Surveying, Leveling, or Alignment Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 25597-25598 [2014-10189]
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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
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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
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Fmt 4703
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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
25598
Federal Register / Vol. 79, No. 86 / Monday, May 5, 2014 / Notices
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov.
To receive the ‘‘Surveying, Leveling,
or Alignment Laser Products’’ draft
guidance you may send an email request
to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the
document. Please use the document
number 1764 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 1040.10 and
1040.11 have been approved under
OMB control number 0910–0025.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: April 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–10189 Filed 5–2–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:56 May 02, 2014
Jkt 232001
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than June 4, 2014.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Patient Survey-Health Centers OMB No.
0915–0368—New.
Abstract: HRSA’s Health Center
Program awards grants to provide
primary and preventive health care
services to medically underserved and
vulnerable populations. The proposed
Health Center Patient Survey (HCPS)
will collect national, in-depth
information about health center
patients, their health status, the reasons
they seek care at the health centers,
their diagnoses, the services they utilize
at health centers and elsewhere, the
quality of those services, and their
satisfaction with the care they receive
through personal interviews of a
stratified random sample of health
center patients. Interviews conducted in
the national study are estimated to take
approximately 1 hour and 15 minutes
each.
The HCPS builds on previous
periodic Patient User-Visit Surveys
which were conducted to learn about
the process and outcomes of care in
health centers reaching goals under the
Health Center Program. The original
questionnaires were derived from the
National Health Interview Survey
(NHIS) and the National Ambulatory
Medical Care Survey (NAMCS)
conducted by the National Center for
Health Statistics (NCHS). Conformance
with the NHIS and NAMCS allowed
comparisons between these NCHS
surveys and the previous Patient UserVisit Surveys. The new HCPS was
developed using a questionnaire
methodology similar to that used in the
past, and will also potentially allow
some time-trend comparisons for health
centers with the previous Patient UserVisit Survey data, including monitoring
of processes and outcomes over time. In
addition, this survey will be conducted
in languages not used during previous
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surveys (English and Spanish) to
include patients from different racial
and ethnic backgrounds, including
Chinese (Mandarin and Cantonese),
Korean, and Vietnamese. With the
exception of Spanish speakers, other
racial and ethnic subgroups were not
able to participate in the previous
surveys.
Need and Proposed Use of the
Information: The HCPS is unique in its
effort to capture national, person-level
data from patients of all types of Health
Center Program grantees. The data
collected from the HCPS will be used to:
• Gather nationally representative
data about the patients of the programs
and the services they obtain;
• enable comparisons of care received
by health center patients with care
received by the general population, as
measured by NHIS and other national
surveys;
• assess how well HRSA-supported
health centers are currently able to meet
health care needs;
• identify areas for improvement and
guide planning decisions; and
• complement data that are not
routinely collected from other Bureau of
Primary Health Care data sources.
The specific priorities for analysis
will be comparisons of health center
patients with patients served in other
primary care settings with respect to:
• Access to care;
• health disparities;
• health conditions;
• quality of care;
• care coordination; and
• patient experience.
Comparisons will be made with
results from national surveys and with
results from the 2009 Patient Survey.
Likely Respondents: Health center
patients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
E:\FR\FM\05MYN1.SGM
05MYN1
Agencies
[Federal Register Volume 79, Number 86 (Monday, May 5, 2014)]
[Notices]
[Pages 25597-25598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10189]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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 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/
[[Page 25598]]
GuidanceDocuments/default.htm. Guidance documents are also available at
https://www.regulations.gov.
To receive the ``Surveying, Leveling, or Alignment Laser Products''
draft guidance you may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document.
Please use the document number 1764 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 1040.10 and 1040.11 have been
approved under OMB control number 0910-0025.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: April 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10189 Filed 5-2-14; 8:45 am]
BILLING CODE 4160-01-P