81 FR 21876 - 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 81, Issue 71 (April 13, 2016)

Page Range		21876-21878
FR Document		2016-08443

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.

Federal Register, Volume 81 Issue 71 (Wednesday, April 13, 2016)

[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)]
[Notices]
[Pages 21876-21878]
From the Federal Register Online  [www.thefederalregister.org]
[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

21876 Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Notices

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of Hours per Total burden
Form name respondents response hours

Total ...................................................................................................................................... 325 NA 295

Exhibit 2 shows the estimated research. The total cost burden is
annualized cost burden associated with estimated to be $27,270.45.
the participants’ time to take part in this

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Total burden Total cost
Interviewee type hourly
hours burden
age rate *

Frontline clinicians ....................................................................................................................... 90 $103.54 a $9,318.60
Medical group administrators ............................................................................................... 205 87.57 b 17,951.85

Total ...................................................................................................................................... 295 NA 27,270.45
a Basedon the average hourly wage for one physician (29–1060; $103.54).
b Basedon the average hourly wage for one Chief Executive (11–1011; $87.57).
* National Industry-Specific Occupational Employment and Wage Estimates, May 2014, from the Bureau of Labor Statistics (available at http://
www.bls.gov/oes/current/naics4_621100.htm [for Offices of Physicians, NAICS 622100]).

Request for Comments DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal:
HUMAN SERVICES Regulation.gov. Follow the instructions
In accordance with the Paperwork for submitting comments.
Reduction Act, comments on AHRQ’s Agency for Toxic Substances and • Mail: Leroy A. Richardson,
information collection are requested Disease Registry Information Collection Review Office,
with regard to any of the following: (a) Centers for Disease Control and
Whether the proposed collection of [60Day–16–0041; Docket No. ATSDR–2016– Prevention, 1600 Clifton Road NE., MS–
0005]
information is necessary for the proper D74, Atlanta, Georgia 30329.
performance of AHRQ health care Instructions: All submissions received
Proposed Data Collection Submitted
research and health care information must include the agency name and
for Public Comment and
dissemination functions, including Docket Number. All relevant comments
Recommendations
whether the information will have received will be posted without change
practical utility; (b) the accuracy of AGENCY: Agency for Toxic Substances to Regulations, gov, including any
AHRQ’s estimate of burden (including and Disease Registry (ATSDR), personal information provided. For
Department of Health and Human access to the docket to read background
hours and costs) of the proposed
Services (HHS). documents or comments received, go to
collection(s) of information; (c) ways to
ACTION: Notice with comment period. Regulations.gov.
enhance the quality, utility, and clarity
of the information to be collected; and Please note: All public comment should be
SUMMARY: The Agency for Toxic submitted through the Federal eRulemaking
(d) ways to minimize the burden of the Substances and Disease Registry portal (Regulations.gov) or by U.S. mail to the
collection of information upon the (ATSDR), as part of its continuing address listed above.
respondents, including the use of efforts to reduce public burden and
automated collection techniques or FOR FURTHER INFORMATION CONTACT: To
maximize the utility of government request more information on the
other forms of information technology. information, invites the general public proposed project or to obtain a copy of
Comments submitted in response to and other Federal agencies to take this the information collection plan and
this notice will be summarized and opportunity to comment on proposed instruments, contact the Information
included in the Agency’s subsequent and/or continuing information Collection Review Office, Centers for
request for OMB approval of the collections, as required by the Disease Control and Prevention, 1600
proposed information collection. All Paperwork Reduction Act of 1995. This Clifton Road NE., MS–D74, Atlanta,
comments will become a matter of notice invites comment on the Georgia 30329; phone: 404–639–7570;
public record. ‘‘National Amyotrophic Lateral Email: omb@cdc.gov.
Sclerosis (ALS) Registry.’’ The National SUPPLEMENTARY INFORMATION: Under the
Sharon B. Arnold, ALS Registry collects information from Paperwork Reduction Act of 1995 (PRA)
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Acting Director. persons with ALS to better describe the (44 U.S.C. 3501–3520), Federal agencies
[FR Doc. 2016–08403 Filed 4–12–16; 8:45 am] prevalence and potential risk factors for must obtain approval from the Office of
BILLING CODE 4160–90–P
ALS. Management and Budget (OMB) for each
DATES: Written comments must be collection of information they conduct
received on or before June 13, 2016. or sponsor. In addition, the PRA also
ADDRESSES: You may submit comments, requires Federal agencies to provide a
identified by Docket No. ATSDR–2016– 60-day notice in the Federal Register
0005 by any of the following methods: concerning each proposed collection of

VerDate Sep<11>2014 17:41 Apr 12, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1

