Agency Information Collection Activities; Submission for OMB Review; Comment Request, 9002-9005 [E7-3397]
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sroberts on PROD1PC70 with NOTICES
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Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices
poultry, fat at 0.08 ppm; poultry, liver
at 0.03 ppm; poultry, muscle at 0.01
ppm; sheep, liver at 0.60 ppm; sheep,
kidney at 0.60 ppm; sheep, muscle at
0.10 ppm; sheep, fat at 0.80 ppm.
Independently validated analytical
methods for plants, plant products, and
animal matrices suitable for
enforcement purposes have been
submitted for measuring NNI-0001.
Typically, plant matrices samples are
extracted, concentrated, and quantified
by liquid chromatography/tandem mass
spectrometry (LC/MS/MS) using
deuterated internal standards. Contact:
Carmen Rodia, (703) 306-0327, e-mail
address: rodia.carmen@epa.gov.
2. PP 6F7161. (Docket ID number
EPA–HQ–OPP–2007–0029). Bayer
CropScience LLC, 2 T.W. Alexander Dr.,
Research Triangle Park, NC 27709,
proposes to establish a tolerance for
residues of the herbicide glufosinateammonium and its metabolites
expressed as butanoic acid, 2-amino-4(hydroxymethylphosphinyl)-,
monoammonium salt, 2-acetamido-4methylphosphinico-butanoic acid and
3-methylphosphinico-propionic acid
(expressed as glufosinate free acid
equivalents) in or on food commodities
aspirated grain fractions at 25.0 parts
per million (ppm); non-transgenic
canola, meal at 1.1 ppm; non-transgenic
canola, seed at 0.4 ppm; non-transgenic
field corn, forage at 4.0 ppm; nontransgenic field corn, grain at 0.2 ppm;
non-transgenic field corn, stover at 6.0
ppm; non-transgenic soybean at 2.0
ppm; and non-transgenic soybean, hulls
at 5.0 ppm. The enforcement analytical
method utilizes gas chromatography for
detecting and measuring levels of
glufosinate-ammonium and its
metabolites with a general limit of
quantitation (LOQ) of 0.05 ppm. This
method allows detection of residues at
or above the proposed tolerances.
Contact: James Stone, telephone
number: (703) 305-7391, e-mail address:
stone.james@epa.gov.
3. PP 6F7162. (Docket ID number
EPA–HQ–OPP–2007–0030). Syngenta
Crop Protection, Inc., P. O. Box 18300,
Greensboro, NC 72409, proposes to
establish tolerances for residues of the
herbicide mesotrione in or on food
commodities asparagus at 0.01 ppm;
grass, forage at 0.01 ppm; grass, hay at
0.01 ppm; grass, seed screenings at 0.01
ppm; grass, straw at 0.10 ppm; oats,
forage at 0.01 ppm; oats, grain at 0.01
ppm; oats, hay, at 0.01 ppm; oats, straw
at 0.01 ppm; okra at 0.01 ppm; rhubarb
at 0.01 ppm; sorghum, forage at 0.01
ppm; sorghum, grain at 0.01 ppm;
sorghum, stover at 0.01 ppm; sorghum,
sweet at 0.01 ppm; and sugarcane at
0.01 ppm. Practical and specific
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analytical method RAM 366/01 is
available for detecting and measuring
the level of mesotrione in or on various
crop commodities. Contact: James
Stone, telephone number: (703) 3057391, e-mail address:
stone.james@epa.gov.
Amendment to Existing Tolerance
PP 6H7114. (Docket ID number EPA–
HQ–OPP–2007–0096). Pytech
Chemicals GmbH, 9330 Zionsville Road,
IN 46268, proposes to amend the
tolerance in 40 CFR 180.438, section (3)
by adding gamma-cyhalothrin to
lambda-cyhalothrin. The residue
definition under section (3) should read
as follows: (3) A food additive tolerance
of 0.01 parts per million is established
for residues of the insecticide lambdacyhalothrin (S)-alpha-cyano-3phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro3,3,3- trifluoroprop-1-enyl)-2,1dimethylcyclopropanecarboxylate) and
(R)-alpha-cyano-3-phenoxybenzyl-(Z)(1S,3S)-3-(2-chloro-3,3,3- trifluoroprop1-enyl)-2,2dimethylcyclopropanecarboxylate, or
the isolated active isomer gammacyhalothrin (S)-alpha-cyano-3phenoxybenzy-(Z)-(1R,3R)-3-(2-chloro3,3,3-trifluoroprop-1-enyl)-2,2dimethylcyclopropanecarboxylate. An
adequate analytical method is available
for enforcement purposes. Contact:
Bewanda Alexander, (703) 305-7460, email address:
alexander.bewanda@epa.gov.
