Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 45013 

Services (CMS), and Bureau of the 

Census. Data collected through the 

NHDS are essential for evaluating health 

status of the population, for the 

planning of programs and policy to 

elevate the health status of the Nation, 

for studying morbidity trends, and for 

research activities in the health field. 

NHDS data have been used extensively 

in the development and monitoring of 

goals for the Year 2000 and 2010 

Healthy People Objectives. In addition, 

NHDS data provide annual updates for 

numerous tables in the Congressionallymandated NCHS report, Health, United 

States. Other users of these data include 

universities, research organizations, 

foundations, and a variety of users in 

the print media. There is no cost to 

respondents other than their time to 

participate. The total estimated 

annualized burden hours are 5,591. 

TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS

Type of data collection Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Current NHDS Primary Procedure Hospitals Sample Listing Sheet ........................................... 13 12 25/60 

Current NHDS Primary Procedure Hospitals Medical Abstract Form ......................................... 13 250 5/60 

Current NHDS Primary Procedure Hospitals Transmittal Notice ................................................ 13 12 1/60 

Current NHDS Alternate Procedure Hospitals locating medical records .................................... 41 250 1/60 

Current NHDS In-House Tape or Printout Hospital—computer programming and submission 29 12 13/60 

Current NHDS Hospital Interview Questionnaire ........................................................................ 10 1 2 

Redesigned pretest Survey presentation to hospital .................................................................. 10 1 1 

Redesigned pretest Facility questionnaire .................................................................................. 10 1 4 

Redesigned pretest Sample discharges within hospital, obtain UB–04 & payment data ........... 10 10 14/60 

Redesigned pretest Verify sampling & reabstract medical records ............................................ 2 10 14/60 

Redesign pretest Debrief hospital staff ....................................................................................... 10 1 1 

Redesigned 2010–2011 Survey presentation to hospital ........................................................... 80 1 1 

Redesigned 2010–2011 Facility questionnaire ........................................................................... 80 1 4 

Redesigned 2010–2011 Sample discharges within hospital, obtain UB–04 & payment data .... 160 120 14/60 

Redesigned 2010–2011 Verify sampling & re-abstract medical records .................................... 3 25 14/60 

Dated: July 24, 2008. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E8–17605 Filed 7–31–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10265] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Mandatory 

Insurer Reporting Requirements of 

Section 111 of the Medicare, Medicaid 

and SCHIP Act of 2007 (MMSEA) (Pub. 

L. 110–173); Use: Section 111 of the 

Medicare, Medicaid and SCHIP 

Extension Act of 2007 (Pub. L. 110–173) 

amends the Medicare Secondary Payer 

(MSP) provisions of the Social Security 

Act (42 U.S.C. 1395y(b)) to provide for 

mandatory reporting by group health 

plan arrangements and by liability 

insurance (including self-insurance), nofault insurance, and workers’

compensation laws and plans. The law 

provides that, not withstanding any 

other provision of law, the Secretary of 

Health and Human Services may 

implement this provision by program 

instruction or otherwise. The Secretary 

has elected not to implement the 

provision through rulemaking and will 

implement by publishing instructions 

on a publicly available Web site and 

submitting an information collection 

request to OMB for review and approval 

of the associated information collection 

requirements. 

Effective January 1, 2009, as required 

by the MMSEA, an entity serving as an 

insurer or third party administrator for 

a group health plan and, in the case of 

a group health plan that is self-insured 

and self-administered, a plan 

administrator or fiduciary must: (1) 

Secure from the plan sponsor and plan 

participants such information as the 

Secretary may specify to identify 

situations where the group health plan 

is a primary plan to Medicare; and (2) 

report such information to the Secretary 

in the form and manner (including 

frequency) specified by the Secretary. 

Effective July 1, 2009, as required by 

the MMSEA, ‘‘applicable plans,’’ must: 

(1) Determine whether a claimant is 

entitled to Medicare benefits; and, if so, 

(2) report the identity of such claimant 

and provide such other information as 

the Secretary may require to properly 

coordinate Medicare benefits with 

respect to such insurance arrangements 

in the form and manner (including 

frequency) as the Secretary may specify 

after the claim is resolved through a 

settlement, judgment, award or other 

payment (regardless of whether or not 

there is a determination or admission of 

liability). Applicable plan refers to the 

following laws, plans or other 

arrangements, including the fiduciary or 

administrator for such law, plan or 

arrangement: (1) Liability insurance 

(including self-insurance); (2) No-fault 

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45014 Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 

insurance; and (3) Workers’

compensation laws or plans. 

