Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Notices 52105 

application. Cumulatively, these 

organizations report the total burden to 

applicants to be 2,863 hours. 

Frequency: Recordkeeping, Reporting, 

on occasion. 

Affected: Individuals. 

Total Annual Respondents: 5,827. 

Total Annual Responses: 6,949. 

Average Burden Per Response: 25 

minutes. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access the HHS Web 

site address at http://www.hhs.gov/ 

oirm/infocollect/pending/ or e-mail your 

request, including your address, phone 

number, OMB number, and OS 

document identifier, to 

naomi.cook@hhs.gov, or call the Reports 

Clearance Office on (202) 690–6162. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

within 60 days of this notice directly to 

the OS Paperwork Clearance Officer 

designated at the following address: 

Department of Health and Human 

Services, Office of the Secretary, 

Assistant Secretary for Budget, 

Technology, and Finance, Office of 

Information and Resource Management, 

Attention: Naomi Cook (4040–0005), 

Room 531–H, 200 Independence 

Avenue, SW., Washington DC 20201. 

Dated: August 18, 2005. 

Robert E. Polson, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 05–17430 Filed 8–31–05; 8:45 am] 

BILLING CODE 4151–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Injury Prevention 

and Control Initial Review Group: 

Notice of Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92–

463) of October 6, 1972, that the 

National Center for Injury Prevention 

and Control Initial Review Group, 

Centers for Disease Control and 

Prevention of the Department of Health 

and Human Services, has been renewed 

for a 2-year period extending through 

August 20, 2007. 

For further information, contact Gwen 

Cattledge, Executive Secretary, National 

Center for Injury Prevention and Control 

Initial Review Group, Centers for 

Disease Control and Prevention of the 

Department of Health and Human 

Services, 4770 Buford Highway, NE., M/ 

S K02, Atlanta, Georgia 30341–3717, 

telephone 770–488–4655. 

The Director, Management and 

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. 

Dated: August 26, 2005. 

B. Kathy Skipper, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 05–17399 Filed 8–31–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel: Epidemiologic Study 

of Inflammatory Bowel Disease, 

Request for Applications Number DP–

05–130; Correction 

Correction: This notice was published 

in the Federal Register on August 18, 

2005, Volume 70, Number 159, page 

48574. The meeting time and date has 

been changed. 

Time and Date: 2:30 p.m.–4 p.m., 

September 27, 2005 (Closed). 

FOR FURTHER INFORMATION CONTACT: J. 

Felix Rogers, PhD, MPH, Scientific 

Review Administrator, National Center 

for Chronic Disease Prevention and 

Health Promotion, 4770 Buford 

Highway, MS–K92, Atlanta, GA 30341, 

Telephone 404.639.6101. 

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. 

Dated: August 26, 2005. 

B. Kathy Skipper, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention (CDC). 

[FR Doc. 05–17410 Filed 8–31–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1308–NC] 

RIN 0938–AN94 

Medicare Program; Withdrawal of 

Ambulance Fee Schedule Issued in 

Accordance With Federal District Court 

Order in Lifestar Ambulance, Inc. v. 

United States, No. 4:02-CV–127–1 (M.D. 

Ga., Jan. 16, 2003)—Medicare Covered 

Ambulance Services 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice with comment 

period withdraws the fee schedule that 

was put in place in 2003 to effect 

compliance with the Order in Lifestar 

Ambulance, Inc. v. United States. [211 

F.R.D. 688 (M.D. Ga. 2003)] That Order 

was vacated on January 10, 2005 by the 

U.S. Court of Appeals for the Eleventh 

Circuit and is no longer in force. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on October 31, 2005. 

ADDRESSES: In commenting, please refer 

to file code CMS–1308–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments to http:// 

www.cms.hhs.gov/regulations/ 

ecomments or to http:// 

www.regulations.gov (attachments 

should be in Microsoft Word, 

WordPerfect, or Excel; however, we 

prefer Microsoft Word). 