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 13, 2007.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
[FR Doc. E7–3117 Filed 2–27–07; 8:45 am]
Agreements (202–523–5793 or
tradeanalysis@fmc.gov).
Agreement No.: 011733–020.
Title: Common Ocean Carrier Platform
Agreement.
Parties: A.P. Moller-Maersk A/S; CMA
¨
CGM; Hamburg-Sud; Hapag-Lloyd AG;
Mediterranean Shipping Company S.A.;
and United Arab Shipping Company
(S.A.G.) as shareholder parties, and
Alianca Navegacao e Logistica Ltda.;
Kawasaki Kisen Kaisha Ltd.; MISC
Berhad; Mitsui O.S.K. lines Ltd.;
Nippon Yusen Kaisha; Safmarine
Container Lines N.V.; Senator Lines
GmbH; Compania Sud Americana de
Vapores, S.A.; Companhia Libra
Navegacao; Norasia Container Lines
Limited; Tasman Orient Line C.V.; and
Emirates Shipping Lines as nonshareholder parties.
Filing Party: Mark J. Fink, Esq.; Sher
& Blackwell LLP; 1850 M Street, NW.,
Suite 900; Washington, DC 20036.
Synopsis: The amendment adds
Emirates Shipping Lines as a nonshareholder party to the agreement.
Agreement No.: 011988.
Title: EUKOR/WWL Mexico Space
Charter Agreement.
Parties: EUKOR Car Carriers, Inc.
(‘‘EUKOR’’) and Wallenius Wilhelmsen
Logistics AS (‘‘WWL’’).
Filing Party: Wayne R. Rohde, Esq.;
Sher & Blackwell LLP; 1850 M Street,
NW., Suite 900; Washington, DC 20036.
Synopsis: The agreement authorizes
EUKOR to charter space to WWL for the
carriage of ro-ro and other noncontainerized cargo in the trade from
Mexico to the United States.
Dated: February 23, 2007.
By Order of the Federal Maritime
Commission.
Bryant L. VanBrakle,
Secretary.
[FR Doc. E7–3506 Filed 2–27–07; 8:45 am]
BILLING CODE 6730–01–P
BILLING CODE 6560–50–S
FEDERAL TRADE COMMISSION
FEDERAL MARITIME COMMISSION
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request
Notice of Agreements Filed
AGENCY:
The Commission hereby gives notice
of the filing of the following agreements
under the Shipping Act of 1984.
Interested parties may submit comments
on agreements to the Secretary, Federal
Maritime Commission, Washington, DC
20573, within ten days of the date this
notice appears in the Federal Register.
Copies of agreements are available
through the Commission’s Office of
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ACTION:
Federal Trade Commission.
Notice.
SUMMARY: The information collection
requirements described below will be
submitted to the Office of Management
and Budget (‘‘OMB’’) for review, as
required by the Paperwork Reduction
Act (‘‘PRA’’). The Federal Trade
Commission (‘‘FTC’’ or ‘‘Commission’’)
is seeking public comments on its
proposal to extend through July 31,
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2010 the current OMB clearance for
information collection requirements
contained in its proposed Affiliate
Marketing Rule (or ‘‘proposed Rule’’).
That clearance expires on July 31, 2007.
DATES: Comments must be filed by April
30, 2007.
ADDRESSES: Interested parties are
invited to submit written comments.
Comments should refer to ‘‘Affiliate
Marketing Rule: FTC File No. R411006’’
to facilitate the organization of
comments. A comment filed in paper
form should include this reference both
in the text and on the envelope and
should be mailed or delivered, with two
complete copies, to the following
address: Federal Trade Commission,
Room H–135 (Annex J), 600
Pennsylvania Ave., NW., Washington,
DC 20580. Because paper mail in the
Washington area and at the Commission
is subject to delay, please consider
submitting your comments in electronic
form, as prescribed below. However, if
the comment contains any material for
which confidential treatment is
requested, it must be filed in paper
form, and the first page of the document
must be clearly labeled ‘‘Confidential.’’ 1
Comments filed in electronic form
should be submitted by following the
instructions on the Web-based form at
https://secure.commentworks.com/
AffiliateMarketingRule. To ensure that
the Commission considers an electronic
comment, you must file it on the Webbased form at the https://
secure.commentworks.com/
AffiliateMarketingRule weblink. If this
notice appears at www.regulations.gov,
you may also file an electronic comment
through that Web site. The Commission
will consider all comments that
regulations.gov forwards to it.
