Appendix B_60 Day FRN

2526

Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices

The Office of Management and Budget
is particularly interested in comments
that:
(a) 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;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to [email protected]. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,

Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
List of Ingredients Added to Tobacco
in the Manufacture of Cigarette Products
(OMB No. 0920–0210, Expiration Date
12/31/2018)—Reinstatement with
Change—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Cigarette smoking is the leading
preventable cause of premature death
and disability in our Nation. Each year
more than 480,000 deaths occur as the
result of cigarette smoking–related
diseases. The CDC, Office on Smoking
and Health (OSH), has the primary
responsibility for the HHS smoking and
health program. Since 1986, as required
by the Comprehensive Smoking
Education Act of 1984, which amended
the Federal Cigarette Labeling and
Advertising Act, 15 U.S.C. 1335a, CDC
has collected information about the
ingredients used in cigarette products.
Respondents are commercial cigarette
manufacturers, packagers, or importers
(or their representatives), who are
required by the CSEA to submit
ingredient reports to HHS on an annual
basis. Respondents are not required to
submit specific forms; however, they are
required to submit a list of all

ingredients used in their products. CDC
requires the ingredient report to be
submitted by chemical name and
Chemical Abstract Service (CAS)
Registration Number, consistent with
accepted reporting practices for other
companies currently required to report
ingredients added to other consumer
products.
Ingredient reports are due annually on
March 31. Information is submitted to
CDC by mailing or faxing a written
report on the respondent’s letterhead.
All faxed lists should be followed up
with a mailed original. Data may also be
submitted to CDC by CD, three-inch
floppy disk, or thumb drive. Electronic
mail submissions are not accepted. Mail
Annual Ingredient Submissions to
Attention: FCLAA Program Manager,
Office on Smoking and Health, National
Center for Chronic Disease Prevention
and Health Promotion, Centers for
Disease Control and Prevention, 4770
Buford Highway NE, MS S107–7,
Atlanta, GA 30341–3717.
Upon receipt and verification of the
annual ingredient report, OSH issues a
Certificate of Compliance to the
respondent. CDC also uses the
information to report to Congress (as
deemed appropriate) discussing the
health effects of these ingredients. There
are no costs to respondents other than
their time. The total estimated
annualized burden hours are 358. OMB
approval is requested for three years.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Form name

Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Business Entities .............................................................................................

N/A

55

1

6.5

Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019–01326 Filed 2–6–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Survey of Head Start Grantees
on Training and Technical Assistance
(New Collection)
Office of Planning, Research,
and Evaluation; Administration for
Children and Families; HHS.
ACTION: Request for public comment.
AGENCY:

The Administration for
Children and Families (ACF) at the U.S.
Department of Health and Human
Services (HHS) seeks approval to
conduct a statistically representative

SUMMARY:

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survey of directors and managers/
coordinators from Head Start grantee
organizations regarding their access to
and use of training and technical
assistance (T/TA) from multiple
sources, including ACF’s Early
Childhood Training and Technical
Assistance system. The purpose of the
data collection is to inform ACF on
three aspects of grantee directors and
managers/coordinators T/TA
experience: (1) Search and selection of
T/TA; (2) receipt of T/TA; (3) and
potential relationships between T/TA
received and perceived change in
practice.
Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,

DATES:

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Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@

ADDRESSES:

acf.hhs.gov. All requests should be
identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The Head Start Directors
Wave 1 survey addresses the grantee’s
organizational characteristics, how the
organization defines and diffuses T/TA,
T/TA received and requested in the
prior program year, and overall
organizational goals and reflections on
T/TA efforts for the current year. The
Head Start Managers/Coordinators Wave
2 survey addresses four distinct
domains of Head Start activity: (1)

Program management and fiscal
operations; (2) education; (3) parent and
family engagement; and (4) health and
wellness. The Wave 2 survey addresses
how these activity domains are
structured and staffed with the grantee
organization, the types of T/TA and
resources sought and used to improve
practice in each domain, perceptions of
usefulness of recent T/TA received, and
T/TA priorities for the next program
year.
Respondents: Head Start Directors,
Head Start Managers/Coordinators.

ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents

Instrument
Wave 1 Head Start Director Survey ................................................................
Wave 2 Head Start Managers/Coordinator Survey .........................................

Estimated Total Annual Burden
Hours: 1,500.
Comments: The Department
specifically requests comments 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) 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. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: The Statutory Authority for this
data collection is: Section 640(a)(2)(D) and
section 649 of the Improving Head Start for
School Readiness Act of 2007.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–01428 Filed 2–6–19; 8:45 am]
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800

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1334]

Opioid Use Disorder: Developing
Depot Buprenorphine Products for
Treatment; Guidance for Industry;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Opioid
Use Disorder: Developing Depot
Buprenorphine Products for
Treatment.’’ This guidance reflects the
Agency’s current thinking regarding
drug product development and trial
design issues relevant to the study of
depot buprenorphine products (i.e.,
modified-release products for injection
or implantation) for the treatment of
opioid use disorder. Passive-compliance
formulations such as sustained-release
injectable depots and implants can
provide effective treatment of opioid use
disorder in a treatment paradigm that
may be less subject to misuse, abuse, or
accidental exposure compared to selfadministered formulations such as
transmucosal tablets and films. This
guidance finalizes the draft guidance
entitled ‘‘Opioid Dependence:
Developing Depot Buprenorphine
Products for Treatment’’ issued in April
2018.

SUMMARY:

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Number of
responses per
respondent
1
1

Average
burden hours
per response

Annual
burden
hours

.75
.75

900
600

The announcement of the
guidance is published in the Federal
Register on February 7, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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,
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:

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