Agency Information Collection Activities: Proposed Collection; Comment Request, 11792-11793 [2014-04613]
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Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices
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.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Forms (If necessary)
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
(hours)
CRM Tool .................................
Total ...................................
Regional Extension Center .......
...................................................
62
............................
12
............................
1.5
............................
Darius Taylor,
Deputy, Information Collection Clearance
Officer.
[FR Doc. 2014–04484 Filed 2–28–14; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10054]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
ACTION: Notice.
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
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 (the
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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 must be received by
April 29, 2014.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number (OCN). To be
VerDate Mar<15>2010
19:40 Feb 28, 2014
Jkt 232001
assured consideration, comments and
recommendations must be submitted in
any one of the following ways:
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 lllll, Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
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,
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:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collection. More
detailed information can be found in the
collection’s supporting statement and
associated materials (see ADDRESSES).
CMS–10054 Recognition of Payment for
New Technology Services for New
Technology Ambulatory Payment
Classification (APC) Groups Under the
Outpatient Prospective Payment System
and Supporting Regulations in 42 CFR
part 419.
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Frm 00043
Fmt 4703
Sfmt 4703
Total burden
hours
1080
1080
Under the Paperwork ReductionAct
(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
requires federal agencies to publish a
60-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.
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Recognition of
Payment for New Technology Services
for New Technology Ambulatory
Payment Classification (APC) Groups
Under the Outpatient Prospective
Payment System and Supporting
Regulations in 42 CFR part 419; Use:
CMS needs to keep pace with emerging
new technologies and make them
accessible to Medicare beneficiaries in a
timely manner. It is necessary that we
continue to collect appropriate
information from interested parties such
as hospitals, medical device
manufacturers, pharmaceutical
companies and others that bring to our
attention specific services that they
wish us to evaluate for New Technology
APC payment. Form Number: CMS–
10054 (OCN: 0938–0860); Frequency:
Once; Affected Public: Private sector
(business or other for-profits); Number
of Respondents: 10; Total Annual
Responses: 10; Total Annual Hours:
160. (For policy questions regarding this
collection contact Barry Levi at 410–
786–4529).
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03MRN1
Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices
Dated: February 26, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–04613 Filed 2–28–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0053]
Revised Draft Guidance for Industry on
Distributing Scientific and Medical
Publications on Unapproved New
Uses—Recommended Practices;
Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘Distributing
Scientific and Medical Publications on
Unapproved New Uses—Recommended
Practices.’’ This draft guidance revises
the final guidance titled ‘‘Good Reprint
Practices for the Distribution of Medical
Journal Articles and Medical or
Scientific Reference Publications on
Unapproved New Uses of Approved
Drugs and Approved or Cleared Medical
Devices’’ published in January 2009.
The revised draft guidance provides
guidance on FDA’s current thinking on
recommended practices for drug or
medical device manufacturers and their
representatives to follow when
distributing to health care professionals
or health care entities scientific or
medical journal articles, scientific or
medical reference texts, or clinical
practice guidelines ((CPGs); all three
collectively referred to as ‘‘scientific and
medical publications’’) that discuss
unapproved new uses for approved
drugs or approved or cleared medical
devices marketed in the United States.
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 comments 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 May 2, 2014.
Submit either electronic or written
comments on the proposed collection of
information by May 2, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
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19:40 Feb 28, 2014
Jkt 232001
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448; or to the Division of
Small Manufacturers, International and
Consumer Assistance, Office of
Communication, Education and
Radiation Programs, 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 selfaddressed adhesive label to assist the
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
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.
FOR FURTHER INFORMATION CONTACT:
Regarding prescription drugs: Bryant
Godfrey, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave, Bldg. 51, Rm. 3258, Silver Spring,
MD 20993–0002, 301–796–1200.
Regarding prescription biological
products: Stephen Ripley, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6210.
Regarding medical devices: Deborah
Wolf, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3414, Silver Spring,
MD 20993–0002, 301–796–5732.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Distributing Scientific and
Medical Publications on Unapproved
New Uses—Recommended Practices.’’
