Agency Forms Undergoing Paperwork Reduction Act Review, 10803-10805 [2010-4885]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices
further foreclose rivals, in whole or in
part, from as much as 40 percent or
more of these downstream distribution
channels. Transitions’ exclusionary
conduct has thus likely caused higher
prices, lower output, and reduced
innovation and consumer choice.
A monopolist may rebut a such a
showing of competitive harm by
demonstrating that the challenged
conduct is reasonably necessary to
achieve a procompetitive benefit.4 Any
proffered justification, if proven, must
be balanced against the harm caused by
the challenged conduct.5
No procompetitive efficiencies justify
Transitions’ exclusionary and
anticompetitive conduct. Transitions
cannot show that the exclusive
arrangements were reasonably necessary
to achieve a procompetitive benefit,
such as protecting Transitions’
intellectual property or technical knowhow, or preventing interbrand freeriding.6 Transitions does not transfer
substantial intellectual property or
technical know-how to its customers,
and even if it did, any such transfer
would likely be protected by existing
confidentiality agreements.
A concern about interbrand freeriding also does not justify the
substantial anticompetitive effects
found here. The vast majority of
Transitions’ promotional efforts are
brand specific, reducing the significance
of any free-riding concern.7 While
Transitions’ marketing efforts may
generate some consumer interest in the
product category as a whole – and not
just in Transitions’ own products – this
is a part of the natural competitive
process. This type of consumer response
does not raise a free-riding concern
sufficient to justify the substantial
anticompetitive effects found here.8
III. The Order
The proposed Order remedies
Transitions’ anticompetitive and
4 E.g.,
Microsoft, 253 F.3d at 59.
sroberts on DSKD5P82C1PROD with NOTICES
5 Id.
6 ‘‘Interbrand free-riding’’ occurs when a
manufacturer provides services, training, or other
incentives in the promotion of its products for
which it cannot easily charge its dealer, and that
dealer ‘‘free-rides’’ on these demand-generating
services by substituting a cheaper, more profitable
product made by another manufacturer that does
not invest in comparable services. See generally
Howard P. Marvel, Exclusive Dealing, 25 J.L. &
Econ. 1, 8 (1982).
7 See United States v. Dentsply Int’l, Inc., 277 F.
Supp. 2d 387, 445 (D. Del. 2003), aff’d in rel. part,
399 F.3d at 196-97; Marvel, Exclusive Dealing, 25
J.L. & Econ. at 8 (explaining that an interbrand freeriding justification ‘‘does not apply if the
promotional investment is purely brand specific. In
such cases, the dealer will not be in a position to
switch customers from brand to brand.’’).
8 See In re Polygram, 136 F.T.C. 310, 361-62
(2003), aff’d, 416 F.3d 29, 37-38 (D.C. Cir. 2005).
VerDate Nov<24>2008
19:04 Mar 08, 2010
Jkt 220001
10803
exclusionary conduct and imposes
certain fencing-in requirements that are
designed to prevent de facto exclusive
dealing.9 Paragraph II of the Order
addresses the core of Transitions’
exclusionary conduct and seeks to lower
entry barriers and to restore
competition. Paragraph III requires
Transitions to implement an antitrust
compliance program, which includes
providing notice of this Order to
Transitions’ customers. Paragraphs IVVI impose reporting and other
compliance requirements. The Order
expires in 20 years unless otherwise
indicated.
Paragraph II.A prohibits Transitions
from adopting or implementing any
agreement or policy that results in
‘‘exclusivity’’ with lens casters, or its
‘‘Direct Customers.’’ ‘‘Exclusivity’’ is
defined in the Order to include any
requirement that a customer limit or
refrain from dealing with a competing
photochromic lens, as well as any
requirement that a customer give
Transitions’ products more favorable
treatment as compared to a competitor’s
products.
