80 FR 15614 - 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 80, Issue 56 (March 24, 2015)

Page Range		15614-15616
FR Document		2015-06654

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 Promotion of the National Amyotrophic Lateral Sclerosis (ALS) Registry to Non-referral Centers.

Federal Register, Volume 80 Issue 56 (Tuesday, March 24, 2015)

[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15614-15616]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06654]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-15-15TG; Docket No. CDC-2015-0009]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Centers for Disease Control and Prevention (CDC).

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 Promotion of the 
National Amyotrophic Lateral Sclerosis (ALS) Registry to Non-referral 
Centers.

DATES: Written comments must be received on or before May 26, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0009 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

[[Page 15615]]

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 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

    Promotion of the National Amyotrophic Lateral Sclerosis (ALS) 
Registry to Non-referral Centers--New--Agency for Toxic Substances and 
Disease Registry, Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting a two-year Office of Management and Budget (OMB) information 
collection clearance for the project entitled ``Promotion of the 
National ALS Registry to Non-referral Centers''. ATSDR is authorized by 
the Public Health Law No: 110-373, ALS Registry Act to (1) develop a 
system to collect data on amyotrophic lateral sclerosis (ALS) and other 
motor neuron disorders that can be confused with ALS, misdiagnosed as 
ALS, or progress to ALS; and (2) establish a national registry for the 
collection and storage of such data to develop a population-based 
registry of cases.
    The primary goal of the National ALS surveillance system/registry 
is to obtain more complete information on the likely prevalence of ALS 
and to better describe the demographic characteristics (age, race, sex, 
and geographic location) of those with ALS. The secondary goal of the 
registry is to collect additional information on potential risk factors 
for ALS including, but not limited to, family history of ALS, smoking 
history, and military service. The proposed project is a new component 
to be added to the existing Registry and ALS Surveillance Projects to 
increase self-enrollment rates of those with ALS.
    ATSDR implemented the National ALS Registry (Registry) in 2009 
using an algorithm applied to national administrative databases. A 
self-registration component was launched in October 2010. The 
Registry's case ascertainment methodology required validation; 
therefore, ATSDR established State and Metropolitan ALS Surveillance 
Projects (Surveillance Projects). In order to avoid biasing results 
from the Surveillance Projects' evaluation of the Registry's 
completeness, staff received instruction to not promote the Registry 
during the surveillance period.
    According to the Morbidity and Mortality Weekly Report (MMWR) 
published in 2014, the proportion of cases identified via self-
registration was lower than those identified in the administrative data 
for the period October 2010-December 2011. On-going self-registration 
is critical because not all persons with ALS can be identified through 
the algorithm, and only self-registering persons with ALS can complete 
the risk-factor surveys. Therefore, efforts to increase Registry 
awareness among non-referral center neurology practices/neurologists is 
needed to increase self-enrollment of persons with ALS.
    This new information collection request is a result of the need to 
promote the Registry among neurologists who do not work at major ALS 
referral centers. The following objectives are set for this project:
     To implement a pilot project to conduct educational and 
promotional outreach activities at non-referral center neurology 
practices in the U.S., to inform neurologists and their staff about the 
Registry;
     To encourage neurologists to inform their patients about 
the Registry, and to increase persons with ALS self-enrollment in the 
Registry through the web portal via the use of existing Registry 
brochures, pamphlets, and factsheets; and
     To examine the effectiveness of educational and 
promotional outreach activities by reviewing persons with ALS self-
enrollment rates before, during, and after the project period.
    The increase in self-enrollment rates will allow ATSDR to produce 
more accurate estimates of prevalence of ALS, and collect risk-factor 
survey data from a more representative sample of persons with ALS 
nationwide. Additionally, self-enrollment of people with ALS provides 
them with opportunities to be informed about the disease risk factors, 
learn more about beneficial therapies and a cure for the disease. In 
due course, these activities will also allow ATSDR to fulfill its 
congressional mandate under the ALS Registry Act.
    To achieve the above mentioned objectives, a four group educational 
and promotional outreach study has been designed. Three groups (Group 
1, Group 2 and Group 3), with two states in each group, will receive 
various educational and promotional components, and a fourth group 
(Group 4) consisting of the remaining 44 states, will serve as a 
comparison (will not receive any intervention). This project will 
implement a methodology similar to that used during previous ALS 
Surveillance Projects to identify all non-referral center neurologists 
in Groups 1, 2, and 3. Neurologists who do or would diagnose and/or 
care for ALS patients in Groups 1 and 2 and all neurologists in

