80 FR 15614 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry

Federal Register Volume 80, Issue 56 (March 24, 2015)

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Promotion of the National Amyotrophic Lateral Sclerosis (ALS) Registry to Non-referral Centers.

[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15614-15616]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06654]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-15-15TG; Docket No. CDC-2015-0009]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Centers for Disease Control and Prevention (CDC).

ACTION: Notice with comment period.

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SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
as part of its continuing efforts to reduce public burden and maximize 
the utility of government information, invites the general public and 
other Federal agencies to take this opportunity to comment on proposed 
and/or continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on Promotion of the 
National Amyotrophic Lateral Sclerosis (ALS) Registry to Non-referral 
Centers.

DATES: Written comments must be received on or before May 26, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0009 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background

[[Page 15615]]

documents or comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Promotion of the National Amyotrophic Lateral Sclerosis (ALS) 
Registry to Non-referral Centers--New--Agency for Toxic Substances and 
Disease Registry, Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting a two-year Office of Management and Budget (OMB) information 
collection clearance for the 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.
    The primary goal of the National ALS surveillance system/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 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.
    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 
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 received instruction to not promote the Registry 
during the surveillance period.
    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 request 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:
     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;
     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
     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.
    The increase in self-enrollment rates will allow ATSDR 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. Additionally, self-enrollment of people with ALS provides 
them with opportunities to be informed about the disease risk factors, 
learn more about beneficial therapies and a cure for the disease. In 
due course, these activities will also allow ATSDR to fulfill its 
congressional mandate under the ALS Registry Act.
    To achieve the above mentioned objectives, a four group educational 
and promotional outreach study has been designed. Three groups (Group 
1, Group 2 and Group 3), with two states in each group, will receive 
various educational and promotional components, and a fourth group 
(Group 4) consisting of the remaining 44 states, will serve as a 
comparison (will not receive any intervention). This project will 
implement a methodology similar to that used during previous ALS 
Surveillance Projects to identify all non-referral center neurologists 
in Groups 1, 2, and 3. Neurologists who do or would diagnose and/or 
care for ALS patients in Groups 1 and 2 and all neurologists in

[[Page 15616]]

Group 3 will receive a mailing about the registry, whereas Group 4 the 
comparison group will not receive any outreach component. To analyze 
the change in ALS registry self-enrollment, ATSDR will compare, on a 
monthly basis, enrollment rates between Groups 1, 2, and 3, and 4, as 
well as with the 44-state Group 4.
    Study activities include, but are not limited to, initial and 
follow-up phone calls, mailings, train-the-trainer sessions, and key 
informant interviews. The initial phone call will: (1) determine if the 
neurologist(s) diagnose/care for patients with ALS; (2) determine how 
many ALS patients are seen on an annual basis, and (3) confirm contact 
information for neurologists. Providers who do or would diagnose/care 
for patients with ALS will receive a targeted mailing about the 
registry. Follow-up phone calls and faxes, as needed, will confirm the 
receipt of mailings (including posters, provider guide pamphlet, 
Persons with ALS Quick Start Guide etc.). Key informant interviews with 
neurologists will allow for better understanding of their knowledge, 
attitudes, and beliefs about the Registry, and for gathering additional 
information about the currently deployed Registry materials. As 
neurologists may not be familiar with the self-enrollment process of 
the Registry, the project includes train-the-trainer site visits that 
will provide neurologists and staff (if requested to attend by the 
neurologist) with information to educate persons with ALS about the 
National ALS Registry self-enrollment process. The train-the-trainer 
module activities do not involve information collections.
    Participation is voluntary. For the duration (2 years), the project 
staff will conduct 3,800 initial phone calls, 1,900 follow-up #1 calls 
at one week post-mailing, 1,900 follow-up #2 calls at three months 
post-mailing, 30 train-the-trainer presentations, and 32 key-informant 
interviews.
    There are no costs to respondents other than their time. The 
estimated annualized burden hours for this data collection activity are 
326.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Neurologist Support Staff.....  Initial Phone              1,900               1            6/60             190
                                 Call Checklist.
Neurologist Support Staff.....  Fax to Determine             380               1            1/60               6
                                 Provider Status.
Neurologist Support Staff.....  Follow-up Phone              950               1            3/60              48
                                 Call #1 (One
                                 Week Post-
                                 Mailing).
Neurologist Support Staff.....  Follow-up Phone              950               1            3/60              48
                                 Call #2 (Three
                                 Months Post-
                                 Mailing).
Neurologist Support Staff.....  Fax to Determine             190               1            1/60               3
                                 if Mailing Was
                                 Received.
Neurologist...................  Train-the-                    15               1               1              15
                                 Trainer.
Neurologist...................  Key Informant                 16               1               1              16
                                 Interview.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             326
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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. 2015-06654 Filed 3-23-15; 8:45 am]
BILLING CODE 4163-18-P