Appendix A_60 Day Federal Register Notice

Federal Register / Vol. 84, No. 175 / Tuesday, September 10, 2019 / Notices
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Comments on the collection(s) of
information must be received by the
OMB desk officer by October 10, 2019.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR Email:
[email protected].
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html
1. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
[email protected].
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
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. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes

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the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: Site
Investigation for Suppliers of Durable
Medical Equipment, Prosthetics,
Orthotics and Supplies (DMEPOS); Use:
The primary function of the site
investigation form is to provide a
standardized, uniform tool to gather
information from a DMEPOS supplier
that tells us whether it meets certain
qualifications to be a DMEPOS supplier
(as found in 42 CFR 424.57(c)) and
where it practices or renders its
services. This site investigation form
also aides the Medicare contractor (the
National Supplier Clearinghouse
Medicare Administrative Contractor
(NSC MAC)) in verifying compliance
with the required supplier standards
found in 42 CFR 424.57(c). Form
Number: CMS–R–263 (OMB control
number: 0938–0749); Frequency: Yearly;
Affected Public: Private Sector—
Business or other for-profits and not-forprofit institutions; Number of
Respondents: 8,255; Total Annual
Responses: 8,255; Total Annual Hours:
8,255. (For policy questions regarding
this collection contact Kimberly
McPhillips at 410–786–5374.)
Dated: September 4, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–19471 Filed 9–9–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Survey of Youth Transitioning
From Foster Care (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) within the
U.S. Department of Health and Human
Services (HHS) is proposing to collect
data on human trafficking and other
victimization experiences among youth
recently or currently involved in the

SUMMARY:

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child welfare system. The goal of the
one-time survey is to better understand
trafficking experiences, to identify
modifiable risk and protective factors
associated with trafficking
victimization, and to inform child
welfare policy, programs, and 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,
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.

DATES:

Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing
[email protected].
Alternatively, copies can also be
obtained 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. All requests,
emailed or written, should be identified
by the title of the information collection.

ADDRESSES:

SUPPLEMENTARY INFORMATION:

Description: ACF is proposing data
collection as part of the study, ‘‘Survey
of Youth Transitioning from Foster
Care’’. This Notice provides the
opportunity to comment on a survey of
youth with current or recent
involvement in foster care.
Primary data collected includes a onetime survey with up to 780 youth aged
18 or 19 who were in foster care during
their 17th year. The survey will be
conducted in-person, with both field
interviewer-administered items and
Audio-Computer Assisted SelfInterview (ACASI) items that the youth
will complete privately for sensitive
topics. Survey questions will be focused
on the youths’ demographic data,
trafficking and other victimization
histories, internal and external assets,
and risk and protective factors.
Involvement with child welfare and
juvenile justice systems, and utilization
of other services will also be addressed
in the data collection.
Respondents: Youth aged 18 or 19
who were in foster care during their
17th year.
Annual Burden Estimates
Data collection is expected to take
place over two years.

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Federal Register / Vol. 84, No. 175 / Tuesday, September 10, 2019 / Notices

Instrument

Total
number of
respondents

Annual
number of
respondents

Number of
responses per
respondent

Average
burden
hours per
response

Annual
burden
hours

Survey of Youth Transitioning from Foster Care .................

780

390

1

1.2

468

Estimated Total Annual Burden
Hours: 468.
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: Section 476(a)(1–2) (42
U.S.C. 676) of the Social Security Act
Part E-Federal Payments for Foster Care
and Adoption Assistance.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–19440 Filed 9–9–19; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–E–0280]

Determination of Regulatory Review
Period for Purposes of Patent
Extension; AEGEA VAPOR SYSTEM
Food and Drug Administration,

HHS.
ACTION:

Notice.

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

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SUMMARY:

Anyone with knowledge that any
of the dates as published (see the

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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 November 12,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 12, 2019.
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.

ADDRESSES:

Electronic Submissions

BILLING CODE 4184–25–P

AGENCY:

SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by November 12, 2019.
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
March 9, 2020. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.

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’’).

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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
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–E–0280 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; AEGEA VAPOR
SYSTEM.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the
docket and, except for those submitted
as ‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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

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