Agency Information Collection Activities: Submission for OMB Review; Comment Request, 25596-25597 [2014-10228]
Download as PDF
25596
Federal Register / Vol. 79, No. 86 / Monday, May 5, 2014 / Notices
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2014–10144 Filed 5–2–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below
concerns Research to Prevent
Prescription Drug Overdoses, Funding
Opportunity Announcement CE14–002,
initial review.
SUMMARY: This document corrects a
notice that was published in the Federal
Register on April 17, 2014 (79 FR
21759). The time and date should read
as follows:
TIME AND DATE: 12:00 p.m.–7:00 p.m.,
May 7, 2014 (Closed).
FOR FURTHER INFORMATION CONTACT: Jane
Suen, Dr. P.H., M.S., Scientific Review
Officer, CDC, 4770 Buford Highway NE.,
Mailstop F63, Atlanta, Georgia 30341–
3724, Telephone: (770) 488–4281,
JSuen@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2014–10145 Filed 5–2–14; 8:45 am]
BILLING CODE 4163–18–P
emcdonald on DSK67QTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10495]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
VerDate Mar<15>2010
17:56 May 02, 2014
Jkt 232001
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: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES: Comments must be received by
June 2, 2014.
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
CMS or the OMB desk officer via one of
the following transmissions:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number llll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
3. 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.
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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: Registration,
Attestation, Dispute & Resolution,
Assumptions Document and Data
Retention Requirements for Open
Payments; Use: Section 6002 of the
Affordable Care Act added section
1128G to the Social Security Act (Act),
which requires applicable
manufacturers and applicable group
purchasing organizations (GPOs) of
covered drugs, devices, biologicals, or
medical supplies to report annually to
CMS certain payments or other transfers
of value to physicians and teaching
hospitals, as well as, certain information
regarding the ownership or investment
interests held by physicians or their
immediate family members in
applicable manufacturers or applicable
GPOs.
Specifically, applicable manufacturers
of covered drugs, devices, biologicals,
and medical supplies are required to
submit on an annual basis the
information required in section
1128G(a)(1) of the Act about certain
payments or other transfers of value
made to physicians and teaching
hospitals (collectively called covered
recipients) during the course of the
E:\FR\FM\05MYN1.SGM
05MYN1
emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 86 / Monday, May 5, 2014 / Notices
preceding calendar year. Similarly,
section 1128G(a)(2) of the Act requires
applicable manufacturers and
applicable GPOs to disclose any
ownership or investment interests in
such entities held by physicians or their
immediate family members, as well as
information on any payments or other
transfers of value provided to such
physician owners or investors.
Applicable manufacturers must report
the required payment and other transfer
of value information annually to CMS in
an electronic format. The statute also
provides that applicable manufacturers
and applicable GPOs must report
annually to CMS the required
information about physician ownership
and investment interests, including
information on any payments or other
transfers of value provided to physician
owners or investors, in an electronic
format by the same date. Applicable
manufacturers and applicable GPOs are
subject to civil monetary penalties
(CMPs) for failing to comply with the
reporting requirements of the statute.
We are required by statute to publish
the reported data on a public Web site.
The data must be downloadable, easily
searchable, and aggregated. In addition,
we must submit annual reports to the
Congress and each state summarizing
the data reported. Finally, section
1128G of the Act generally preempts
state laws that require disclosure of the
same type of information by
manufacturers.
With this notice, we are announcing
the addition of the dispute resolution
and corrections process to this
information collection request (ICR).
The dispute resolution and corrections
process was discussed in our initial
submission to OMB. However, based on
the detailed processes of review and
corrections as well as the sensitivities
around these processes, we felt it
appropriate to solicit additional public
feedback on how these interactions
would occur. Therefore we are
resubmitting a revised ICR for OMB
review and approval. While we are
submitting a revision of the entire ICR,
we are specifically seeking comments
on the dispute resolution and comment
process. Form Number: CMS–10495
(OCN: 0938–1237); Frequency: Once;
Affected Public: Private sector—
business or other for-profits; Number of
Respondents: 227,157; Total Annual
Responses: 457,454; Total Annual
Hours: 3,099,297. (For policy questions
regarding this collection contact Melissa
Heesters at 410–786–0618.)
VerDate Mar<15>2010
17:56 May 02, 2014
Jkt 232001
Dated: April 30, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–10228 Filed 5–1–14; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0435]
Surveying, Leveling, or Alignment
Laser Products; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Surveying, Leveling, or
Alignment Laser Products.’’ This draft
guidance, in question and answer
format, is intended for manufacturers of
laser products and outlines the FDA’s
proposed approach regarding the
applicability of FDA’s performance
standard regulations to surveying,
leveling, or alignment (SLA) laser
products. SLA lasers are a subcategory
of specific-purpose laser products that
transmit laser radiation through open
space for surveying, alignment, or
leveling purposes. The draft guidance is
not final nor is in effect at this time.
