60 Day FRN

26464

Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–18AFX; Docket No. CDC–2018–
0052]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Traumatic Brain Injury Disparities
in Rural Areas (TBIDRA). This study
will conduct a formative research to
understand the challenges that rural
healthcare providers face when
diagnosing, treating, and managing
traumatic brain injury (TBI) and develop
a knowledge base to address gaps in
services to improve clinical care and
TBI outcomes in rural communities.
DATES: CDC must receive written
comments on or before August 6, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0052 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, 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. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
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

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SUMMARY:

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instruments, contact Jeffery M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
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 the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. 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 submissions
of responses.
5. Assess information collection costs.
Proposed Project
Traumatic Brain Injury Disparities in
Rural Areas (TBIDRA)—New—National
Center for Injury Prevention and Control
(NCIPC), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Traumatic Brain Injury (TBI) is a
significant public health concern in the
United States, research indicates that
residents of rural areas have both higher

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incidence and higher mortality rates
from TBI than do residents of urban
areas, and that the prevalence of TBIrelated disability in rural geographical
areas is higher than in urban and
suburban areas. The obstacles
healthcare providers and patients face
in rural areas are vastly different than
those in urban areas. There is little
published research specifically related
to the challenges rural providers face in
TBI diagnosis and treatment, and even
less examination into effective ways to
address gaps in service and improve TBI
outcomes. The National Center for
Injury Prevention and Control at the
CDC, in a 2015 ‘‘Report to Congress on
TBI in the United States,’’ determined
that certain population groups,
including residents of rural geographic
areas, require special consideration
when it comes to researching TBI.
This is a new Information Collection
Request for 2 years to collect
information on challenges that rural
healthcare providers face in diagnosing,
treating, and managing TBI of all
severities and develop a knowledge base
upon which we can begin to address
gaps in services to improve clinical care
and TBI outcomes in rural communities.
The target population for the data
collection effort includes physicians,
nurse practitioners (NPs), and physician
assistants (PAs) in selected specialties
(general or family practice, emergency
medicine, pediatrics) working in direct
patient care in rural and urban areas.
The focus of the study is rural
healthcare providers; urban healthcare
providers will be included in this study
to allow for comparison in identifying
the distinct challenges and
opportunities for rural healthcare
providers. This study has two data
collection methods. A web survey to
gather quantitative data on the unique
challenges faced by rural clinicians, and
focus groups to gain deeper insight into
the context supporting and/or inhibiting
access to comprehensive TBI evaluation
and treatment, the study will collect
qualitative data through focus groups
with rural clinicians.
The proposed information collection
is authorized by the Public Health
Services Act (PHS Act) which provides
the legislative means for states to
advance public health across the
lifespan and to reduce health
disparities.
The total estimated annualized
burden hours is 200. There are no costs
to respondents other than their time.

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26465

Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Health care providers (Primary Care
Physician, Emergency Physician,
Nurse Practitioner and Physician
Assistant).

TBI Provider Survey .........................

600

1

15/60

150

Focus group screener ......................
Focus group questionnaire ..............
Focus group discussion guide .........

36
31
31

1
1
1

5/60
5/60
85/60

3
3
44

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

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

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

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

200

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

Jeffrey M. Zirger,
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. 2018–12251 Filed 6–6–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]

Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
049
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA or Agency) is
announcing a publication containing
modifications the Agency is making to
the list of standards FDA recognizes for
use in premarket reviews (FDA
Recognized Consensus Standards). This
publication, entitled ‘‘Modifications to
the List of Recognized Standards,
Recognition List Number: 049’’
(Recognition List Number: 049), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: These modifications to the list of
recognized standards are applicable
June 7, 2018.
ADDRESSES: You may submit comments
as follows:
SUMMARY:

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Number of
responses per
respondent

Number of
respondents

Type of respondent

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the

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instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2004–N–0451 for ‘‘Food and Drug
Administration Modernization Act of
1997: Modifications to the List of
Recognized Standards, Recognition List
Number: 049.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at

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https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday. FDA will consider any
comments received in determining
whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
049.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the

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