60 day FRN

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in-person survey of 210 incarcerated
individuals. A purposive sample of
participants will be chosen from each
group. Gay and lesbian individuals will
be oversampled in the MT group. The
incarcerated group will be equally
stratified if individuals are intimate
partner violence (IPV) offenders or not.

Data analysis will include a
combination of Factor Analysis and
Latent Profile Analysis.
OMB approval is requested for two
years for this new collection. Findings
from this data collection will be used to
understand and identify classes of
intimate partner violence (IPV)

perpetrators based on shared
characteristics such as their personal
attributes, risk factors, relationship
characteristics, and characteristics of the
violence they commit.
The estimated annual burden hours
are 1,322. There are no costs to
respondents.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Mechanical Turk Survey Respondents ...........
Mechanical Turk Survey Respondents ...........

Screener Survey ............................................
Understanding Relationship Dynamics and
Conflict Survey.
Understanding Relationship Dynamics and
Conflict Survey.

Incarcerated Survey Respondents .................

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. 2017–07960 Filed 4–19–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17ABE; Docket No. CDC–2017–
0034]

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 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, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection plan
titled ‘‘Developmental Projects to
Improve the National Health and
Nutrition Examination Survey and
Related Programs Generic.’’ This generic
clearance request covers projects that
will help evaluate and improve upon
issues such as survey design and
operations, as well as examine the
feasibility and challenges that may arise
with developing future content for the

SUMMARY:

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Type of respondents

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National Health and Nutrition
Examination Survey (NHANES) (OMB#
0920–0950, expires December 31, 2019)
or similar studies.
DATES: Written comments must be
received on or before June 19, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0034 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.
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: 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

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Number of
responses per
respondent

Average
burden per
response
(in hours)

4,300
1,000

1
1

5/60
50/60

105

1

1.25

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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Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
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
Developmental Projects to Improve
the National Health and Nutrition
Examination Survey and Related
Programs Generic—New—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. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability; environmental,
social and other health hazards; and
determinants of health of the population
of the United States. The Division of
Health and Nutrition Examination
Surveys (DHNES) has conducted
national surveys and related projects
periodically between 1970 and 1994,
and continuously since 1999.
The mission of DHNES programs is to
produce descriptive statistics which
measure the health and nutrition status
of the general population. The
continuous operation of DHNES
programs presents unique challenges in
testing new survey content and
activities, such as outreach or
participant screening etc.
This generic request covers
developmental projects to help evaluate
and enhance DHNES existing and
proposed data collection activities to
increase research capacity and improve

for accessing participant’s medical
records from healthcare settings (e.g.,
hospitals and physician offices); testing
the feasibility and protocols for home
examination measurements; testing
survey materials and procedures to
improve response rates, including
changes to advance materials and
protocols, changes to the incentive
structure, introduction of new and
timely outreach and awareness
procedures including the use of social
media; conducting crossover studies;
creating and testing digital survey
materials; conducting customer
satisfaction assessments.
The types of participants covered by
the NHANES generic may include
current or past NHANES participants;
family or household members of
NHANES participants; individuals
eligible to be participants in NHANES,
but who did not screen into the actual
survey; convenience samples;
volunteers; subject matter experts or
consultants such as survey
methodologist, academic researchers,
clinicians or other health care providers;
NHANES data or Web site users;
members of the general public or
individuals abroad who would be part
of a collaborative development project
or projects between NCHS and related
public health agencies in the U.S. and/
or abroad.
The type of participant involved in a
given developmental project would be
determined by the nature of the project.
The details of each project will be
included in the specific information
collection requests under this generic
plan.
There is no cost to respondents other
than their time. A three year clearance
is requested.

data quality. The information collected
through this Generic Information
Collection Request will not be used to
make generalizable statements about the
population of interest or to inform
public policy; however, methodological
findings from these projects may be
reported.
The purpose and use of projects under
this NHANES generic clearance would
include developmental projects
necessary for activities such as testing
new procedures, equipment, and
approaches that are going to be folded
into NHANES; designing and testing
examination components or survey
questions; creating new studies
including biomonitoring and clinical
measures; creating new cohorts,
including a pregnancy and/or a birth—
24 month cohort; testing of the cognitive
and interpretive aspects of survey
methodology; feasibility testing of
proposed new components or
modifications to existing components;
testing of human-computer interfaces/
usability; assessing the acceptability of
proposed NHANES components among
likely participants; testing alternative
approaches to existing NHANES
procedures, including activities related
to improving nonresponse; testing the
use of or variations/adjustments in
incentives; testing content of Web based
surveys; testing the feasibility of
obtaining bodily fluid specimens (blood,
urine, semen, saliva, breastmilk) and
tissue sample (swabs); testing digital
imaging technology and related
procedures (e.g., retinal scan, liver
ultrasound, Dual-energy X-ray
absorptiometry (DEXA), prescription
and over-the-counter dietary
supplements bottles); testing the
feasibility of and procedure/processes

ESTIMATED ANNUALIZED BURDEN HOURS

Individuals, Households, Volunteers,
and NHANES participants.
Subject Matter Experts ......................

