[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.)
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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]
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