Paragraph II.B allows Transitions to
enter into exclusive agreements with
retailers and wholesale labs (‘‘Indirect
Customers’’), provided certain
safeguards are met. Specifically, any
exclusive agreements with Indirect
Customers must: i) be terminable
without cause, and without penalty, on
30 days written notice; ii) be available
on a partially exclusive basis, if
requested by the customer; and iii) not
offer flat payments of monies in
exchange for exclusivity. These
provisions, along with Paragraph II.E,
which prohibits Transitions from
bundling discounts, are designed to
enable a competitor or entrant to
compete for a customer’s business, even
if it does not offer a photochromic
treatment that applies to a full line of
ophthalmic lenses. Creating conditions
conducive to effective entry on an
incremental basis is likely to hasten new
entry and to restore competition.
Under Paragraph II.C, Transitions may
not limit its customers from
communicating or discussing a
competing photochromic lens with
consumers and others. This Paragraph
also requires Transitions to allow a lens
caster or another customer that sells
Transitions’ photochromic treatment on
a particular brand of lens to sell a
competitors’ photochromic treatment on
the same brand.
Paragraph II.D has two provisions
designed to prevent de facto exclusive
dealing through pricing policies. First,
Transitions cannot offer market share
discounts, i.e., discounts based on the
percentage of a customer’s sales of
Transitions’ lenses as a percentage of all
photochromic lens sales. Second,
Transitions cannot offer discounts that
are applied retroactively once a
customer reaches a specified threshold.
For example, Transitions may provide a
discount on sales beyond 1000 units but
it may not lower the price of the first
999 units if and when the customer
buys the 1000th unit. The provisions in
Paragraph II.D, along with Paragraph
II.E, will be in effect for 10 years.
Notwithstanding any provision of the
Order, Paragraph II.G explicitly allows
Transitions to provide volume discounts
that reflect certain cost differences, and
to offer discounts to meet competition.
It also allows Transitions to require that
any monies it provides to customers be
used solely for the manufacture,
promotion or sale of Transitions lenses.
Finally, Paragraph II.F prohibits
Transitions from retaliating against a
customer that purchases or sells
Transitions lenses on a non-exclusive
basis.
9 We use the term ‘‘de facto exclusive dealing’’ to
refer to practices that significantly deter a customer
from purchasing or selling a competing
photochromic lens.
Proposed Project
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2010–4979 Filed 3–8–10; 7:23 am]
BILLING CODE 6750–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–10–09AM]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Prevalence Survey of Healthcare
Associated Infections (HAIs) and
E:\FR\FM\09MRN1.SGM
09MRN1
10804
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices
Antimicrobial Use in U.S. Acute Care
Hospitals—New—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID) (proposed), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
CDC is requesting OMB approval to
conduct two surveys to obtain national
estimates of HAI prevalence and
antimicrobial use in the United States.
Preventing HAIs is a CDC priority, and
an essential step in reducing the
occurrence of HAIs is to accurately
estimate the burden of these infections
in U.S. hospitals and to describe the
types of HAIs and their causative
organisms, including antimicrobialresistant pathogens.
The scope and magnitude of HAIs in
the U.S. were last directly estimated in
the 1970s and 1980s by CDC’s Study on
the Efficacy of Nosocomial Infection
Control (SENIC), in which
comprehensive data were collected from
a sample of 338 hospitals; 5% of
hospitalized patients acquired an
infection not present at the time of
admission. CDC’s current HAI
surveillance system, the National
Healthcare Safety Network (NHSN)
(OMB Control No. 0920–0666,
expiration date 9/30/2012), focuses
instead on device-associated and
procedure-associated infections in a
variety of patient locations, and does
not receive data on all types of HAIs to
make hospital-wide burden estimates.
The purpose of this information
collection request is to assess the
magnitude and types of HAIs and
antimicrobial use occurring in all
patient populations within acute care
hospitals. This information will be used
to inform decisions made by local and
national policy makers and hospital
infection control personnel regarding
appropriate targets and strategies for
Practitioner (ICP) in his/her own facility
will be asked to review 1⁄3 or 33% of this
number (250); thus, the ICP would
review 82.5 records (rounded up to 83).