2. By mail. You may mail written 

comments (one original and two copies) 

to the following address ONLY: Centers 

for Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–1308–NC, 

P.O. Box 8011, Baltimore, MD 21244–

1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–1308–NC, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

52106 Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Notices 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

7197 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

Humphrey Building is not readily 

available to persons without Federal 

Government identification, commenters 

are encouraged to leave their comments 

in the CMS drop slots located in the 

main lobby of the building. A stamp-in 

clock is available for persons wishing to 

retain a proof of filing by stamping in 

and retaining an extra copy of the 

comments being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

EFFECTIVE DATE: This notice is effective 

on September 1, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Anne Tayloe, (410) 786–4546. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this rule to assist us in fully 

considering issues and developing 

policies. You can assist us by 

referencing the file code CMS–1308–NC 

and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. CMS posts all electronic 

comments received before the close of 

the comment period on its public Web 

site as soon as possible after they have 

been received. Hard copy comments 

received timely will be available for 

public inspection as they are received, 

generally beginning approximately 3 

weeks after publication of a document, 

at the headquarters of the Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Baltimore, 

Maryland 21244, Monday through 

Friday of each week from 8:30 a.m. to 

4 p.m. To schedule an appointment to 

view public comments, phone 1–800–

743–3951. 

I. Background 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘BACKGROUND’’ at the 

beginning of your comments.] 

Section 4531 of the Balanced Budget 

Act of 1997 (BBA) required the 

Secretary of the Department of Health 

and Human Services (HHS) (the 

Secretary) to establish a national fee 

schedule (FS) for payment of ambulance 

services through a negotiated 

rulemaking process. The statute 

provides that the Secretary phase in the 

application of payment rates under the 

FS in a fair and efficient manner and 

that the aggregate amount of payment 

for the services under the new FS not 

exceed the amount that would be paid 

under the old system as stated in section 

1834(l) of the Social Security Act (the 

Act). The BBA provided that the FS 

would apply to services furnished on or 

after January 1, 2000. 

The proposed and final FS rules both 

provided for payment for ambulance 

services to be made in two parts: (1) A 

base rate; and (2) a payment for mileage. 

Section 423 of the Medicare, Medicaid 

and SCHIP Benefits Improvement and 

Protection Act of 2000 (BIPA), which 

was passed after the publication of the 

proposed FS rule and prior to the 

publication of the final rule, provided 

that during the phase-in of the FS there 

would be full payment of any national 

mileage rate for ambulance services 

furnished by suppliers in States where 

the Medicare carrier did not previously 

pay separately for all mileage within the 

county from which the beneficiary is 

transported (‘‘BIPA mileage provision’’). 

Two States were identified as qualifying 

under this provision: North Carolina 

(NC) and Tennessee (TN). BIPA 

specifies that this provision applies to 

services furnished on or after July 1, 

2001. 

This FS was implemented on April 1, 

2002 by a final rule published in the 

Federal Register on February 27, 2002 

(67 FR 9100). As stated in the final rule, 

the phase-in is accomplished over five 

years by blending a percentage of the 

payment that is based on the old 

payment system with a percentage of 

the payment based on the FS according 

to the following schedule: 

Year Old 

(percent) 

FS 

(percent) 

4/1/2002–12/ 

31/2002 

80 20 

2003 60 40 

2004 40 60 

Year Old 

(percent) 

FS 

(percent) 

2005 20 80 

2006 0 100 

The full national FS mileage rate in 

those States that qualify for BIPA 

provision section 423 (NC, TN) was paid 

as of April 1, 2002. 

In Lifestar Ambulance Service, Inc. v. 

United States, 211 F.R.D. 688 (M.D. Ga. 