[[Page 15616]]

Group 3 will receive a mailing about the registry, whereas Group 4 the 
comparison group will not receive any outreach component. To analyze 
the change in ALS registry self-enrollment, ATSDR will compare, on a 
monthly basis, enrollment rates between Groups 1, 2, and 3, and 4, as 
well as with the 44-state Group 4.
    Study activities include, but are not limited to, initial and 
follow-up phone calls, mailings, train-the-trainer sessions, and key 
informant interviews. The initial phone call will: (1) determine if the 
neurologist(s) diagnose/care for patients with ALS; (2) determine how 
many ALS patients are seen on an annual basis, and (3) confirm contact 
information for neurologists. Providers who do or would diagnose/care 
for patients with ALS will receive a targeted mailing about the 
registry. Follow-up phone calls and faxes, as needed, will confirm the 
receipt of mailings (including posters, provider guide pamphlet, 
Persons with ALS Quick Start Guide etc.). Key informant interviews with 
neurologists will allow for better understanding of their knowledge, 
attitudes, and beliefs about the Registry, and for gathering additional 
information about the currently deployed Registry materials. As 
neurologists may not be familiar with the self-enrollment process of 
the Registry, the project includes train-the-trainer site visits that 
will provide neurologists and staff (if requested to attend by the 
neurologist) with information to educate persons with ALS about the 
National ALS Registry self-enrollment process. The train-the-trainer 
module activities do not involve information collections.
    Participation is voluntary. For the duration (2 years), the project 
staff will conduct 3,800 initial phone calls, 1,900 follow-up #1 calls 
at one week post-mailing, 1,900 follow-up #2 calls at three months 
post-mailing, 30 train-the-trainer presentations, and 32 key-informant 
interviews.
    There are no costs to respondents other than their time. The 
estimated annualized burden hours for this data collection activity are 
326.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Neurologist Support Staff.....  Initial Phone              1,900               1            6/60             190
                                 Call Checklist.
Neurologist Support Staff.....  Fax to Determine             380               1            1/60               6
                                 Provider Status.
Neurologist Support Staff.....  Follow-up Phone              950               1            3/60              48
                                 Call #1 (One
                                 Week Post-
                                 Mailing).
Neurologist Support Staff.....  Follow-up Phone              950               1            3/60              48
                                 Call #2 (Three
                                 Months Post-
                                 Mailing).
Neurologist Support Staff.....  Fax to Determine             190               1            1/60               3
                                 if Mailing Was
                                 Received.
Neurologist...................  Train-the-                    15               1               1              15
                                 Trainer.
Neurologist...................  Key Informant                 16               1               1              16
                                 Interview.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             326
----------------------------------------------------------------------------------------------------------------


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. 2015-06654 Filed 3-23-15; 8:45 am]
BILLING CODE 4163-18-P

15614 Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET—
Continued
Dates Electronic addresses Addresses Other information

