60 day FRN

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Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices
HIV prevention activities and use of
funds in HIV prevention nationwide.
CDC HIV prevention program grantees
will collect, enter or upload, and report
agency-identifying information, budget
data, intervention information, and

gathering and maintaining data,
document compilation, review of data,
and data entry or upload into the web
based system.
There are no additional costs to
respondents other than their time.

client demographics and behavioral risk
characteristics with an estimate of
207,186 burden hours, an increase from
the previously approved, 206,226
burden hours. Data collection will
include searching existing data sources,

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

Total burden
(in hours)

Form name

Health Departments ..........................
Community-based Organization .......

Health Department Reporting ..........
Community-Based Organization Reporting.

66
150

2
2

1,435.5
59

189,486
17,700

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

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

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

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

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

207,186

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. 2018–08382 Filed 4–20–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–FY–0840; Docket No. CDC–2018–
0036]

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 ‘‘Formative Research and Tool
Development’’.

SUMMARY:

CDC must receive written
comments on or before June 22, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0036 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
DATES:

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Number of
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Number of
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• 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. 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
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:
[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 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

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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
Formative Research and Tool
Development (OMB Control Number
0920–0840, Expiration Date
1/31/2019)—Extension—National
Center for HIV/AIDS, Viral Hepatitis,
STD, TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention, National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP) requests
approval for an approval of a three-year
extension to the generic information
collection plan titled ‘‘Formative
Research and Tool Development.’’ CDC
designed this information collection
project to allow CDC’s National Center
for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention (NCHHSTP) to conduct
formative research information
collection activities used to inform
many aspects of surveillance,

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Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices

communications, health promotion, and
research project development for
NCHHSTP’s four priority disease
prevention focus areas: (1) HIV/AIDS;
(2) sexually transmitted diseases/
infections (STD/STI); (3) viral hepatitis,
tuberculosis elimination (TB); and (4)
school and adolescent health (DASH).
Formative research is the basis for
developing effective strategies including
communication channels, for
influencing behavior change. It helps
researchers identify and understand the
characteristics—interests, behaviors and
needs of target populations that
influence their decisions and actions.
Formative research is integral in
developing programs as well as
improving existing and ongoing
programs. Formative research also looks
at the community in which a public
health intervention is being or will be
implemented and helps the project staff
understand the interests, attributes and
needs of different populations and
persons in that community. Formative
research is research that occurs before a
program is designed and implemented,
or while a program is being conducted.
NCHHSTP formative research is
necessary for developing new programs
or adapting programs that deal with the
complexity of behaviors, social context,
cultural identities, and health care that
underlie the epidemiology of HIV/AIDS,
viral hepatitis, STDs, and TB in the U.S.
as well as for school and adolescent
health.
CDC conducts formative research to
develop public-sensitive
communication messages and user
friendly tools prior to developing or
recommending interventions, or care.
Sometimes these studies are entirely
behavioral but most often they are
cycles of interviews and focus groups

needs. CDC will use the information
collected to advise programs and
provide capacity-building assistance
tailored to identified needs.
Overall, these development activities
are intended to provide information that
will increase the success of the
surveillance or research projects
through increasing response rates and
decreasing response error, thereby
decreasing future data collection burden
to the public. The studies that CDC will
cover under this request will include
one or more of the following
investigational modalities: (1)
Structured and qualitative interviewing
for surveillance, research, interventions
and material development; (2) cognitive
interviewing for development of specific
data collection instruments; (3)
methodological research; (4) usability
testing of technology-based instruments
and materials; (5) field testing of new
methodologies and materials; (6)
investigation of mental models for
health decision-making, to inform
health communication messages; and (7)
organizational needs assessments to
support development of capacity.
Respondents who will participate in
individual and group interviews
(qualitative, cognitive, and computer
assisted development activities) are
selected purposively from those who
respond to recruitment advertisements.
In addition to utilizing advertisements
for recruitment, respondents who will
participate in research on survey
methods may be selected purposively or
systematically from within an ongoing
surveillance or research project.
Participation of respondents is
voluntary.
There is no cost to participants other
than their time.

designed to inform the development of
a product.
Products from these formative
research studies will be used for
prevention of HIV/AIDS, Sexually
Transmitted Infections (STI), viral
Hepatitis, and Tuberculosis. Findings
from these studies may also be
presented as evidence to diseasespecific National Advisory Committees,
to support revisions to recommended
prevention and intervention methods, as
well as new recommendations.
Much of CDC’s health communication
takes place within campaigns that have
fairly lengthy planning periods—
timeframes that accommodate the
standard Federal process for approving
data collections. Short term qualitative
interviewing and cognitive research
techniques have previously proven
invaluable in the development of
scientifically valid and populationappropriate methods, interventions, and
instruments.
This information collection approval
request will include CDC studies to
investigate the utility and acceptability
of proposed sampling and recruitment
methods, intervention contents and
delivery, questionnaire domains,
individual questions, and interactions
with project staff or electronic data
collection equipment. These activities
will also provide information about how
respondents answer questions and ways
in which question response bias and
error can be reduced.
This information collection approval
request will also include collection of
information from public health
programs to assess needs related to
initiation of a new program activity or
expansion or changes in scope or
implementation of existing program
activities to adapt them to current

ESTIMATED ANNUALIZED BURDEN HOURS

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Type of respondent

General public
viders.
General public
viders.
General public
viders.
General public
viders.
General public
viders.

