Agency Information Collection Activities: Submission for OMB Review; Comment Request, 62503-62504 [2016-21625]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
whether such items are in written form,
in the form of computer data, or in any
other form, for a period of three years
after final payment. This information is
necessary for examination and audit of
contract surveillance, verification of
contract pricing, and to provide
reimbursement of contractor costs,
where applicable. The records retention
period is required by the statutory
authorities at 10 U.S.C. 2313, 41 U.S.C.
254, and 10 U.S.C. 2306, and are
implemented through the following
clauses: Audit and Records-Negotiation
clause, 52.215–2; Contract Terms and
Conditions Required to Implement
Statutes or Executive OrdersCommercial Items clause, 52.212–5; and
Audit and Records-Sealed Bidding
clause, 52.214–26. This information
collection does not require contractors
to create or maintain any records that
the contractor does not normally
maintain in its usual course of business.
B. Annual Reporting Burden
Respondents: 14,830.
Responses per Respondent: 10.
Total number of responses: 148,300.
Hours per Response: 1.0.
Total Burden Hours: 148,300.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the Federal
Acquisition Regulation (FAR), and
whether it will have practical utility;
whether our estimate of the public
burden of this collection of information
is accurate, and based on valid
assumptions and methodology and ways
to enhance the quality, utility, and
clarity of the information to be
collected.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control Number 9000–0034,
Examination of Records by Comptroller
General and Contract Audit, in all
correspondence.
Dated: September 6, 2016.
Lorin S. Curit,
Director, Federal Acquisition Policy, Office
of Government-wide Acquisition Policy,
Office of Acquisition Policy, Office of
Government-wide Policy.
[FR Doc. 2016–21721 Filed 9–8–16; 8:45 am]
BILLING CODE 6820–EP–P
VerDate Sep<11>2014
17:11 Sep 08, 2016
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10328]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; the accuracy of
the estimated burden; ways to enhance
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.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by October 11, 2016.
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’ Web site address at
https://www.cms.hhs.gov/Paperwork
ReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
62503
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
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: Revision of a currently
approved collection; Title of
Information Collection: Medicare SelfReferral Disclosure Protocol; Use: The
Affordable Care Act (‘‘ACA’’) was
enacted on March 23, 2010. Section
6409 of the ACA requires the Secretary
of the Department of Health and Human
Services (the ‘‘Secretary’’), in
cooperation with the Office of Inspector
General of the Department of Health and
Human Services, to establish a Medicare
self-referral disclosure protocol
(‘‘SRDP’’). The SRDP enables providers
of services and suppliers to self-disclose
actual or potential violations of the
physician self-referral statute, section
1877 of the Social Security Act (the
‘‘Act’’). Section 6409(b) of the ACA
gives the Secretary the authority to
reduce the amount due and owing for
all violations of section 1877 of the Act.
In establishing the amount by which an
overpayment may be reduced, the
Secretary may consider: the nature and
extent of the improper or illegal
practice; the timeliness of the selfdisclosure; the cooperation in providing
additional information related to the
disclosure; and such other factors as the
Secretary considers appropriate.
In accordance with the ACA, CMS
established the SRDP on September 23,
2010, and information concerning how
E:\FR\FM\09SEN1.SGM
09SEN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
62504
Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
to disclose an actual or potential
violation of section 1877 of the Act was
posted on the CMS Web site. The most
recent approval of this information
collection request (‘‘ICR’’) was issued by
the Office of Management and Budget
on August 26, 2014.
We are now seeking approval to revise
the currently approved ICR. Under the
currently approved collection, a party
must provide a financial analysis of
overpayments arising from actual or
potential violations of section 1877 of
the Act based on a 4-year lookback
period. On February 12, 2016, CMS
published a final rule on the reporting
and returning of overpayments. See
CMS- 6037–F, Medicare Program;
Reporting and Returning of
Overpayments, 81 FR 7654 (Feb. 12,
2016) (the ‘‘final overpayment rule’’).
The final overpayment rule establishes
a 6-year lookback period for reporting
and returning overpayments. We are
revising the information collection for
the SRDP to reflect the 6-year lookback
period established by the final
overpayment rule. The revision is
necessary to ensure that parties
submitting self-disclosures to the SRDP
report overpayments for the entire 6year lookback period. The 6-year
lookback period applies only to
submissions to the SRDP received on or
after March 14, 2016, the effective date
of the final overpayment rule; parties
submitting self-disclosures to the SRDP
prior to March 14, 2016 need only
provide a financial analysis of potential
overpayments based on a 4-year
lookback period.
We are also taking the opportunity to
streamline and simplify the SRDP by
issuing a required form for SRDP
submissions. The SRDP Form will
reduce the burden on disclosing parties
by reducing the amount of information
that is required for submissions to the
SRDP and providing a streamlined and
standardized format for the presentation
of the required information. Form
Number: CMS–10328 (OMB control
number: 0938–1106); Frequency:
Annually and semi-annually; Affected
Public: Private sector (Business or other
for-profits and Not-for-profits); Number
of Respondents: 200; Total Annual
Responses: 200; Total Annual Hours:
5,000. (For policy questions regarding
this collection contact Matt Edgar at
410–786–0698).
Dated: September 2, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–21625 Filed 9–8–16; 8:45 am]
BILLING CODE 4120–01–P
VerDate Sep<11>2014
17:11 Sep 08, 2016
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Blood Products Advisory Committee
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Blood Products Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public.