Submit electronic Submit com- Federal eRulemaking Portal: Mail/Hand delivery/Courier (for Identify your comments with the
or written com- ments by May http://www.regulations.gov. Fol- paper submissions): Division of docket number listed in brack-
ments. 26, 2015. low the instructions for submit- Dockets Management (HFA– ets in the heading of this docu-
ting comments. 305), Food and Drug Adminis- ment. We encourage you to
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IV. Comments, Transcripts, and DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
Recorded Video HUMAN SERVICES HUMAN SERVICES
Regardless of attendance at the public Centers for Disease Control and Agency for Toxic Substances and
meeting, interested persons may submit Prevention Disease Registry
to FDA’s Division of Dockets
[60Day–15–15TG; Docket No. CDC–2015–
Management (see Addresses in table 1 of Interagency Committee on Smoking 0009]
this document) either electronic or and Health: Notice of Charter Renewal
written comments on FSMA Proposed Data Collection Submitted
implementation issues. You only need This gives notice under the Federal for Public Comment and
to send one set of comments. Identify Advisory Committee Act (Pub. L. 92– Recommendations
the comments with the docket number 463) of October 6, 1972, that the
AGENCY: Agency for Toxic Substances
listed in brackets in the heading of this Interagency Committee on Smoking and and Disease Registry (ATSDR), Centers
document. However, we will not use Health, Department of Health and for Disease Control and Prevention
any information or data submitted Human Services, has been renewed for (CDC).
during the public meeting or through a 2-year period through March 20, 2017. ACTION: Notice with comment period.
the docket to inform any FSMA For information, contact Simon
rulemakings where the comment McNabb, Designated Federal Officer, SUMMARY: The Agency for Toxic
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With respect to transcripts, please be
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and other Federal agencies to take this
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Administration, 5630 Fishers Lane, rm. the authority to sign Federal Register notice invites comment on Promotion of
1061, Rockville, MD 20852. A transcript notices pertaining to announcements of the National Amyotrophic Lateral
will also be available in either hardcopy meetings and other committee Sclerosis (ALS) Registry to Non-referral
or on CD–ROM, after submission of a management activities, for both the Centers.
Freedom of Information request. Send Centers for Disease Control and DATES: Written comments must be
written requests to the Division of Prevention and the Agency for Toxic received on or before May 26, 2015.
Freedom of Information (ELEM–1029), Substances and Disease Registry. ADDRESSES: You may submit comments,
12420 Parklawn Dr., Element Bldg., identified by Docket No. CDC–2015–
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Additionally, we will be video
Director, Management Analysis and Services • Federal eRulemaking Portal:
Office, Centers for Disease Control and Regulation.gov. Follow the instructions
recording the public meeting. Once the Prevention.
recorded video is available, it will be for submitting comments.
[FR Doc. 2015–06649 Filed 3–23–15; 8:45 am] • Mail: Leroy A. Richardson,
accessible at FDA’s FSMA Web site at
BILLING CODE 4163–18–P Information Collection Review Office,
http://www.fda.gov/FSMA. Centers for Disease Control and
Dated: March 18, 2015. Prevention, 1600 Clifton Road NE., MS–
mstockstill on DSK4VPTVN1PROD with NOTICES

Leslie Kux, D74, Atlanta, Georgia 30329.
Associate Commissioner for Policy. Instructions: All submissions received
must include the agency name and
[FR Doc. 2015–06656 Filed 3–23–15; 8:45 am]
Docket Number. All relevant comments
BILLING CODE 4164–01–P
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background

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15616 Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices

Group 3 will receive a mailing about the Providers who do or would diagnose/ attend by the neurologist) with
registry, whereas Group 4 the care for patients with ALS will receive information to educate persons with
comparison group will not receive any a targeted mailing about the registry. ALS about the National ALS Registry
outreach component. To analyze the Follow-up phone calls and faxes, as self-enrollment process. The train-the-
change in ALS registry self-enrollment, needed, will confirm the receipt of trainer module activities do not involve
ATSDR will compare, on a monthly mailings (including posters, provider information collections.
basis, enrollment rates between Groups guide pamphlet, Persons with ALS
Participation is voluntary. For the
1, 2, and 3, and 4, as well as with the Quick Start Guide etc.). Key informant
duration (2 years), the project staff will
44-state Group 4. interviews with neurologists will allow
Study activities include, but are not conduct 3,800 initial phone calls, 1,900
for better understanding of their
limited to, initial and follow-up phone follow-up #1 calls at one week post-
knowledge, attitudes, and beliefs about
calls, mailings, train-the-trainer the Registry, and for gathering mailing, 1,900 follow-up #2 calls at
sessions, and key informant interviews. additional information about the three months post-mailing, 30 train-the-
The initial phone call will: (1) currently deployed Registry materials. trainer presentations, and 32 key-
determine if the neurologist(s) diagnose/ As neurologists may not be familiar informant interviews.
care for patients with ALS; (2) with the self-enrollment process of the There are no costs to respondents
determine how many ALS patients are Registry, the project includes train-the- other than their time. The estimated
seen on an annual basis, and (3) confirm trainer site visits that will provide annualized burden hours for this data
contact information for neurologists. neurologists and staff (if requested to collection activity are 326.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response (in hours)
respondent (in hours)

