
omb.eop.gov.
(2) Mail: (a) DMF (M–30), DOT, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue SE.,
Washington, DC 20590–0001. (b) To
OIRA, 725 17th Street NW.,
Washington, DC 20503, attention Desk
Officer for the Coast Guard.
(3) Hand Delivery: To DMF address
above, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays. The telephone number is 202–
366–9329.
(4) Fax: (a) To DMF, 202–493–2251.
(b) To OIRA at 202–395–6566. To
ensure your comments are received in a
timely manner, mark the fax, attention
Desk Officer for the Coast Guard.
The DMF maintains the public docket
for this Notice. Comments and material
received from the public, as well as
documents mentioned in this Notice as
being available in the docket, will
become part of the docket and will be

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