This number is estimated to be the same
in each phase of the prevalence survey
effort.
EIP Personnel will be reviewing
medical records of approximately 40%
of all patients surveyed in their EIP site
in both surveys #1 and #2. In Survey #1,
the total number of patient records
surveyed in each EIP site (assuming 3
facilities in each EIP site and 83 patient
records per site) is 247.5 patient records.
Forty percent of that number (247.5) is
99 patient records or 99 responses per
EIP site. In Survey #2, there will be
more facilities participating per EIP site
(50 facilities per EIP site for a total of
500 facilities). Again, CDC assumes 82.5
records surveyed per site (50 × 82.5) or
a total of 4,125 patient records. As
above, EIP personnel in each of the 10
sites will review approximately 40% of
the 4,125 patient records per site or
1,650 patient records.
CDC will use the data provided to
estimate the prevalence of HAIs and
antimicrobial use across this sample of
U.S. hospitals as well as to estimate the
distribution of infection types, causative
organisms, and nature of and rationale
for antimicrobial use.
This proposed project supports CDC’s
Strategic Goal of ‘‘Healthy Healthcare
Settings,’’ specifically the objectives to
‘‘Promote compliance with evidencebased guidelines for preventing,
identifying, and managing disease in
healthcare settings’’ and ‘‘Prevent
adverse events in patients and
healthcare workers in healthcare
settings.’’
There are no costs to respondents,
other than their time to complete the
survey. The total annualized burden for
this data collection is 8,039 hours.
preventing HAIs and the emergence of
antimicrobial-resistant pathogens and
encouraging appropriate antimicrobial
use. Such assessments can be obtained
in periodic national prevalence studies,
such as those that have been conducted
in several European countries.
CDC proposes to conduct two surveys
to collect this data. The first survey will
be a limited roll-out survey and will be
conducted in 30 facilities across 10
states in collaboration with state public
health authorities and CDC’s Emerging
Infections Program (EIP). The survey
will be conducted on a single day in
participating facilities. Infection Control
Practitioners in participating facilities,
such as infection control personnel, will
collect limited demographic and clinical
information on a sample of eligible
inpatients and, on the same day, EIP site
personnel will collect information on
HAIs and antimicrobial use for surveyed
patients who are on antimicrobial
therapy at the time of the survey. The
second survey will involve 500 facilities
across the same 10 states and use the
same methodology. As with the first
survey, CDC will collaborate with state
public health authorities and EIP sites.
CDC has made the following
assumptions in calculating the response
burden. Infection Control Practitioners
will be asked to collect a minimal
amount of data, limited to basic
demographic and risk factor/
antimicrobial use information. We
anticipate that this data collection will
take 5 minutes per patient. EIP
personnel will complete data collection
on antimicrobial use and HAIs. CDC
estimates that this data collection will
take approximately 15 minutes per
patient.
CDC has assumed an average daily
patient census of 250 patients for each
of the 30 participating facilities in
Survey #1. An Infection Control
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
sroberts on DSKD5P82C1PROD with NOTICES
Infection Control Practitioners—Survey #1 .................................................................................
EIP Personnel—Survey #1 ..........................................................................................................
Infection Control Practitioners—Survey #2 .................................................................................
EIP Personnel—Survey #2 ..........................................................................................................
VerDate Nov<24>2008
19:04 Mar 08, 2010
Jkt 220001
PO 00000
Frm 00051
Fmt 4703
Sfmt 9990
E:\FR\FM\09MRN1.SGM
30
10
500
10
09MRN1
Number of responses per
respondent
83
99
83
1,650
Average
burden per
response
(in hours)
5/60
15/60
5/60
15/60
10805
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices
Dated: February 26, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–4885 Filed 3–8–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Child Support Enforcement
Program Expenditure Report (Form
OCSE–396A) and the Child Support
Enforcement Program Collection Report
(Form OCSE–34A).
OMB No.: 0970–0181.