The FTC Act and other laws the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. All timely and responsive
public comments will be considered by
the Commission and will be available to
the public on the FTC Web site, to the
extent practicable, at www.ftc.gov. As a
matter of discretion, the FTC makes
every effort to remove home contact
information for individuals from the
public comments it receives before
placing those comments on the FTC
1 Commission Rule 4.2(d), 16 CFR 4.2(d). The
comment must be accompanied by an explicit
request for confidential treatment, including the
factual and legal basis for the request, and must
identify the specific portions of the comment to be
withheld from the public record. The request will
be granted or denied by the Commission’s General
Counsel, consistent with applicable law and the
public interest. See Commission Rule 4.9(c), 16 CFR
4.9(c).
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Web site. More information, including
routine uses permitted by the Privacy
Act, may be found in the FTC’s privacy
policy at https://www.ftc.gov/ftc/
privacy.htm.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be addressed to Anthony
Rodriguez or Loretta Garrison,
Attorneys, Division of Privacy and
Identity Protection, Bureau of Consumer
Protection, Federal Trade Commission,
600 Pennsylvania Avenue, NW.,
Washington, DC 20580, (202) 326–2252.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act (‘‘PRA’’), 44
U.S.C. 3501–3520, federal agencies must
obtain approval from OMB for each
collection of information they conduct
or sponsor. ‘‘Collection of information’’
means agency requests or requirements
that members of the public submit
reports, keep records, or provide
information to a third party. 44 U.S.C.
3502(3); 5 CFR 1320.3(c). As required by
section 3506(c)(2)(A) of the PRA, the
FTC is providing this opportunity for
public comment before requesting that
OMB extend the existing paperwork
clearance for the regulations noted
herein.
The FTC invites comments on: (1)
Whether the required collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information has practical utility; (2) the
accuracy of the agency’s estimate of the
burden of the required collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on those who are to respond, including
through the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology, e.g., permitting electronic
submission of responses. All comments
should be filed as prescribed in the
ADDRESSES section above, and must be
received on or before April 30, 2007.
The Affiliate Marketing Rule, 16 CFR
part 680, was proposed by the FTC
under section 214 of the Fair and
Accurate Credit Transactions Act
(‘‘FACT Act’’), Pub. L. No. 108–159
(December 6, 2003). The FACT Act
amended the Fair Credit Reporting Act,
15 U.S.C. 1681 et seq., which was
enacted to enable consumers to protect
the privacy of their consumer credit
information. As mandated by the FACT
Act, the proposed Rule specifies
disclosure requirements for certain
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affiliate companies subject to the
Commission’s jurisdiction. Except as
discussed below, these requirements
constitute ‘‘collections of information’’
for purposes of the PRA. Specifically,
the FACT Act and the proposed Rule
require covered entities to provide
consumers with notice and an
opportunity to opt out of the use of
certain information before sending
marketing solicitations. The proposed
Rule generally provides that, if a
company communicates certain
information about a consumer
(‘‘eligibility information’’) to an affiliate,
the affiliate may not use that
information to make or send
solicitations to the consumer unless the
consumer is given notice and a
reasonable opportunity to opt out of
such use of the information and the
consumer does not opt out.
To minimize compliance costs and
burdens for entities, particularly any
small businesses that may be affected,
the proposed Rule contains model
disclosures and opt-out notices that may
be used to satisfy the statutory
requirements. The proposed Rule also
gives covered entities flexibility to
satisfy the notice and opt-out
requirement by sending the consumer a
free-standing opt-out notice or by
adding the opt-out notice to the privacy
notices already provided to consumers,
such as those provided in accordance
with the provisions of Title V, subtitle
A of the GLBA. For covered entities that
choose to prepare a free-standing optout notice, the time necessary to prepare
it would be minimal because those
entities could simply use the model
disclosure. For covered entities that
choose to incorporate the model opt-out
notice into their GLBA privacy notices
the time necessary to do so also would
be minimal. Arguably, verbatim
adoption of the model notice would not
even be a PRA ‘‘collection of
information.’’ 2
Burden Statement
Except where otherwise specifically
noted, staff’s estimates of burden are
based on its knowledge of the consumer
credit industries and knowledge of the
entities over which the Commission has
jurisdiction. This said, estimating PRA
burden of the proposed Rule’s
disclosure requirements is difficult
given the highly diverse group of
affected entities that includes affiliated
companies which may use certain
eligibility information shared by their
2 ‘‘The public disclosure of information originally
supplied by the Federal government to the recipient
for purpose of disclosure to the public is not
included within [the definition of collection of
information].’’ 5 CFR 1320.3(c)(2).
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affiliates to send marketing notices to
consumers who are not regulated by a
federal financial regulatory agency.