As indicated, the Secretary has 

elected to implement this provision by 

publishing instructions at a Web site 

established for such purpose. The Web 

site is http://www.cms.hhs.gov/ 

MandatoryInsRep/. CMS shall use this 

Web site to publish preliminary 

guidance as well as the final 

instructions. The Web site also advises 

interested parties how to comment on 

the preliminary guidance. Form 

Number: CMS–10265 (OMB# 0938–

New); Frequency: Yearly; Affected 

Public: Business or other for-profits, 

Not-for-profit institutions and State, 

Local or Tribal Governments; Number of 

Respondents: 290,404; Total Annual 

Responses: 6,920,504; Total Annual 

Hours: 2,120,478. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786–

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by September 30, 2008: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number___, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: July 2, 2008. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E8–17731 Filed 7–31–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0420] 

Medical Device User Fee Rates for 

Fiscal Year 2009 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing the 

fee rates and payment procedures for 

medical device user fees for fiscal year 

(FY) 2009. The Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA), 

the Medical Device User Fee 

Stabilization Act of 2005 (MDUFSA), 

and the Medical Device User Fee 

Amendments of 2007 (Title II of the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA)), 

authorizes FDA to collect user fees for 

certain medical device submissions, and 

annual fees both for certain periodic 

reports and for certain establishments 

subject to registration. The FY 2009 fee 

rates are provided in this notice. These 

fees apply from October 1, 2008, 

through September 30, 2009. To avoid 

delay in the review of your application, 

you should pay the fee before or at the 

time you submit your application to 

FDA. The fee you must pay is the fee 

that is in effect on the later of the date 

that your application is received by FDA 

or the date your fee payment is received. 

If you want to pay a reduced small 

business fee, you must qualify as a small 

business before you make your 

submission to FDA; if you do not 

qualify as a small business before you 

make your submission to FDA, you will 

have to pay the higher standard fee. 

This notice provides information on 

how the fees for FY 2009 were 

determined, the payment procedures 

you should follow, and how you may 

qualify for reduced small business fees. 

FOR FURTHER INFORMATION CONTACT: For 

information on MDUFMA: Visit FDA’s 

Web site, http://www.fda.gov/cdrh/ 

mdufma. 

For questions relating to this notice: 

David Miller, Office of Financial 

Management (HFA–100), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3917. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 738 of the act (21 U.S.C. 379j) 

establishes fees for certain medical 

device applications, submissions, 

supplements, and notices (for 

simplicity, this notice refers to these 

collectively as ‘‘submissions’’); for 

periodic reporting on class III devices; 

and for the registration of certain 

establishments. Under statutorilydefined conditions, a qualified 

applicant may receive a fee waiver or 

may pay a lower small business fee (see 

21 U.S.C. 379j(d) and (e)). 

Under the act, the fee rate for each 

type of submission is set at a specified 

percentage of the standard fee for a 

premarket application (a premarket 

application is a premarket approval 

application (PMA), a product 

development protocol (PDP), or a 

biologics licensing application (BLA)). 

The act specifies the standard fee for a 

premarket application for each year 

from FY 2008 through FY 2012; the 

standard fee for a premarket application 

received by FDA during FY 2009 is 

$200,725. From this starting point, this 

notice establishes FY 2009 fee rates for 

other types of submissions, and for 

periodic reporting, by applying criteria 

specified in the act. 

The act specifies the annual fee for 

establishment registration for each year 

from FY 2008 through FY 2012; the 

registration fee for FY 2009 is $1,851. 

There is no reduction in the registration 

fee for small businesses. An 

establishment must pay the registration 

fee if it is any of the following types of 

establishments: 

• Manufacturer. An establishment 

that makes by any means any article that 

is a device, including an establishment 

that sterilizes or otherwise makes such 

article for or on behalf of a specification 

developer or any other person. 

• Single-Use Device Reprocessor. An 

establishment that performs 

manufacturing operations on a singleuse device that has previously been 

used on a patient. 

• Specification Developer. An 

establishment that develops 

specifications for a device that is 

distributed under the establishment’s 

name but which performs no 

manufacturing, including an 

establishment that, in addition to 

developing specifications, also arranges 

for the manufacturing of devices labeled 

with another establishment’s name by a 

contract manufacturer. 

The fees for FY 2009 go into effect on 

October 1, 2008, and will remain in 

effect through September 30, 2009. 

II. Fees for FY 2009 

Under the act, all submission fees and 

the periodic reporting fee are set as a 

percent of the standard (full) fee for a 

premarket application (see 21 U.S.C. 

379j(a)(2)(A)), and the act sets the 

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