Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 58399 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section/ 

FDAMA Section 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

814.82(a)(9) 18 1 18 135 2,430 

814.84(b) 648 1 648 10 6,480 

Section 201 (FDAMA) Agreement 

Meeting 3 1 3 50 150 

Section 202 (FDAMA) Expedited 

Review Request 5 1 5 10 50 

Section 205 (FDAMA) Effectiveness 

Meeting 5 1 5 50 250 

Section 208 (FDAMA) Classification 

Panel Meetings 20 1 20 30 600 

Section 209 (FDAMA) 100-day 

meeting 28 1 28 10 280 

Totals 2,050 13 2,050 1,214 89,004 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Recordkeeper Total Hours 

814.82(a)(5) and (a)(6) 698 1 698 17 11,866 

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

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23912 Filed 9–23–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: ANA Consultant and Evaluator 

Qualifications Form. 

OMB No.: 0970–0265. 

Description: The ANA Consultant and 

Evaluator Qualifications Form is used to 

collect information from prospective 

proposal reviewers in compliance with 

42 U.S.C. 2991d–1. The form allows the 

Commissioner of ANA to select 

qualified people to review grant 

applications for Social and Economic 

Development Strategies (SEDS), Native 

Language Preservation and 

Maintenance, and Environmental 

Regulatory Enhancement. The panel 

review process is a legislative mandate 

in the ANA grant funding process. 

Respondents: Native Americans, 

Native Alaskans, Native Hawaiians and 

other Pacific Islanders. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ANA Consultant and Evaluator Qualifications Form ....................................... 300 1 1 300 

Estimated Total Annual Burden 

Hours: 300. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments 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 


srobinson on DSKHWCL6B1PROD with NOTICES
58400 Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 

proposed collection of information; 

(c) 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. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: September 21, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–23923 Filed 9–23–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Donor Management Research: 

Improvements in Clinical Management 

of Deceased Organ Donors 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Request for information. 

SUMMARY: The Health Resources and 

Services Administration (HRSA), 

Division of Transplantation, is soliciting 

input, feedback, and suggestions from 

researchers and interested parties 

within the organ donation and 

transplant community regarding 

guidance for a possible grant or contract 

that focuses on improvements in 

clinical management of deceased organ 

donors. 

Given the continued imbalance 

between the demand for and supply of 

deceased donor organs, it is essential 

that deceased donors be managed 

appropriately to optimize the number 

and function of donor organs. It is 

reasonable to expect that better clinical 

donor management would improve 

organ quality, organs transplanted per 

donor (OTPD), and post-transplant 

recipient outcomes. 

DATES: Written or electronic comments 

must be received by HRSA by October 

15, 2010. 

ADDRESSES: Please send all written 

comments to James Bowman, MD 

Medical Director, Division of 

Transplantation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration, 5600 Fishers Lane, 

Suite 12C–06, Rockville, Maryland 

20857; Telephone (301) 443–4861 Fax 

(301) 594–6095; or e-mail: 

jbowman@hrsa.gov. 

Docket: For access to the docket to 

view comments received, phone 301– 

443–7577 to schedule an appointment 

to view public comments. 

FOR FURTHER INFORMATION CONTACT: 

James Bowman, MD, Medical Director at 

Division of Transplantation, Healthcare 

Systems Bureau, Health Resources and 

Services Administration, at the contact 

information cited above. 

SUPPLEMENTARY INFORMATION: 

Background 

Since 2002, HRSA has funded the 

Clinical Interventions to Increase Organ 

Procurement (CIOP) Grant Program, 

authorized by Public Health Service 

Act, as amended, Section 377A(b), (42 

U.S.C. 274f–1). The CIOP Grant Program 

has provided support for the 

implementation and evaluation of 

highly promising strategies and 

approaches serving as model 

interventions for identifying appropriate 

organ donor candidates, evaluating 

donated organs, maintaining donor 

clinical stability and optimizing 

methods for organ procurement. Other 

than the fiscal year 2007 CIOP grant 

cycle, which focused on uncontrolled 

donation after circulatory death donors, 

the CIOP Program has not focused on 

specific research issues. Since the 

inception of the grant program, 19 

grants have been awarded. While these 

grants have furthered knowledge 

regarding clinical management of 

donors, the studies have generally 

focused on specific organ systems and 

not on donor management approaches 

with the goal of optimizing all organ 

systems. 

The CIOP Grant Program was not 

funded in Fiscal Year 2010 to allow 

HRSA to consider how to best utilize 

the limited Federal research funds 

available in a more useful and beneficial 

manner. There has been considerable 

discussion among critical care and 

transplant specialists regarding donor 

management. A Donor Management 

Task Force was convened in August 

2010 to address relevant issues in donor 

management practices. This task force 

discussed: (1) Advancing the scientific 

knowledge that influences organ donor 

management practices; (2) promoting 

the adoption of critical care and quality 

improvement practices in each Donation 

Service area (DSA) that optimize organ 

viability and increase OTPD; (3) 

ensuring that all patients meeting the 

neurologic criteria for determination of 

death are pronounced in a timely 

manner so that organ donation 

intentions may be fully honored; and (4) 

ensuring that each donation case occurs 

using the most appropriate donation 

pathway: Either donation after 

neurologic determination of death or 

donation after cardiac determination of 

death. Although quality donor 

management may be assumed to 

improve transplantation outcomes, there 

are limited scientifically rigorous 

studies validating this assumption. The 

studies that do exist involve a limited 

number of DSAs. These studies do 

suggest an improvement in OTPD based 

on certain donor management practices, 

but further investigation is needed. 

Upon review of research possibilities 

being discussed in meetings and in the 

literature, HRSA believes that research 

should be directed to help establish 

evidence-based donor management 

protocols. 

Therefore HRSA is considering 

funding through a grant or contract 

mechanism to one or two parties, a total 

of up to $1 million/year for three (3) 

years to conduct a multicenter, 

nationwide study focused on donor 

management and improvement in 

outcomes, particularly OTPD, organ 

quality, and post-transplant recipient 

outcomes. 

Request for Comments 

For this Request for Information, 

respondents are asked to present their 

experiences and opinions regarding the 

importance of further study into donor 

management and its outcomes. 

Suggestions and comments concerning 

specific areas of analysis are 

encouraged. Such studies might 

consider developing or refining a 

validated tool useful for predicting 

donor outcomes based upon appropriate 

and readily available donor data (e.g., 

collected for purposes of OPTN data 

submission, or routinely collected by 

Organ Procurement Organizations). 

Donor management study designs that 

include OPTN data collected on most, if 

not all, deceased donor organs will be 

encouraged. 

HRSA is seeking guidance from the 

community to help structure either a 

donor management study to be 

accomplished by contract or targeted 

research questions that will be 

incorporated into the CIOP FY 2011 

request for application. 

Dated: September 16, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–23893 Filed 9–23–10; 8:45 am] 

BILLING CODE 4165–15–P 


srobinson on DSKHWCL6B1PROD with NOTICES