The estimates provided in this burden
statement may well overstate actual
burden. First, an uncertain but possibly
significant number of entities subject to
the FTC’s jurisdiction do not have
affiliates and would thus not be covered
by section 214 of the FACT Act or the
proposed Rule. Second, the
Commission’s staff does not know how
many companies subject to the FTC’s
jurisdiction under the proposed rule
actually share eligibility information
among affiliates and, of those, how
many affiliates use such information to
make marketing solicitations to
consumers. The staff considered the
wide variations in covered entities and
the fact that, in some instances, covered
entities may make the required
disclosures in the ordinary course of
business, apart from the FACT Act Rule,
voluntarily as a service to their
customers, while still other entities may
choose to rely on the exceptions to the
proposed Rule’s notice and opt-out
requirements.3
Staff’s estimates assume a higher
burden will be incurred during the first
year of the OMB clearance period with
a lesser burden for each of the
subsequent two years, since the opt-out
notice to consumers is required to be
given only once. Institutions may
provide for an indefinite period for the
opt-out or they may time limit it, but for
no less than five years. Given this
minimum time period, Commission staff
did not estimate burden for preparing
and distributing extension notices by
entities that limit the duration of the
opt-out time period. The relevant PRA
time frame for burden calculation is
three years from renewed OMB
clearance, and the five-year notice
period will not begin until this
proposed Rule becomes final.
Staff’s labor cost estimates take into
account: Managerial and professional
time for reviewing internal policies and
determining compliance obligations;
technical time for creating the notice
and opt-out, in either paper or
electronic form; and clerical time for
disseminating the notice and opt-out.4
In addition, staff’s cost estimates
presume that the availability of model
disclosures and opt-out notices will
simplify the compliance review and
3 Exceptions include, for example, having a
preexisting business relationship with a consumer,
using information in response to a communication
initiated by the consumer or to solicitations
authorized or requested by the consumer.
4 No clerical time was included in staff’s burden
analysis for GLBA entities as the notice would
likely be combined with existing GLBA notices.
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implementation processes, thereby
significantly reducing the cost of
compliance. Moreover, the proposed
Rule gives entities considerable
flexibility to determine the scope and
duration of the opt-out. Indeed, this
flexibility permits entities to send a
single joint notice on behalf of all of its
affiliates.
Estimated total annual hours burden:
2,662,000 hours, rounded.
Staff estimates that approximately
1.17 million (rounded) non-GLBA
entities under the jurisdiction of the
FTC have affiliates and would be
affected by the proposed Rule.5 Staff
further estimates that there are an
average of 5 businesses per family or
affiliated relationship, and that the
affiliated entities will choose to send a
joint notice, as permitted by the
proposed Rule. Thus an estimated
233,400 (rounded) non-GLBA entities
may send the new affiliate marketing
notice. Staff also estimates that nonGLBA entities under the jurisdiction of
the FTC would each incur 14 hours of
burden during the first year of the
clearance period, comprised of a
projected 7 hours of managerial time, 2
hours of technical time, and 5 hours of
clerical assistance.
Based on the above, total annual
burden for non-GLBA entities during
the first year of the clearance period
would be approximately 2,646,000
hours and the total annual labor cost
would be approximately $86,676,000,
rounded.6 These estimates include the
start-up burden and attendant costs,
such as determining compliance
obligations. Paperwork burden in later
years would be significantly lower, with
non-GLBA entities each incurring 10
hours of annual burden during the
remaining two years of the clearance.7
5 This estimate is derived from an analysis of a
database of U.S. businesses based on SIC codes for
businesses that market goods or services to
consumers, which included the following
industries: transportation services; communication;
electric, gas, and sanitary services; retail trade;
finance, insurance, and real estate; and services
(excluding business services and engineering,
management services). This estimate excludes
businesses not subject to the FTC’s jurisdiction as
well as businesses that do not use data or
information subject to the rule.
6 The figure is derived from the estimated 7 hours
of managerial labor at $34.21 per hour; 2 hours of
technical labor at $29.80 per hour; and 5 hours of
clerical labor at $14.44 per hour (a combined
$371.27) for the estimated 233,400+ non-GLBA
business families subject to the proposed Rule. The
hourly rates are based on average annual Bureau of
Labor Statistics National Compensation Survey
data, June 2005 (with 2005 as the most recent whole
year information available at the BLS Web site).
https://www.bls.gov/ncs/ocs/sp/ncbl0832.pdf (Table
1.1).
7 This estimate assumes that in subsequent years,
non-GLBA entities would spend 4 hours of
managerial time, 1 hour of technical time, and 5
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Thus, the estimated annual burden for
non-GLBA entities, averaged over the
three-year clearance period, would be
2,646,000 hours and $66,065,000 in
labor costs.
