Agency Information Collection Activities; Proposed Collection; Comment Request, 65392-65393 [2012-26354]
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65392
Federal Register / Vol. 77, No. 208 / Friday, October 26, 2012 / Notices
established for the purpose of helping
children who are in, or at risk of
entering, foster care reconnect with
family members through the
implementation of programs of kinship
navigator programs, programs using
intensive family finding efforts,
programs using family group decisionmaking meetings, and residential family
treatment programs. In September 2011,
the Children’s Bureau awarded a cluster
of 36-month demonstration grants,
including the grant relinquished by
AHA, to focus on using family group
decision-making meetings to build
protective factors for children and
families.
Statutory Authority: Section 427 of the
Social Security Act (42 U.S.C. Sections 620–
629) as amended by the Fostering
Connections to Success and Increasing
Adoptions Act of 2008 (Pub. L. 110–351,
Section 102(a)).
Bryan Samuels,
Commissioner, Administration on Children,
Youth and Families.
[FR Doc. 2012–26349 Filed 10–25–12; 8:45 am]
BILLING CODE 4184–01–P
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 Title
44, United States Code, as amended by
the Paperwork Reduction Act of 1995,
SUMMARY:
Pub. L. 104–13), the Health Resources
and Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. 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
Reports Clearance Officer at (301) 443–
1984.
HRSA 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.
Information Collection Request Title:
Drug Pricing Program Reporting
Requirements (OMB No. 0915–0176)—
[Extension]
Abstract: 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
participates in Medicaid must sign a
Pharmaceutical Pricing Agreement with
the Secretary of Health and Human
Services in which the manufacturer
agrees to charge enrolled covered
entities 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
Number of
respondents
Reporting/notification requirement
Responses
per
respondent
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)(5)(C) to permit the
Secretary or manufacturers to conduct
audits of covered entities and because of
the potential for disputes involving
covered entities and participating drug
manufacturers, the HRSA Office of
Pharmacy Affairs (OPA) developed a
dispute resolution process for
manufacturers and covered entities, as
well as manufacturer guidelines for
audit of covered entities (Federal
Register Final Notice, December 12,
1996 (Vol. 61, No. 240, pp. 65406–
65413)).
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/
response
Total burden
hours
AUDITS
Audit Notification to Entity 1 .................................................
Audit Workplan 1 ..................................................................
Audit Report 1 .......................................................................
Entity Response ...................................................................
10
8
6
6
1
1
1
1
10
8
6
6
4
8
8
8
40
64
48
48
emcdonald on DSK67QTVN1PROD with NOTICES
DISPUTE RESOLUTION
Mediation Request ...............................................................
Rebuttal ................................................................................
10
10
4
1
40
10
10
16
400
160
Total ..............................................................................
50
........................
80
........................
760
1 Prepared
by the manufacturer.
Recordkeeping Burden:
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65393
Federal Register / Vol. 77, No. 208 / Friday, October 26, 2012 / Notices
Number of
recordkeepers
Recordkeeping requirement
Dispute Records ..............................................................................................................
Addresses: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857.
Deadline: Comments on this
Information Collection Request must be
received within 60 days of this notice.
Dated: October 22, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–26354 Filed 10–25–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2012–0063]
President’s National Security
Telecommunications Advisory
Committee
National Protection and
Programs Directorate, DHS.
ACTION: Committee Management; Notice
of an Open Federal Advisory Committee
Teleconference.
AGENCY:
The President’s National
Security Telecommunications Advisory
Committee (NSTAC) will meet on
Monday, November 5, 2012, via a
conference call. The meeting will be
open to the public.
DATES: The NSTAC will meet Monday,
November 5, 2012, from 2:00 p.m. to
3:15 p.m. Please note that the meeting
may close early if the committee has
completed its business.
ADDRESSES: The meeting will be held
via a conference call. For access to the
conference bridge, contact Ms. Deirdre
Gallop-Anderson by email at
deirdre.gallop-anderson@hq.dhs.gov by
5:00 p.m. October 29, 2012.
To facilitate public participation, we
are inviting public comment on the
issues to be considered by the
committee as listed in the
SUPPLEMENTARY INFORMATION section
below. Documents associated with the
issues to be discussed during the
conference will be available at
www.ncs.gov/nstac for review by
October 30, 2012. Written comments
must be received by the NSTAC
Designated Federal Officer no later than
November 19, 2012, and may be
submitted by any one of the following
methods:
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
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• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting written
comments.
• Email: NSTAC@hq.dhs.gov. Include
the docket number in the subject line of
the email message.
• Fax: (703) 235–4981.
• Mail: Alternate Designated Federal
Officer, National Communications
System, National Protection and
Programs Directorate, Department of
Homeland Security, 245 Murray Lane,
Mail Stop 0615, Arlington, VA 20598–
0615.
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and the docket
number for this action. Comments
received will be posted without
alteration at www.regulations.gov,
including any personal information
provided.
Docket: For access to the docket,
including all documents and comments
received by the NSTAC, go to
www.regulations.gov.
A public comment period will be held
during the meeting on November 5,
2012, from 2:15 p.m. to 2:35 p.m.
