[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Notices]
[Pages 40065-40067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-15-15TG]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Agency for Toxic Substances and Disease Registry (ATSDR) has 
submitted the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the

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burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (c) Enhance the 
quality, utility, and clarity of the information to be collected; (d) 
Minimize the burden of the collection of information on those who are 
to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses; and (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Promotion of the National ALS Registry to Non-referral Centers--
New--Agency for Toxic Substances and Disease Registry (ATSDR).

Background and Brief Description

    ATSDR is requesting a two-year OMB approval for the information 
collection project entitled ``Promotion of the National ALS Registry to 
Non-referral Centers''. ATSDR is authorized by the Public Health Law 
No: 110-373, ALS Registry Act to (1) develop a system to collect data 
on amyotrophic lateral sclerosis (ALS) and other motor neuron disorders 
that can be confused with ALS, misdiagnosed as ALS, or progress to ALS; 
and (2) establish a national registry for the collection and storage of 
such data to develop a population-based registry of cases.
    ATSDR implemented the National ALS Registry (Registry) in 2009 
using an algorithm applied to national administrative databases. A 
self-registration component was launched in October 2010.
    The primary goal of the Registry is to obtain more complete 
information on the likely prevalence of ALS and to better describe the 
demographic characteristics (age, race, sex, and geographic location) 
of those with ALS. The secondary goal of the registry is to collect 
additional information on potential risk factors for ALS including, but 
not limited to, family history of ALS, smoking history, and military 
service.
    The Registry's case ascertainment methodology required validation; 
therefore, ATSDR established State and Metropolitan ALS Surveillance 
Projects (Surveillance Projects). In order to avoid biasing results 
from the Surveillance Projects' evaluation of the Registry's 
completeness, staff were instructed to not promote the Registry during 
the surveillance period.
    The proposed project is a new component to be added to the existing 
Registry and ALS Surveillance Projects to increase self-enrollment 
rates of those with ALS. According to the Morbidity and Mortality 
Weekly Report (MMWR) published in 2014, the proportion of cases 
identified via self-registration was lower than those identified in the 
administrative data for the period October 2010-December 2011. On-going 
self-registration is critical because not all persons with ALS can be 
identified through the algorithm, and only self-registering persons 
with ALS can complete the risk-factor surveys. Therefore, efforts to 
increase Registry awareness among non-referral center neurology 
practices/neurologists is needed to increase self-enrollment of persons 
with ALS.
    This new information collection aims to evaluate educational and 
promotional outreach activities among select non-referral/non-specialty 
center neurology practices and is a result of the need to promote the 
Registry among neurologists who do not work at major ALS referral 
centers. The following objectives are set for this project:
    (1) To implement a pilot project to conduct educational and 
promotional outreach activities at non-referral center neurology 
practices in the U.S., to inform neurologists and their staff about the 
Registry;
    (2) To encourage neurologists to inform their patients about the 
Registry, and to increase persons with ALS self-enrollment in the 
Registry through the web portal via the use of existing Registry 
brochures, pamphlets, and factsheets; and
    (3) To examine the effectiveness of educational and promotional 
outreach activities by reviewing persons with ALS self-enrollment rates 
before, during, and after the project period.
    By increasing self-enrollment rates, ATSDR will be able to produce 
more accurate estimates of prevalence of ALS, and collect risk-factor 
survey data from a more representative sample of persons with ALS 
nationwide which will allow ATSDR to fulfill its congressional mandate 
under the ALS Registry Act.
    To achieve these objectives, a four group educational and 
promotional outreach project respondents has been designed.
    Data for the study will be gathered by means of initial eligibility 
phone calls and follow-up phone calls and mailings, for neurologists 
who do or would diagnose/care for patients with ALS. Train-the trainer 
sessions will be conducted to educate neurologists about the Registry 
and key informant interviews with neurologists will be done to better 
understand their knowledge, attitudes, and beliefs about the Registry, 
and to gather additional information about the currently deployed 
Registry materials.
    Participation is voluntary. The total annual burden hours for the 
proposed project is 344. There is no cost to the respondents other than 
their time.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of      Avg. burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Neurologist Support Staff.............  Initial Phone Call......           1,900               1            6/60
Neurologist Support Staff.............  Fax to Determine                     380               1            1/60
                                         Provider Status.
Neurologist Support Staff.............  Follow-up Phone Call 1               950               1            3/60
                                         (One-Week Post Mailing).
Neurologist Support Staff.............  Follow-up Phone Call 2               950               1            3/60
                                         (Three Months Post
                                         Mailing).
Neurologist Support Staff.............  Fax to Determine if                  190               1            1/60
                                         Mailing was Received.
Neurologist/Neurologist Support Staff.  Train-the-trainer                     60               1            6/60
                                         Invitation Phone Call.
Neurologist/Neurologist Support Staff.  Key Informant Interview               64               1            6/60
                                         Invitation Phone Call.
Neurologist/Neurologist Support Staff.  Train-the-trainer.......              21               1               1

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Neurologist...........................  Key Informant Interview.              16               1               1
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-17011 Filed 7-10-15; 8:45 am]
 BILLING CODE 4163-18-P