21878 Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Notices

Leroy A. Richardson, Control and Prevention (CDC) DEPARTMENT OF HEALTH AND
Chief, Information Collection Review Office, announces a meeting for the initial HUMAN SERVICES
Office of Scientific Integrity, Office of the review of applications in response to
Associate Director for Science, Office of the Funding Opportunity Announcement Centers for Disease Control and
Director, Centers for Disease Control and Prevention
Prevention.
(FOA), PAR 15–353, Centers for
Agricultural Safety and Health. [60Day-16–16ZX; Docket No. CDC–2016–
[FR Doc. 2016–08443 Filed 4–12–16; 8:45 am]
Times and Dates: 0037]
BILLING CODE 4163–70–P
8:30 a.m.–8:30 p.m., EDT, May 9, 2016 Proposed Data Collection Submitted
(Closed) for Public Comment and
DEPARTMENT OF HEALTH AND Recommendations
HUMAN SERVICES 8:30 a.m.–8:30 p.m., EDT, May 10, 2016
(Closed) AGENCY: Centers for Disease Control and
Centers for Disease Control and 8:30 a.m.–8:30 p.m., EDT, May 11, 2016 Prevention (CDC), Department of Health
Prevention (Closed) and Human Services (HHS).
8:30 a.m.–8:30 p.m., EDT, May 12, 2016 ACTION: Notice with comment period.
Advisory Board on Radiation and
Worker Health (ABRWH or Advisory (Closed)
SUMMARY: The Centers for Disease
Board), National Institute for 8:30 a.m.–8:30 p.m., EDT, May 13, 2016 Control and Prevention (CDC), as part of
Occupational Safety and Health (Closed) its continuing efforts to reduce public
(NIOSH): Notice of Charter Re- Place: Crowne Plaza Atlanta burden and maximize the utility of
establishment government information, invites the
Perimeter at Ravinia, 4355 Ashford
Pursuant to Executive Order 13708 Dunwoody Road, Atlanta, Georgia general public and other Federal
and the Federal Advisory Committee 30346–1521 Telephone: (770) 395–7700 agencies to take this opportunity to
Act (Pub. L. 92–463) of October 6, 1972, comment on proposed and/or
Status: The meeting will be closed to continuing information collections, as
the Director, Centers for Disease Control the public in accordance with
and Prevention (CDC) announces the re- required by the Paperwork Reduction
provisions set forth in Section Act of 1995. This notice invites
establishment of the Advisory Board on 552b(c)(4) and (6), Title 5 U.S.C., and
Radiation and Worker Health, comment on the Environmental Public
the Determination of the Director, Health Tracking Network, an
Department of Health and Human
Management Analysis and Services information system which collects data
Services, extending through September
30, 2017. Office, CDC, pursuant to Public Law 92– from (1) other CDC programs such as the
Contact Person for More Information: 463. National Center for Health Statistics, (2)
Theodore Katz, Designated Federal Matters for Discussion: The meeting other federal agencies such as the
Officer, NIOSH, CDC, 1600 Clifton Road will include the initial review, Environmental Protection Agency, (3)
NE., MS E–20, Atlanta, Georgia 30329– discussion, and evaluation of publically accessible systems such as
4027, telephone (513) 533–6800, toll applications received in response to the Census Bureau, and (4) funded and
free: 1–800–CDC–INFO, email: ‘‘Centers for Agricultural Safety and unfunded state and local health
dcas@cdc.gov. departments (SLHD).
Health’’, PAR 15–353.
The Director, Management Analysis DATES: Written comments must be
and Services Office, has been delegated Contact Person for More Information: received on or before June 13, 2016.
the authority to sign Federal Register Donald Blackman, Ph.D., Scientific
ADDRESSES: You may submit comments,
notices pertaining to announcements of Review Officer, CDC/NIOSH, 2400
identified by Docket No. CDC–2016–
meetings and other committee Century Center Parkway NE., 4th Floor, 0037 by any of the following methods:
management activities, for both the Room 4204, Mailstop E–74, Atlanta, • Federal eRulemaking Portal:
Centers for Disease Control and Georgia 30345, Telephone: (404) 498– Regulation.gov. Follow the instructions
Prevention and the Agency for Toxic 6185, DYB7@CDC.GOV. for submitting comments.
Substances and Disease Registry. The Director, Management Analysis • Mail: Leroy A. Richardson,
Elaine L. Baker, and Services Office, has been delegated Information Collection Review Office,
the authority to sign Federal Register Centers for Disease Control and
Director, Management Analysis and Services
notices pertaining to announcements of Prevention, 1600 Clifton Road NE., MS–
Office, Centers for Disease Control and
Prevention. meetings and other committee D74, Atlanta, Georgia 30329.
management activities, for both the Instructions: All submissions received
[FR Doc. 2016–08517 Filed 4–12–16; 8:45 am]
Centers for Disease Control and must include the agency name and
BILLING CODE 4163–18–P
Prevention and the Agency for Toxic Docket Number. All relevant comments
received will be posted without change
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND to Regulations.gov, including any
HUMAN SERVICES Elaine L. Baker, personal information provided. For
Director, Management Analysis and Services access to the docket to read background
Centers for Disease Control and Office, Centers for Disease Control and documents or comments received, go to
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Prevention Prevention. Regulations.gov.
[FR Doc. 2016–08518 Filed 4–12–16; 8:45 am] Please note: All public comment should be
Disease, Disability, and Injury BILLING CODE 4163–18–P submitted through the Federal eRulemaking
Prevention and Control Special portal (Regulations.gov) or by U.S. mail to the
Emphasis Panel (SEP): Initial Review address listed above.
In accordance with Section 10(a)(2) of FOR FURTHER INFORMATION CONTACT: To
the Federal Advisory Committee Act request more information on the
(Pub. L. 92–463), the Centers for Disease proposed project or to obtain a copy of

VerDate Sep<11>2014 17:41 Apr 12, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1

Document Created: 2016-04-13 03:11:29
Document Modified: 2016-04-13 03:11:29

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
Action		Notice with comment period.
Dates		Written comments must be received on or before June 13, 2016.
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]
FR Citation		81 FR 21876

81 FR 21876 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 81, Issue 71 (April 13, 2016)

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