Submission for OMB Review; Comment Request, 62536-62537 [2015-26320]
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62536
Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
(OMB control number: 0938–0997);
Frequency: On occasion; Affected
Public: Private sector (Business or other
for-profit and Not-for-profit
institutions); Number of Respondents:
53,111; Total Annual Responses:
181,909,654; Total Annual Hours:
1,567,455. (For policy questions
regarding this collection contact Matt
Klischer at 410–786–7488.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Health
Insurance Common Claims Form and
Supporting Regulations at 42 CFR part
424, Subpart C; Use: The Form CMS–
1500 answers the needs of many health
insurers. It is the basic form prescribed
by CMS for the Medicare program for
claims from physicians and suppliers.
The Medicaid State Agencies,
CHAMPUS/TriCare, Blue Cross/Blue
Shield Plans, the Federal Employees
Health Benefit Plan, and several private
health plans also use it; it is the de facto
standard ‘‘professional’’ claim form.
Medicare carriers use the data
collected on the CMS–1500 and the
CMS–1490S to determine the proper
amount of reimbursement for Part B
medical and other health services (as
listed in section 1861(s) of the Social
Security Act) provided by physicians
and suppliers to beneficiaries. The
CMS–1500 is submitted by physicians/
suppliers for all Part B Medicare.
Serving as a common claim form, the
CMS–1500 can be used by other thirdparty payers (commercial and nonprofit
health insurers) and other Federal
programs (e.g., CHAMPUS/TriCare,
Railroad Retirement Board (RRB), and
Medicaid). However, as the CMS–1500
displays data items required for other
third-party payers in addition to
Medicare, the form is considered too
complex for use by beneficiaries when
they file their own claims. Therefore,
the CMS–1490S (Patient’s Request for
Medicare Payment) was explicitly
developed for easy use by beneficiaries
who file their own claims. The form can
be obtained from any Social Security
office or Medicare carrier. Form
Number: CMS–1500(08/05), CMS–1490–
S (OMB control number: 0938–0999)
Frequency: On occasion; Affected
Public: State, Local, or Tribal
Governments, Private sector (Business
or other-for-profit and Not-for-profit
institutions); Number of Respondents:
1,448,346; Total Annual Responses:
988,005,045; Total Annual Hours:
21,418,336. (For policy questions
regarding this collection contact
Shannon Seales at 410–786–4089.)
Dated: October 13, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–26390 Filed 10–15–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Native Language Preservation
and Maintenance Grant Application
Template Pilot (Funding Application
Submission Tool (F.A.S.T. form))
OMB No.:
Description: The proposed F.A.S.T.
form is intended to be used by
applicants in the Administration for
Native Americans’ Native American
Language Preservation and Maintenance
grant competition in FY 2016. The
F.A.S.T. form is proposed to be piloted
as a consolidated and streamlined pre-
formatted electronic application form
that is user-friendly and has an
interactive interface providing structure
and clarity for applicants. The proposed
F.A.S.T. form is not intended to replace
the Funding Opportunity
Announcement (FOAs) which will still
function as the full text of all funding
opportunities for which applications are
sought and considered by the
Administration for Native Americans.
The proposed F.A.S.T. form will be
used in a pilot capacity in just one
Administration for Native Americans’
discretionary program areas: Native
American Language Preservation and
Maintenance. All applicants applying
for funding in that program area will be
required to use the F.A.S.T. form during
the pilot competition proposed for FY16
unless they request and receive
approval to submit a paper application.
By using the F.A.S.T. form no applicant
will be required to provide any
information beyond what is already
required by the FOA. Additionally, free
training and technical assistance will be
available to all applicants on use of the
F.A.S.T. form.
ANA intends to use the project
proposals submitted via the F.A.S.T.
form to make funding decisions for
Native American Language Preservation
and Maintenance grant awards made in
the FY 2016 pilot year. In addition,
ANA will solicit feedback from
applicants and panel reviewers to obtain
feedback on the results, outcomes, and
their recommendations regarding the
F.A.S.T. form as a user friendly method
of applying for funding opportunities. If
the pilot is successful in making it
easier for applicants to apply, ANA will
consider potentially expanding use of
the F.A.S.T. form to all Administration
for Native Americans’ discretionary
funding areas in subsequent years.
Respondents: 40.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
F.A.S.T. form ...................................................................................................
40
28
.50
14
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
srobinson on DSK5SPTVN1PROD with NOTICES
Estimated Total Annual Burden
Hours: 560.