Neurologist Support Staff .................. Initial Phone Call Checklist .............. 1,900 1 6/60 190
Neurologist Support Staff .................. Fax to Determine Provider Status ... 380 1 1/60 6
Neurologist Support Staff .................. Follow-up Phone Call #1 (One 950 1 3/60 48
Week Post-Mailing).
Neurologist Support Staff .................. Follow-up Phone Call #2 (Three 950 1 3/60 48
Months Post-Mailing).
Neurologist Support Staff .................. Fax to Determine if Mailing Was Re- 190 1 1/60 3
ceived.
Neurologist ........................................ Train-the-Trainer .............................. 15 1 1 15
Neurologist ........................................ Key Informant Interview ................... 16 1 1 16

Total ........................................... ........................................................... ........................ ........................ ........................ 326

Leroy A. Richardson, individuals associated with the grant Review/DERA, National Heart, Lung, and
Chief, Information Collection Review Office, applications, the disclosure of which Blood Institute, 6701 Rockledge Drive, Room
Office of Scientific Integrity, Office of the would constitute a clearly unwarranted 7178, Bethesda, MD 20892–7924, 301–435–
Associate Director for Science, Office of the invasion of personal privacy. 0725, johnsonwj@nhlbi.nih.gov.
Director, Centers for Disease Control and Name of Committee: National Heart, Lung,
Prevention. Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel; and Blood Institute Special Emphasis Panel;
[FR Doc. 2015–06654 Filed 3–23–15; 8:45 am] Basic Research in HIV-Related Heart, Lung
Basic Research in HIV-Related Heart, Lung
BILLING CODE 4163–18–P and Blood Diseases. and Blood Diseases (R21).
Time: April 16, 2015. Date: April 16, 2015.
Time: 8:00 a.m. to 11:00 a.m. Time: 11:00 a.m. to 5:00 p.m.
DEPARTMENT OF HEALTH AND Agenda: To review and evaluate grant Agenda: To review and evaluate grant
HUMAN SERVICES applications.
applications.
Place: Renaissance Washington, DC
Dupont Circle Hotel, 1143 New Hampshire Place: Renaissance Washington, DC
National Institutes of Health
Avenue NW., Washington, DC 20037. Dupont Circle Hotel, 1143 New Hampshire
National Heart, Lung, and Blood Contact Person: Susan Wohler Sunnarborg, Avenue NW., Washington, DC 20037.
Institute; Notice of Closed Meetings Ph.D. Scientific Review Officer, Office of Contact Person: Susan Wohler Sunnarborg,
Scientific Review/DERA National, Heart, Ph.D. Scientific Review Officer, Office of
Pursuant to section 10(d) of the Lung, and Blood Institute, 6701 Rockledge Scientific Review/DERA National, Heart,
Federal Advisory Committee Act, as Drive, Room 7182, Bethesda, MD 20892, Lung, and Blood Institute, 6701 Rockledge
amended (5 U.S.C. App.), notice is sunnarborgsw@nhlbi.nih.gov. Drive, Room 7182, Bethesda, MD 20892,
hereby given of the following meetings. Name of Committee: National Heart, Lung, sunnarborgsw@nhlbi.nih.gov.
The meetings will be closed to the and Blood Institute Special Emphasis Panel;
(Catalogue of Federal Domestic Assistance
mstockstill on DSK4VPTVN1PROD with NOTICES

public in accordance with the Translational Programs in Lung Diseases.
Date: April 16, 2015. Program Nos. 93.233, National Center for
provisions set forth in sections Sleep Disorders Research; 93.837, Heart and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant Vascular Diseases Research; 93.838, Lung
as amended. The grant applications and applications. Diseases Research; 93.839, Blood Diseases
the discussions could disclose Place: Crystal City Marriott, 1999 Jefferson and Resources Research, National Institutes
confidential trade secrets or commercial Davis Highway, Arlington, VA 22202. of Health, HHS)
property such as patentable material, Contact Person: William J. Johnson, Ph.D.,
and personal information concerning Scientific Review Officer, Office of Scientific

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Document Created: 2015-12-18 11:44:37
Document Modified: 2015-12-18 11:44:37

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 May 26, 2015.
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		80 FR 15614

80 FR 15614 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 80, Issue 56 (March 24, 2015)

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