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indicated or the offices of the Board of
Governors not later than October 31,
2016.
A. Federal Reserve Bank of Boston
(Prabal Chakrabarti, Senior Vice
President) 600 Atlantic Avenue, Boston,
Massachusetts 02210–2204. Comments
can also be sent electronically to
BOS.SRC.Applications.Comments@
bos.frb.org:
1. TCT Holdings Inc., Teachers
Insurance and Annuity Association of
America and TIAA Board of Overseers,
all of New York, New York; to acquire
EverBank Financial Corp and thereby
indirectly acquire EverBank, both of
Jacksonville, Florida.
Board of Governors of the Federal Reserve
System, October 3, 2016.
Michele Taylor Fennell,
Assistant Secretary of the Board.
[FR Doc. 2016–24221 Filed 10–5–16; 8:45 am]
BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0733]; [Docket No. CDC–2016–
0095]

Proposed Data Collections 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 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
requires by the Paperwork Reduction
Act of 1995. This notice invites
comments on Early Hearing Detection
and Intervention (EDHI) Hearing and
Screening Follow-up Survey.
DATES: Written comments must be
received on or before December 5, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0095 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instruction
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and

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SUMMARY:

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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 Regulation.gov, including any
personal information provided. For
access to the docket to read the
background documents or comments
received, go to Regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Leroy A. Richardson, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329.
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, and each reinstatement of
previously approved information
collection before submitting the collect
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; and (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

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the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Early Hearing Detection and
Intervention (EDHI) Hearing and
Screening Follow-up Survey (OMB No.
0920–0733, Expiration 08/30/2016)—
Reinstatement with Change—National
Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Division of Human Development
and Disability, located within NCBDDD,
promotes the health of babies, children,
and adults, with a focus on preventing
birth defects and developmental
disabilities and optimizing the health
outcomes of those with disabilities. As
part of these efforts the Center is
actively involved in addressing the early
identification of hearing loss among
newborns and infants. Congenital
hearing loss is a common birth defect
that affects 1 to 3 per 1,000 live births,
or approximately 12,000 children across
the United States annually.1 2 Studies
have shown that children with a
delayed diagnosis of hearing loss can
experience preventable delays in
speech, language, and cognitive
development.3–5 To ensure children
with hearing loss are identified as soon
as possible, many states and United
States (U.S.) territories have
implemented Early Hearing Detection
and Intervention (EHDI) programs and
enacted laws related to infant hearing
screening. The majority of these EHDI
programs have adopted the ‘‘1–3–6’’
plan, which consists of three core goals:
(1) Screening all infants for hearing loss
before 1 month of age, (2) ensuring
diagnostic audiologic evaluation before
3 months of age for those who do not
pass the screening, and (3) enrollment
in early intervention services before 6
months of age for those identified with
hearing loss.
Federal support for identifying
children with hearing loss began with
the Children’s Health Act of 2000,
which authorized federal programs to
support EHDI activities at the state
level. Since then, funds have been
distributed to states via cooperative
agreements from the CDC and grants
from the Health Resources and Services
Administration (HRSA). States are using
these federal monies to enhance EHDI
programs and develop corresponding
tracking and surveillance systems.
These systems are intended to help
EHDI programs ensure infants and
children are receiving recommended

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Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices
hearing screening, follow-up, and
intervention services.
The CDC’s NCBDDD will fund this
work to obtain standardized annual
jurisdictional data related to the number
of children screened for hearing loss,
referred for and receiving follow-up
testing (e.g., diagnostic audiologic
evaluation). As with the original and
reinstated information collection the
overall purpose of this updated survey
is to consistently gather the aggregatelevel data required to assess progress
toward the National EHDI Goals.
Proposed changes for the updated
survey have been made in response to
feedback from respondents and requests
for additional information from state
and national partners. These updates are
intended to further increase the
standardization and completeness of the
data collected and make the survey
easier to complete. These changes
include adding new fields to capture
data about hearing screening conducted
by using one-stage, two-stage, or
blended (both one-stage and two-stage)
screening protocol. In addition, fields
were added to be able to report the
number of occurring homebirths and the
number of infants not documented to
have received recommended screening,
diagnostic and/or intervention services,
due to reasons such as the infant being
adopted, no referral from the Primary
Care Physician (PCP)/Ear-Nose-Throat
(ENT) specialist and/or due to medical
reasons. Several fields have been
removed in order to improve data
quality and better evaluate whether
jurisdictions are meeting the nationwide
benchmarks. The table for reporting
type and severity of hearing loss data
has been updated so that this data can

currently collecting and able to report.
This information is anticipated to
continue to be important in developing
methods to help minimize loss to
follow-up so all children receive
recommended hearing-related services
in a timely manner.
Third, the data will be helpful in
determining to what extent
jurisdictional tracking and surveillance
systems are capturing essential
information related to follow-up
services, identification, and enrollment
in early intervention. It will also be used
by CDC EHDI to identify areas in
jurisdictional EHDI systems that may
require additional modification. This is
anticipated to be helpful in providing
technical support to funded
jurisdictions as well as for assessing the
impact of federal initiatives related to
hearing loss in infants and children.
Fourth, the requested data will aid in
efforts to determine the prevalence of
differing degrees of hearing loss (e.g.,
mild, severe, profound, etc.) among
infants and children.
Information provided by this updated
survey also has the potential to be used
for other purposes. These include
quality improvement activities by
jurisdictional EHDI programs (e.g.,
identifying areas within the EHDI
processes that could benefit from further
development) and providing requested
data for Healthy People 2020, Objective
ENT–VSL–1 on newborn hearing
screening, evaluation, and intervention.
In addition, the aggregate-level data will
continue to be made available online to
other state and federal agencies,
organizations, and the general public.
The total burden hours is 238.

