[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24143-24144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10836]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substance and Disease Registry

[60Day-19-0041; Docket No. ATSDR-2019-0007]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Department of Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
as part of its continuing effort to reduce public burden and maximize 
the utility of government information, invites the general public and 
other Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``National Amyotrophic Lateral 
Sclerosis (ALS) Registry.'' The National ALS Registry collects 
information from persons with ALS to better describe the prevalence and 
potential risk factors for ALS.

DATES: ATSDR must receive written comments on or before July 23, 2019.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2019-0007 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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. ATSDR will post, without change, all relevant 
comments to Regulations.gov.
    Please note: Submit all comments 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 Jeffrey M. Zirger, 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 the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    The National Amyotrophic Lateral Sclerosis (ALS) Registry (OMB 
Control No. 0923-0041, Expiration Date 11/30/2019)--Revision--Agency 
for Toxic Substances and Disease Registry (ATSDR).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting a three-year Paperwork Reduction Act (PRA) clearance for the 
National Amyotrophic Lateral Sclerosis (ALS) Registry (0923-0041, 
Expiration Date 11/30/2019). The current request is a revision designed 
to strengthen the usefulness of the National ALS Registry for 
researchers. The changes to the ICR include:
    (1) Addition of an organized sports participation survey to capture 
history and current participation in physical activities. This 
additional survey will take approximately 5 minutes to complete and 
will add an additional 63 total burden hours for respondents;
    (2) Two additional questions to capture race and ethnicity upon 
registration with other basic demographic information will be added to 
ALS Case Registration Form prior to Persons with ALS (PALS) completing 
more detailed surveys.
    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 ongoing effort to maintain the 
National ALS Registry.
    First approved in 2010 for self-registration, the primary goal of 
the surveillance system/registry remains to obtain reliable information 
on the incidence and prevalence of ALS and to better describe the 
demographic characteristics (age, race, sex, and geographic location) 
of persons with ALS. Those interested in participating in the National 
ALS Registry must answer a series of validation questions and if 
determined to be eligible they can register.
    The secondary goal of the surveillance system/registry is to 
collect additional information on potential risk factors for ALS, 
including, but not limited to, family history of ALS, smoking history, 
military service, residential history, lifetime occupational exposure, 
home pesticide use, hobbies, participation in sports, hormonal and 
reproductive history (women only), caffeine use, trauma, health 
insurance, open-ended supplemental questions, and clinical signs and 
symptoms. After registration, participants complete as many as 17 
voluntary survey modules, each taking up to five minutes. In addition, 
in Year 1, a disease progression survey for new registrants is 
completed at zero, three, and six months. In Year 2 and Year 3, the 
disease progression survey is repeated at the yearly anniversary and at 
six months. For burden estimation, the number of disease progression 
survey responses per year has been rounded up to three times.
    A biorepository component was added in 2016 to increase the value 
of the National ALS Registry to researchers. As part of registration 
the participant can request additional information about the 
biorepository and provide additional contact information. A 
geographically representative sample is selected to provide specimens. 
There are two types of specimen collections, in-home and postmortem. 
The in-home

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collection includes blood, urine, and saliva. The postmortem collection 
includes the brain, spinal cord, cerebral spinal fluid (CSF), bone, 
muscle, and skin.
    In addition to fulfilling the two-part Congressional mandate, the 
Registry is designed to be a tool for ALS researchers. Now that the 
Registry has matured, ATSDR has made data and specimens available to 
approved researchers and has added a respondent type. Researchers can 
request access to specimens, data, or both collected by the National 
ALS Registry for their research projects. ATSDR will review 
applications for scientific validity and human subjects' protection and 
make data/specimens available to approved researchers. ATSDR is 
collaborating with ALS service organizations to conduct outreach 
activities through their local chapters and districts as well as on a 
national level. They provide ATSDR with information on their outreach 
efforts in support of the Registry on a monthly basis.
    There are no costs to the respondents other than their time. 
Participation in this proposed information collection is completely 
voluntary. The total number of burden hours requested is 1,946 hours.

                                                            Estimated Annualized Burden Hours
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                                                                                                              No. of      Average burden
              Type of respondents                               Form name                     No. of       responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
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Person with ALS................................  ALS Case Validation Questions..........           1,670               1            2/60              56
                                                 ALS Case Registration Form.............           1,500               1           10/60             250
                                                 Voluntary Survey Modules...............             750               1           85/60           1,063
                                                 Disease Progression Survey*............             750               3            5/60             188
                                                 ALS Biorepository Specimen Processing               325               1           30/60             163
                                                  Form and In-Home Collection.
                                                 ALS Biorepository Saliva Collection....             350               1           10/60              59
Researchers....................................  ALS Registry Research Application Form.              36               1           30/60              18
                                                 Annual Update..........................              24               1           15/60               6
ALS Service Organization.......................  Chapter/District Outreach Reporting                 135              12            5/60             135
                                                  Form.
                                                 National Office Outreach Reporting Form               2              12           20/60               8
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           1,946
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-10836 Filed 5-23-19; 8:45 am]
 BILLING CODE 4163-18-P