Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 6720-6721 [2015-02313]
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Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices
drug. Rather, generic suppliers compete
only against each other. In generic
pharmaceutical product markets, price
generally decreases as the number of
generic competitors increases. The
United States is the relevant geographic
market for generic drugs because the
U.S. Food and Drug Administration
(‘‘FDA’’) must approve them for sale
within the United States.
There are currently only three
suppliers of each dosage strength of
generic minocycline tablets in the
United States: Ranbaxy, Dr. Reddy’s
Laboratories Ltd., and Par
Pharmaceutical Companies, Inc. Sun is
one of only a limited number of firms
likely to enter the generic minocycline
tablets markets in the near future. Sun’s
acquisition of Ranbaxy would therefore
deprive consumers of the increased
competition and likely price reductions
that would have occurred as a result of
Sun’s independent entry.
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II. Entry
Entry into the markets for generic
minocycline tablets would not be
timely, likely, or sufficient in
magnitude, character, and scope to deter
or counteract the anticompetitive effects
of the Proposed Acquisition. The
combination of drug development times
and regulatory requirements, including
approval by the FDA, is costly and
lengthy.
III. Effects
The Proposed Acquisition likely
would cause significant anticompetitive
harm to consumers by eliminating
future competition that would otherwise
have occurred when Sun’s generic
minocycline tablets entered the markets.
Market participants characterize generic
minocycline tablets as commodities,
and each market as one in which the
number of generic suppliers has a direct
impact on pricing. Customers and
competitors have confirmed that the
price of generic pharmaceutical
products decreases with new entry even
after several other suppliers have
entered the market. Further, customers
generally believe that having at least
four suppliers in each generic
pharmaceutical market produces more
competitive prices than if fewer
suppliers are available to them.
The Proposed Acquisition would
eliminate significant future competition
between Sun and Ranbaxy. The
evidence shows that anticompetitive
effects are likely to result from the
Proposed Acquisition due to the
elimination of an additional
independent competitor in the markets
for generic minocycline tablets, which
would have allowed customers to
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negotiate lower prices. Thus, absent a
remedy, the Proposed Acquisition will
likely cause U.S. consumers to pay
significantly higher prices for generic
minocycline tablets.
IV. The Consent Agreement
The proposed Consent Agreement
effectively remedies the Proposed
Acquisition’s anticompetitive effects in
the relevant markets. Pursuant to the
Consent Agreement and the Order, the
parties are required to divest all of
Ranbaxy’s rights and assets to generic
minocycline tablets to Torrent. The
parties must accomplish these
divestitures and relinquish their rights
no later than ten days after the Proposed
Acquisition is consummated.
The Commission’s goal in evaluating
possible purchasers of divested assets is
to maintain the competitive
environment that existed prior to the
Proposed Acquisition. If the
Commission determines that Torrent is
not an acceptable acquirer, or that the
manner of the divestitures is not
acceptable, the proposed Order requires
the parties to unwind the sale of rights
to Torrent and then divest the products
to a Commission-approved acquirer
within six months of the date the Order
becomes final. The proposed Order
further allows the Commission to
appoint a trustee in the event the parties
fail to divest the products as required.
The proposed Consent Agreement and
Order contain several provisions to help
ensure that the divestitures are
successful. The Order requires that
Ranbaxy transfer to Torrent all
confidential business information and
requires that Sun and Ranbaxy take all
actions that are necessary to maintain
the full viability and marketing of the
generic minocycline tablets until
Torrent commences the distribution,
marketing, and sale of the products.