Developmental Projects, Special
Study, Focus Group documents.
Focus
Group/
Developmental
Project Documents.
Customer Satisfaction/ Usability
Documents.

5,500

1

3

16,500

15

1

1

15

1,100

2

5/60

183

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

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

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

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

16,698

Total ...........................................
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(in hours)

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NHANES Web and Data users .........

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Federal Register / Vol. 82, No. 75 / Thursday, April 20, 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. 2017–07963 Filed 4–19–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1619]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).

SUMMARY:

Fax written comments on the
collection of information by May 22,
2017.

DATES:

To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0606. Also
include the FDA docket number found
in brackets in the heading of this
document.

ADDRESSES:

asabaliauskas on DSK3SPTVN1PROD with NOTICES

FOR FURTHER INFORMATION CONTACT:

JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.

SUPPLEMENTARY INFORMATION:

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Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements—21 CFR Part 111; OMB
Control Number 0910–0606—Extension
On October 25, 1994, the Dietary
Supplement Health and Education Act
(DSHEA) (Pub. L. 103–417) was signed
into law. DSHEA, among other things,
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) by adding
section 402(g) of the FD&C Act (21
U.S.C. 342(g)). Section 402(g)(2) of the
FD&C Act provides, in part, that the
Secretary of Health and Human Services
may, by regulation, prescribe good
manufacturing practices for dietary
supplements. Section 402(g) of the
FD&C Act also stipulates that such
regulations will be modeled after
current good manufacturing practice
(CGMP) regulations for food and may
not impose standards for which there
are no current, and generally available,
analytical methodology. Section
402(g)(1) of the FD&C Act states that a
dietary supplement is adulterated if ‘‘it
has been prepared, packed, or held
under conditions that do not meet
current good manufacturing practice
regulations.’’ Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA may
issue regulations necessary for the
efficient enforcement of the FD&C Act.
In the Federal Register of June 25, 2007
(72 FR 34752), (the June 25, 2007, final
rule), FDA published a final rule that
established, in part 111 (21 CFR part
111), the minimum CGMP necessary for
activities related to manufacturing,
packaging, labeling, or holding dietary
supplements to ensure the quality of the
dietary supplement.
Records are an indispensable
component of CGMP. The records
required by FDA’s regulations in part
111 provide the foundation for the
planning, control, and improvement
processes that constitute a quality
control system. Implementation of these
processes in a manufacturing operation
serves as the backbone to CGMP. The
records show what is to be
manufactured; what was, in fact,
manufactured; and whether the controls
that the manufacturer put in place to
ensure the identity, purity, strength, and
composition and limits on contaminants
and to prevent adulteration were
effective. Further, records will show
whether and what deviations from
control processes occurred, facilitate
evaluation and corrective action
concerning these deviations (including,
where necessary, whether associated
batches of product should be recalled
from the marketplace), and enable a
manufacturer to assure that the

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corrective action was effective. In
addition, by establishing recordkeeping
requirements, FDA can ensure that
industry follows CGMP during
manufacturing, packaging, labeling, or
holding operations. The regulations in
part 111 establish the minimum
manufacturing practices necessary to
ensure that dietary supplements are
manufactured, packaged, labeled, or
held in a manner that will ensure the
quality of the dietary supplements
during manufacturing, packaging,
labeling or holding operations.
The recordkeeping requirements of
the regulations include establishing
written procedures and maintaining
records pertaining to: (1) Personnel; (2)
sanitation; (3) calibration of instruments
and controls; (4) calibration, inspection,
or checks of automated, mechanical, or
electronic equipment; (5) maintaining,
cleaning, and sanitizing equipment and
utensils and other contact surfaces; (6)
water used that may become a
component of the dietary supplement;
(7) production and process controls; (8)
quality control; (9) components,
packaging, labels and product received
for packaging and labeling; (10) master
manufacturing and batch production;
(11) laboratory operations; (12)
manufacturing operations; (13)
packaging and labeling operations; (14)
holding and distributing operations; (15)
returned dietary supplements; and (16)
product complaints.
Description of Respondents:
Manufacturers, dietary supplement
manufacturers, packagers and
repackagers, labelers and re-labelers,
holders, distributors, warehousers,
exporters, importers, large businesses,
and small businesses engaged in the
dietary supplement industry.
The recordkeeping requirements of
the regulations in part 111 are set forth
in each subpart. In table 1, we list the
annual burdens associated with
recordkeeping, as described in the June
25, 2007, final rule. For some provisions
listed in table 1, we did not estimate the
number of records per recordkeeper
because recordkeeping occasions consist
of frequent brief entries of dates,
temperatures, monitoring results, or
documentation that specific actions
were taken. Information might be
recorded a few times a day, week, or
month. When the records burden
involves frequent brief entries, we
entered 1 as the default for the number
of records per recordkeeper. For
example, many of the records listed
under § 111.35 in table 1, such as
§ 111.35(b)(2) (documentation, in
individual equipment logs, of the date
of the use, maintenance, cleaning, and
sanitizing of equipment), involve many

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