Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Notices 28621 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per response 

(in hours) 

Caller who contacts the Quitline on behalf of 

someone else.

Intake Questionnaire ...................................... 230,000 1 1/60 

Caller who contacts the Quitline for personal 

use.

......................................................................... 500,000 1 10/60 

Quitline caller who received a Quitline service Follow-up Questionnaire ................................ 28,900 1 7/60 

Tobacco Control Manager .............................. Quitline Services Questionnaire ..................... 53 4 7/60 

Dated: May 13, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–12181 Filed 5–20–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–10–10DE] 

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 I. 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 

Creation of state and metropolitan 

area-based surveillance projects for 

Amyotrophic Lateral Sclerosis (ALS)— 

New—Agency for Toxic Substances and 

Disease Registry (ATSDR), Coordinating 

Center for Environmental Health and 

Injury Prevention (CCEHIP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

On October 10, 2008, President Bush 

signed S. 1382: ALS Registry Act which 

amended the Public Health Service Act 

to provide for the establishment of an 

Amyotrophic Lateral Sclerosis (ALS) 

Registry. The activities described are 

part of the effort to create the National 

ALS Registry. The purpose of the 

registry is to: (1) Better describe the 

incidence and prevalence of ALS in the 

United States; (2) examine appropriate 

factors, such as environmental and 

occupational, that might be associated 

with the disease; (3) better outline key 

demographic factors (such as age, race 

or ethnicity, gender, and family history) 

associated with the disease; and (4) 

better examine the connection between 

ALS and other motor neuron disorders 

that can be confused with ALS, 

misdiagnosed as ALS, and in some cases 

progress to ALS. The registry will 

collect personal health information that 

may provide a basis for further scientific 

studies of potential risks for developing 

ALS. 

This project purposes to collect 

information specific data related to ALS. 

The objective of this project is to 

develop state-based and metropolitan 

area-based surveillance projects for 

ALS. The primary goal of the state-based 

and metropolitan area-based 

surveillance project is to use these data 

to evaluate the completeness of the 

National ALS Registry. The secondary 

goal of the surveillance project is to 

obtain reliable and timely information 

on the incidence and prevalence of ALS 

and to better describe the demographic 

characteristics (e.g., age, race, sex, and 

geographic location) of those with ALS. 

Neurologists or their staff will 

complete an ALS Case Reporting Form 

on each of their ALS patients. This will 

be transmitted to the state or 

metropolitan health department. 

Approval is being requested for a 3-year 

period; it is estimated that there will be 

approximately 6,750 cases of ALS 

reported in the state and metropolitan 

areas during this 3-year period. An ALS 

Medical Record Verification Form will 

be collected on a subset of cases 

reported. 

Surveillance items to be collected 

include information to make sure that 

there are no duplicates such as full 

name, address, date of birth, and last 

five digits of the Social Security 

number. 

There are no costs to the neurologist 

respondents reporting the cases other 

than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form 

Number of 

responses 

per respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

Neurologists .......................................................... Case Reporting Form ........................................... 2,250 5/60 188 

Neurologists .......................................................... Case Verification Form ......................................... 540 20/60 180 

Total ...................................................................... ............................................................................... .................... .................... 368 


emcdonald on DSK2BSOYB1PROD with NOTICES
28622 Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Notices 

Dated: May 13, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–12182 Filed 5–20–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Conducting 

Public Health Research in Kenya 

(U01)(Panel A), Funding Opportunity 

Announcement (FOA) GH10–003, Initial 

Review 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

TIME AND DATE: 1 p.m.–5 p.m., June 29, 

2010 (Closed). 

PLACE: Teleconference. 

STATUS: The meeting will be closed to 

the public in accordance with 

provisions set forth in Section 552b(c) 

(4) and (6), Title 5 U.S.C., and the 

Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92– 

463. 

MATTERS TO BE DISCUSSED: The meeting 

will include the initial review, 

discussion, and evaluation of 

applications received in response to 

‘‘Conducting Public Health Research in 

Kenya (U01)(Panel A),’’ FOA GH10–003. 