The proposed Order also requires the
parties to divest Ranbaxy’s generic
minocycline hydrochloride 50 mg, 75
mg, and 100 mg capsules (‘‘minocycline
capsules’’) to Torrent to ensure that
Torrent achieves regulatory approval to
qualify a new API supplier for its
minocycline tablets as quickly as
Ranbaxy would have. Torrent will be
able to establish the current API
supplier of the minocycline capsules as
the API supplier for its minocycline
tablets through a less time-intensive
regulatory process if Torrent controls
both products and uses the same API
supplier for both. Moreover, the
proposed Order requires Sun and
Ranbaxy to manufacture and supply
generic minocycline tablets and
capsules to Torrent following the
divestiture to allow Torrent to enter the
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markets while it validates its
manufacturing process and seeks the
necessary FDA approvals.
The Commission will appoint Frank
Civille to act as an interim monitor to
assure that Sun and Ranbaxy
expeditiously comply with all of their
obligations and perform all of their
responsibilities pursuant to the Consent
Agreement. In order to ensure that the
Commission remains informed about
the status of the transfer of rights and
assets, the Consent Agreement requires
Sun and Ranbaxy to file reports with the
interim monitor who will report in
writing to the Commission concerning
performance by the parties of their
obligations under the Consent
Agreement.
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.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2015–02461 Filed 2–5–15; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–New–
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for a
new collection. Comments submitted
during the first public review of this ICR
will be provided to OMB. OMB will
accept further comments from the
public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before March 9, 2015.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
SUMMARY:
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6721
Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
Information Collection Request Title
and document identifier HHS–OS–
0990–New–30D for reference.
Information Collection Request Title:
Evaluation of the National Training on
Trauma-Informed Care (TIC).
Abstract: The HHS OWH is requesting
OMB approval to conduct a new, one
time outcome evaluation of the National
Training Initiative on Trauma-Informed
Care (TIC) for Community-Based
Providers From Diverse Service Systems
training curriculum. Policymakers and
providers in many service sectors
recognize the central role of trauma in
causing or complicating physical and
behavioral health conditions and the
critical need for trauma-informed care
(TIC) systems. The proposed evaluation
will capture both knowledge gained and
implementation impact achieved as a
result of the TIC training and TA.
Analyses and findings will be used to
further refine the TIC curriculum and
training approach, and can help inform
OWH and HHS in future policymaking
efforts. Information collected will also
help researchers and practitioners better
understand the impact of adopting a
trauma-informed approach on and the
quality of care provided by communitybased providers.
Likely respondents:
Site Visits
Site visits are designed to capture
both the knowledge gained by training
participants and the implementation
impact achieved in their organizations
as a result of the OWH TIC training and
technical assistance.
Online Survey
The goal of the online survey is to
assess the impact of the training on
participants’ skills acquired in,
knowledge about, and values and beliefs
surrounding trauma-informed care.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Form name
Type of respondent
Online Survey ...................................
300
1
25/60
125
Site Visits ..........................................
Leadership and Line/Other Frontline
Staff.
Leadership and Line/Other Frontline
Staff.
144
1
40/60
96
Total ...........................................
...........................................................
........................
........................
........................
221
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2015–02313 Filed 2–5–15; 8:45 am]
BILLING CODE 4150–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Written Comments on
the Draft National Adult Immunization
Plan
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The National Vaccine
Advisory Committee (NVAC) was
established in 1987 to comply with Title
XXI of the Public Health Service Act
(Pub. L. 99–660) (§ 2105) (42 U.S. Code
300aa–5 (PDF—78 KB)). Its purpose is to
advise and make recommendations to
the Director of the National Vaccine
Program on matters related to program
responsibilities. The Assistant Secretary
for Health (ASH) has been designated by
the Secretary of Health and Human
Services (HHS) as the Director of the
National Vaccine Program. The National
Vaccine Program Office (NVPO) is
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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18:52 Feb 05, 2015
Jkt 235001
located within the Office of the
Assistant Secretary for Health (OASH),
Office of the Secretary, U.S. Department
of Health and Human Services (HHS).
NVPO provides leadership and fosters
collaboration among the various federal
agencies involved in vaccine and
immunization activities. The NVPO also
supports the National Vaccine Advisory
Committee (NVAC). The NVAC advises
and makes recommendations to the
ASH in his capacity as the Director of
National Vaccine Program on matters
related to vaccine program
responsibilities.