DATES: The meeting will be held on
November 17, 2016, from 8 a.m. to 5:30
p.m. and on November 18, 2016, from
8:30 a.m. to 1 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD, 20993–
0002. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
LCDR Bryan Emery or Joanne Lipkind,
Division of Scientific Advisors and
Consultants, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, Bldg. 71, Rm. 6132, at 240–
402–8054, bryan.emery@fda.hhs.gov
and 240–402–8106, joanne.lipkind@
fda.hhs.gov, respectively, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting. For those unable to attend in
person, the meeting will also be
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
available via Webcast. The Webcast will
be available at the following link for
both days: https://collaboration.fda.gov/
bpac1116/.
SUPPLEMENTARY INFORMATION:
Agenda: On the morning of November
17, 2016, the Committee will meet in
open session to discuss strategies to
manage iron deficiency associated with
blood donation. The Committee will
also discuss proposed procedures for
assuring donor safety for collections of
blood from female donors with
hemoglobin values of 12.0–12.4g/dL or
a hematocrit value between 36 and 38.
In the afternoon, the Committee will
meet in open session to discuss adverse
reactions related to blood donation in
teenage (16 to 18 years) donors, and the
effectiveness of several mitigation
measures. On November 18, 2016, the
Committee will meet in open session to
hear an informational session on Zika
virus and blood safety in the United
States. Following the informational
session, the Committee will hear
presentations on the following topics:
(1) The Transfusion Transmissible
Infections Monitoring System; (2) a
summary of the FDA workshop on new
methods to predict the immunogenicity
of therapeutic coagulation proteins; and
(3) a summary of the FDA workshop on
preclinical evaluation of red blood cells
for transfusion.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before November 4, 2016.
Oral presentations from the public will
be scheduled between approximately 11
a.m. to 11:45 a.m. and 4 p.m. to 4:30
p.m. on November 17, 2016. Oral
presentations from the public will also
be scheduled between approximately
10:30 a.m. and 11 a.m. and 12:30 p.m.
to 1 p.m. on November 18, 2016. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62503-62504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21625]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10328]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including any of the following subjects: The
necessity and utility of the proposed information collection for the
proper performance of the agency's functions; the accuracy of the
estimated burden; ways to enhance 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.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by October 11, 2016.
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' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
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: Reports Clearance Office at (410) 786-
1326.
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: Revision of a currently
approved collection; Title of Information Collection: Medicare Self-
Referral Disclosure Protocol; Use: The Affordable Care Act (``ACA'')
was enacted on March 23, 2010. Section 6409 of the ACA requires the
Secretary of the Department of Health and Human Services (the
``Secretary''), in cooperation with the Office of Inspector General of
the Department of Health and Human Services, to establish a Medicare
self-referral disclosure protocol (``SRDP''). The SRDP enables
providers of services and suppliers to self-disclose actual or
potential violations of the physician self-referral statute, section
1877 of the Social Security Act (the ``Act''). Section 6409(b) of the
ACA gives the Secretary the authority to reduce the amount due and
owing for all violations of section 1877 of the Act. In establishing
the amount by which an overpayment may be reduced, the Secretary may
consider: the nature and extent of the improper or illegal practice;
the timeliness of the self-disclosure; the cooperation in providing
additional information related to the disclosure; and such other
factors as the Secretary considers appropriate.
In accordance with the ACA, CMS established the SRDP on September
23, 2010, and information concerning how
[[Page 62504]]
to disclose an actual or potential violation of section 1877 of the Act
was posted on the CMS Web site. The most recent approval of this
information collection request (``ICR'') was issued by the Office of
Management and Budget on August 26, 2014.
We are now seeking approval to revise the currently approved ICR.
Under the currently approved collection, a party must provide a
financial analysis of overpayments arising from actual or potential
violations of section 1877 of the Act based on a 4-year lookback
period. On February 12, 2016, CMS published a final rule on the
reporting and returning of overpayments. See CMS- 6037-F, Medicare
Program; Reporting and Returning of Overpayments, 81 FR 7654 (Feb. 12,
2016) (the ``final overpayment rule''). The final overpayment rule
establishes a 6-year lookback period for reporting and returning
overpayments. We are revising the information collection for the SRDP
to reflect the 6-year lookback period established by the final
overpayment rule. The revision is necessary to ensure that parties
submitting self-disclosures to the SRDP report overpayments for the
entire 6-year lookback period. The 6-year lookback period applies only
to submissions to the SRDP received on or after March 14, 2016, the
effective date of the final overpayment rule; parties submitting self-
disclosures to the SRDP prior to March 14, 2016 need only provide a
financial analysis of potential overpayments based on a 4-year lookback
period.
We are also taking the opportunity to streamline and simplify the
SRDP by issuing a required form for SRDP submissions. The SRDP Form
will reduce the burden on disclosing parties by reducing the amount of
information that is required for submissions to the SRDP and providing
a streamlined and standardized format for the presentation of the
required information. Form Number: CMS-10328 (OMB control number: 0938-
1106); Frequency: Annually and semi-annually; Affected Public: Private
sector (Business or other for-profits and Not-for-profits); Number of
Respondents: 200; Total Annual Responses: 200; Total Annual Hours:
5,000. (For policy questions regarding this collection contact Matt
Edgar at 410-786-0698).
Dated: September 2, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2016-21625 Filed 9-8-16; 8:45 am]
BILLING CODE 4120-01-P
