Proposed Data Collections Submitted for Public Comment and Recommendations, 28621-28622 [2010-12182]

Download as PDF 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 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) 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 VerDate Mar<15>2010 16:40 May 20, 2010 Jkt 220001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1 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] BILLING CODE 4163–18–P VerDate Mar<15>2010 16:40 May 20, 2010 Jkt 220001 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 https://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 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 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 (https:// 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 E:\FR\FM\21MYN1.SGM 21MYN1

Agencies

[Federal Register Volume 75, Number 98 (Friday, May 21, 2010)]
[Notices]
[Pages 28621-28622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12182]

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
Number of Average
responses burden per Total
Type of respondents Form per response burden
respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Neurologists.............................. Case Reporting Form.......... 2,250 5/60 188
Neurologists.............................. Case Verification Form....... 540 20/60 180
---------------------------------------------------------------------
Total..................................... ............................. ........... ........... 368
----------------------------------------------------------------------------------------------------------------

[[Page 28622]]

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

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