HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations, 25355-25356 [2011-10871]
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Federal Register / Vol. 76, No. 86 / Wesnesday, May 4, 2011 / Notices
Administration approval, takes at least
two years. In addition to the regulatory
hurdles facing a potential entrant,
manufacturing difficulties in producing
generic injectable products, combined
with the small size of the markets in
question, makes additional entry
unlikely to occur.
jlentini on DSKJ8SOYB1PROD with NOTICES
Effects
The Proposed Acquisition would
cause significant anticompetitive harm
to consumers in the U.S. markets for the
manufacture and sale of generic
injectable phenytoin and generic
injectable promethazine. In generic
injectable pharmaceuticals markets,
price generally decreases as the second,
third, or fourth competitors enter. Thus,
reducing the number of competitors to
two and one in each market,
respectively, would cause
anticompetitive harm to consumers in
these U.S. markets by increasing the
likelihood that consumers would pay
higher prices.
The Consent Agreement
The proposed Consent Agreement
effectively remedies the Proposed
Acquisition’s anticompetitive effects in
the relevant markets by requiring Hikma
to divest certain rights and assets related
to generic injectable phenytoin and
generic injectable promethazine to a
Commission-approved acquirer no later
than ten days after the acquisition. The
acquirer of the divested assets must
receive the prior approval of the
Commission. The Commission’s goal in
evaluating a possible purchaser of
divested assets is to maintain the
competitive environment that existed
prior to the acquisition.
The proposed Consent Agreement
remedies the competitive concerns the
acquisition raises by requiring Hikma to
divest its generic injectable phenytoin
and generic injectable promethazine
products to X-Gen, which will purchase
all rights currently held by Hikma. XGen is a New York-based generic
injectable pharmaceutical company
with 40 active products and an active
product development pipeline. With its
experience in generic injectable markets
and strong ties to manufacturing
partners, X-Gen is expected to replicate
the competition that would otherwise be
lost with the Proposed Acquisition.
If the Commission determines that XGen is not an acceptable acquirer of the
assets to be divested, or that the manner
of the divestitures is not acceptable, the
parties must unwind the sale to X-Gen
and divest the phenytoin and
promethazine product lines, within six
months of the date the Order becomes
final, to a Commission-approved
VerDate Mar<15>2010
17:45 May 03, 2011
Jkt 223001
acquirer. The Commission may appoint
a trustee to divest the products if Hikma
fails to divest the products as required.
The proposed Consent Agreement
contains several provisions to help
ensure that the divestitures are
successful. The Order requires Hikma to
take all action to maintain the economic
viability, marketability, and
competitiveness of the products until
such time as they are transferred to a
Commission-approved acquirer. In
addition, the parties must supply X-Gen
with phenytoin and promethazine
pursuant to a supply agreement while
Hikma transfers the manufacturing
technology to X-Gen or a third-party
manufacturer of X-Gen’s choice.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Order or
to modify its terms in any way.
[FR Doc. 2011–10783 Filed 5–3–11; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Office of the Secretary
Delegation of Authority
Notice is hereby given that I have
delegated to HHS’ Operating and Staff
Division heads and the Chair(s) of the
HHS Innovation Council, or their
successors, the authorities vested in the
Secretary under Section 105 of the
America COMPETES Reauthorization
Act of 2010 (Pub. L. 111–358) (which
added Section 24 of the StevensonWydler Technology Innovation Act of
1980, 15 U.S.C. 3701 et seq), as
amended, to administer and fund prize
competitions aimed at stimulating
innovation. This delegation excludes
the authority under Section 24(k)(3) to
develop guidelines for the appointment
of judges, which I hereby delegate to the
Chair(s), HHS Innovation Council.
Additionally, I reserve the authorities
under Section 24(m)(3)(B) to approve an
increase in the amount of a prize after
initial announcement has been made
and to approve the award of more than
$500,000 in cash prizes.
These authorities may be redelegated.
The authorities granted herein shall be
exercised in accordance with the
Department’s applicable policies,
procedures, and guidelines. I hereby
affirm and ratify any actions taken by
you or your subordinates, which involve
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the exercise of this authority prior to the
effective date of this delegation. This
delegation is effective upon date of
signature.
Authority: 44 U.S.C. 3101.