CONTACT PERSON FOR MORE INFORMATION: 

Susan Stanton, D.D.S., Scientific Review 

Officer, CDC, 1600 Clifton Road, NE., 

Mailstop D74, Atlanta, GA 30333, 

Telephone: (404) 639–4640. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: May 6, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–12174 Filed 5–20–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0247] 

FDA Transparency Initiative: Draft 

Proposals for Public Comment 

Regarding Disclosure Policies of the 

U.S. Food and Drug Administration; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; request 

for comments. 

SUMMARY: As part of the second phase 

of the Transparency Initiative, the Food 

and Drug Administration (FDA) is 

announcing the availability of a report 

entitled ‘‘FDA Transparency Initiative: 

Draft Proposals for Public Comment 

Regarding Disclosure Policies of the 

U.S. Food and Drug Administration.’’ 

The report includes 21 draft proposals 

about expanding disclosure of 

information by the agency while 

maintaining confidentiality of trade 

secrets and individually identifiable 

patient information. FDA is seeking 

public comment on the draft proposals, 

as well as on which draft proposals 

should be given priority. Some of the 

draft proposals may require extensive 

resources to implement, and some may 

require changes to regulations or 

legislation. 

DATES: Submit either electronic or 

written comments by July 20, 2010. 

ADDRESSES: Submit electronic 

comments to http://www.regulations.gov 

or on the FDA Web site, www.fda.gov/ 

transparency. Submit written comments 

to the Division of Dockets 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 at the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Afia 

Asamoah, Office of the Commissioner, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg 1, rm. 2220, 

Silver Spring, MD 20993, 301–796– 

4625, FAX: 301–847–3531, e-mail: 

Afia.Asamoah@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Every day, the U.S. Food and Drug 

Administration (FDA) makes important 

health and safety decisions about foods, 

drugs, medical devices, cosmetics, and 

other widely used consumer products. 

Transparency in FDA’s activities and 

decisionmaking allows the public to 

better understand the agency’s 

decisions, increasing credibility and 

promoting accountability. Transparency 

helps the agency to more effectively 

protect and promote the public health. 

In January 2009, President Obama 

issued a memorandum on Transparency 

and Open Government calling for an 

‘‘unprecedented level of openness in 

Government’’ and directing the Director 

of the Office of Management and Budget 

(OMB) to issue an Open Government 

Directive instructing executive 

departments and agencies to take 

specific actions to implement the 

principles of transparent, collaborative, 

and participatory government. The 

Open Government Directive was issued 

in December. Under the leadership of 

Secretary Kathleen Sebelius, the U.S. 

Department of Health and Human 

Services has also prioritized 

transparency and openness. In June 

2009, FDA Commissioner Dr. Margaret 

Hamburg launched FDA’s Transparency 

Initiative to implement these efforts at 

FDA. 

The initiative is overseen by a Task 

Force representing key leaders of FDA. 

The internal task force is chaired by the 

Principal Deputy Commissioner of the 

FDA and includes five of the agency’s 

center directors, the Chief Counsel, the 

Associate Commissioner of Regulatory 

Affairs, and the Chief Scientist. The 

Task Force is charged with submitting a 

written report to the Commissioner on 

the Task Force’s findings and 

recommendations. 

Over the last 11 months, the Task 

Force has held two public meetings, 

launched an online blog (http:// 

fdatransparencyblog.fda.gov/), and 

opened a docket. The online blog and 

the docket have received over 1,500 

comments. 

The Task Force is proceeding with the 

Transparency Initiative in three phases: 

• Phase I: FDA Basics 

• Phase II: Public Disclosure 

• Phase III: Transparency to 

Regulated Industry 

Phase I is intended to provide the 

public with basic information about 

FDA and how the agency does its work. 

This phase was unveiled in early 

January 2010 with the launch of a webbased resource called FDA Basics 

(www.fda.gov/fdabasics). The resource 

now includes (1) 126 questions and 

answers about FDA and the products 

that the agency regulates, (2) 9 short 

videos that explain various FDA 

activities, and (3) 10 conversations with 

FDA officials about the work of their 

Offices. Each month, senior officials 

from FDA product centers and offices 

host online sessions about a specific 

topic and answer questions from the 


emcdonald on DSK2BSOYB1PROD with NOTICES