Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Notices 71165 

finding and its reasons in the notice 

issued. 

We find it unnecessary to undertake 

notice and comment rulemaking 

because the statute and regulation 

specify the methods of computation of 

annual updates, and we have no 

discretion in this matter. Further, this 

notice does not change substantive 

policy, but merely applies the update 

methods specified in statute and 

regulation. Therefore, for good cause, 

we waive notice and comment 

procedures. 

Under the Congressional Review Act, 

major rules generally cannot take effect 

until 60 days after the rule is published 

in the Federal Register. However, 

section 808(2) of the Congressional 

Review Act states that agencies may 

waive this 60-day requirement for ‘‘good 

cause’’ and establish an earlier effective 

date. As explained above, we believe 

that there is ‘‘good cause’’ for waiver of 

the APA requirement for notice and 

comment rulemaking because it would 

be unnecessary for us to fulfill that 

requirement. For the same reason, we 

believe that the ‘‘good cause’’ exception 

applies to the 60-day effective date 

requirement for major rules in the 

Congressional Review Act. 

V. Regulatory Impact Statement 

We have examined the impacts of this 

notice as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 16, 

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. 

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). As stated above, the AIF 

(equal to the percentage increase in the 

CPI–U of June 30, 2005 as compared to 

June 30, 2004) for 2006 is 2.5 percent. 

We estimate that the application of the 

AIF will result in this notice being 

considered a major rule because it will 

result in an additional total program 

expenditure of approximately $112 

million in CY 2006. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. 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. For purposes of the RFA, all 

ambulance providers or suppliers are 

considered to be small entities. 

Individuals and States are not included 

in the definition of a small entity. 

The Department of Health and Human 

Services (HHS) considers that a 

substantial number of entities are 

affected if the rule impacts more than 5 

percent of the total number of small 

entities as it does in this notice. This 

notice will impact every ambulance 

provider and supplier in the same way 

because all ambulance payment rates for 

all ambulance services furnished by all 

types of ambulance providers and 

suppliers are increased by the same 

ambulance inflation factor. While all 

ambulance payment rates are increased 

by the 2.5 percent AIF, the impact of 

this increase does not meet the 

threshold established by HHS to be 

considered a significant impact. 

In addition, section 1102(b) of 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. 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 no data to indicate that 

a substantial number of small rural 

hospitals will be impacted by this 

notice. 

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 expenditure in 

any 1 year by State, local, or tribal 

governments, in the aggregate, or by the 

private sector, of $110 million. This 

notice does not result in expenditures in 

any 1 year by State, local, or tribal 

governments of $110 million. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it publishes a notice 

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. 

We estimate that the total program 

expenditure for CY 2006 for ambulance 

services covered by the Medicare 

program is approximately $4.5 billion. 

Application of an AIF of 2.5 percent 

will result in an additional total 

program expenditure of approximately 

$112 million over CY 2005. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

Authority: Section 1834(l) of the Social 

Security Act (42 U.S.C. 1395m(l)). 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program) 

Dated: August 9, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: October 7, 2005. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 05–23163 Filed 11–23–05; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0443] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Focus Groups as 

Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

focus groups as used by FDA to gauge 

public opinion. Policymakers can use 

focus group results to test and refine 

their ideas so they can conduct further 

research, as well as, adopt new policies 

and to allocate or redirect significant 

resources to support these policies. 

DATES: Submit written or electronic 

comments on the collection of 

information by January 24, 2006. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

71166 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Notices 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn P. Capezzuto, Office of 

Management Programs (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Focus Groups as Used by the Food and 

Drug Administration—(OMB Control 

Number 0910–0497) 

FDA will collect and use information 

gathered through the focus group 

vehicle. This information will be used 

to develop programmatic proposals, and 

as such, compliments other important 

research findings to develop these 

proposals. Focus groups do provide an 

important role in gathering information 

because they allow for a more in-depth 

understanding of consumers’ attitudes, 

beliefs, motivations, and feelings than 

do quantitative studies. 

Also, information from these focus 

groups will be used to develop policy 

and redirect resources, when necessary, 

to our constituents. If this information is 

not collected, a vital link in information 

gathering by FDA to develop policy and 

programmatic proposals will be missed 

causing further delays in policy and 

program development. 

FDA estimates the burden for 

completing the forms for this collection 

of information as follows: 

The total annual estimated burden 

imposed by this collection of 

information is 4,252 hours annually. 

TABLE 1.1

Center Subject 

No. of Focus 

Groups per 

Study 

No. of Focus 

Groups 

Sessions Conducted Annually 

No. of 

Participants per 

Group 

Hours of Duration for Each 

Group (Includes 

Screening) 

Total Hours 

Center for Biologics Evaluation and Research May Use Focus Groups 

When Appropriate 

1 5 9 1 .58 71 

Center for Drug Evaluation 

and Research Varies (e.g., Direct-toConsumer Rx Drug 

Promotion, Physician 

Labeling of Rx Drugs, 

Medication Guides, 

Over-the-Counter Drug 

Labeling, Risk 

Communication 

10 200 9 1 .58 2,844 

Center for Devices and Radiological Health Varies (e.g., FDA Seal 

of Approval, Patient 

Labeling, Tampons, Online Sales of Medical 

Products, Latex Gloves 

4 16 9 2 .08 300 

Center for Food Safety and 

Applied Nutrition Varies (e.g., Food 

Safety, Nutrition, Dietary 

Supplements, Consumer 

Education) 

8 40 9 1 .58 569 

Center for Veterinary Medicine Varies (e.g., Animal 

Nutrition, Supplements, 

Labeling of Animal Rx) 

5 25 9 2 .08 468 

Total 28 286 1 .78 4,252 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Notices 71167 

Annually, FDA projects about 28 

focus group studies using 186 focus 

groups lasting an average of 1.78 hours 

each. FDA has allowed burden for 

unplanned focus groups to be 

completed so as not to restrict the 

agency’s ability to gather information on 

public sentiment for its proposals in its 

regulatory as well as other programs. 

