45204 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

Dated: August 17, 2009. 

Anita L. Davis, 

Chief, Superfund Enforcement & Information 

Management Branch, Superfund Division. 

[FR Doc. E9–21122 Filed 8–31–09; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

Notice of Public Information Collection 

Being Reviewed by the Federal 

Communications Commission, 

Comments Requested 

August 26, 2009. 

SUMMARY: The Federal Communications 

Commission, as part of its continuing 

effort to reduce paperwork burden 

invites the general public and other 

Federal agencies to take this 

opportunity to comment on the 

following information collection(s), as 

required by the Paperwork Reduction 

Act of 1995, 44 U.S.C. 3501–3520. An 

agency may not conduct or sponsor a 

collection of information unless it 

displays a currently valid control 

number. No person shall be subject to 

any penalty for failing to comply with 

a collection of information subject to the 

Paperwork Reduction Act (PRA) that 

does not display a valid control number. 

Comments are requested concerning (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

Commission, including whether the 

information shall have practical utility; 

(b) the accuracy of the Commission’s 

burden estimate; (c) ways to enhance 

the quality, utility, and clarity of the 

information collected; and (d) ways to 

minimize the burden of the collection of 

information on the respondents, 

including the use of automated 

collection techniques or other forms of 

information technology. 

DATES: Persons wishing to comments on 

this information collection should 

submit comments on November 2, 2009. 

If you anticipate that you will be 

submitting comments, but find it 

difficult to do so within the period of 

time allowed by this notice, you should 

advise the contact listed below as soon 

as possible. 

ADDRESSES: Direct all PRA comments to 

Nicholas A. Fraser, Office of 

Management and Budget (OMB), via fax 

at (202) 395–5167, or via the Internet at 

Nicholas_A._Fraser@omb.eop.gov and 

to Cathy Williams, Federal 

Communications Commission (FCC), 

445 12th Street S.W., Washington, DC 

20554. To submit your comments by e– 

mail send then to: PRA@fcc.gov and to 

Cathy.Williams@fcc.gov. 

FOR FURTHER INFORMATION CONTACT: For 

additional information about the 

information collection(s) send an e–mail 

to PRA@fcc.gov or contact Cathy 

Williams on (202) 418–2918. 

SUPPLEMENTARY INFORMATION: 

OMB Control Number: 3060–XXXX. 

Title: Application for Permit to 

Deliver Programs to Foreign Broadcast 

Stations, FCC 

Form 308. 

Form No.: FCC Form 308. 

Type of Review: New information 

collection. 

Respondents: Business or other for– 

profit entities. 

Number of Respondents/Responses: 

22 respondents; 22 responses. 

Estimated Time Per Response: 1 hour. 

Obligation to Respond: Required to 

obtain or retain benefits. The statutory 

authority for this collection is contained 

in Section 325(c) of the 

Communications Act of 1934, as 

amended. 

Total Annual Burden: 22 hours. 

Annual Cost Burden: $10,890. 

Privacy Act Impact Assessment: No 

impact(s). 

Nature and Extent of Confidentiality: 

In general, there is no need for 

confidentiality with this collection of 

information. 

Needs and Uses: The Federal 

Communications Commission 

(‘‘Commission’’) is requesting that the 

Office of Management and Budget 

(OMB) approve the establishment of a 

new information collection titled, 

‘‘Application for Permit to Deliver 

Programs to Foreign Broadcast Stations 

(FCC Form 308).’’ Applicants use the 

FCC Form 308 to apply, under Section 

325(c) of the Communications Act of 

1934, as amended, for authority to 

locate, use, or maintain a studio in the 

United States for the purpose of 

supplying program material to a foreign 

radio or TV broadcast station whose 

signals are consistently received in the 

United States, or for extension of 

existing authority. 

Currently, the FCC Form 308 is only 

available to the public in paper form. 

The Commission is requesting OMB 

approval of a revised FCC Form 308, in 

Excel format, that will be made 

available to the public on the FCC 

Forms page of the FCC’s website, 

www.fcc.gov <http://www.fcc.gov/>. 

The form was revised to make it more 

user friendly and to include questions to 

obtain only the legal and technical 

information that is essential to grant 

authority to U.S. broadcasters to supply 

program material to a foreign radio or 

TV broadcast station whose signals are 

consistently received in the U.S. or to 

extend the current authority. After the 

applicant completes the form, it is 

mailed to the U.S. Bank along with the 

application fee. Then, it is forwarded to 

the International Bureau with the 

exception of fee exempt applications 

which are filed directly with the FCC 

Secretary’s Office and then forwarded to 

the Bureau. 