2003), three ambulance suppliers 

seeking to represent a nationwide class 

of ambulance suppliers sued the 

Secretary, arguing that he had no 

discretion to give the FS an effective 

date other than January 1, 2000. The 

district court agreed with the plaintiff 

suppliers and issued an order certifying 

a nationwide class of ambulance 

suppliers and requiring the Secretary to 

adopt a FS for the January 1, 2000, 

through March 31, 2002 period. The 

court’s decision also required the 

Secretary to pay full mileage under the 

BIPA provision for the July 1, 2001 

through March 31, 2002 period. 

On April 16, 2003, the Secretary 

issued a notice in compliance with the 

district court’s order. (68 FR 18654) The 

Secretary established a FS based on the 

FS as described in the Federal Register 

(67 FR 9100), with a modified phase-in 

as follows: 

Year Old 

(percent) 

FS 

(percent) 

2000 95 5 

2001 90 10 

1/1/2002–3/31/ 

2002 

80 20 

Additionally, under the district 

court’s order, the notice stated that the 

Medicare program would pay full BIPA 

mileage for services provided on or after 

July 1, 2001. The notice stated that the 

Secretary had appealed the decision in 

Lifestar and that any FS or BIPA mileage 

payment made under the notice for the 

January 1, 2000 through March 31, 2002 

period would be subject to recoupment 

if the district court’s decision was 

reversed on appeal. The Secretary has 

not made any payments under this FS. 

In addition, we are not aware of any 

ambulance suppliers seeking payment 

under this FS prior to the Eleventh 

Circuit’s reversal of the district court 

decision, although some were seeking 

full mileage under the BIPA mileage 

provision. 

On appeal, the Eleventh Circuit found 

that the district court had lacked 

jurisdiction over the case because the 

plaintiffs had not gone through the 

administrative process before filing suit. 

See Lifestar Ambulance Service, Inc. v. 

Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Notices 52107 

United States, 365 F.3d 1293 (11th Cir. 

2004), cert. denied, -US-, 125 S.Ct. 866 

(Jan 10, 2005). It reversed and vacated 

the district court decision and 

remanded the case with instructions to 

dismiss for lack of subject-matter 

jurisdiction. Plaintiffs unsuccessfully 

sought rehearing en banc and Supreme 

Court review. The district court 

dismissed the complaint in accordance 

with the Eleventh Circuit’s mandate on 

February 2, 2005. 

II. Provisions of the Notice With 

Comment Period 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘PROVISIONS’’ at the 

beginning of your comments.] 

The purpose of this notice is to 

withdraw the FS covering the period of 

January 1, 2000 through March 31, 2002 

that was published in the April 16, 2003 

notice. As we stated explicitly in the 

April 16, 2003 notice, we only issued 

this ambulance fee schedule to comply 

with the Lifestar district court order and 

that order was vacated and the Lifestar 

case dismissed. Although the April 16, 

2003 notice clearly states that payment 

under the FS for the January 1, 2000 

through March 31, 2002 period is 

dependent on the district court opinion 

not being reversed by the Eleventh 

Circuit Court of Appeals, refraining 

from formally withdrawing the FS for 

this period could create unnecessary 

confusion. 

In light of our inability to issue a fee 

schedule by January 1, 2000, we 

continue to believe that giving the fee 

schedule prospective application clearly 

meets the intent of the Congress. The 

Congress made no indication that it 

wanted us to apply the base rate or the 

mileage provisions of the FS 

retroactively in the event that we were 

unable to issue the final FS by January 

1, 2000. Also, given ample opportunity, 

the Congress did not provide specific 

direction regarding this issue after the 

January 1, 2000 date passed. The 

Congress itself took no further action on 

the issue (such as directing the 

implementation of its own version of an 

ambulance fee schedule). 

Furthermore, the BBA directed the 

Secretary to phase in the application of 

the payment rates under the fee 

schedule in an efficient and fair manner 

and required that payments under the 

schedule in the year 2000 not exceed 

the inflation-adjusted expenditures that 

were made under the prior statute as 

stated in section 1834(l) of the Act. The 

FS was to reallocate expenditures 

among ambulance providers and 

suppliers in a manner that did not result 

in an increase in aggregate payments for 

ambulance services (for example, some 

providers and suppliers would have 

received higher payments, others would 

have received lower payments, and the 

changes would have offset each other.) 

