Att 2 - 60 day FRN

28621

Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per response
(in hours)

230,000

1

1/60

.........................................................................

500,000

1

10/60

Follow-up Questionnaire ................................
Quitline Services Questionnaire .....................

28,900
53

1
4

7/60
7/60

Number of
respondents

Type of respondent

Form name

Caller who contacts the Quitline on behalf of
someone else.
Caller who contacts the Quitline for personal
use.
Quitline caller who received a Quitline service
Tobacco Control Manager ..............................

Intake Questionnaire ......................................

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

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

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
[email protected].
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)

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.

emcdonald on DSK2BSOYB1PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
per respondent

Average
burden per
response
(in hours)

Total
burden
hours

Type of respondents

Form

Neurologists ..........................................................
Neurologists ..........................................................

Case Reporting Form ...........................................
Case Verification Form .........................................

2,250
540

5/60
20/60

188
180

Total ......................................................................

...............................................................................

....................

....................

368

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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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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

[Docket No. FDA–2009–N–0247]

BILLING CODE P

FDA Transparency Initiative: Draft
Proposals for Public Comment
Regarding Disclosure Policies of the
U.S. Food and Drug Administration;
Availability

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

AGENCY:

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).

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.

emcdonald on DSK2BSOYB1PROD with NOTICES

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]
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Food and Drug Administration,

HHS.

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

PLACE:

Food and Drug Administration

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:
[email protected].
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

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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

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