Adult vaccination rates remain low in
the United States, and significant racial
and ethnic disparities exist. In 2011,
NVAC recommended the development
of a strategic plan with the goal of
improving adult immunization.
Through an environmental scan of
past reports issued by vaccine
stakeholders, a survey, several focus
groups, and in-depth interviews with
subject matter experts, and in
consultation with federal partners,
NVPO has developed the draft National
Adult Immunization Plan (NAIP). The
NAIP details background on the
immunization landscape and provides a
strategic plan for federal and nonfederal
stakeholders.
NVPO is soliciting public comment
on the draft NAIP from a variety of
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Fmt 4703
Sfmt 4703
stakeholders, including the general
public, for consideration as they
develop their final report to the
Secretary. It is anticipated that the draft
NAIP, as revised with consideration
given to public comment and
stakeholder input, will be presented to
the Secretary in the first quarter of 2015.
Comments for consideration by
NVPO should be received no later than
5:00 p.m. EDT on March 9, 2015.
DATES:
(1) The draft NAIP is
available on the web at https://
www.hhs.gov/nvpo/.
(2) Electronic responses are preferred
and may be addressed to: Rebecca.Fish@
hhs.gov.
(3) Written responses should be
addressed to: National Vaccine Program
Office, U.S. Department of Health and
Human Services, 200 Independence
Avenue SW., Room 733G, Washington,
DC 20201. Attn: HHS Adult
Immunization c/o Rebecca Fish.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Rebecca Fish, National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Department of Health and
Human Services; telephone (202) 260–
9283; fax (202) 260–1165; email:
Rebecca.Fish@hhs.gov.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06FEN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 25 (Friday, February 6, 2015)]
[Notices]
[Pages 6720-6721]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02313]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-0990-New-30D]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, has submitted an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB) for review and approval. The ICR is for a new collection.
Comments submitted during the first public review of this ICR will be
provided to OMB. OMB will accept further comments from the public on
this ICR during the review and approval period.
DATES: Comments on the ICR must be received on or before March 9, 2015.
ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via
facsimile to (202) 395-5806.
[[Page 6721]]
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the Information Collection Request Title
and document identifier HHS-OS-0990-New-30D for reference.
Information Collection Request Title: Evaluation of the National
Training on Trauma-Informed Care (TIC).
Abstract: The HHS OWH is requesting OMB approval to conduct a new,
one time outcome evaluation of the National Training Initiative on
Trauma-Informed Care (TIC) for Community-Based Providers From Diverse
Service Systems training curriculum. Policymakers and providers in many
service sectors recognize the central role of trauma in causing or
complicating physical and behavioral health conditions and the critical
need for trauma-informed care (TIC) systems. The proposed evaluation
will capture both knowledge gained and implementation impact achieved
as a result of the TIC training and TA. Analyses and findings will be
used to further refine the TIC curriculum and training approach, and
can help inform OWH and HHS in future policymaking efforts. Information
collected will also help researchers and practitioners better
understand the impact of adopting a trauma-informed approach on and the
quality of care provided by community-based providers.
Likely respondents:
Site Visits
Site visits are designed to capture both the knowledge gained by
training participants and the implementation impact achieved in their
organizations as a result of the OWH TIC training and technical
assistance.
Online Survey
The goal of the online survey is to assess the impact of the
training on participants' skills acquired in, knowledge about, and
values and beliefs surrounding trauma-informed care.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response Total burden
respondent respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Online Survey................. Leadership and 300 1 25/60 125
Line/Other
Frontline Staff.
Site Visits................... Leadership and 144 1 40/60 96
Line/Other
Frontline Staff.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 221
----------------------------------------------------------------------------------------------------------------
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2015-02313 Filed 2-5-15; 8:45 am]
BILLING CODE 4150-33-P
