Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 56925 

Attachment 1 List of SUDs Known To Be Reprocessed or Considered for Reprocessing—Continued 

Medical 

Specialty Device Type Regulation Number Class Product Code RiskA

Critical/ 

Semicritical/Noncritical 

Premarket 

Exempt 

226 Surgery Surgical Cutting Accessories 878.4800, 

874.4420 

I GDZ, GDX, 

GES, 

KBQ, 

KAS 

2 C Y 

227 Surgery Electrosurgical Electrodes/ 

Handles/Pencils 

876.4300 

878.4400 

II HAM, GEI, 

FAS 

2 C N 

228 Surgery Scissor Tips 878.4800, 

884.4520, 

874.4420 

I LRW, HDK, 

HDJ, 

JZB, 

KBD 

2 C Y 

229 Surgery Laser Fiber Delivery Systems 878.4810 

874.4500 

886.4390 

884.4550 

886.4690 

II GEX EWG 

LLW 

HQF 

HHR 

HQB 

1 C N 

ARisk categorization may be either: 

1 = low risk according to RPS 

2 = moderate risk according to RPS 

3 = high risk according to RPS 

3* = high risk due to neurological use 

See section II of this document, ‘‘FDA’s Implementation of New Section 510(o) of the Act’’ for methodology and criteria used to identify the 

risk. 

Dated: September 22, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19510 Filed 9–28–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to OMB under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, call the HRSA Reports 

Clearance Officer at (301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Maternal and Child 

Health Services Title V Block Grant 

Program—Guidance and Forms for the 

Title V Application/Annual Report, 

OMB No.0915–0172: Revision 

The Health Resources and Services 

Administration (HRSA) proposes to 

revise the Maternal and Child Health 

Services Title V Block Grant Program—

Guidance and Forms for the 

Application/Annual Report. The 

guidance is used annually by the 50 

States and 9 jurisdictions in making 

application for Block Grants under Title 

V of the Social Security Act, and in 

preparing the required annual report. 

The proposed revisions follow and 

build on extensive consultation received 

from a workgroup convened to provide 

suggestions to improve the guidance 

and forms. The proposed revisions are 

editorial and technical revisions based 

on the experience of the states and 

jurisdictions in using the guidance and 

forms since 2003. 

Two new performance measures were 

developed (obesity in children aged 2 to 

5 years; and smoking in the last 

trimester of pregnancy) and two existing 

performance measures were either 

removed entirely (low birth weight) or 

incorporated into an existing health 

status capacity indicator (eligible 

children receiving services under 

Medicaid). This will result in no net 

increase in the number of performance 

measures. In addition, the directions in 

the guidance for the Health Systems 

Capacity Indicators (HSCI) were 

expanded to enhance clarification. This 

proposed change will make it easier for 

the states to report on these indicators. 

The existing electronic system used 

by the states to submit their Block Grant 

Application and Annual Report has also 

been enhanced. First, using the 

electronic system, the narrative from the 

prior year’s submission is available 

online in the system so that the 

applicant need only edit those sections 

that have changed. This reduces burden 

by avoiding duplicating material. For 

national performance measures 2–6, the 

data obtained from the National Survey 

of Children with Special Health Care 

Needs are pre-populated which 

eliminates the need to retrieve and enter 

data from this survey, unless the states 

choose to use another data source. Also, 

notes from the prior year’s submission 

are available to the states allowing for 

more efficient updating through edits 

rather then recreating them. Data are 

entered once (in a data entry field on a 

given form), and where those data are 

referenced elsewhere, the value is 

56926 Federal Register / Vol. 70, No. 188 / Thursday, September 29, 2005 / Notices 

copied and displayed. The electronic 

system includes an automatic character 

counter that tells the user how many 

characters the states have left. This 

eliminates the need to independently 

track entries against the Maternal and 

Child Health Bureau’s limits for each 

section and ensures compliance. The 

electronic system includes forms status 

checker and data alerts, which conduct 

automated checks on data validity, data 

consistency, and application 

completeness, as well as value tolerance 

checks. This facilitates application 

review and eliminates much of 

previously required data cleaning 

activity. Also, this allows the user to 

obtain an immediate update at any point 

in time on the completeness and 

compliance of the application, reducing 

the need to conduct a review of the 

application. Data are saved directly to 

the HRSA server so that no manual 

transmission is required. Finally, the 

automatic commitment of data to the 

HRSA server eliminates the need for 

version control or data migration. 