Entities that are subject to the
Commission’s GLBA privacy notice
regulation already provide privacy
notices to their customers. Because the
FACT Act and the proposed Rule
contemplate that the new affiliate
marketing notice can be included in the
GLBA notices, the burden on GLBA
regulated entities would be greatly
reduced. Accordingly, the GLBA entities
would incur 6 hours of burden during
the first year of the clearance period,
comprised of a projected 5 hours of
managerial time and 1 hour of technical
time to execute the notice, given that the
proposed Rule provides a model.8 Staff
also estimates that 3,350 GLBA entities
under the FTC’s jurisdiction would be
affected, so that the total annual burden
for GLBA entities during the first year
of the clearance period would
approximate 20,000 hours and total
annual labor cost would approximate
$673,000.9 The paperwork burden in
subsequent years would be significantly
lower, with GLBA entities each
incurring 4 hours of annual burden (3
hours of managerial time and 1 hour of
technical time) during the remaining
two years of the clearance, which
amounts to 13,400 hours and $443,540
in labor costs in each of the ensuing two
years. Thus, averaged over the threeyear clearance period, the estimated
annual burden for GLBA entities is
15,600 hours and $520,000 in labor
costs.
Cumulatively for both GLBA and nonGLBA entities, the average annual
burden over the prospective three-year
clearance period, rounded, is
approximately 2,662,000 burden hours
and $87,349,000 in labor costs. GLB
entities are already providing notices to
their customers so there are no new
capital or non-labor costs, as this notice
may be consolidated into their current
notices. For non-GLB entities, the rule
provides for simple and concise model
forms that institutions may use to
comply. Thus, any capital or non-labor
hours of clerical time each year. Thus, the resulting
estimated burden for each of the remaining two
years of the clearance period would be 2,334,590
hours and approximately $55,759,000 in labor
costs.
8 As stated above, no clerical time is included in
the estimate because the notice likely would be
combined with existing GLBA notices.
9 3,350 GLBA entities × [($34.20 × 5 hours) +
($29.80 × 1 hour)].
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costs associated with compliance for
these entities are negligible.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
William Blumenthal,
General Counsel.
[FR Doc. E7–3397 Filed 2–27–07; 8:45 am]
Food and Drug Administration
BILLING CODE 6750–01–P
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification
[Docket No. 2006N–0425]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
AGENCY:
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel: Scientific, Technical
and Operational Services for
Epidemiology, Surveillance and
Laboratory Program, Contract
Solicitation Number (CSN) 2006–N–
08556
sroberts on PROD1PC70 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces a meeting of the
aforementioned Special Emphasis
Panel.
Time And Date: 12 p.m.–3 p.m.,
March 21, 2007 (Closed).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in section 552b(c)(4)
and (6), Title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters To Be Discussed: The meeting
will include the review, discussion, and
evaluation of the scientific merit of
research applications in response to
CSN 2006–N–08556, ‘‘Scientific,
Technical and Operational Services for
Epidemiology, Surveillance and
Laboratory Program.’’
Contact Person For More Information:
Christine Morrison, PhD., Designated
Federal Officer, 1600 Clifton Road,
Mailstop D72, Atlanta, GA 30333,
telephone (404) 639–3098.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–3470 Filed 2–27–07; 8:45 am]
BILLING CODE 4163–18–P
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Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 30,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance:
SUPPLEMENTARY INFORMATION:
Premarket Notification—21 CFR Part
807; Subpart E—(OMB Control Number
0910–0120)—Extension
Section 510(k) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360(k)) and the implementing
regulation under part 807 (21 CFR part
807, subpart E) require a person who
intends to market a medical device to
submit a premarket notification
submission to FDA at least 90 days
before proposing to begin the
introduction, or delivery for
introduction into interstate commerce,
for commercial distribution of a device
intended for human use. Based on the
information provided in the
notification, FDA must determine
whether the new device is substantially
equivalent to a legally marketed device,
as defined in § 807.92(a)(3). If the device
is determined to be not substantially
equivalent to a legally marketed device,
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it must have an approved premarket
approval application (PMA), Product
Development Protocol or be reclassified
into Class I or Class II before being
marketed. The FDA makes the final
decision of whether a device is
equivalent or not equivalent.
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250) added section
510(o) to the act to establish new
regulatory requirements for reprocessed
single-use devices (SUDs). MDUFMA
was signed into law on October 26,
2002.
Section 510(o) of the act requires that
FDA review the types of reprocessed
SUDs subject to premarket notification
requirements and identify which of
these devices require the submission of
validation data to ensure their
substantial equivalence to predicate
devices. Section 510(o) also requires
that FDA review critical and semicritical reprocessed SUDs that are
currently exempt from premarket
notification requirements and determine
which of these devices require the
submission of premarket notifications to
ensure their substantial equivalence to
predicate devices.