Without this collection of 

information, the Commission would not 

be able to ascertain whether the main 

studio owner in the US meets various 

legal requirements or the foreign 

broadcast facility, which receives and 

retransmits programming from the main 

studio in the US, meets various 

technical requirements that prevent 

harmful interference to other broadcast 

stations or telecommunications 

facilities. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

[FR Doc. E9–21014 Filed 8–31–09; 8:45 am] 

BILLING CODE 6712–01–S 

FEDERAL TRADE COMMISSION 

[Docket No. 9336] 

Dyna-E International, Inc.; Analysis of 

Proposed Consent Order to Aid Public 

Comment 

AGENCY: Federal Trade Commission. 

ACTION: Proposed Consent Agreement. 

SUMMARY: The consent agreement in this 

matter settles alleged violations of 

federal law prohibiting unfair or 

deceptive acts or practices or unfair 

methods of competition. The attached 

Analysis to Aid Public Comment 

describes both the allegations in the 

complaint and the terms of the consent 

order — embodied in the consent 

agreement — that would settle these 

allegations. 

DATES: Comments must be received on 

or before September 25, 2009. 

ADDRESSES: Interested parties are 

invited to submit written comments 

electronically or in paper form. 

Comments should refer to ‘‘Dyna-E, Inc., 

Docket No. 9336’’ to facilitate the 

organization of comments. Please note 

that your comment — including your 

name and your state — will be placed 

on the public record of this proceeding, 

including on the publicly accessible 

FTC website, at (http://www.ftc.gov/os/ 

publiccomments.shtm). 

Because comments will be made 

public, they should not include any 

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Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45205 

1The 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 FTC 

Rule 4.9(c), 16 CFR 4.9(c). 

sensitive personal information, such as 

an individual’s Social Security Number; 

date of birth; driver’s license number or 

other state identification number, or 

foreign country equivalent; passport 

number; financial account number; or 

credit or debit card number. Comments 

also should not include any sensitive 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, comments should not include 

any ‘‘[t]rade secret or any commercial or 

financial information which is obtained 

from any person and which is privileged 

or confidential. . . .,’’ as provided in 

Section 6(f) of the FTC Act, 15 U.S.C. 

46(f), and Commission Rule 4.10(a)(2), 

16 CFR 4.10(a)(2). Comments containing 

material for which confidential 

treatment is requested must be filed in 

paper form, must be clearly labeled 

‘‘Confidential,’’ and must comply with 

FTC Rule 4.9(c), 16 CFR 4.9(c).1

Because paper mail addressed to the 

FTC is subject to delay due to 

heightened security screening, please 

consider submitting your comments in 

electronic form. Comments filed in 

electronic form should be submitted by 

using the following weblink: (https:// 

secure.commentworks.com/ftc-DynaE) 

and following the instructions on the 

web-based form). To ensure that the 

Commission considers an electronic 

comment, you must file it on the webbased form at the weblink: (https:// 

secure.commentworks.com/ftc-DynaE). 

If this Notice appears at (http:// 

www.regulations.gov/search/index.jsp), 

you may also file an electronic comment 

through that website. The Commission 

will consider all comments that 

regulations.gov forwards to it. You may 

also visit the FTC website at (http:// 

www.ftc.gov/) to read the Notice and the 

news release describing it. 

A comment filed in paper form 

should include the ‘‘Dyna-E, Inc., 

Docket No. 9336’’ reference both in the 

text and on the envelope, and should be 

mailed or delivered to the following 

address: Federal Trade Commission, 

Office of the Secretary, Room H-135 

(Annex D), 600 Pennsylvania Avenue, 

NW, Washington, DC 20580. The FTC is 

requesting that any comment filed in 

paper form be sent by courier or 

overnight service, if possible, because 

U.S. postal mail in the Washington area 

and at the Commission is subject to 

delay due to heightened security 

precautions. 

The Federal Trade Commission Act 

(‘‘FTC Act’’) and other laws the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives, 

whether filed in paper or electronic 

form. Comments received will be 

available to the public on the FTC 

website, to the extent practicable, at 

(http://www.ftc.gov/os/ 

publiccomments.shtm). As a matter of 

discretion, the Commission makes every 

effort to remove home contact 

information for individuals from the 

public comments it receives before 

placing those comments on the FTC 

website. 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.shtm). 

FOR FURTHER INFORMATION CONTACT: 

Michael J. Davis, Bureau of Consumer 

Protection, 600 Pennsylvania Avenue, 

NW, Washington, DC 20580, (202) 326- 

2458. 

SUPPLEMENTARY INFORMATION: Pursuant 

to section 6(f) of the Federal Trade 

Commission Act, 38 Stat. 721, 15 U.S.C. 