Description: State and Tribal agencies
administering the Child Support
Enforcement Program under Title IV–D
of the Social Security Act are required
to provide information each fiscal
quarter to the Office of Child Support
Enforcement (OCSE) concerning
administrative expenditures and the
receipt and disposition of child support
payments from non-custodial parents.
State title IV–D agencies report quarterly
expenditures and collections using
Forms OCSE–396A and OCSE–34A,
respectively. Tribal title IV–D agencies
report quarterly expenditures using
Form SF–269, as prescribed in program
regulations, and formerly reported
quarterly collections using only a
modified version of Form OCSE–34A.
The information collected on these
reporting forms is used to compute
quarterly grant awards to States and
Tribes, the annual incentive payments
to States and provides valuable
information on program finances. This
information is also included in a
published annual statistical and
financial report, available to the general
public.
Under Public Law 111–5, the
‘‘American Recovery and Reinvestment
Act of 2009’’ (ARRA), enacted in
February 2009, the availability of
Federal funding to State administered
child support enforcement programs
was substantially increased with a
change in methodology of calculating
these funds. We propose to formally
incorporate this necessary revision into
the quarterly expenditure report and to
update the existing quarterly collection
report to enable the same version of that
form to be used by both State and Tribal
IV–D agencies. We also propose to
review other data entry elements and
the accompanying instructions in both
data collection forms to assure that the
financial information requested from
States and Tribes remains relevant and
will assure that OCSE collects the
information needed in the most efficient
format feasible.
Respondents: State agencies
(including the District of Columbia,
Puerto Rico, Guam and the Virgin
Islands) administering the Child
Support Enforcement Program. Tribal
agencies with approved plans to
administer the Child Support
Enforcement Program.
ANNUAL BURDEN ESTIMATES
Number of respondents
Instrument
Number of responses per
respondent
Average burden hours per
response
54
100
4
4
8
8
sroberts on DSKD5P82C1PROD with NOTICES
OCSE–396A ....................................................................................................
OCSE–34A ......................................................................................................
Estimated Total Annual Burden
Hours: 4,928.
In compliance with the requirements
of Section 506(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
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)
VerDate Nov<24>2008
19:04 Mar 08, 2010
Jkt 220001
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: March 3, 2010.
Robert Sargis,
Reports Clearance Officer.
Fmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2008–P–0435 and FDA–
2008–P–0554]
Determination That DOVONEX
(Calcipotriene) Ointment, 0.005%, Was
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
determination that DOVONEX
(calcipotriene) Ointment, 0.005%, was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for calcipotriene
Ointment, 0.005%, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
David Joy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
BILLING CODE 4184–01–P
Frm 00052
1,728
3,200
HHS.
[FR Doc. 2010–4895 Filed 3–8–10; 8:45 am]
PO 00000
Total burden
hours
Sfmt 4703
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Notices]
[Pages 10803-10805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4885]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-10-09AM]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-5806.
Written comments should be received within 30 days of this notice.
Proposed Project
Prevalence Survey of Healthcare Associated Infections (HAIs) and
[[Page 10804]]
Antimicrobial Use in U.S. Acute Care Hospitals--New--National Center
for Emerging and Zoonotic Infectious Diseases (NCEZID) (proposed),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
CDC is requesting OMB approval to conduct two surveys to obtain
national estimates of HAI prevalence and antimicrobial use in the
United States. Preventing HAIs is a CDC priority, and an essential step
in reducing the occurrence of HAIs is to accurately estimate the burden
of these infections in U.S. hospitals and to describe the types of HAIs
and their causative organisms, including antimicrobial-resistant
pathogens.