Number of
respondents

Form name

Number of
responses per
respondent

Total
response
burden
(hours)

Average
hours per
response

and health care pro-

Screener ...........................................

81,200

1

10/60

13,533

and health care pro-

Consent Forms .................................

40,600

1

5/60

3,383

and health care pro-

Individual Interview ...........................

6,600

1

1

6,600

and health care pro-

Focus Group Interview .....................

4,000

1

2

8,000

and health care pro-

Survey of Individual ..........................

30,000

1

30/60

15,000

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

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

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

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

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

46,516

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Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / 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. 2018–08383 Filed 4–20–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry (BSC, NCEH/
ATSDR)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:

In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry (BSC, NCEH/
ATSDR). This meeting is open to the
public, limited only by available
seating. The meeting room
accommodates approximately 60
people. The public is also welcome to
listen to the meeting by calling 888–
989–4501, passcode 9885805, limited by
100 lines. The deadline for notification
of attendance is May 14, 2018. The
public comment period is scheduled on
June 5, 2018 from 2:30 p.m. until 2:45
p.m., EDT and June 6, 2018 from 10:10
a.m. until 10:25 a.m., EDT. Individuals
wishing to make a comment during
Public Comment period, please email
your name, organization, and phone
number by May 7, 2018 to Amanda
Malasky at [email protected].
DATES: The meeting will be held on June
5, 2018, 8:30 a.m. to 4:00 p.m., EDT and
June 6, 2018, 8:30 a.m. to 11:30 a.m.,
EDT.
ADDRESSES: CDC, 4770 Buford Highway,
CDC Building 106, Room 1B, Atlanta,
GA 30341.
FOR FURTHER INFORMATION CONTACT:
Shirley Little, Program Analyst, NCEH/
ATSDR, CDC, 4770 Buford Hwy., Mail
Stop F–45, Atlanta, GA 30341,
telephone (770) 488–0577; email snl7@
cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The Secretary, Department
of Health and Human Services (HHS)
and by delegation, the Director, CDC

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and Administrator, NCEH/ATSDR, are
authorized under Section 301 (42 U.S.C.
241) and Section 311 (42 U.S.C. 243) of
the Public Health Service Act, as
amended, to: (1) Conduct, encourage,
cooperate with, and assist other
appropriate public authorities, scientific
institutions, and scientists in the
conduct of research, investigations,
experiments, demonstrations, and
studies relating to the causes, diagnosis,
treatment, control, and prevention of
physical and mental diseases and other
impairments; (2) assist states and their
political subdivisions in the prevention
of infectious diseases and other
preventable conditions and in the
promotion of health and wellbeing; and
(3) train state and local personnel in
health work. The BSC, NCEH/ATSDR
provides advice and guidance to the
Secretary, HHS; the Director, CDC and
Administrator, ATSDR; and the
Director, NCEH/ATSDR, regarding
program goals, objectives, strategies, and
priorities in fulfillment of the agency’s
mission to protect and promote people’s
health. The board provides advice and
guidance that will assist NCEH/ATSDR
in ensuring scientific quality,
timeliness, utility, and dissemination of
results. The board also provides
guidance to help NCEH/ATSDR work
more efficiently and effectively with its
various constituents and to fulfill its
mission in protecting America’s health.
Matters to be Considered: The agenda
will include discussions on Recovery
Efforts to Address Environmental Health
Impacts after the 2017 Hurricanes,
NCEH/ATSDR Program Responses to
BSC Guidance and Action Items, PFAS
multi-site study, PEASE, Biomonitoring
for PFAS in children, Use of Citizen
Science for Assessment of Health Risks,
Statistical Inferences in Environmental
Epidemiology, and NCEH/ASTDR work
with tribes/Tribal Programs. Agenda
items are subject to change as priorities
dictate.
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.
Elizabeth Millington,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2018–08367 Filed 4–20–18; 8:45 am]
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17665

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1242]

Advisory Committee; Arthritis
Advisory Committee, Renewal
AGENCY:

Food and Drug Administration,

HHS.
Notice; renewal of advisory
committee.

ACTION:

The Food and Drug
Administration (FDA) is announcing the
renewal of the Arthritis Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Arthritis Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until April 5, 2020.
DATES: Authority for the Arthritis
Advisory Committee will expire on
April 5, 2020, unless the Commissioner
formally determines that renewal is in
the public interest.
FOR FURTHER INFORMATION CONTACT:
Yinghua Wang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, email: [email protected].
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Arthritis Advisory Committee (the
Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of arthritis,
rheumatism, and related diseases, and
makes appropriate recommendations to
the Commissioner.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
SUMMARY:

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