Proposed Information Collection Activity; Comment Request, 29865-29866 [2016-11325]
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29865
Federal Register / Vol. 81, No. 93 / Friday, May 13, 2016 / Notices
days after the meeting). Interested
parties may submit written comments
on the proposed determinations for new
test codes or the preliminary
determinations for reconsidered codes
by early October, 2016, to the address
specified in the ADDRESSES section of
this notice or electronically to Glenn
McGuirk at Glenn.McGuirk@
cms.hhs.gov (the specific date for the
publication of the determinations on the
CMS Web site, as well as the deadline
for submitting comments regarding the
determinations, will be published on
the CMS Web site). Final determinations
for new test codes to be included for
payment on the CLFS for CY 2017 and
reconsidered codes will be posted on
the CMS Web site in November 2016,
along with the rationale for each
determination, the data on which the
determinations are based, and responses
to comments and suggestions received
from the public. The final
determinations with respect to
reconsidered codes are not subject to
further reconsideration. With respect to
the final determinations for new test
codes, the public may request
reconsideration of the basis and amount
of payment as set forth in § 414.509.
III. Registration Instructions
The Division of Ambulatory Services
in the CMS Center for Medicare is
coordinating the public meeting
registration. Beginning June 6, 2016,
registration may be completed on-line at
the following Web site: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
ClinicalLabFeeSched/
index.html?redirect=/
ClinicalLabFeeSched/. All the following
information must be submitted when
registering:
• Name.
• Company name.
• Address.
• Telephone numbers.
• Email addresses.
When registering, individuals who
want to make a presentation must also
specify, which new test codes they will
be presenting comments. A
confirmation will be sent upon receipt
of the registration. Individuals must
register by the date specified in the
DATES section of this notice.
IV. Security, Building, and Parking
Guidelines
The meeting will be held in a Federal
government building; therefore, Federal
security measures are applicable. In
planning your arrival time, we
recommend allowing additional time to
clear security. It is suggested that you
arrive at the CMS facility between 8:15
a.m. and 8:30 a.m., so that you will be
able to arrive promptly at the meeting
by 9:00 a.m. Individuals who are not
registered in advance will not be
permitted to enter the building and will
be unable to attend the meeting. The
public may not enter the building earlier
than 8:15 a.m. (45 minutes before the
convening of the meeting).
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel. Persons without
proper identification may be denied
access to the building.
• Interior and exterior inspection of
vehicles (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Passing through a metal detector
and inspection of items brought into the
building. We note that all items brought
to CMS, whether personal or for the
purpose of demonstration or to support
a demonstration, are subject to
inspection. We cannot assume
responsibility for coordinating the
receipt, transfer, transport, storage, setup, safety, or timely arrival of any
personal belongings or items used for
demonstration or to support a
demonstration.
V. Special Accommodations
Individuals attending the meeting
who are hearing or visually impaired
and have special requirements, or a
condition that requires special
assistance, should provide that
information upon registering for the
meeting. The deadline for registration is
listed in the DATES section of this notice.
Dated: April 11, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–11269 Filed 5–12–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Tribal Child Support
Enforcement Direct Funding Request: 45
CFR 309—Plan.
OMB No.: 0970–0218.
Description: The final rule within 45
CFR part 309, published in the Federal
Register on March 30, 2004, contains a
regulatory reporting requirement that, in
order to receive funding for a Tribal IV–
D program a Tribe or Tribal organization
must submit a plan describing how the
Tribe or Tribal organization meets or
plans to meet the objectives of section
455(f) of the Social Security Act,
including establishing paternity,
establishing, modifying, and enforcing
support orders, and locating
noncustodial parents. The plan is
required for all Tribes requesting
funding; however, once a Tribe has met
the requirements to operate a
comprehensive program, a new plan is
not required annually unless a Tribe
makes changes to its title IV–D program.
Tribes and Tribal organizations must
respond if they wish to operate a fully
funded program. This paperwork
collection activity is set to expire in
December 31, 2016.
Respondents: Tribes and Tribal
Organizations.
ANNUAL BURDEN ESTIMATES
mstockstill on DSK3G9T082PROD with NOTICES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
45 CFR 309—Plan ..........................................................................................
60
2
480
57,600
Estimated Total Annual Burden
Hours: 57,600.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
VerDate Sep<11>2014
18:05 May 12, 2016
Jkt 238001
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
PO 00000
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Sfmt 4703
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
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Federal Register / Vol. 81, No. 93 / Friday, May 13, 2016 / Notices
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–11325 Filed 5–12–16; 8:45 am]
BILLING CODE 4184–01–P
Food and Drug Administration
[Docket No. FDA–2013–D–0880]
Frequently Asked Questions About
Medical Foods; Second Edition;
Guidance for Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance for industry entitled
‘‘Frequently Asked Questions About
Medical Foods; Second Edition.’’ FDA
published earlier versions of the
guidance in May 1997 and May 2007.
The second edition of the guidance
provides responses to additional
questions regarding the definition and
labeling of medical foods and updates
some prior responses.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
Submit either electronic or
written comments on FDA guidances at
any time.
DATES:
ADDRESSES:
You may submit comments
as follows:
VerDate Sep<11>2014
18:05 May 12, 2016
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Electronic Submissions
Jkt 238001
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2013–D–0880 for ‘‘Frequently Asked
Questions About Medical Foods;
Second Edition.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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
PO 00000
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Fmt 4703
Sfmt 4703
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 Division of Dockets
Management. 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 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the guidance to Office of
Nutrition and Food Labeling, Center for
Food Safety and Applied Nutrition
(HFS–850), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Shawne Suggs-Anderson, Center for
Food Safety and Applied Nutrition
(HFS–850), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1451.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a guidance for industry, entitled
‘‘Frequently Asked Questions About
Medical Foods; Second Edition.’’ We are
issuing this guidance consistent with
our good guidance practices regulation
E:\FR\FM\13MYN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29865-29866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11325]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Tribal Child Support Enforcement Direct Funding Request: 45
CFR 309--Plan.
OMB No.: 0970-0218.
Description: The final rule within 45 CFR part 309, published in
the Federal Register on March 30, 2004, contains a regulatory reporting
requirement that, in order to receive funding for a Tribal IV-D program
a Tribe or Tribal organization must submit a plan describing how the
Tribe or Tribal organization meets or plans to meet the objectives of
section 455(f) of the Social Security Act, including establishing
paternity, establishing, modifying, and enforcing support orders, and
locating noncustodial parents. The plan is required for all Tribes
requesting funding; however, once a Tribe has met the requirements to
operate a comprehensive program, a new plan is not required annually
unless a Tribe makes changes to its title IV-D program. Tribes and
Tribal organizations must respond if they wish to operate a fully
funded program. This paperwork collection activity is set to expire in
December 31, 2016.
Respondents: Tribes and Tribal Organizations.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
45 CFR 309--Plan............................ 60 2 480 57,600
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 57,600.
In compliance with the requirements of Section 506(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
[[Page 29866]]
to the Administration for Children and Families, Office of Planning,
Research and Evaluation, 330 C Street SW., Washington DC 20201. Attn:
ACF Reports Clearance Officer. Email address:
infocollection@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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016-11325 Filed 5-12-16; 8:45 am]
BILLING CODE 4184-01-P