Dated: November 14, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–23248 Filed 11–23–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

Extension Agency Information 

Collection Activity Under OMB Review: 

Department of Homeland Security—

Vulnerability Identification SelfAssessment Tool—Transportation 

(DHS–VISAT–T) 

AGENCY: Transportation Security 

Administration (TSA), DHS. 

ACTION: Notice. 

SUMMARY: This notice announces that 

TSA has forwarded the Information 

Collection Request (ICR) abstracted 

below to the Office of Management and 

Budget (OMB) for review and approval 

of an extension of the currently 

approved collection under the 

Paperwork Reduction Act. The ICR 

describes the nature of the information 

collection and its expected burden. TSA 

published a Federal Register notice, 

with a 60-day comment period soliciting 

comments, of the following collection of 

information on September 23, 2005, 70 

FR 55915. 

DATES: Send your comments by 

December 27, 2005. A comment to OMB 

is most effective if OMB receives it 

within 30 days of publication. 

ADDRESSES: Comments may be faxed to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Attention: DHS–TSA Desk 

Officer, at (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Katrina Wawer, Information Collection 

Specialist, Office of Transportation 

Security Policy, TSA–9, Transportation 

Security Administration, 601 South 

12th Street, Arlington, VA 22202–4220. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

(et seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information, 

unless it displays a valid OMB control 

number. Therefore, in preparation for 

OMB review and approval of the 

following information collection, TSA is 

soliciting comments to—

(1) Evaluate whether the proposed 

information requirement is necessary for 

the proper performance of the functions 

of the agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including using 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Information Collection Requirement 

Title: Department of Homeland 

Security—Vulnerability Identification 

Self-Assessment Tool—Transportation 

(DHS–VISAT–T). 

Type of Request: Extension of a 

currently approved collection. 

OMB Control Number: 1652–0037. 

Forms(s): Not applicable. 

Affected Public: Various modal 

transportation sector owners and 

operators. 

Abstract: This voluntary collection, 

by way of a web-based vulnerability 

assessment tool, allows TSA to gather 

security-related data and provides a 

cost-free service to the transportation 

sector. TSA designed this tool to be 

flexible to support the unique 

characteristics of each transportation 

mode, while still providing a common 

framework from which analysis and 

trends can be identified. Users may use 

the results of the assessment to develop 

a security plan or to identify areas of 

potential vulnerability. Information 

regarding how to access the tool is 

available on TSA’ Web site: http:// 

www.tsa.gov. Select ‘‘Industry Partners,’’

then ‘‘Risk Management,’’ then finally 

select the ‘‘DHS–VISAT’’ link. 

Number of Respondents: 300,245. 

Estimated Annual Burden Hours: An 

estimated 2,401,960 hours annually. 

Issued in Arlington, Virginia, on November 

18, 2005. 

Lisa S. Dean, 

Privacy Officer. 

[FR Doc. 05–23243 Filed 11–23–05; 8:45 am] 

BILLING CODE 4910–62–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–4971–N–60] 

Notice of Submission of Proposed 

Information Collection to OMB; Local 

Appeals to Single-Family Mortgage 

Limits 

AGENCY: Office of the Chief Information 

Officer, HUD. 

ACTION: Notice. 

SUMMARY: The proposed information 

collection requirement described below 

has been submitted to the Office of 

Management and Budget (OMB) for 

review, as required by the Paperwork 

Reduction Act. The Department is 

soliciting public comments on the 

subject proposal. 

Housing industry groups may appeal 

for increases in FHA’s maximum 

mortgage limits for specific counties or 

metropolitan statistical areas (MSA’s). 

DATES: Comments Due Date: December 

27, 2005. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

approval Number (2502–0302) and 

should be sent to: HUD Desk Officer, 

Office of Management and Budget, New 

Executive Office Building, Washington, 

DC 20503; fax: 202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Wayne Eddins, Reports Management 

Officer, AYO, Department of Housing 

and Urban Development, 451 Seventh 

Street, SW., Washington, DC 20410; email Wayne_Eddins@HUD.gov; or 

Lillian Deitzer at 

Lillian_L_Deitzer@HUD.gov or 

telephone (202) 708–2374. This is not a 

toll-free number. 

Copies of available documents 

submitted to OMB may be obtained 

from Mr. Eddins or Ms Deitzer. 

SUPPLEMENTARY INFORMATION: This 

notice informs the public that the 

Department of Housing and Urban 

Development has submitted to OMB a 

request for approval of the information 

collection described below. This notice 

is soliciting comments from members of 

the public and affecting agencies 

concerning the proposed collection of 

information to: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information; (3) Enhance the quality, 

utility, and clarity of the information to