Dated: April 22, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011–10847 Filed 5–3–11; 8:45 am]
BILLING CODE 4150–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
HIT Standards Committee; Schedule
for the Assessment of HIT Policy
Committee Recommendations
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice.
AGENCY:
Section 3003(b)(3) of the
American Recovery and Reinvestment
Act of 2009 mandates that the HIT
Standards Committee develop a
schedule for the assessment of policy
recommendations developed by the HIT
Policy Committee and publish it in the
Federal Register. This notice fulfills the
requirements of Section 3003(b)(3) and
updates the schedule posted in the
Federal Register on October 8, 2010. In
anticipation of receiving
recommendations originally developed
by the HIT Policy Committee, the HIT
Standards Committee has created four
(4) workgroups or subcommittees to
analyze the areas of clinical quality,
clinical operations, implementation,
and privacy and security.
HIT Standards Committee’s Schedule
for the Assessment of HIT Policy
Committee Recommendations is as
follows: The National Coordinator will
establish priority areas based in part on
recommendations received from the HIT
Policy Committee regarding health
information technology standards,
implementation specifications, and/or
certification criteria. Once the HIT
Standards Committee is informed of
those priority areas, it will:
(A) Direct the appropriate workgroup
or subcommittee to develop a report for
the HIT Standards Committee, to the
extent possible, within 90 days, which
will include, among other items, the
following:
(1) An assessment of what standards,
implementation specifications, and
certification criteria are currently
available to meet the priority area;
(2) An assessment of where gaps exist
(i.e., no standard is available or
harmonization is required because more
than one standard exists) and identify
SUMMARY:
By direction of the Commission.
Donald S. Clark,
Secretary.
25355
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04MYN1
25356
Federal Register / Vol. 76, No. 86 / Wesnesday, May 4, 2011 / Notices
potential organizations that have the
capability to address those gaps; and
(3) A timeline, which may also
account for NIST testing, where
appropriate, and include dates when the
HIT Standards Committee is expected to
issue recommendation(s) to the National
Coordinator.
(B) Upon receipt of a subcommittee
report, the HIT Standards Committee
will:
(1) Accept the timeline provided by
the subcommittee, and, if necessary,
revise it; and
(2) Assign subcommittee(s) to conduct
research and solicit testimony, where
appropriate, and issue
recommendations to the full committee
in a timely manner.
(C) Advise the National Coordinator,
consistent with the accepted timeline in
(B)(1) and after NIST testing, where
appropriate, on standards,
implementation specifications, and/or
certification criteria, for the National
Coordinator’s review and determination
whether or not to endorse the
recommendations, and possible
adoption of the proposed
recommendations by the Secretary of
the Department of Health and Human
Services.
For a listing of upcoming HIT
Standards Committee meetings, please
visit the ONC Web site at https://
healthit.hhs.gov.
Notice of this schedule is given under
the American Recovery and
Reinvestment Act of 2009 (Pub. L.
111–5), section 3003.
Dated: April 25, 2011.
Judith Sparrow,
Office of Policy and Planning, Office of the
National Coordinator for Health Information
Technology.
[FR Doc. 2011–10871 Filed 5–3–11; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Annual Report on Households
Assisted by the Low Income Home
Energy Assistance (LIHEAP).
OMB No. 0970–0060.
Description
This report is an annual activity
required by statute (42 U.S.C. 8629) and
Federal regulations (45 CFR 96.92) for
the Low Income Home Energy
Assistance Program (LIHEAP).
Submission of the completed report is
one requirement for LIHEAP grantees
applying for Federal LIHEAP block
grant funds.
States, the District of Columbia, and
the Commonwealth of Puerto Rico are
required to report statistics for the
previous Federal fiscal year on:
• Assisted and applicant households,
by type of LIHEAP assistance;
• Assisted and applicant households,
by type of LIHEAP assistance and
poverty level;
• Assisted households, regardless of
the type(s) of LIHEAAP assistance;
• Assisted households, by type of
LIHEAP assistance, having at least one
vulnerable member broken out; by a
person at least 60 years or younger,
disabled person, or a child five years old
or younger;
• Assisted households, by type of
LIHEAP assistance, with least one
member age 2 years or under;
• Assisted households, by type of
LIHEAP assistance, with at least one
member ages 3 years through 5 years;
and
• Assisted households, regardless of
the type(s) of LIHEAP assistance, having
at least one member 60 years or older,
disabled, or five years old or younger.