46(f), and § 3.25(f) the Commission 

Rules of Practice, 16 CFR 3.25(f), notice 

is hereby given that the above-captioned 

consent agreement containing a consent 

order to cease and desist, having been 

filed with and accepted, subject to final 

approval, by the Commission, has been 

placed on the public record for a period 

of thirty (30) days. The following 

Analysis to Aid Public Comment 

describes the terms of the consent 

agreement, and the allegations in the 

complaint. An electronic copy of the 

full text of the consent agreement 

package can be obtained from the FTC 

Home Page (for August 26, 2009), on the 

World Wide Web, at (http:// 

www.ftc.gov/os/actions.shtm). A paper 

copy can be obtained from the FTC 

Public Reference Room, Room 130-H, 

600 Pennsylvania Avenue, NW, 

Washington, DC 20580, either in person 

or by calling (202) 326-2222. 

Public comments are invited, and may 

be filed with the Commission in either 

paper or electronic form. All comments 

should be filed as prescribed in the 

ADDRESSES section above, and must be 

received on or before the date specified 

in the DATES section. 

Analysis of Agreement Containing 

Consent Order to Aid Public Comment 

The Federal Trade Commission 

(‘‘FTC’’ or ‘‘Commission’’) has accepted, 

subject to final approval, an agreement 

containing a consent order from DynaE International, Inc., a corporation, and 

its president and director, George 

Wheeler (‘‘respondents’’). 

The proposed consent order has been 

placed on the public record for thirty 

(30) days for reception of comments by 

interested persons. Comments received 

during this period will become part of 

the public record. After thirty (30) days, 

the Commission will again review the 

agreement and the comments received 

and will decide whether it should 

withdraw from the agreement or make 

final the agreement’s proposed order. 

This matter involves respondents’ 

marketing and sale of Lightload Towels 

with packaging and other marketing 

materials that prominently state 

‘‘biodegradable’’ without qualification. 

According to the FTC complaint, 

respondents represented that Lightload 

Towels will completely break down and 

return to nature, i.e., decompose into 

elements found in nature, within a 

reasonably short period of time after 

customary disposal. The complaint 

alleges respondents’ biodegradable 

claim is false because a substantial 

majority of total household waste is 

disposed of either in landfills, 

incinerators, or recycling facilities and 

these customary disposal methods do 

not present conditions that would allow 

for Lightload Towels to completely 

break down and return to nature, i.e., 

decompose into elements found in 

nature, within a reasonably short period 

of time. The complaint further alleges 

that respondents failed to have 

substantiation for their biodegradable 

claim. The proposed consent order 

contains provisions designed to prevent 

respondents from engaging in similar 

acts and practices in the future. 

Part I.A of the proposed order 

prohibits respondents from making a 

representation that any product is 

degradable unless the representation is 

true, not misleading, and substantiated 

by competent and reliable scientific 

evidence. Part I.B prohibits respondents 

from making any other environmental 

benefit claim about any product, unless 

at the time the representation is made, 

it is truthful and not misleading, and 

substantiated by competent and reliable 

evidence, which when appropriate must 

be competent and reliable scientific 

evidence. 

Parts II through VI require 

respondents to keep copies of relevant 

advertisements and materials 

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45206 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

substantiating claims made in the 

advertisements; to provide copies of the 

order to certain of their personnel; to 

notify the Commission of changes in 

corporate structure that might affect 

compliance obligations under the order; 

to notify the Commission of changes in 

residence, employment, or business 

affiliation; to file compliance reports 

with the Commission; and to respond to 

other requests from FTC staff. Part VII 

provides that the order will terminate 

after twenty (20) years under certain 

circumstances. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed order. It is not intended to 

constitute an official interpretation of 

the agreement and proposed order or to 

modify in any way their terms. 

By direction of the Commission. 

Donald S. Clark 

Secretary. 

[FR Doc. E9–20976 Filed 8–31–09: 2:25 pm] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice Regarding 340B Drug Pricing 

Program—Children’s Hospitals 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Final notice. 

SUMMARY: Section 340B of the Public 

Health Service Act (section 340B) and 

section 1927(a) of the Social Security 

Act (section 1927(a)) implement a drug 

pricing program in which manufacturers 

who sell covered outpatient drugs to 

covered entities must agree to charge a 

price that will not exceed an amount 

determined under a statutory formula. 