Speakers who wish to participate in the
public comment period must register in
advance no later than October 29, 2012,
at 5:00 p.m. by emailing Deirdre GallopAnderson at deirdre.gallopanderson@hq.dhs.gov. Speakers are
requested to limit their comments to
three minutes and will speak in order of
registration as time permits. Please note
that the public comment period may
end before the time indicated, following
the last call for comments.
FOR FURTHER INFORMATION CONTACT:
Allen F. Woodhouse, NSTAC Alternate
Designated Federal Officer, Department
of Homeland Security, telephone (703)
235–4900.
SUPPLEMENTARY INFORMATION: Notice of
this meeting is given under the Federal
Advisory Committee Act (FACA), 5
U.S.C. App. (Pub. L. 92–463). The
NSTAC advises the President on matters
related to national security and
emergency preparedness (NS/EP)
telecommunications policy.
Agenda: The NSTAC members will
receive an update on progress made to
date by the Nationwide Public Safety
Broadband Network (NPSBN)
Subcommittee as well as an update
regarding the work of the Secure
Government Communications
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Hours of
recordkeeping
50
Total burden
0.5
25
Subcommittee. The committee is not
taking any action on the work of these
subcommittees at this meeting. The
NPSBN Subcommittee is currently
examining any NS/EP policy that
should be considered when facilitating
priority access across a diverse
community of potential users of the
Nationwide Public Safety Broadband
Network, particularly during NS/EP
events. Additionally, they are reviewing
policy changes that could possibly
encourage the innovative evolution of
NS/EP functions by or through the
NPSBN. The Secure Government
Communications Scoping
Subcommittee is charged with
examining how commercial-off-the-shelf
technologies and private sector best
practices can be used to secure
unclassified communications between
and among Federal civilian departments
and agencies.
Additionally, NSTAC members will
discuss and vote on their Executive
Letter to the President regarding their
review of the Department of Homeland
Security’s (DHS) National Cybersecurity
and Communications Integration Center
(NCCIC). This review was conducted
June 2012—September 2012 and will
provide the President with an
assessment of whether the NCCIC has
developed in ways consistent with
previous NSTAC recommendations.
The FACA requires that notices of
meetings of advisory committees be
announced in the Federal Register 15
days prior to the meeting date. A notice
of the meeting of the NSTAC is being
published in the Federal Register with
less than 15 days notice due to an effort
to assure the accuracy and validity of
the NSTAC meeting agenda and
contents. NSTAC changes in leadership
and stakeholder approval of the NSTAC
meeting discussion points created a
longer than usual adjudication process.
Although the meeting notice was
published in the Federal Register late,
the agenda will be published on the
NCS Web site: www.ncs.gov and an
email will be sent out to the NSTAC
Members.
Dated: October 19, 2012.
Allen F. Woodhouse,
Alternate Designated Federal Officer for the
NSTAC.
[FR Doc. 2012–26325 Filed 10–25–12; 8:45 am]
BILLING CODE 4410–09–P
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[Federal Register Volume 77, Number 208 (Friday, October 26, 2012)]
[Notices]
[Pages 65392-65393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26354]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. 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 Reports Clearance Officer at (301) 443-1984.
HRSA 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.
Information Collection Request Title: Drug Pricing Program
Reporting Requirements (OMB No. 0915-0176)--[Extension]
Abstract: 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 participates
in Medicaid must sign a Pharmaceutical Pricing Agreement with the
Secretary of Health and Human Services in which the manufacturer agrees
to charge enrolled covered entities 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)(5)(C) to
permit the Secretary or manufacturers to conduct audits of covered
entities and because of the potential for disputes involving covered
entities and participating drug manufacturers, the HRSA Office of
Pharmacy Affairs (OPA) developed a dispute resolution process for
manufacturers and covered entities, as well as manufacturer guidelines
for audit of covered entities (Federal Register Final Notice, December
12, 1996 (Vol. 61, No. 240, pp. 65406-65413)).
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:
----------------------------------------------------------------------------------------------------------------
Reporting/notification Number of Responses per Total Hours/ Total burden
requirement respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
AUDITS
----------------------------------------------------------------------------------------------------------------
Audit Notification to Entity \1\ 10 1 10 4 40
Audit Workplan \1\.............. 8 1 8 8 64
Audit Report \1\................ 6 1 6 8 48
Entity Response................. 6 1 6 8 48
----------------------------------------------------------------------------------------------------------------
DISPUTE RESOLUTION
----------------------------------------------------------------------------------------------------------------
Mediation Request............... 10 4 40 10 400
Rebuttal........................ 10 1 10 16 160
-------------------------------------------------------------------------------
Total....................... 50 .............. 80 .............. 760
----------------------------------------------------------------------------------------------------------------
\1\ Prepared by the manufacturer.
Recordkeeping Burden:
[[Page 65393]]
----------------------------------------------------------------------------------------------------------------
Number of Hours of
Recordkeeping requirement recordkeepers recordkeeping Total burden
----------------------------------------------------------------------------------------------------------------
Dispute Records........................................... 50 0.5 25
----------------------------------------------------------------------------------------------------------------
Addresses: Submit your comments to paperwork@hrsa.gov or mail the
HRSA Reports Clearance Officer, Room 10-29, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Deadline: Comments on this Information Collection Request must be
received within 60 days of this notice.
Dated: October 22, 2012.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2012-26354 Filed 10-25-12; 8:45 am]
BILLING CODE 4165-15-P
