[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Notices]
[Pages 47954-47956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-19-0041]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Agency 
for Toxic Substances and Disease Registry (ATSDR) has submitted the 
information collection request titled ``National Amyotrophic Lateral 
Sclerosis (ALS) Registry'' to the Office of Management and Budget (OMB) 
for review and approval. ATSDR previously published a ``Proposed Data 
Collection Submitted for Public Comment and Recommendations'' notice on 
May 24, 2019 to obtain comments from the public and affected agencies. 
ATSDR did not receive comments related to the previous notice. This 
notice serves to allow an additional 30 days for public and affected 
agency comments.
    ATSDR will accept all comments for this proposed information 
collection

[[Page 47955]]

project. The Office of Management and Budget is particularly interested 
in comments that:
    (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 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]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    National Amyotrophic Lateral Sclerosis (ALS) Registry--(OMB Control 
No. 0923-0041, Exp. 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 a 
revision information collection request (ICR) entitled ``The National 
Amyotrophic Lateral Sclerosis (ALS) Registry.'' (OMB Control No. 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 five 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 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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Person with ALS.......................  ALS Case Validation                1,670               1            2/60
                                         Questions.
                                        ALS Case Registration              1,500               1           10/60
                                         Form.
                                        Voluntary Survey Modules             750               1           85/60
                                        Disease Progression                  750               3            5/60
                                         Survey *.
                                        ALS Biorepository                    325               1           30/60
                                         Specimen Processing
                                         Form and In-Home
                                         Collection.

[[Page 47956]]

 
                                        ALS Biorepository Saliva             350               1           10/60
                                         Collection.
Researchers...........................  ALS Registry Research                 36               1           30/60
                                         Application Form.
                                        Annual Update...........              24               1           15/60
ALS Service Organization..............  Chapter/District                     135              12            5/60
                                         Outreach Reporting Form.
                                        National Office Outreach               2              12           20/60
                                         Reporting Form.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-19632 Filed 9-10-19; 8:45 am]
 BILLING CODE 4163-18-P