60d FRN - published

39586

Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / 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. 2017–17581 Filed 8–18–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–0214; Docket No. CDC–2017–
0063]

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 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 Health
Interview Survey (NHIS). The annual
National Health Interview Survey is a
major source of general statistics on the
health of the U.S. population.
DATES: Written comments must be
received on or before October 20, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0063 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.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.

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SUMMARY:

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To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, 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 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.
FOR FURTHER INFORMATION CONTACT:

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Proposed Project
National Health Interview Survey
(NHIS) (OMB Control No. 0920–0124,
Exp. 12/31/2019)—Revision—National
Center for Health Statistics (NCHS),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C.), as
amended, authorizes that the Secretary
of Health and Human Services (HHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability of the population
of the United States.
The annual National Health Interview
Survey (NHIS) is a major source of
general statistics on the health of the
U.S. population and has been in the
field continuously since 1957. This
voluntary and confidential householdbased survey collects demographic and
health-related information from a
nationally-representative sample of
households and noninstitutionalized,
civilian persons throughout the country.
NHIS data have long been used by
government, academic, and private
researchers to evaluate both general
health and specific issues, such as
smoking, diabetes, health care coverage,
and access to health care. The survey is
also a leading source of data for the
Congressionally-mandated ‘‘Health US’’
and related publications, as well as the
single most important source of
statistics to track progress toward
Departmental health objectives.
The 2018 NHIS questionnaire remains
largely unchanged from its 2017
version, with the exception of new
supplements that are being added on
asthma and cancer control. These
supplements replace those from 2017 on
receipt of culturally and linguistically
appropriate health care services,
epilepsy, cognitive disability,
complementary health, hepatitis B/C
screening, vision, and heart disease and
stroke prevention. Continuing from
2017 are questions about access to and
utilization of care and barriers to care,
chronic pain, diabetes, disability and
functioning, family food security, ABCS
of heart disease and stroke prevention,
immunizations, smokeless tobacco and
e-cigarettes, and children’s mental
health.
In addition, in the last quarter of
2018, a portion of the regular 2018 NHIS
sample will be used to carry out a dress
rehearsal and systems test of the
redesigned NHIS questionnaire that is
scheduled for launch in January 2019.
The redesigned questionnaire revises
the NHIS both in terms of content and

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39587

Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices
structure in order to (1) improve the
measurement of covered health topics,
(2) reduce respondent burden by
shortening the length of the
questionnaire and seamlessly
integrating supplements, (3) harmonize
overlapping content with other federal
health surveys, (4) establish a long-term
structure of ongoing and periodic topics,

in short, Web-based methodological and
cognitive testing activities to evaluate
the redesigned questionnaire and/or
inform the development of new rotating
and supplemental content using Web
and/or mail survey tools.
There is no cost to the respondents
other than their time. Clearance is
sought for three years, to collect data for
2018–2020.

and (5) incorporate advances in survey
methodology and measurement.
As in past years, and in accordance
with the 1995 initiative to increase the
integration of surveys within the DHHS,
respondents to the 2018 NHIS will serve
as the sampling frame for the Medical
Expenditure Panel Survey. In addition,
a subsample of NHIS respondents and/
or members of commercial survey
panels may be identified to participate

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Adult Household Member .................

39,375

1

23/60

15,094

Sample Adult .....................................
Adult Family Member ........................
Adult Family Member ........................
Adult Household Member .................
Sample Adult .....................................
Adult Family Member ........................
Adult Family Member ........................
Adult Family Member ........................

Main Household Composition and
Family Core.
Main Adult Core ...............................
Main Child Core ...............................
Main Supplements ...........................
Redesigned Family Core .................
Redesigned Adult Core ....................
Redesigned Child Core ....................
Methodological Projects ...................
Reinterview Survey ..........................

31,500
12,250
45,000
5,625
4,500
1,750
15,000
5,000

1
1
1
1
1
1
1
1

15/60
10/60
20/60
23/60
15/60
10/60
20/60
5/60

7,875
2,042
15,000
2,156
1,125
292
5,000
417

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

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

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

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

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

49,000

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. 2017–17582 Filed 8–18–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–E–0264; FDA–
2013–E–0263; and FDA–2013–E–0218]

Determination of Regulatory Review
Period for Purposes of Patent
Extension; RECUVYRA
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for RECUVYRA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that animal drug
product.

SUMMARY:

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Number of
responses per
respondent

Number of
respondents

Type of respondent

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Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 20, 2017.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 20, 2018. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 20,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 20, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,

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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

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