Proposed Information Collection Activity; Comment Request; Job Search Assistance (JSA) Strategies Evaluation-Extension, 2162-2163 [2018-00612]
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Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
Comments on the collection(s) of
information must be received by the
OMB desk officer by February 15, 2018.
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:
OIRA_submission@omb.eop.gov.
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
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. 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
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:
Medicare Authorization to Disclose
Personal Health Information; Use:
Unless permitted or required by law, the
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DATES:
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Health Insurance Portability and
Accountability Act (HIPAA) Privacy
Rule (§ 164.508) prohibits Medicare (a
HIPAA covered entity) from disclosing
an individual’s protected health
information without a valid
authorization. In order to be valid, an
authorization must include specified
core elements and statements. Medicare
will make available to Medicare
beneficiaries a standard, valid
authorization to enable beneficiaries to
request the disclosure of their protected
health information. This standard
authorization will simplify the process
of requesting information disclosure for
beneficiaries and minimize the response
time for Medicare. Form CMS–10106,
the Medicare Authorization to Disclose
Personal Health Information, will be
used by Medicare beneficiaries to
authorize Medicare to disclose their
protected health information to a third
party. Form Number: CMS–10106 (OMB
control number: 0938–0930); Frequency:
Occasionally; Affected Public:
Individuals or Households; Number of
Respondents: 2,200,000; Total Annual
Responses: 2,200,000; Total Annual
Hours: 550,000. (For policy questions
regarding this collection contact Sam
Jenkins at 410–786–3261.)
Dated: January 9, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–00486 Filed 1–12–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB NO.: 0970–0440]
Proposed Information Collection
Activity; Comment Request; Job
Search Assistance (JSA) Strategies
Evaluation—Extension
Description: The Administration for
Children and Families (ACF), is
proposing the extension without
changes to an existing data collection
activity as part of the Job Search
Assistance (JSA) Strategies Evaluation.
The JSA evaluation will aim to
determine which JSA strategies are most
effective in moving TANF applicants
and recipients into work and will
produce impact and implementation
findings. To date, the study has
randomly assigned individuals to
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contrasting JSA approaches. The study
will next compare participant
employment and earnings to determine
the relative effectiveness of these
strategies. The project will also report
on the implementation of these
strategies, including measures of
services participants receive under each
approach, as well as provide operational
lessons gathered directly from
practitioners.
Data collection efforts previously
approved for JSA, include: Data
collection activities to document
program implementation, a staff survey,
a baseline information form for program
participants, and a follow-up survey for
JSA participants approximately 6
months after program enrollment.
Approval for these activities expires on
February 28, 2018.
This Federal Register Notice provides
the opportunity to comment on the
extension of the 6-month follow-up
survey to allow follow-up data to be
collected for all study participants.
Although the enrollment period was
originally estimated to span 12 months,
it took 18 months to complete
enrollment, leaving insufficient time to
complete the 6-month follow-up survey.
A four-month extension is requested in
order to allow individuals randomly
assigned between June and August 2017
to complete the follow-up survey in the
same timeframe as earlier enrollees. The
purpose of the survey is to follow-up
with study participants and document
their job search assistance services and
experiences including their receipt of
job search assistance services, their
knowledge and skills for conducting a
job search, the nature of their job search
process, including tools and services
used to locate employment, and their
search outputs and outcomes, such as
the number of applications submitted,
interviews attended, offers received and
jobs obtained. In addition, the survey
will provide an opportunity for
respondents to provide contact data for
possible longer-term follow-up. There
are no changes to the currently
approved instruments.
Respondents: JSA study participants.
Annual Burden Estimates
This extension is specific to the 6month survey and covers the remaining
766 participants that may be completing
the six-month follow up survey during
the four-month extension period. All
other information collection under
0970–0440 will be complete by the
original OMB expiration date of
February 28, 2018.
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16JAN1
Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
Total/annual
number
of respondents
Instrument
Number of responses
per respondent
2163
Average
burden hours
per response
Annual
burden hours
.333
255
Extension of Previously Approved Information Collection
6-Month Follow-Up Survey ..............................................................................
Estimated Total Annual Burden
Hours: 255.
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.
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@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
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.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–00612 Filed 1–12–18; 8:45 am]
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BILLING CODE 4184–09–P
766
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5569]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Device Tracking
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.
DATES: Fax written comments on the
collection of information by February
15, 2018.
ADDRESSES: 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 0910–0442. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUMMARY:
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:
Medical Devices; Device Tracking—21
CFR Part 821
OMB Control Number 0910–0442—
Extension
Section 211 of the Food and Drug
Administration Modernization Act of
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1
1997 (FDAMA) (Pub. L. 105–115)
became effective on February 19, 1998.
