16872 Federal Register / Vol. 74, No. 69 / Monday, April 13, 2009 / Notices 

member of the public who would like to 

participate in this session is encouraged 

to contact the Executive Secretary at 

his/her earliest convenience. It is 

requested that those who wish to have 

printed material distributed to the 

Committee provide thirty (30) copies of 

the document to be distributed to the 

Executive Secretary, ACBSA, prior to 

close of business April 27, 2009. If it is 

not possible to provide 30 copies of the 

material to be distributed, then 

individuals are requested to provide at 

a minimum one (1) copy of the 

document(s) to be distributed prior to 

the close of business April 27, 2009. It 

also is requested that any member of the 

public who wishes to provide comments 

to the Committee utilizing electronic 

data projection submit the necessary 

material to the Executive Secretary prior 

to close of business April 27, 2009. 

Dated: April 8, 2009. 

Jerry A. Holmberg, 

Executive Secretary, Advisory Committee on 

Blood Safety and Availability. 

[FR Doc. E9–8398 Filed 4–10–09; 8:45 am] 

BILLING CODE 4140–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Solicitation of Written Comments on 

Draft National Vaccine Advisory 

Committee Vaccine Safety Working 

Group Recommendations to the 

Immunization Safety Office 

AGENCY: Department of Health and 

Human Services, Office of the Secretary. 

ACTION: Notice. 

SUMMARY: The National Vaccine 

Program Office (NVPO) is soliciting 

public comment on the National 

Vaccine Advisory Committee (NVAC) 

Vaccine Safety Working Group draft 

Recommendations to the Centers for 

Disease Control and Prevention’s 

Immunization Safety Office (ISO). 

DATES: Comments on the NVAC Vaccine 

Safety Working Group draft report 

should be received no later than 5 p.m. 

on May 13, 2009. 

ADDRESSES: Electronic responses are 

preferred and may be addressed to 

vaccinesafetyRFI@hhs.gov. Written 

responses should be addressed to 

National Vaccine Program Office, U.S. 

Department of Health and Human 

Services, 200 Independence Avenue, 

SW., Room 715–H, Washington, DC 

20201, Attention: Vaccine Safety RFI. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Kirsten Vannice, National Vaccine 

Program Office, Department of Health 

and Human Services, Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Room 443–H, 

Washington, DC 20201; telephone (202) 

690–5566; fax 202–260–1165; e-mail 

vaccinesafetyRFI@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Ensuring the optimal safety of 

vaccines and immunizations is 

important to everyone. The National 

Vaccine Program Office (NVPO) is 

located within the Office of Public 

Health and Science, Office of the 

Secretary, Department of Health and 

Human Services (HHS), and has 

responsibility for coordinating and 

ensuring collaboration among the many 

Federal agencies involved in vaccine 

and immunization activities. NVPO also 

has responsibility for managing and 

providing support services for the 

National Vaccine Advisory Committee 

(NVAC). NVAC is a statutory Federal 

advisory committee that was established 

to provide advice and make 

recommendations to the Director of the 

National Vaccine Program on matters 

related to the Program’s responsibilities. 

The Assistant Secretary for Health 

serves as Director of the National 

Vaccine Program. 

The Centers for Disease Control and 

Prevention’s (CDC) Immunization Safety 

Office (ISO) has significant 

responsibility for monitoring and 

studying the safety of vaccines after they 

are licensed and used in the United 

States (http://www.cdc.gov/ 

vaccinesafety). ISO has drafted a fiveyear scientific agenda that identifies 

vaccine safety issues to consider for 

scientific study, in addition to any new 

questions that may arise. The draft ISO 

Scientific Agenda can be found at: 

http://www.cdc.gov/vaccinesafety/

00_pdf/draft_agenda_

recommendations_080404.pdf and the 

addendum at http://www.cdc.gov/

vaccinesafety/00_pdf/

draft_recommendations_add_080410

.pdf. 

Since not all questions and issues can 

be addressed at once, setting priorities 

is also important, and ISO has requested 

a review of the draft Scientific Agenda 

by the National Vaccine Advisory 

Committee (NVAC) for the purpose of 

identifying gaps and setting priorities. 

The NVAC Vaccine Safety Working 

Group has written a draft report of 

recommendations on the content and 

priorities of the draft ISO Scientific 

Agenda. The draft report may be found 

at http://www.hhs.gov/nvpo/nvac/ 

reports.html. 

Through this request for information 

(RFI) HHS is seeking comments from 

everyone, including stakeholders and 

the broad public, on the NVAC Vaccine 

Safety Working Group draft report. 

Comments received will be available for 

public viewing on the NVAC Vaccine 

Safety Working Group Web site (http:// 

www.hhs.gov/nvpo/nvac/ 

vaccinesafety.html). 

