Agency Forms Undergoing Paperwork Reduction Act Review, 45256-45257 [2011-19109]

Download as PDF 45256 Federal Register / Vol. 76, No. 145 / Thursday, July 28, 2011 / Notices rmajette on DSK89S0YB1PROD with NOTICES could be categorized as strong skin sensitizers, but chemicals that do not meet the criterion would require additional testing or information to determine that they are not strong skin sensitizers. The ICCVAM evaluation found that only 52% of the strong human skin sensitizers in the validation database would be identified as strong skin sensitizers using the LLNA potency criterion in the 2009 United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Accordingly, chemicals that do not meet the criterion would require additional testing or information to determine that a substance is not a strong human skin sensitizer. Background Information on ICCVAM, NICEATM, and SACATM ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological and safety testing methods that more accurately assess the safety and hazards of chemicals and products and that reduce, refine (decrease or eliminate pain and distress), or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies applicable to the needs of U.S. Federal agencies. Additional information about NICEATM and ICCVAM can be found on the NICEATM–ICCVAM Web site (https:// iccvam.niehs.nih.gov). SACATM was established in response to the ICCVAM Authorization Act [Section 285l–3(d)] and is composed of scientists from the public and private sectors (67 FR 11358). SACATM advises ICCVAM, NICEATM, and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and VerDate Mar<15>2010 15:51 Jul 27, 2011 Jkt 223001 activities related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods. Additional information about SACATM, including the charter, roster, and records of past meetings, can be found at https://ntp.niehs.nih.gov/go/167. References ICCVAM. 2011. ICCVAM Test Method Evaluation Report: Usefulness and Limitations of the Murine Local Lymph Node Assay for Potency Categorization of Chemicals Causing Allergic Contact Dermatitis in Humans. NIH Publication No. 11–7709. Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available at: https:// iccvam.niehs.nih.gov/methods/ immunotox/llna-ELISA/LLNA-pot/ TMER.htm. ICCVAM. 2010. ICCVAM Test Method Evaluation Report on the Murine Local Lymph Node Assay: BrdU–ELISA, a Nonradioactive Alternative Test Method to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products. NIH Publication No. 10–7552. Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available at: https:// iccvam.niehs.nih.gov/methods/ immunotox/llna-ELISA/TMER.htm. ICCVAM. 2010. ICCVAM Test Method Evaluation Report on the Murine Local Lymph Node Assay: DA, a Nonradioactive Alternative Test Method to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products. NIH Publication No. 10–7551. Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available at: https:// iccvam.niehs.nih.gov/methods/ immunotox/llna-DA/TMER.htm. ICCVAM. 2010. ICCVAM Test Method Evaluation Report on Using the Murine Local Lymph Node Assay for Testing Pesticide Formulations, Metals, Substances in Aqueous Solutions, and Other Products. NIH Publication No. 10–7512. Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available at: https:// iccvam.niehs.nih.gov/methods/ immunotox/LLNA-app/TMER.htm. ICCVAM. 2009. Recommended Performance Standards: Murine Local Lymph Node Assay. NIH Publication No. 09–7357. Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available at: https:// iccvam.niehs.nih.gov/methods/ immunotox/llna_PerfStds.htm. ICCVAM. 2009. ICCVAM Test Method Evaluation Report. The Reduced Murine PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Local Lymph Node Assay: An Alternative Test Method Using Fewer Animals to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products. NIH Publication No. 09–6439. Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available at: https:// iccvam.niehs.nih.gov/methods/ immunotox/LLNA–LD/TMER.htm. ICCVAM. 1999. The Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals/ Compounds. The Results of an Independent Peer Review Evaluation Coordinated by ICCVAM and NICEATM. NIH Publication No. 99– 4494. Research Triangle Park, NC: National Institute of Environmental Health Sciences. Available at: https:// iccvam.niehs.nih.gov/methods/ immunotox/llna_PeerPanel98.htm. Dated: July 14, 2011. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2011–18639 Filed 7–27–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–11–11EM] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC, or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project National Survey of Primary Care Policies for Managing Patients with High Blood Pressure, High Cholesterol, or Diabetes—New—Division of Heart Disease and Stroke Prevention (DHDSP), National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). E:\FR\FM\28JYN1.SGM 28JYN1 45257 Federal Register / Vol. 76, No. 145 / Thursday, July 28, 2011 / Notices Background and Brief Description Cardiovascular disease is a leading cause of death and disability for men and women in the United States, among the most costly health problems facing our nation today, and among the most preventable. Risk factors for cardiovascular disease include high blood pressure and high cholesterol. Because over 50% of diabetics