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
VerDate Sep<11>2014
18:54 Oct 15, 2015
Jkt 238001
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
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Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
E:\FR\FM\16OCN1.SGM
16OCN1
Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–26320 Filed 10–15–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–3474]
Draft Recommendations for the
Permitted Daily Exposures for Two
Solvents, Triethylamine and
Methylisobutylketone, According to
the Maintenance Procedures for the
Guidance Q3C Impurities: Residual
Solvents; International Conference on
Harmonisation; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of draft
recommendations for a new permitted
daily exposure (PDE) for the residual
solvent triethylamine and a revised PDE
for the residual solvent
methylisobutylketone, according to the
maintenance procedures for the
guidance for industry entitled ‘‘Q3C
Impurities: Residual Solvents.’’ The
draft recommendations were prepared
under the auspices of the International
Conference on Harmonisation of
Technical Requirements for Registration
of Pharmaceuticals for Human Use
(ICH). The document is intended to
recommend acceptable amounts for the
listed residual solvents in
pharmaceuticals for the safety of the
patient.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on the draft
recommendations before it begins work
on the final recommendations, submit
either electronic or written comments
on the document by December 15, 2015.
ADDRESSES: You may submit comments
as follows:
srobinson on DSK5SPTVN1PROD with NOTICES
SUMMARY:
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://
VerDate Sep<11>2014
18:54 Oct 15, 2015
Jkt 238001
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:
• 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–
2015–D–3474 for ‘‘Draft
Recommendations for the Permitted
Daily Exposures for Two Solvents,
Triethylamine and
Methylisobutylketone, According to the
Maintenance Procedures for the
Guidance Q3C Impurities: Residual
Solvents; International Conference on
Harmonisation; Availability.’’ 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
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
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62537
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 draft recommendations to
the Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research (CDER), Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft recommendations
may also be obtained by mail by calling
CBER at 1–800–835–4709 or 240–402–
8010. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft recommendations.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Timothy J.
McGovern, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6300, Silver Spring,
MD 20993–0002, 240–402–0477.
Regarding the ICH: Michelle Limoli,
CBER International Programs, Food and
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62536-62537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26320]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Native Language Preservation and Maintenance Grant
Application Template Pilot (Funding Application Submission Tool
(F.A.S.T. form))
OMB No.:
Description: The proposed F.A.S.T. form is intended to be used by
applicants in the Administration for Native Americans' Native American
Language Preservation and Maintenance grant competition in FY 2016. The
F.A.S.T. form is proposed to be piloted as a consolidated and
streamlined pre-formatted electronic application form that is user-
friendly and has an interactive interface providing structure and
clarity for applicants. The proposed F.A.S.T. form is not intended to
replace the Funding Opportunity Announcement (FOAs) which will still
function as the full text of all funding opportunities for which
applications are sought and considered by the Administration for Native
Americans.
The proposed F.A.S.T. form will be used in a pilot capacity in just
one Administration for Native Americans' discretionary program areas:
Native American Language Preservation and Maintenance. All applicants
applying for funding in that program area will be required to use the
F.A.S.T. form during the pilot competition proposed for FY16 unless
they request and receive approval to submit a paper application. By
using the F.A.S.T. form no applicant will be required to provide any
information beyond what is already required by the FOA. Additionally,
free training and technical assistance will be available to all
applicants on use of the F.A.S.T. form.
ANA intends to use the project proposals submitted via the F.A.S.T.
form to make funding decisions for Native American Language
Preservation and Maintenance grant awards made in the FY 2016 pilot
year. In addition, ANA will solicit feedback from applicants and panel
reviewers to obtain feedback on the results, outcomes, and their
recommendations regarding the F.A.S.T. form as a user friendly method
of applying for funding opportunities. If the pilot is successful in
making it easier for applicants to apply, ANA will consider potentially
expanding use of the F.A.S.T. form to all Administration for Native
Americans' discretionary funding areas in subsequent years.
Respondents: 40.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
F.A.S.T. form............................... 40 28 .50 14
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 560.
Additional Information
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Planning, Research
and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn:
ACF Reports Clearance Officer. All requests should be identified by the
title of the information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision concerning the collection of
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information
collection should be sent directly to the following: Office of
Management and Budget, Paperwork Reduction Project, Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
[[Page 62537]]
Attn: Desk Officer for the Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-26320 Filed 10-15-15; 8:45 am]
BILLING CODE 4184-01-P
