9002 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-4- 

methylphosphinico-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 

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) 305- 

7391, 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-3- 

phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro3,3,3- trifluoroprop-1-enyl)-2,1- 

dimethylcyclopropanecarboxylate) and 

(R)-alpha-cyano-3-phenoxybenzyl-(Z)- 

(1S,3S)-3-(2-chloro-3,3,3- trifluoroprop1-enyl)-2,2- 

dimethylcyclopropanecarboxylate, or 

the isolated active isomer gammacyhalothrin (S)-alpha-cyano-3- 

phenoxybenzy-(Z)-(1R,3R)-3-(2-chloro3,3,3-trifluoroprop-1-enyl)-2,2- 

dimethylcyclopropanecarboxylate. 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] 

BILLING CODE 6560–50–S 

FEDERAL MARITIME COMMISSION 

Notice of Agreements Filed 

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 

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-Su ̈d; 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 

FEDERAL TRADE COMMISSION 

Agency Information Collection 

Activities; Submission for OMB 

Review; Comment Request 

AGENCY: Federal Trade Commission. 

ACTION: 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, 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 9003 

1Commission 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). 

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). 

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 

Web site. More information, including 

routine uses permitted by the Privacy 

Act, may be found in the FTC’s privacy 

policy at http://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 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 


sroberts on PROD1PC70 with NOTICES
9004 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 

3Exceptions 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. 

4No clerical time was included in staff’s burden 

analysis for GLBA entities as the notice would 

likely be combined with existing GLBA notices. 

5This 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. 

6The 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). 

http://www.bls.gov/ncs/ocs/sp/ncbl0832.pdf (Table 

1.1). 

7This 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. 

8As 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)]. 

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 

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

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 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 9005 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

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 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0425] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Premarket 

Notification 

AGENCY: 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. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance: 

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, 

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 


sroberts on PROD1PC70 with NOTICES