81 FR 43202 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 81, Issue 127 (July 1, 2016)

Page Range		43202-43203
FR Document		2016-15645
Federal Register, Volume 81 Issue 127 (Friday, July 1, 2016)
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43202-43203]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15645]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-16-0041]


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 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, 
Washington, DC 20503 or by fax to (202) 395-5806. Written comments 
should be received within 30 days of this notice.

Proposed Project

National Amyotrophic Lateral Sclerosis (ALS) Registry--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 
researchers. They 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 also collaborating with ALS service organizations to 
conduct outreach activities through their local chapters and districts 
as well as on a national level. They will 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

[[Page 43203]]

of burden hours requested is 1,824 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form name             respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Person with ALS....................  ALS Case Validation                   1,670               1            2/60
                                      Questions.
                                     ALS Case Registration Form.           1,500               1           10/60
                                     Voluntary Survey Modules...             750               1           80/60
                                     Disease Progression Survey.             750               3            5/60
                                     ALS Biorepository Specimen              325               1           30/60
                                      Processing Form.
Researchers........................  ALS Registry Research                    36               1           30/60
                                      Application Form.
                                     Annual Update..............              24               1           15/60
ALS Service Organization...........  Chapter/District Outreach               135              12            5/60
                                      Reporting Form.
                                     National Office Outreach                  2              12           20/60
                                      Reporting Form.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Health Scientist, Acting 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. 2016-15645 Filed 6-30-16; 8:45 am]
 BILLING CODE 4163-18-P
43202 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices

acquisitions. The provision is among the Budget (OMB) for review and approval geographic location) of persons with
representations and certifications that in accordance with the Paperwork ALS (PALS). Those interested in
are available for completion in the Reduction Act of 1995. The notice for participating in the National ALS
System for Award Management (SAM). the proposed information collection is Registry must answer a series of
published to obtain comments from the validation questions and if determined
B. Annual Reporting Burden public and affected agencies. to be eligible they can register.
Respondents: 397,000. Written comments and suggestions The secondary goal of the surveillance
Responses per Respondent: 1.46. from the public and affected agencies system/registry is to collect additional
Total Responses: 579,620. concerning the proposed collection of information on potential risk factors for
Hours per Response: .500. information are encouraged. Your ALS, including, but not limited to,
Total Burden Hours: 289,810. comments should address any of the family history of ALS, smoking history,
Frequency: On Occasion. following: (a) Evaluate whether the military service, residential history, life-
Affected Public: Businesses or other proposed collection of information is time occupational exposure, home
for-profit and not-for-profit institutions. necessary for the proper performance of pesticide use, hobbies, hormonal and
the functions of the agency, including reproductive history (women only),
C. Public Comments whether the information will have caffeine use, trauma, health insurance,
Public comments are particularly practical utility; (b) Evaluate the open-ended supplemental questions,
invited on: Whether this collection of accuracy of the agencies estimate of the and clinical signs and symptoms. After
information is necessary for the proper burden of the proposed collection of registration, participants complete as
performance of functions of the Federal information, including the validity of many as 16 voluntary survey modules,
Acquisition Regulations (FAR), and the methodology and assumptions used; each taking five minutes (maximum 80
whether it will have practical utility; (c) Enhance the quality, utility, and minutes). In addition, in Year 1, a
whether our estimate of the public clarity of the information to be disease progression survey for new
burden of this collection of information collected; (d) Minimize the burden of registrants is completed at 0, 3, and 6
is accurate, and based on valid the collection of information on those months. In Years 2 and 3, the disease
assumptions and methodology; ways to who are to respond, including through progression survey is repeated at the
enhance the quality, utility, and clarity the use of appropriate automated, yearly anniversary and at 6 months. For
of the information to be collected; and electronic, mechanical, or other burden estimation, the number of
ways in which we can minimize the technological collection techniques or disease progression survey responses
burden of the collection of information other forms of information technology, per year has been rounded up to 3
on those who are to respond, through e.g., permitting electronic submission of times.
the use of appropriate technological responses; and (e) Assess information A biorepository component is being
collection techniques or other forms of collection costs. added to increase the value of the
information technology. To request additional information on National ALS Registry to researchers. As
Obtaining Copies of Proposals: the proposed project or to obtain a copy part of registration the participant can
Requesters may obtain a copy of the of the information collection plan and request additional information about the
information collection documents from instruments, call (404) 639–7570 or biorepository and provide additional
the General Services Administration, send an email to omb@cdc.gov. Direct contact information. A geographically
Regulatory Secretariat Division (MVCB), written comments and/or suggestions representative sample will be selected to
1800 F Street NW., Washington, DC regarding the items contained in this provide specimens. There are two types
20405, telephone 202–501–4755. notice to the Attention: CDC Desk of specimen collections, in-home and
Please cite OMB Control No. 9000– Officer, Office of Management and postmortem. The in-home collection
0136 regarding Commercial Item Budget, Washington, DC 20503 or by fax includes blood, urine, hair and nails.
Acquisitions in all correspondence. to (202) 395–5806. Written comments The postmortem collection includes the
should be received within 30 days of brain, spinal cord, cerebral spinal fluid
Dated: June 28, 2016. (CSF), bone, muscle, and skin.
this notice.
Mahruba Uddowla, In addition to fulfilling the two-part
Acting Director, Federal Acquisition Policy Proposed Project Congressional mandate, the Registry is
Division, Office of Governmentwide National Amyotrophic Lateral Sclerosis designed to be a tool for ALS
Acquisition Policy, Office of Acquisition researchers. Now that the Registry has
Policy, Office of Governmentwide Policy.
(ALS) Registry—Revision—Agency for
Toxic Substances and Disease Registry matured, ATSDR will make data and
[FR Doc. 2016–15703 Filed 6–30–16; 8:45 am] specimens available to researchers.
(ATSDR)
BILLING CODE 6820–EP–P They can request access to specimens,
Background and Brief Description data, or both collected by the National
On October 10, 2008, President Bush ALS Registry for their research projects.
DEPARTMENT OF HEALTH AND signed S. 1382: ALS Registry Act which ATSDR will review applications for
HUMAN SERVICES amended the Public Health Service Act scientific validity and human subjects
to provide for the establishment of an protection and make data/specimens
Agency for Toxic Substances and Amyotrophic Lateral Sclerosis (ALS) available to approved researchers.
Disease Registry Registry. The activities described are ATSDR is also collaborating with ALS
part of the ongoing effort to maintain the service organizations to conduct
asabaliauskas on DSK3SPTVN1PROD with NOTICES

[30Day–16–0041]
National ALS Registry. outreach activities through their local
Agency Forms Undergoing Paperwork First approved in 2010 for self- chapters and districts as well as on a
Reduction Act Review registration, the primary goal of the national level. They will provide
surveillance system/registry remains to ATSDR with information on their
The Agency for Toxic Substances and obtain reliable information on the outreach efforts in support of the
Disease Registry (ATSDR) has submitted incidence and prevalence of ALS and to Registry on a monthly basis.
the following information collection better describe the demographic There are no costs to the respondents
request to the Office of Management and characteristics (age, race, sex, and other than their time. The total number

VerDate Sep<11>2014 19:05 Jun 30, 2016 Jkt 238001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1
Document Created: 2016-07-14 11:37:35
Document Modified: 2016-07-14 11:37:35
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		81 FR 43202
81 FR 43202 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Toxic Substances and Disease Registry

Federal Register Volume 81, Issue 127 (July 1, 2016)

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