60 Day FRN

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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

Submit electronic
or written comments.

Dates

Electronic addresses

Addresses

Other information

Submit comments by May
26, 2015.

Federal eRulemaking Portal:
http://www.regulations.gov. Follow the instructions for submitting comments.

Mail/Hand delivery/Courier (for
paper submissions): Division of
Dockets Management (HFA–
305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.

Identify your comments with the
docket number listed in brackets in the heading of this document. We encourage you to
submit electronic comments by
using the Federal eRulemaking
Portal.

mstockstill on DSK4VPTVN1PROD with NOTICES

1 You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your registration information and send to: Courtney Treece, Planning Professionals Ltd., 1210 West McDermott Dr., suite 111, Allen, TX 75013, 704–
258–4983, FAX: 469–854–6992, email: [email protected].

IV. Comments, Transcripts, and
Recorded Video

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Regardless of attendance at the public
meeting, interested persons may submit
to FDA’s Division of Dockets
Management (see Addresses in table 1 of
this document) either electronic or
written comments on FSMA
implementation issues. You only need
to send one set of comments. Identify
the comments with the docket number
listed in brackets in the heading of this
document. However, we will not use
any information or data submitted
during the public meeting or through
the docket to inform any FSMA
rulemakings where the comment
periods have closed.
With respect to transcripts, please be
advised that as soon as a transcript is
available it will be accessible at http://
www.regulations.gov and at FDA’s
FSMA Web site at http://www.fda.gov/
FSMA. You may also view the transcript
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Send
written requests to the Division of
Freedom of Information (ELEM–1029),
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Additionally, we will be video
recording the public meeting. Once the
recorded video is available, it will be
accessible at FDA’s FSMA Web site at
http://www.fda.gov/FSMA.

Centers for Disease Control and
Prevention

Agency for Toxic Substances and
Disease Registry

Interagency Committee on Smoking
and Health: Notice of Charter Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the
Interagency Committee on Smoking and
Health, Department of Health and
Human Services, has been renewed for
a 2-year period through March 20, 2017.
For information, contact Simon
McNabb, Designated Federal Officer,
Interagency Committee on Smoking and
Health, Centers for Disease Control and
Prevention, Department of Health and
Human Services, Patriot’s Plaza, 395 E
Street SW., M/S P06, Washington, DC
20201, telephone 202/245–0550 or fax
202/245–0599, Email: [email protected].
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–06649 Filed 3–23–15; 8:45 am]
BILLING CODE 4163–18–P

Dated: March 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06656 Filed 3–23–15; 8:45 am]
BILLING CODE 4164–01–P

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

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Agency for Toxic Substances
and Disease Registry (ATSDR), Centers
for Disease Control and Prevention
(CDC).
ACTION: Notice with comment period.
AGENCY:

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
SUMMARY:

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

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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

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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 selfenrollment rates of those with ALS.
ATSDR implemented the National
ALS Registry (Registry) in 2009 using an
algorithm applied to national
administrative databases. A selfregistration 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

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15615

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 selfregistering 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 selfenrollment 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 nonreferral 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

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

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-thetrainer 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-thetrainer 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 postmailing, 1,900 follow-up #2 calls at
three months post-mailing, 30 train-thetrainer presentations, and 32 keyinformant 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
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

Form name

Neurologist Support Staff ..................
Neurologist Support Staff ..................
Neurologist Support Staff ..................

1,900
380
950

1
1
1

6/60
1/60
3/60

190
6
48

950

1

3/60

48

190

1

1/60

3

Neurologist ........................................
Neurologist ........................................

Initial Phone Call Checklist ..............
Fax to Determine Provider Status ...
Follow-up Phone Call #1 (One
Week Post-Mailing).
Follow-up Phone Call #2 (Three
Months Post-Mailing).
Fax to Determine if Mailing Was Received.
Train-the-Trainer ..............................
Key Informant Interview ...................

15
16

1
1

1
1

15
16

Total ...........................................

...........................................................

........................

........................

........................

326

Neurologist Support Staff ..................
Neurologist Support Staff ..................

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings

mstockstill on DSK4VPTVN1PROD with NOTICES

Number of
respondents

Type of respondent

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning

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individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Basic Research in HIV-Related Heart, Lung
and Blood Diseases.
Time: April 16, 2015.
Time: 8:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Washington, DC
Dupont Circle Hotel, 1143 New Hampshire
Avenue NW., Washington, DC 20037.
Contact Person: Susan Wohler Sunnarborg,
Ph.D. Scientific Review Officer, Office of
Scientific Review/DERA National, Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7182, Bethesda, MD 20892,
[email protected].
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Translational Programs in Lung Diseases.
Date: April 16, 2015.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crystal City Marriott, 1999 Jefferson
Davis Highway, Arlington, VA 22202.
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific

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Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–435–
0725, [email protected].
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Basic Research in HIV-Related Heart, Lung
and Blood Diseases (R21).
Date: April 16, 2015.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Washington, DC
Dupont Circle Hotel, 1143 New Hampshire
Avenue NW., Washington, DC 20037.
Contact Person: Susan Wohler Sunnarborg,
Ph.D. Scientific Review Officer, Office of
Scientific Review/DERA National, Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7182, Bethesda, MD 20892,
[email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)

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