FDA has identified the reprocessed
SUDs that require the submission of
validation data to date. The requirement
to submit validation data for certain
reprocessed single-use devices has been
incorporated into the premarket
notification program. As with all other
devices, new premarket notifications for
reprocessed SUDs will be required as
new manufacturers enter the market or
manufacturers with cleared premarket
notifications make significant changes
to their device. The burden estimates in
this document include the burden for
submitting premarket notifications for
reprocessed SUDs with the burden for
all other devices. FDA may amend the
lists of reprocessed SUDs that require
the submission of premarket
notifications with validation data as
necessary.
Section 807.81 states when a
premarket notification is required. A
premarket notification is required to be
submitted by a person who is:
• Introducing a device to the market
for the first time;
• Introducing or reintroducing a
device which is significantly changed or
modified in design, components,
method of manufacturer, or the
intended use that could affect the safety
and effectiveness of the device.
Section 807.87 specifies information
required in a premarket notification
submission.
Section 204 of the Food and Drug
Administration Modernization Act
E:\FR\FM\28FEN1.SGM
28FEN1
Agencies
[Federal Register Volume 72, Number 39 (Wednesday, February 28, 2007)]
[Notices]
[Pages 9002-9005]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3397]
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FEDERAL TRADE COMMISSION
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Federal Trade Commission.
ACTION: Notice.
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SUMMARY: The information collection requirements described below will
be submitted to the Office of Management and Budget (``OMB'') for
review, as required by the Paperwork Reduction Act (``PRA''). The
Federal Trade Commission (``FTC'' or ``Commission'') is seeking public
comments on its proposal to extend through July 31,
[[Page 9003]]
2010 the current OMB clearance for information collection requirements
contained in its proposed Affiliate Marketing Rule (or ``proposed
Rule''). That clearance expires on July 31, 2007.
DATES: Comments must be filed by April 30, 2007.
ADDRESSES: Interested parties are invited to submit written comments.
Comments should refer to ``Affiliate Marketing Rule: FTC File No.
R411006'' to facilitate the organization of comments. A comment filed
in paper form should include this reference both in the text and on the
envelope and should be mailed or delivered, with two complete copies,
to the following address: Federal Trade Commission, Room H-135 (Annex
J), 600 Pennsylvania Ave., NW., Washington, DC 20580. Because paper
mail in the Washington area and at the Commission is subject to delay,
please consider submitting your comments in electronic form, as
prescribed below. However, if the comment contains any material for
which confidential treatment is requested, it must be filed in paper
form, and the first page of the document must be clearly labeled
``Confidential.'' \1\
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\1\ Commission Rule 4.2(d), 16 CFR 4.2(d). The comment must be
accompanied by an explicit request for confidential treatment,
including the factual and legal basis for the request, and must
identify the specific portions of the comment to be withheld from
the public record. The request will be granted or denied by the
Commission's General Counsel, consistent with applicable law and the
public interest. See Commission Rule 4.9(c), 16 CFR 4.9(c).
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Comments filed in electronic form should be submitted by following
the instructions on the Web-based form at https://
secure.commentworks.com/AffiliateMarketingRule. To ensure that the
Commission considers an electronic comment, you must file it on the
Web-based form at the https://secure.commentworks.com/
AffiliateMarketingRule weblink. If this notice appears at
www.regulations.gov, you may also file an electronic comment through
that Web site. The Commission will consider all comments that
regulations.gov forwards to it.
The FTC Act and other laws the Commission administers permit the
collection of public comments to consider and use in this proceeding as
appropriate. All timely and responsive public comments will be
considered by the Commission and will be available to the public on the
FTC Web site, to the extent practicable, at www.ftc.gov. As a matter of
discretion, the FTC makes every effort to remove home contact
information for individuals from the public comments it receives before
placing those comments on the FTC Web site. More information, including
routine uses permitted by the Privacy Act, may be found in the FTC's
privacy policy at https://www.ftc.gov/ftc/privacy.htm.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be addressed to Anthony Rodriguez or Loretta Garrison,
Attorneys, Division of Privacy and Identity Protection, Bureau of
Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue,
NW., Washington, DC 20580, (202) 326-2252.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act (``PRA''),
44 U.S.C. 3501-3520, federal agencies must obtain approval from OMB for
each collection of information they conduct or sponsor. ``Collection of
information'' means agency requests or requirements that members of the
public submit reports, keep records, or provide information to a third
party. 44 U.S.C. 3502(3); 5 CFR 1320.3(c). As required by section
3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for
public comment before requesting that OMB extend the existing paperwork
clearance for the regulations noted herein.
The FTC invites comments on: (1) Whether the required collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information has practical utility;
(2) the accuracy of the agency's estimate of the burden of the required
collection of information, including the validity of the methodology
and assumptions used; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) ways to minimize
the burden of the collection of information on those who are to
respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. All comments should be filed as prescribed in
the ADDRESSES section above, and must be received on or before April
30, 2007.