FDAMA amended the previous medical
device tracking provisions under section
519(e)(1) and (2) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360i(e)(1) and (2)) that were
added by the Safe Medical Devices Act
of 1990 (SMDA) (Pub. L. 101–629).
Unlike the tracking provisions under
SMDA, which required tracking of any
medical device meeting certain criteria,
FDAMA allows FDA discretion in
applying tracking provisions to medical
devices meeting certain criteria and
provides that tracking requirements for
medical devices can be imposed only
after FDA issues an order. In the Federal
Register of February 8, 2002 (67 FR
5943), FDA issued a final rule that
conformed existing tracking regulations
to changes in tracking provisions
effected by FDAMA under part 821 (21
CFR part 821).
Section 519(e)(1) of the FD&C Act, as
amended by FDAMA, provides that
FDA may require by order that a
manufacturer adopt a method for
tracking a class II or III medical device,
if the device meets one of the three
following criteria: (1) The failure of the
device would be reasonably likely to
have serious adverse health
consequences, (2) the device is intended
to be implanted in the human body for
more than 1 year (referred to as a
‘‘tracked implant’’), or (3) the device is
life-sustaining or life-supporting
(referred to as a ‘‘tracked l/s-l/s device’’)
and is used outside a device user
facility.
Tracked device information is
collected to facilitate identifying the
current location of medical devices and
patients possessing those devices, to the
extent that patients permit the
collection of identifying information.
Manufacturers and FDA (where
necessary) use the data to: (1) Expedite
the recall of distributed medical devices
that are dangerous or defective and (2)
facilitate the timely notification of
patients or licensed practitioners of the
risks associated with the medical
device.
In addition, the regulations include
provisions for: (1) Exemptions and
variances; (2) system and content
requirements for tracking; (3)
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Agencies
[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2162-2163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00612]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB NO.: 0970-0440]
Proposed Information Collection Activity; Comment Request; Job
Search Assistance (JSA) Strategies Evaluation--Extension
Description: The Administration for Children and Families (ACF), is
proposing the extension without changes to an existing data collection
activity as part of the Job Search Assistance (JSA) Strategies
Evaluation. The JSA evaluation will aim to determine which JSA
strategies are most effective in moving TANF applicants and recipients
into work and will produce impact and implementation findings. To date,
the study has randomly assigned individuals to contrasting JSA
approaches. The study will next compare participant employment and
earnings to determine the relative effectiveness of these strategies.
The project will also report on the implementation of these strategies,
including measures of services participants receive under each
approach, as well as provide operational lessons gathered directly from
practitioners.
Data collection efforts previously approved for JSA, include: Data
collection activities to document program implementation, a staff
survey, a baseline information form for program participants, and a
follow-up survey for JSA participants approximately 6 months after
program enrollment. Approval for these activities expires on February
28, 2018.
This Federal Register Notice provides the opportunity to comment on
the extension of the 6-month follow-up survey to allow follow-up data
to be collected for all study participants. Although the enrollment
period was originally estimated to span 12 months, it took 18 months to
complete enrollment, leaving insufficient time to complete the 6-month
follow-up survey. A four-month extension is requested in order to allow
individuals randomly assigned between June and August 2017 to complete
the follow-up survey in the same timeframe as earlier enrollees. The
purpose of the survey is to follow-up with study participants and
document their job search assistance services and experiences including
their receipt of job search assistance services, their knowledge and
skills for conducting a job search, the nature of their job search
process, including tools and services used to locate employment, and
their search outputs and outcomes, such as the number of applications
submitted, interviews attended, offers received and jobs obtained. In
addition, the survey will provide an opportunity for respondents to
provide contact data for possible longer-term follow-up. There are no
changes to the currently approved instruments.
Respondents: JSA study participants.
Annual Burden Estimates
This extension is specific to the 6-month survey and covers the
remaining 766 participants that may be completing the six-month follow
up survey during the four-month extension period. All other information
collection under 0970-0440 will be complete by the original OMB
expiration date of February 28, 2018.
[[Page 2163]]
----------------------------------------------------------------------------------------------------------------
Total/annual Number of Average burden
Instrument number of responses per hours per Annual burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Extension of Previously Approved Information Collection
----------------------------------------------------------------------------------------------------------------
6-Month Follow-Up Survey.................... 766 1 .333 255
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 255.
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. 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:
[email protected]. All requests should be identified by
the title of the information collection.
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.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018-00612 Filed 1-12-18; 8:45 am]
BILLING CODE 4184-09-P