Only additional payments made under 

the BIPA mileage provision were not 

required to meet this criteria. Applying 

the FS to the January 1, 2000 through 

March 31, 2002 period would violate 

this principle unless the FS applied to 

all ambulance providers and suppliers, 

not just those seeking additional 

payment under it. Accordingly, we may 

have to recoup monies paid to those 

providers and suppliers whose 

payments were greater under the preexisting ‘‘reasonable charge’’ and 

‘‘reasonable cost’’ system when 

compared to what they would have 

received under the FS for the January 1, 

2000 through March 31, 2002 period. 

Applying the FS retroactively to the 

providers and suppliers would arguably 

not constitute a fair phase-in of the FS 

provisions. 

III. Waiver of Proposed Rulemaking 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register and invite public comment on 

the proposed rule. The notice of 

proposed rulemaking includes a 

reference to the legal authority under 

which the rule is proposed, and the 

terms and substance of the proposed 

rule or a description of the subjects and 

issues involved. This procedure can be 

waived, however, if an agency finds 

good cause that a notice-and-comment 

procedure is impracticable, 

unnecessary, or contrary to the public 

interest and incorporates a statement of 

the finding and its reasons in the rule 

issued. 

The FS being withdrawn by this 

notice was only put in place pursuant 

to the court’s order in Lifestar, and 

explicitly provided that it would not be 

effective in the event the Lifestar 

decision was overturned on appeal. The 

Lifestar decision has been vacated, and 

the case in district court dismissed. To 

our knowledge no payments have been 

made under the FS to date and, had they 

been, such payments would be subject 

to recoupment pursuant to the 

provisions of the April 16, 2003, notice. 

Accordingly, there is no reason to keep 

a FS in place that CMS is no longer 

required to promulgate, and under 

which it would make no payments in 

light of the appellate court decision. To 

leave the FS in place while awaiting 

comments would only generate 

confusion on the part of ambulance 

providers and suppliers. 

Therefore, we find good cause to 

waive the notice of proposed 

rulemaking with respect to the issuance 

of this notice. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

V. Regulatory Impact Statement or 

Analysis 

We have examined the impact of this 

notice as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and Executive Order 13132. 

Because the FS for the January 1, 2000 

through March 31, 2002 is not one 

under which we are required to make 

payments in light of the Eleventh 

Circuit reversal of the district court 

decision, withdrawing the FS will have 

no financial impact on providers and 

suppliers, or on government spending. 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million or more 

in any 1 year). Because the FS being 

withdrawn is not one under which we 

are required to make payments, in light 

of the Eleventh Circuit decision, 

withdrawing it will have no financial 

impact on program spending. Therefore, 

this notice is not a major notice as 

defined in Title 5, United States Code, 

section 804(2) and is not an 

economically significant notice under 

Executive Order 12866. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $6 million to $29 million in any 1 

year. Individuals and States are not 

considered to be small entities. We have 

determined that this notice will not 

52108 Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Notices 

have a significant economic impact on 

a substantial number of small entities. 

Therefore, we are not preparing an 

analysis for the RFA. 

In addition, section 1102(b) of the 

Social Security Act (the Act) requires us 

to prepare a regulatory impact analysis 

if a rule may have a significant impact 

on the operations of a substantial 

number of small rural hospitals. This 

analysis must conform to the provisions 

of section 604 of the RFA. For purposes 

of section 1102(b) of the Act, we define 

a small rural hospital as a hospital that 

is located outside of a Metropolitan 

Statistical Area and has fewer than 100 

beds. We have determined that this 

notice will not have a significant effect 

on the operations of a substantial 

number of small rural hospitals. 