The Affiliate Marketing Rule, 16 CFR part 680, was proposed by the
FTC under section 214 of the Fair and Accurate Credit Transactions Act
(``FACT Act''), Pub. L. No. 108-159 (December 6, 2003). The FACT Act
amended the Fair Credit Reporting Act, 15 U.S.C. 1681 et seq., which
was enacted to enable consumers to protect the privacy of their
consumer credit information. As mandated by the FACT Act, the proposed
Rule specifies disclosure requirements for certain affiliate companies
subject to the Commission's jurisdiction. Except as discussed below,
these requirements constitute ``collections of information'' for
purposes of the PRA. Specifically, the FACT Act and the proposed Rule
require covered entities to provide consumers with notice and an
opportunity to opt out of the use of certain information before sending
marketing solicitations. The proposed Rule generally provides that, if
a company communicates certain information about a consumer
(``eligibility information'') to an affiliate, the affiliate may not
use that information to make or send solicitations to the consumer
unless the consumer is given notice and a reasonable opportunity to opt
out of such use of the information and the consumer does not opt out.
To minimize compliance costs and burdens for entities, particularly
any small businesses that may be affected, the proposed Rule contains
model disclosures and opt-out notices that may be used to satisfy the
statutory requirements. The proposed Rule also gives covered entities
flexibility to satisfy the notice and opt-out requirement by sending
the consumer a free-standing opt-out notice or by adding the opt-out
notice to the privacy notices already provided to consumers, such as
those provided in accordance with the provisions of Title V, subtitle A
of the GLBA. For covered entities that choose to prepare a free-
standing opt-out notice, the time necessary to prepare it would be
minimal because those entities could simply use the model disclosure.
For covered entities that choose to incorporate the model opt-out
notice into their GLBA privacy notices the time necessary to do so also
would be minimal. Arguably, verbatim adoption of the model notice would
not even be a PRA ``collection of information.'' \2\
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\2\ ``The public disclosure of information originally supplied
by the Federal government to the recipient for purpose of disclosure
to the public is not included within [the definition of collection
of information].'' 5 CFR 1320.3(c)(2).
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Burden Statement
Except where otherwise specifically noted, staff's estimates of
burden are based on its knowledge of the consumer credit industries and
knowledge of the entities over which the Commission has jurisdiction.
This said, estimating PRA burden of the proposed Rule's disclosure
requirements is difficult given the highly diverse group of affected
entities that includes affiliated companies which may use certain
eligibility information shared by their
[[Page 9004]]
affiliates to send marketing notices to consumers who are not regulated
by a federal financial regulatory agency.
The estimates provided in this burden statement may well overstate
actual burden. First, an uncertain but possibly significant number of
entities subject to the FTC's jurisdiction do not have affiliates and
would thus not be covered by section 214 of the FACT Act or the
proposed Rule. Second, the Commission's staff does not know how many
companies subject to the FTC's jurisdiction under the proposed rule
actually share eligibility information among affiliates and, of those,
how many affiliates use such information to make marketing
solicitations to consumers. The staff considered the wide variations in
covered entities and the fact that, in some instances, covered entities
may make the required disclosures in the ordinary course of business,
apart from the FACT Act Rule, voluntarily as a service to their
customers, while still other entities may choose to rely on the
exceptions to the proposed Rule's notice and opt-out requirements.\3\
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\3\ Exceptions include, for example, having a preexisting
business relationship with a consumer, using information in response
to a communication initiated by the consumer or to solicitations
authorized or requested by the consumer.
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Staff's estimates assume a higher burden will be incurred during
the first year of the OMB clearance period with a lesser burden for
each of the subsequent two years, since the opt-out notice to consumers
is required to be given only once. Institutions may provide for an
indefinite period for the opt-out or they may time limit it, but for no
less than five years. Given this minimum time period, Commission staff
did not estimate burden for preparing and distributing extension
notices by entities that limit the duration of the opt-out time period.
The relevant PRA time frame for burden calculation is three years from
renewed OMB clearance, and the five-year notice period will not begin
until this proposed Rule becomes final.
Staff's labor cost estimates take into account: Managerial and
professional time for reviewing internal policies and determining
compliance obligations; technical time for creating the notice and opt-
out, in either paper or electronic form; and clerical time for
disseminating the notice and opt-out.\4\ In addition, staff's cost
estimates presume that the availability of model disclosures and opt-
out notices will simplify the compliance review and implementation
processes, thereby significantly reducing the cost of compliance.
Moreover, the proposed Rule gives entities considerable flexibility to
determine the scope and duration of the opt-out. Indeed, this
flexibility permits entities to send a single joint notice on behalf of
all of its affiliates.
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\4\ No clerical time was included in staff's burden analysis for
GLBA entities as the notice would likely be combined with existing
GLBA notices.
