[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)]
[Notices]
[Pages 21876-21878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08443]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-16-0041; Docket No. ATSDR-2016-0005]


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.

-----------------------------------------------------------------------

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 the ``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: Written comments must be received on or before June 13, 2016.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2016-0005 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 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

[[Page 21877]]

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

    The National Amyotrophic Lateral Sclerosis (ALS) Registry (OMB 
Control No. 0923-0041, Expiration Date 09/30/2016)--Revision--Agency 
for Toxic Substances and Disease Registry (ATSDR).

Background and Brief Description

    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 (PALS). 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, life-time occupational exposure, 
home pesticide use, hobbies, 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 16 voluntary survey modules, each 
taking five minutes (maximum 80 minutes). In addition, in Year 1, a 
disease progression survey for new registrants is completed at 0, 3, 
and 6 months. In Years 2 and 3, the disease progression survey is 
repeated at the yearly anniversary and at 6 months. For burden 
estimation, the number of disease progression survey responses per year 
has been rounded up to 3 times.
    A biorepository component is being added 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 will be selected to provide specimens. There are 
two types of specimen collections, in-home and postmortem. The in-home 
collection includes blood, urine, hair and nails. 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 will make 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. The 
total number of burden hours requested is 1,986 hours.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
                 Type of respondent                                Form name                respondents    responses per   response  (in    (in hours)
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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           80/60           1,000
                                                      Disease Progression Survey........             750               3            5/60             188
                                                      ALS Biorepository Specimen                     325               1               1             325
                                                       Processing Form.
Researchers.........................................  ALS Registry Research Application               36               1           30/60              18
                                                       Application Form.
                                                      Annual Update Form................              24               1           15/60               6
ALS Service Organization............................  Chapter/District Outreach                      135              12            5/60             135
                                                       Reporting Form.
                                                      National Office Outreach Reporting               2              12           20/60               8
                                                       Form.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...........................................  ..................................  ..............  ..............  ..............           1,986
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 21878]]

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. 2016-08443 Filed 4-12-16; 8:45 am]
BILLING CODE 4163-70-P