be reported using only the classification
system from the American Speech and
Hearing Association (ASHA). The table
for reporting demographics has also
been updated to include fewer columns,
in order to improve data quality and
data standardization with the previous
sections of the survey.
The collected data will continue to be
used in four key ways. First, it will be
used to determine annual rates of
hearing screening, referral for further
diagnostic testing, loss to follow-up,
incidence of hearing loss in infants, and
enrollment in early intervention. These
data will assist in determining if infants
and children are receiving
recommended EHDI-related services in
a timely fashion. The information is
intended to be made available through
presentations, articles related to EHDI
programs and infant hearing loss, and
online at: www.cdc.gov/ncbddd/
hearingloss/ehdi-data.html.
Second, the data will be used to
determine rates of loss to follow-up
within different stages of the EHDI
process. Aggregated information about
maternal race, ethnicity, education, and
age will be used to help determine
whether rates of loss to follow-up are
correlated with any of these
demographic variables. As with the
most recent reinstatement with change
(2013), the updated survey will
continue to use same set of demographic
data items, which will make it possible
to continue analyzing the association
between factors such as maternal race
and loss to follow-up, maintain
comparability between previous and
future data, and minimize burden on
respondents by continuing to request
the same data that programs are

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Form name

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EHDI Program State Program Coordinators Contacted ......

Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

Survey
Directions

59

1

10/60

10

EHDI Program State Program Coordinators who return the
survey ...............................................................................

Survey

57

1

240/60

228

Totals ............................................................................

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

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

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

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

238

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Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices

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. 2016–24132 Filed 10–5–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2896]

Public Meeting on Pre-Market
Evaluation of Abuse-Deterrent
Properties of Opioid Drug Products
AGENCY:

Food and Drug Administration,

HHS.
Notice of public meeting;
request for comments.

ACTION:

The Food and Drug
Administration (FDA) is announcing a
public meeting to discuss scientific and
technical issues relating to formulation
development and pre-market evaluation
of opioid drug products with abusedeterrent properties. The meeting is
intended to give FDA the opportunity to
discuss, and seek public input from
stakeholders on, the approach to testing
FDA recommended in its draft guidance
‘‘General Principles for Evaluating the
Abuse Deterrence of Generic Solid Oral
Opioid Drug Products.’’ The meeting
will also provide an opportunity to
discuss FDA’s efforts to develop
standardized in vitro testing
methodologies for evaluating the abuse
deterrence of opioid drug products. FDA
is seeking input from all stakeholders,
including patients, health care
providers, health care payers, the
pharmaceutical industry, patient
advocates, academics, researchers, and
other government entities.
FDA may hold one or more additional
meetings in the future to discuss the
risk-benefit paradigm for opioid drug
products to ensure that FDA is
appropriately considering the full
public health impact of prescription
opioid drug products and the postmarket impact (‘‘real world effects’’) of
abuse-deterrent opioid drug products.
DATES: The public meeting will be held
on October 31, 2016, from 8:30 a.m. to
4:30 p.m. and November 1, 2016, from
8:30 a.m. to 4 p.m. The meeting may be
extended or end early depending on the
level of public participation. Individuals
seeking to attend or to present at the
meeting must register by October 17,
2016. Please register here for the
meeting: http://www.cvent.com/d/

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SUMMARY:

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wvq0sm/4W. Electronic or written
comments regarding scientific and
technical issues relating to formulation
development and pre-market evaluation
of abuse-deterrent properties of opioid
drug products will be accepted until
December 1, 2016.
ADDRESSES: The public meeting will be
held at College Park Marriott Hotel and
Conference Center, 3501 University
Blvd. East, Hyattsville, MD 20783.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to http://
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 http://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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–N–2896 for ‘‘Public Meeting on
Pre-Market Evaluation of AbuseDeterrent Properties of Opioid Drug
Products.’’ Received comments will be
placed in the docket and, except for

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those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
http://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• 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 http://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. 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: http://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to http://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA will post the agenda
approximately 3 days before the public
meeting at: http://www.fda.gov/Drugs/
NewsEvents/ucm509853.htm. FDA will
also post a link to the live Webcast of
this public meeting on the day of the
public meeting.
FOR FURTHER INFORMATION CONTACT:
Michelle Eby, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6184,
Silver Spring, MD 20993, 301–796–
4714, [email protected].

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