have high blood pressure, high cholesterol, or both conditions, the optimal systems to treat people with hypertension, high cholesterol, or diabetes are interrelated. In 2005, CDC’s Division for Heart Disease and Stroke Prevention (DHDSP) began developing evaluation indicators that reflect evidence-based outcomes from policy, systems, and environmental changes related to heart disease and stroke prevention. However, many of the indicators for short-term policy and systems changes do not have readily available data sources. This is particularly true for outcomes related to health care systems changes. conducted two years after completion of the baseline NSPCP. Approximately 900 physicians will participate in each cycle of data collection (baseline and followup). On an annualized basis, approximately 600 physicians will participate in the NSPCP per year, and 1,333 practices will be screened for participation. Information from both cycles of data collection will be compared to monitor changes in health systems and dissemination of health systems technology. Results will be used by primary care practices to inform their systems for managing patients with chronic conditions and to improve the quality of care delivered. Results will be used by CDC to improve technical assistance to public health partners. OMB approval is requested for three years. Participation in the NSPCP is voluntary, and all responses will be deidentified. There are no costs to respondents other than their time. The total estimated annualized burden hours are 317. In 2011, CDC proposes to conduct a new information collection, the National Survey of Primary Care Policies for Managing Patients with High Blood Pressure, High Cholesterol, or Diabetes (NSPCP). The survey will be targeted to practice managers of nonfederally run primary care physician practices that include at least one family practitioner or at least one physician specializing in internal medicine. Respondents will be drawn from a nationally representative sample of physician practices. The NSPCP survey instrument will undergo cognitive testing before dissemination. The Web-based NSPCP will collect information about physician practices’ use of evidence-based systems, including multidisciplinary team approaches for chronic disease treatment, electronic health records (EHR) with features appropriate for treating patients with chronic disease (e.g., clinical decision supports, patient registries), and patient follow-up mechanisms. A follow-up survey will be ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name Physician ......................................................... Medical Secretary ........................................... Physician ......................................................... DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. [FR Doc. 2011–19109 Filed 7–27–11; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Background and Brief Description [30Day–11–11CD] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, VerDate Mar<15>2010 15:51 Jul 27, 2011 Jkt 223001 Proposed Project Tourette Syndrome National Education and Outreach Program— New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). BILLING CODE 4163–18–P rmajette on DSK89S0YB1PROD with NOTICES 5 1,333 600 1 1 1 Cognitive Testing Interview Guide ................. NSPCP Screener ........................................... NSPCP ........................................................... Dated: July 22, 2011. Daniel Holcomb, Reports Clearance Officer, Centers for Disease Control and Prevention. Number of responses per respondent This program will collect program evaluation data from participants of educational workshops and recipients of educational resources on Tourette Syndrome (TS) conducted by the Tourette Syndrome Association in a cooperative agreement with the CDC. TS is an inherited, neurobiological movement disorder characterized by involuntary motor and vocal tics that typically manifest during childhood. The exact number of people with TS is unknown. Data from the National Survey of Children’s Health 2007 resulted in an estimate that 3 out of every 1,000 U.S. children (about 148,000) 6 through 17 years of age had PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Avg. burden per response (in hr) 75/60 5/60 20/60 been diagnosed with TS. Higher prevalence estimates obtained from community studies likely mean that there are a significant number of individuals who have TS, but who have not been diagnosed. TS is three to four times more common among males than females. It is estimated that tens of thousands or Americans with TS either go undiagnosed or the clinical care they do receive is inadequate. There is no known cure. The disorder may express itself with mild symptoms for some, and severe symptoms for others. Depending on the severity and duration, tic symptoms may also be diagnosed as chronic motor or vocal tic disorder, transient tic disorder, and tic disorder not otherwise specified. TS is associated with a high rate of co-morbid conditions. There is a lack of accurate treatment information among the medical community as well as the general public, and a limited number of expert physicians—all resulting in significant under-diagnosis, misdiagnosis, and inadequate treatment with scant followup care. Children also meet with stigma E:\FR\FM\28JYN1.SGM 28JYN1