The scope and magnitude of HAIs in the U.S. were last directly
estimated in the 1970s and 1980s by CDC's Study on the Efficacy of
Nosocomial Infection Control (SENIC), in which comprehensive data were
collected from a sample of 338 hospitals; 5% of hospitalized patients
acquired an infection not present at the time of admission. CDC's
current HAI surveillance system, the National Healthcare Safety Network
(NHSN) (OMB Control No. 0920-0666, expiration date 9/30/2012), focuses
instead on device-associated and procedure-associated infections in a
variety of patient locations, and does not receive data on all types of
HAIs to make hospital-wide burden estimates. The purpose of this
information collection request is to assess the magnitude and types of
HAIs and antimicrobial use occurring in all patient populations within
acute care hospitals. This information will be used to inform decisions
made by local and national policy makers and hospital infection control
personnel regarding appropriate targets and strategies for preventing
HAIs and the emergence of antimicrobial-resistant pathogens and
encouraging appropriate antimicrobial use. Such assessments can be
obtained in periodic national prevalence studies, such as those that
have been conducted in several European countries.
CDC proposes to conduct two surveys to collect this data. The first
survey will be a limited roll-out survey and will be conducted in 30
facilities across 10 states in collaboration with state public health
authorities and CDC's Emerging Infections Program (EIP). The survey
will be conducted on a single day in participating facilities.
Infection Control Practitioners in participating facilities, such as
infection control personnel, will collect limited demographic and
clinical information on a sample of eligible inpatients and, on the
same day, EIP site personnel will collect information on HAIs and
antimicrobial use for surveyed patients who are on antimicrobial
therapy at the time of the survey. The second survey will involve 500
facilities across the same 10 states and use the same methodology. As
with the first survey, CDC will collaborate with state public health
authorities and EIP sites.
CDC has made the following assumptions in calculating the response
burden. Infection Control Practitioners will be asked to collect a
minimal amount of data, limited to basic demographic and risk factor/
antimicrobial use information. We anticipate that this data collection
will take 5 minutes per patient. EIP personnel will complete data
collection on antimicrobial use and HAIs. CDC estimates that this data
collection will take approximately 15 minutes per patient.
CDC has assumed an average daily patient census of 250 patients for
each of the 30 participating facilities in Survey 1. An
Infection Control Practitioner (ICP) in his/her own facility will be
asked to review \1/3\ or 33% of this number (250); thus, the ICP would
review 82.5 records (rounded up to 83). This number is estimated to be
the same in each phase of the prevalence survey effort.
EIP Personnel will be reviewing medical records of approximately
40% of all patients surveyed in their EIP site in both surveys
1 and 2. In Survey 1, the total number of
patient records surveyed in each EIP site (assuming 3 facilities in
each EIP site and 83 patient records per site) is 247.5 patient
records. Forty percent of that number (247.5) is 99 patient records or
99 responses per EIP site. In Survey 2, there will be more
facilities participating per EIP site (50 facilities per EIP site for a
total of 500 facilities). Again, CDC assumes 82.5 records surveyed per
site (50 x 82.5) or a total of 4,125 patient records. As above, EIP
personnel in each of the 10 sites will review approximately 40% of the
4,125 patient records per site or 1,650 patient records.
CDC will use the data provided to estimate the prevalence of HAIs
and antimicrobial use across this sample of U.S. hospitals as well as
to estimate the distribution of infection types, causative organisms,
and nature of and rationale for antimicrobial use.
This proposed project supports CDC's Strategic Goal of ``Healthy
Healthcare Settings,'' specifically the objectives to ``Promote
compliance with evidence-based guidelines for preventing, identifying,
and managing disease in healthcare settings'' and ``Prevent adverse
events in patients and healthcare workers in healthcare settings.''
There are no costs to respondents, other than their time to
complete the survey. The total annualized burden for this data
collection is 8,039 hours.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Infection Control Practitioners--Survey 1.............. 30 83 5/60
EIP Personnel--Survey 1................................ 10 99 15/60
Infection Control Practitioners--Survey 2.............. 500 83 5/60
EIP Personnel--Survey 2................................ 10 1,650 15/60
----------------------------------------------------------------------------------------------------------------
[[Page 10805]]
Dated: February 26, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2010-4885 Filed 3-8-10; 8:45 am]
BILLING CODE 4163-18-P