Therefore, we are not preparing an 

analysis for section 1102(b) of the Act. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule that may result in expenditures in 

any 1 year by State, local, or tribal 

governments, in the aggregate, or by the 

private sector, of $110 million. This 

notice has no consequential effect on 

State, local, or tribal governments or on 

the private sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it publishes a rule that 

imposes substantial direct requirement 

costs on State and local governments, 

preempts State law, or otherwise has 

Federalism implications. This notice 

will not have a substantial effect on 

State or local governments. There are no 

other alternatives at this time. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget. 

Authority: Sections 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program) 

Dated: May 17, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: August 25, 2005. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 05–17278 Filed 8–26–05; 9:46 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Family and Youth Services Bureau; 

Positive Youth Development State and 

Local Collaboration Demonstration 

Projects 

AGENCY: Family and Youth Services 

Bureau, Administration for Children 

and Families (ACF), Department of 

Health and Human Services (HHS). 

ACTION: Award announcement. 

CFDA#: The Catalog of Federal 

Domestic Assistance (CFDA) number for 

this program is 93.623. The title is the 

Positive Youth Development State and 

Local Collaboration Demonstration 

Projects. 

Legislative Authority: Grants for 

Runaway and Homeless Youth programs 

are authorized by the Runaway and 

Homeless Youth Act (title III of the 

Juvenile Justice and Delinquency 

Prevention Act of 1974), as amended by 

the Missing, Exploited, and Runaway 

Children Protection Act of 1999, (Pub. 

L. 106–71). 

Amount of Award: $100,000 per 

grantee. 

Project Period: 9/30/04–9/29/05. 

SUMMARY: Notice is hereby given that a 

noncompetitive grant supplement is 

being made to the following state 

agencies: State of Nebraska Health & 

Human Services, University of 

Kentucky Research Foundation, State of 

Oregon, New York Office of Children & 

Family Services, State of Louisiana, 

Iowa Dept. of Human Rights Criminal & 

Juvenile Justice, Commonwealth of 

Massachusetts, Illinois Department of 

Human Services, Governor’s Office for 

Children Youth & Families. The purpose 

of this supplement is to support 

collaborations between state-level 

agencies and local community 

jurisdictions regarding positive 

development opportunities available to 

young people as approved in their 

original planning grant. 

FOR FURTHER INFORMATION CONTACT: 

Administration for Children and 

Families, Family and Youth Services 

Bureau, 330 C Street, SW., Washington, 

DC 20447, Courtney Workman—(202) 

205–8657, cworkman@acf.hhs.gov. 

Dated: August 22, 2005. 

Joan E. Ohl, 

Commissioner, Administration on Children, 

Youth and Families. 

[FR Doc. 05–17371 Filed 8–31–05; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0343] 

Agency Emergency Processing Under 

Office of Management and Budget 

Review; Guidance for Requesting an 

Extension to Use Existing Label Stock 

After the Trans Fat Labeling Effective 

Date of January 1, 2006 

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 emergency processing under 

the Paperwork Reduction Act of 1995 

(the PRA). FDA is preparing a guidance 

document to notify the public of 

procedures being implemented by the 

agency to assist firms that wish to 

request, on a case-by-case basis upon an 

appropriate showing, an extension to 

use existing label stock after the 

effective date of the trans fat labeling 

final rule. This notice solicits comments 

on the proposed collection of 

information associated with the 

guidance document entitled ‘‘Guidance 

for Requesting an Extension to Use 

Existing Label Stock After the Trans Fat 

Labeling Effective Date of January 1, 

2006.’’

DATES: Fax written comments on the 

collection of information by October 3, 

2005. FDA is requesting approval of this 

emergency processing by September 8, 

2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that comments be 

faxed to the Office of Information and 

Regulatory Affairs, OMB, Attn: Fumie 

Yokota, Desk Officer for FDA, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: FDA has 

requested emergency processing of this 

proposed collection of information 

under section 3507(j) of the PRA (44 

U.S.C. 3507(j)) and 5 CFR 1320.13. FDA 

issued a final rule (the trans fat final 

rule) on July 11, 2003 (68 FR 41434) to