Agencies

[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45256-45257]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19109]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-11-11EM]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC, or by fax to (202) 395-5806. 
Written comments should be received within 30 days of this notice.

Proposed Project

    National Survey of Primary Care Policies for Managing Patients with 
High Blood Pressure, High Cholesterol, or Diabetes--New--Division of 
Heart Disease and Stroke Prevention (DHDSP), National Center for 
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for 
Disease Control and Prevention (CDC).

[[Page 45257]]

Background and Brief Description

    Cardiovascular disease is a leading cause of death and disability 
for men and women in the United States, among the most costly health 
problems facing our nation today, and among the most preventable. Risk 
factors for cardiovascular disease include high blood pressure and high 
cholesterol. Because over 50% of diabetics have high blood pressure, 
high cholesterol, or both conditions, the optimal systems to treat 
people with hypertension, high cholesterol, or diabetes are 
interrelated.
    In 2005, CDC's Division for Heart Disease and Stroke Prevention 
(DHDSP) began developing evaluation indicators that reflect evidence-
based outcomes from policy, systems, and environmental changes related 
to heart disease and stroke prevention. However, many of the indicators 
for short-term policy and systems changes do not have readily available 
data sources. This is particularly true for outcomes related to health 
care systems changes.
    In 2011, CDC proposes to conduct a new information collection, the 
National Survey of Primary Care Policies for Managing Patients with 
High Blood Pressure, High Cholesterol, or Diabetes (NSPCP). The survey 
will be targeted to practice managers of non-federally run primary care 
physician practices that include at least one family practitioner or at 
least one physician specializing in internal medicine. Respondents will 
be drawn from a nationally representative sample of physician 
practices. The NSPCP survey instrument will undergo cognitive testing 
before dissemination.
    The Web-based NSPCP will collect information about physician 
practices' use of evidence-based systems, including multidisciplinary 
team approaches for chronic disease treatment, electronic health 
records (EHR) with features appropriate for treating patients with 
chronic disease (e.g., clinical decision supports, patient registries), 
and patient follow-up mechanisms. A follow-up survey will be conducted 
two years after completion of the baseline NSPCP. Approximately 900 
physicians will participate in each cycle of data collection (baseline 
and follow-up). On an annualized basis, approximately 600 physicians 
will participate in the NSPCP per year, and 1,333 practices will be 
screened for participation.
    Information from both cycles of data collection will be compared to 
monitor changes in health systems and dissemination of health systems 
technology. Results will be used by primary care practices to inform 
their systems for managing patients with chronic conditions and to 
improve the quality of care delivered. Results will be used by CDC to 
improve technical assistance to public health partners.
    OMB approval is requested for three years. Participation in the 
NSPCP is voluntary, and all responses will be de-identified. There are 
no costs to respondents other than their time. The total estimated 
annualized burden hours are 317.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of      Avg. burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent        (in hr)
----------------------------------------------------------------------------------------------------------------
Physician.............................  Cognitive Testing                      5               1           75/60
                                         Interview Guide.
Medical Secretary.....................  NSPCP Screener..........           1,333               1            5/60
Physician.............................  NSPCP...................             600               1           20/60
----------------------------------------------------------------------------------------------------------------


    Dated: July 22, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-19109 Filed 7-27-11; 8:45 am]
BILLING CODE 4163-18-P
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