Section 6004 of the Deficit Reduction 

Act of 2005 (Pub. L. 109–171) (section 

6004) added certain qualifying 

children’s hospitals to the list of 

covered entities eligible to access 340B 

discounted drugs. The purpose of this 

notice is to inform interested parties of 

final guidelines regarding the addition 

of children’s hospitals that meet certain 

requirements, specifically: (1) The 

process for the registration of children’s 

hospitals to the 340B Program; and (2) 

the obligation of manufacturers to 

provide the statutorily mandated 

discount to those children’s hospitals. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Jimmy Mitchell, Director, Office of 

Pharmacy Affairs (OPA), Healthcare 

Systems Bureau (HSB), Health 

Resources and Services Administration 

(HRSA), 5600 Fishers Lane, Parklawn 

Building, Room 10C–03, Rockville, MD 

20857, or by telephone through the 

Pharmacy Services Support Center at 

1–800–628–6297. 

DATES: Effective Date: September 1, 

2009. 

SUPPLEMENTARY INFORMATION: 

(A) Background 

Proposed guidelines for children’s 

hospitals were announced in the 

Federal Register at 72 FR 37250 on July 

9, 2007. A comment period of 60 days 

was established to allow interested 

parties to submit comments. HRSA, 

HSB, acting through the OPA, received 

20 comments concerning the proposal. 

Section 602 of Public Law 102–585, 

the Veterans Health Care Act of 1992, 

established section 340B of the Public 

Health Service Act and added certain 

implementation provisions for the 340B 

Program to section 1927(a) of the Social 

Security Act. Section 340B contains the 

majority of the requirements for covered 

entities participating in the 340B 

Program, while the relevant provisions 

of section 1927(a) of the Social Security 

Act provide primarily for the 

requirement that manufacturers provide 

the statutorily mandated discount to 

covered entities. 

Section 340B contains a list of 

covered entities that are eligible to 

receive discounts through the 340B 

Program. The list includes entities such 

as Federally Qualified Health Centers, 

State-operated AIDS drug purchasing 

assistance programs, and certain 

disproportionate share hospitals. 

Children’s hospitals were not included 

as covered entities under section 340B 

in the Veterans Health Care Act of 1992 

as enacted. 

Section 6004 of the Deficit Reduction 

Act (DRA), Pub. L. 109–171, added 

certain qualifying children’s hospitals as 

covered entities eligible to access 340B 

discounted drugs. Section 6004 did not 

amend section 340B (which contains 

many of the requirements for covered 

entities), however, the DRA provision 

amended section 1927(a) of the Social 

Security Act (which primarily contains 

requirements for manufacturers’ 

participation) to add children’s 

hospitals to the 340B Program. 

To be eligible for the 340B Drug 

Pricing Program, section 1927(a), as 

amended by section 6004 of the DRA, 

requires children’s hospitals to meet the 

requirements of clauses (i) and (iii) of 

section 340B(a)(4)(L) of the Public 

Health Service Act, which contain 

provisions for State or local government 

affiliations and non-participation in 

group purchasing organizations. In 

addition, children’s hospitals must meet 

the requirements of clause (ii) of such 

section, which contains requirements 

for the provision of indigent care, if 

such section ‘‘were applied by taking 

into account the percentage of care 

provided by the hospital to patients 

eligible for medical assistance’’ under 

Medicaid. 

We received several comments in 

support of the proposal. Supporting 

comments agreed with the proposed 

guidelines and that section 6004 of the 

DRA brings eligible children’s hospitals 

into the 340B program. Several 

commenters agreed with requiring 

children’s hospitals to demonstrate their 

status as defined by the Social Security 

Act section 1886(d)(1)(B)(iii) and to 

obtain a Medicare provider number in 

the 3300 series. Many comments 

supported obtaining an independent 

audit to certify eligibility requirements 

and to help ensure program integrity. 

Comments supported HRSA’s position 

that current Pharmaceutical Pricing 

Agreements (PPAs) are already broad 

enough to include children’s hospitals 

as covered entities. 

Additional comments challenged 

HRSA’s legal authority and compliance 

with the Administrative Procedure Act 

as well as contractual authority with 

existing PPAs. Other comments raised 

issues of retroactive discounts, 

prevention of duplicate discounts, and 

alternative eligibility criteria such as 

using disproportionate patient 

percentages and independent audits. All 

comments discussed the potential 

impacts on covered entities, patients, 

and manufacturers. 

The following section presents a 

summary of all major comments, 

grouped by subject, and a response to 

each comment. All comments were 

considered in developing this final 

notice and changes were made to 

content when appropriate. 

(B) Comments and Responses 

(1) HRSA’s Legal Authority 

Comment: HRSA lacks authority to 

add children’s hospitals to the 340B 

program through guidelines. 

Response: HRSA disagrees. The 

Department publishes guidelines in the 

Federal Register providing a public 

comment period to obtain input into 

guidance development. Congress did 

not prescribe the process by which 

children’s hospitals would be added 

into the 340B program. HRSA has 

authority to provide guidelines 

interpreting the statute and its intended 

administration of the 340B program. 

The guidelines are not subject to the 

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