The estimated average annual burden 

per year is as follows for the Annual 

Report and Application without the 

Needs Assessment: 

Type of respondent Number of respondents 

Responses 

per 

respondent 

Burden hours 

per response 

Total burden 

hours 

States ............................................................................................................... 50 1 297 14,868 

Jurisdictions ..................................................................................................... 9 1 120 1,077

Total .......................................................................................................... ........................ ........................ 59 15,945 

Burden in the 3 Year Reporting Cycle 

for the Annual Report and Application 

with Needs Assessment is: 

Needs assessment Number of respondents 

Burden hours per 

responses 

Responses per 

respondent 

Total burden 

hours 

States/Jurisdictions .................................................................................. 59 378.5 1 22,303 

Total Average Burden for 3 year cycle ............................................ ........................ ............................ ............................ 18,064 

Send comments to Susan G. Queen, 

PhD., HRSA Reports Clearance Officer, 

Room 10–33, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857. 

Written comments should be received 

within 60 days of notice. 

Dated: September 23, 2005. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. 05–19432 Filed 9–28–05; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Ricky Ray Hemophilia Relief Fund 

Program Administrative Close-Out 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: This Notice announces the 

administrative close-out of the Ricky 

Ray Hemophilia Relief Fund Program 

(the Program). All business concerning 

petitions and related payment 

documentation associated with the 

Program will conclude on October 31, 

2005. 

As of that date, the Program will cease 

to accept or process any additional 

documentation submitted by 

individuals (or their representatives) 

relating to the eligibility or payment of 

petitions still pending. Remaining funds 

will be returned to the United States 

Treasury, and the Program will archive 

all outstanding documentation at the 

Washington National Records Center in 

Suitland, Maryland, in accordance with 

the requirements of the National 

Archives and Records Administration. 

DATES: Effective Date: October 31, 2005. 

ADDRESSES: Ricky Ray Hemophilia 

Relief Fund Program, Healthcare 

Systems Bureau, Health Resources and 

Services Administration, U.S. 

Department of Health and Human 

Services, 5600 Fishers Lane, Room 11C–

06, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: Paul 

T. Clark, Director, Ricky Ray 

Hemophilia Relief Fund Program, 5600 

Fishers Lane, Room 11C–06, Rockville, 

MD 20857; (301) 443–2330. 

SUPPLEMENTARY INFORMATION: The 

Program implemented the Ricky Ray 

Hemophilia Relief Fund Act of 1998 

(the Act), Pub. Law 105–369. The Act 

established a Trust Fund to provide 

compassionate payments to individuals 

with blood-clotting disorders, such as 

hemophilia, who were treated with 

antihemophilic factor between July 1, 

1982 and December 31, 1987, and 

contracted human immunodeficiency 

virus (HIV), as well as to certain persons 

who contracted HIV from these 

individuals. In the event individuals 

eligible for payment were deceased, the 

Act also provided for payments to 

certain survivors of these individuals. 

Under section 101(d) of the Act, the 

Trust Fund terminated on November 12, 

2003. The Act requires all remaining 

funds to be deposited in the 

miscellaneous receipts account in the 

Treasury of the United States. 

The Program has made compassionate 

payments totaling in excess of $559 

million to more than 7,171 eligible 

individuals and survivors. 

Dated: September 22, 2005. 

Dennis P. Williams, 

Deputy Administrator. 

[FR Doc. 05–19430 Filed 9–28–05; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meetings: Organ Transplantation 

Advisory Committee 

AGENCY: Health Resources and Services 

Administration, HHS.