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 this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 4, 2014.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Surveying,
Leveling, or Alignment Laser Products’’
to the Office of the Center Director,
Guidance and Policy Development,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 4613, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to 301–
847–8149. See the SUPPLEMENTARY
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
25597
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Robert J. Doyle, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4672, Silver Spring,
MD 20993–0002, 301–796–5863.
I. Background
This draft guidance is intended to
provide a brief summary of the FDA’s
proposed approach on the applicability
of performance standards for laser
products to specific purpose SLA laser
products. An SLA laser product is
defined in 21 CFR 1040.10(b)(39) as ‘‘a
laser product manufactured, designed,
intended or promoted for one or more
of the following uses: (i) Determining
and delineating the form, extent, or
position of a point, body, or area by
taking angular measurement, (ii)
positioning or adjusting parts in proper
relation to one another, (iii) defining a
plane, level, elevation, or straight line.’’
The topics that are addressed include
the definition of an SLA laser product,
examples of SLA laser products, design
features of SLA laser products, the
applicability of class limits to SLA laser
products, and questions and answers
relating to the application of FDA’s
performance standard regulations to
SLA laser products.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on surveying, leveling, or alignment
laser products. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
E:\FR\FM\05MYN1.SGM
05MYN1
Agencies
[Federal Register Volume 79, Number 86 (Monday, May 5, 2014)]
[Notices]
[Pages 25596-25597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10228]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10495]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
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: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
DATES: Comments must be received by June 2, 2014.
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
CMS or the OMB desk officer via one of the following transmissions:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number --------, Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
3. 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: Registration,
Attestation, Dispute & Resolution, Assumptions Document and Data
Retention Requirements for Open Payments; Use: Section 6002 of the
Affordable Care Act added section 1128G to the Social Security Act
(Act), which requires applicable manufacturers and applicable group
purchasing organizations (GPOs) of covered drugs, devices, biologicals,
or medical supplies to report annually to CMS certain payments or other
transfers of value to physicians and teaching hospitals, as well as,
certain information regarding the ownership or investment interests
held by physicians or their immediate family members in applicable
manufacturers or applicable GPOs.
Specifically, applicable manufacturers of covered drugs, devices,
biologicals, and medical supplies are required to submit on an annual
basis the information required in section 1128G(a)(1) of the Act about
certain payments or other transfers of value made to physicians and
teaching hospitals (collectively called covered recipients) during the
course of the
[[Page 25597]]
preceding calendar year. Similarly, section 1128G(a)(2) of the Act
requires applicable manufacturers and applicable GPOs to disclose any
ownership or investment interests in such entities held by physicians
or their immediate family members, as well as information on any
payments or other transfers of value provided to such physician owners
or investors. Applicable manufacturers must report the required payment
and other transfer of value information annually to CMS in an
electronic format. The statute also provides that applicable
manufacturers and applicable GPOs must report annually to CMS the
required information about physician ownership and investment
interests, including information on any payments or other transfers of
value provided to physician owners or investors, in an electronic
format by the same date. Applicable manufacturers and applicable GPOs
are subject to civil monetary penalties (CMPs) for failing to comply
with the reporting requirements of the statute. We are required by
statute to publish the reported data on a public Web site. The data
must be downloadable, easily searchable, and aggregated. In addition,
we must submit annual reports to the Congress and each state
summarizing the data reported. Finally, section 1128G of the Act
generally preempts state laws that require disclosure of the same type
of information by manufacturers.
With this notice, we are announcing the addition of the dispute
resolution and corrections process to this information collection
request (ICR). The dispute resolution and corrections process was
discussed in our initial submission to OMB. However, based on the
detailed processes of review and corrections as well as the
sensitivities around these processes, we felt it appropriate to solicit
additional public feedback on how these interactions would occur.
Therefore we are resubmitting a revised ICR for OMB review and
approval. While we are submitting a revision of the entire ICR, we are
specifically seeking comments on the dispute resolution and comment
process. Form Number: CMS-10495 (OCN: 0938-1237); Frequency: Once;
Affected Public: Private sector--business or other for-profits; Number
of Respondents: 227,157; Total Annual Responses: 457,454; Total Annual
Hours: 3,099,297. (For policy questions regarding this collection
contact Melissa Heesters at 410-786-0618.)
Dated: April 30, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2014-10228 Filed 5-1-14; 11:15 am]
BILLING CODE 4120-01-P