II. Information Request 

NVPO, on behalf of the NVAC 

Vaccine Safety Working Group, requests 

input on the draft Working Group report 

(http://www.hhs.gov/nvpo/nvac/ 

reports.html). In addition to general 

comments, NVPO is seeking input on 

any additional gaps not addressed in the 

ISO Scientific Agenda nor the NVAC 

Vaccine Safety Working Group draft 

report, and/or prioritization criteria and 

its application to the ISO Scientific 

Agenda. 

Please limit comments to 6 pages. 

III. Potential Responders 

HHS invites input from a broad range 

of individuals and organizations that 

have interests in vaccines and vaccine 

safety. Some examples of these 

organizations include but are not 

limited to the following: 

—General public; 

—Advocacy groups and public interest 

organizations; 

—State and local governments; 

—State and local public health 

departments; 

—Vaccine manufacturing industry, 

distributors and other businesses; 

—Health care professional societies and 

organizations. 

When responding, please self-identify 

with any of the above or other categories 

(include all that apply) and your name. 

All comments submitted will be made 

publicly available. Anonymous 

submissions will not have their 

comments posted and will not be 

considered. 

The submission of written materials 

in response to the RFI should not 

exceed six pages, not including 

appendices and supplemental 

documents. Responders may submit 

other forms of electronic materials to 

demonstrate or exhibit concepts of their 

written responses. Any information you 

submit will be made public. 

Consequently, do not send proprietary, 

commercial, financial, business 

confidential, trade secret, or personal 

information that you do not wish to be 

made public. 

Public Access: Responses to this RFI 

will be available to the public on the 

NVAC Web site at http://www.hhs.gov/ 

nvpo/nvac/vaccinesafety.html. You may 

access public comments received from 

this RFI by going to the above Web site. 

Federal Register / Vol. 74, No. 69 / Monday, April 13, 2009 / Notices 16873 

Dated: March 31, 2009. 

Bruce G. Gellin, 

Deputy Assistant Secretary for Health, 

Director, National Vaccine Program Office, 

U.S. Department of Health and Human 

Services. 

[FR Doc. E9–8399 Filed 4–10–09; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–09–08AU] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

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. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Assessing Problem Areas in Referrals 

for Chronic Hematologic Malignancies 

and Developing Interventions to 

Address Them—New—Division of 

Cancer Prevention and Control, National 

Center for Chronic Disease Prevention 

and Health Promotion (NCCDPHP), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

One of the six aims of the Institute of 

Medicine’s Crossing the Quality Chasm 

report is to improve the timeliness of 

care for patients. Data from Europe and 

Canada, as well as single-site studies in 

the United States, allude to a problem 

of timely referral and diagnosis for 

patients with cancer. Despite the advent 

of new diagnostics and therapeutics for 

patients with chronic hematological 

malignancies, the size and scope of a 

potential problem regarding their 

referral from primary care providers to 

specialists is not well-defined in the 

current literature. 

CDC proposes to conduct a one-time 

study to collect qualitative and 

quantitative information on optimal and 

sub-optimal referral patterns for patients 

with confirmed or suspected chronic 

hematologic malignancies. Information 

will be collected to identify specific 

factors related to delays in diagnosis 

and/or referral to appropriate medical 

specialists. Information will be collected 

through in-depth interviews with 

hematologic cancer patients, in-depth 

interviews and focus groups with 

primary care providers, interviews with 

specialists in hematology and oncology 

in Texas, and a one-time postal survey 

to a sample of primary care providers in 

Massachusetts. 

The ultimate goal is to develop tools 

that will improve the awareness, 

diagnosis, and referral of persons with 

chronic hematological cancers by 

primary care providers. 

There are no costs to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Avg. burden 

per response 

(in hrs) 

Total burden 

(in hours) 

Community Hematologists and 

Oncologists.

Hematologists and Oncologists 

Interview Phone Recruitment 

Script.

100 1 2/60 3 

Hematologists and Oncologists 

Interview Guide.

18 1 1.5 27 

Patients ............................................. Patient Interview Phone Recruitment 

Script.

50 1 2/60 2 

Patient Interview Guide .................... 18 1 1.5 27 

Primary Care Providers (PCP) ......... PCP Survey Cover Letter ................. 250 1 2/60 8 

PCP Survey ...................................... 150 1 20/60 50 

PCP Opt-Out Card ........................... 100 1 2/60 3 

PCP Survey Reminder Letter ........... 200 1 2/60 7 

PCP Interview Phone Recruitment 

Script.

100 1 3/60 5 

PCP Interview Guide ........................ 18 1 1.5 27 

PCP Focus Group Phone Recruitment Script.50 1 3/60 3 

PCP Focus Group Guide ................. 18 1 2 36 

Total ........................................... ........................................................... ........................ ........................ ........................ 198