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Estimated total annual hours burden: 2,662,000 hours, rounded.
Staff estimates that approximately 1.17 million (rounded) non-GLBA
entities under the jurisdiction of the FTC have affiliates and would be
affected by the proposed Rule.\5\ Staff further estimates that there
are an average of 5 businesses per family or affiliated relationship,
and that the affiliated entities will choose to send a joint notice, as
permitted by the proposed Rule. Thus an estimated 233,400 (rounded)
non-GLBA entities may send the new affiliate marketing notice. Staff
also estimates that non-GLBA entities under the jurisdiction of the FTC
would each incur 14 hours of burden during the first year of the
clearance period, comprised of a projected 7 hours of managerial time,
2 hours of technical time, and 5 hours of clerical assistance.
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\5\ This estimate is derived from an analysis of a database of
U.S. businesses based on SIC codes for businesses that market goods
or services to consumers, which included the following industries:
transportation services; communication; electric, gas, and sanitary
services; retail trade; finance, insurance, and real estate; and
services (excluding business services and engineering, management
services). This estimate excludes businesses not subject to the
FTC's jurisdiction as well as businesses that do not use data or
information subject to the rule.
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Based on the above, total annual burden for non-GLBA entities
during the first year of the clearance period would be approximately
2,646,000 hours and the total annual labor cost would be approximately
$86,676,000, rounded.\6\ These estimates include the start-up burden
and attendant costs, such as determining compliance obligations.
Paperwork burden in later years would be significantly lower, with non-
GLBA entities each incurring 10 hours of annual burden during the
remaining two years of the clearance.\7\ Thus, the estimated annual
burden for non-GLBA entities, averaged over the three-year clearance
period, would be 2,646,000 hours and $66,065,000 in labor costs.
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\6\ The figure is derived from the estimated 7 hours of
managerial labor at $34.21 per hour; 2 hours of technical labor at
$29.80 per hour; and 5 hours of clerical labor at $14.44 per hour (a
combined $371.27) for the estimated 233,400+ non-GLBA business
families subject to the proposed Rule. The hourly rates are based on
average annual Bureau of Labor Statistics National Compensation
Survey data, June 2005 (with 2005 as the most recent whole year
information available at the BLS Web site). https://www.bls.gov/ncs/
ocs/sp/ncbl0832.pdf (Table 1.1).
\7\ This estimate assumes that in subsequent years, non-GLBA
entities would spend 4 hours of managerial time, 1 hour of technical
time, and 5 hours of clerical time each year. Thus, the resulting
estimated burden for each of the remaining two years of the
clearance period would be 2,334,590 hours and approximately
$55,759,000 in labor costs.
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Entities that are subject to the Commission's GLBA privacy notice
regulation already provide privacy notices to their customers. Because
the FACT Act and the proposed Rule contemplate that the new affiliate
marketing notice can be included in the GLBA notices, the burden on
GLBA regulated entities would be greatly reduced. Accordingly, the GLBA
entities would incur 6 hours of burden during the first year of the
clearance period, comprised of a projected 5 hours of managerial time
and 1 hour of technical time to execute the notice, given that the
proposed Rule provides a model.\8\ Staff also estimates that 3,350 GLBA
entities under the FTC's jurisdiction would be affected, so that the
total annual burden for GLBA entities during the first year of the
clearance period would approximate 20,000 hours and total annual labor
cost would approximate $673,000.\9\ The paperwork burden in subsequent
years would be significantly lower, with GLBA entities each incurring 4
hours of annual burden (3 hours of managerial time and 1 hour of
technical time) during the remaining two years of the clearance, which
amounts to 13,400 hours and $443,540 in labor costs in each of the
ensuing two years. Thus, averaged over the three-year clearance period,
the estimated annual burden for GLBA entities is 15,600 hours and
$520,000 in labor costs.
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\8\ As stated above, no clerical time is included in the
estimate because the notice likely would be combined with existing
GLBA notices.
\9\ 3,350 GLBA entities x [($34.20 x 5 hours) + ($29.80 x 1
hour)].
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Cumulatively for both GLBA and non-GLBA entities, the average
annual burden over the prospective three-year clearance period,
rounded, is approximately 2,662,000 burden hours and $87,349,000 in
labor costs. GLB entities are already providing notices to their
customers so there are no new capital or non-labor costs, as this
notice may be consolidated into their current notices. For non-GLB
entities, the rule provides for simple and concise model forms that
institutions may use to comply. Thus, any capital or non-labor
[[Page 9005]]
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costs associated with compliance for these entities are negligible.
William Blumenthal,
General Counsel.
[FR Doc. E7-3397 Filed 2-27-07; 8:45 am]
BILLING CODE 6750-01-P