Insular areas (other than the
Commonwealth of Puerto Rico) and
Indian Tribal Grantees are required to
submit data only on the number of
households receiving heating, cooling,
energy crisis, or weatherization benefits.
The information is being collected for
the Department’s annual LIHEAP Report
to Congress. The data also provides
information about the need for LIHEAP
funds. Finally, the data are used in the
calculation of LIHEAP performance
measures under the Government
Performance and Results Act of 1993.
The data elements will allow the
accuracy of measuring LIHEAP targeting
performance and LIHEAP cost
efficiency.
Respondents: State Governments,
Tribal Governments, Insular Areas, the
District of Columbia, and the
Commonwealth of Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Assisted Household Report—Long Form ........................................................
Assisted Household Report—Short Form .......................................................
Applicant Household Report ............................................................................
Estimated Total Annual Burden Hours: ....................................................
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Instrument
52
164
52
........................
1
1
1
........................
25
1
13
........................
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
VerDate Mar<15>2010
17:45 May 03, 2011
Jkt 223001
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
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Total burden
hours
1,300
164
676
2,140
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–10729 Filed 5–3–11; 8:45 am]
BILLING CODE 4184–01–P
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]]>Agencies
[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Notices]
[Pages 25355-25356]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10871]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
HIT Standards Committee; Schedule for the Assessment of HIT
Policy Committee Recommendations
AGENCY: Office of the National Coordinator for Health Information
Technology, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Section 3003(b)(3) of the American Recovery and Reinvestment
Act of 2009 mandates that the HIT Standards Committee develop a
schedule for the assessment of policy recommendations developed by the
HIT Policy Committee and publish it in the Federal Register. This
notice fulfills the requirements of Section 3003(b)(3) and updates the
schedule posted in the Federal Register on October 8, 2010. In
anticipation of receiving recommendations originally developed by the
HIT Policy Committee, the HIT Standards Committee has created four (4)
workgroups or subcommittees to analyze the areas of clinical quality,
clinical operations, implementation, and privacy and security.
HIT Standards Committee's Schedule for the Assessment of HIT Policy
Committee Recommendations is as follows: The National Coordinator will
establish priority areas based in part on recommendations received from
the HIT Policy Committee regarding health information technology
standards, implementation specifications, and/or certification
criteria. Once the HIT Standards Committee is informed of those
priority areas, it will:
(A) Direct the appropriate workgroup or subcommittee to develop a
report for the HIT Standards Committee, to the extent possible, within
90 days, which will include, among other items, the following:
(1) An assessment of what standards, implementation specifications,
and certification criteria are currently available to meet the priority
area;
(2) An assessment of where gaps exist (i.e., no standard is
available or harmonization is required because more than one standard
exists) and identify
[[Page 25356]]
potential organizations that have the capability to address those gaps;
and
(3) A timeline, which may also account for NIST testing, where
appropriate, and include dates when the HIT Standards Committee is
expected to issue recommendation(s) to the National Coordinator.
(B) Upon receipt of a subcommittee report, the HIT Standards
Committee will:
(1) Accept the timeline provided by the subcommittee, and, if
necessary, revise it; and
(2) Assign subcommittee(s) to conduct research and solicit
testimony, where appropriate, and issue recommendations to the full
committee in a timely manner.
(C) Advise the National Coordinator, consistent with the accepted
timeline in (B)(1) and after NIST testing, where appropriate, on
standards, implementation specifications, and/or certification
criteria, for the National Coordinator's review and determination
whether or not to endorse the recommendations, and possible adoption of
the proposed recommendations by the Secretary of the Department of
Health and Human Services.
For a listing of upcoming HIT Standards Committee meetings, please
visit the ONC Web site at https://healthit.hhs.gov.
Notice of this schedule is given under the American Recovery and
Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.
Dated: April 25, 2011.
Judith Sparrow,
Office of Policy and Planning, Office of the National Coordinator for
Health Information Technology.
[FR Doc. 2011-10871 Filed 5-3-11; 8:45 am]
BILLING CODE 4150-45-P