This draft guidance describes
recommended practices for drug or
medical device manufacturers or their
representatives to follow when
distributing to health care professionals
or health care entities scientific and
medical publications that discuss
unapproved new uses of approved drugs
or approved or cleared medical devices.
In January 2009, FDA published a
final guidance titled ‘‘Good Reprint
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Fmt 4703
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11793
Practices for the Distribution of Medical
Journal Articles and Medical or
Scientific Reference Publications on
Unapproved New Uses of Approved
Drugs and Approved or Cleared Medical
Devices,’’ which set forth the Agency’s
thinking as of that time regarding the
dissemination by manufacturers of
medical journal articles and scientific or
medical reference publications that
discuss unapproved or uncleared uses
of medical products.1 FDA received
comments to the docket for the 2009
guidance, including submissions
requesting clarification of how the
principles set forth in the 2009 guidance
would apply to medical textbooks and
potential changes to those principles.
In July 2011 and September 2013,
FDA received citizen petitions, filed on
behalf of multiple prescription drug and
medical device manufacturers, that
include several requests related to
FDA’s approach to the distribution of
scientific and medical information
reflecting unapproved or uncleared
uses, specifically including CPGs.2 FDA
continues to consider the specific
requests made in the citizen petitions,
which include requests for issuance or
revision of regulations, and has not yet
reached a final determination on those
petitions.
At the same time, FDA continues
actively to review, analyze, and develop
approaches to a variety of topics of
interest to industry and others,
including issues raised in the petition.
As part of this process, FDA is soliciting
public comment on the draft guidance
made available here. Similarly, as part
of the Agency’s ongoing efforts to
address industry questions, FDA
continues to solicit public input and
consider approaches with respect to
several related issues, including the
following:
(1) Further explaining ‘‘scientific
exchange.’’ On December 28, 2011, FDA
issued a Federal Register notice (76 FR
81508) opening a docket and requesting
comments and information related to
‘‘scientific exchange.’’ Comments were
submitted to Docket No. FDA–2011–N–
0912. FDA is reviewing those comments
and considering how that information
may inform future Agency action related
to its policies on communications and
activities related to unapproved or
uncleared uses of marketed drugs and
devices, as well as communications and
activities related to use of products that
are not yet legally marketed for any use.
1 Please visit https://www.regulations.gov and
enter docket number FDA–2008–D–0053.
2 Please visit https://www.regulations.gov and
enter docket numbers FDA–2011–P–0512 and FDA–
2013–P–1079.
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Agencies
[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Notices]
[Pages 11792-11793]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04613]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10054]
Agency Information Collection Activities: Proposed Collection;
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 (the 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 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates 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 must be received by April 29, 2014.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number (OCN). To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
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.
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:
Contents
This notice sets out a summary of the use and burden associated
with the following information collection. More detailed information
can be found in the collection's supporting statement and associated
materials (see ADDRESSES). CMS-10054 Recognition of Payment for New
Technology Services for New Technology Ambulatory Payment
Classification (APC) Groups Under the Outpatient Prospective Payment
System and Supporting Regulations in 42 CFR part 419.
Under the Paperwork ReductionAct (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 requires federal agencies to publish a 60-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.
Information Collection
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Recognition of
Payment for New Technology Services for New Technology Ambulatory
Payment Classification (APC) Groups Under the Outpatient Prospective
Payment System and Supporting Regulations in 42 CFR part 419; Use: CMS
needs to keep pace with emerging new technologies and make them
accessible to Medicare beneficiaries in a timely manner. It is
necessary that we continue to collect appropriate information from
interested parties such as hospitals, medical device manufacturers,
pharmaceutical companies and others that bring to our attention
specific services that they wish us to evaluate for New Technology APC
payment. Form Number: CMS-10054 (OCN: 0938-0860); Frequency: Once;
Affected Public: Private sector (business or other for-profits); Number
of Respondents: 10; Total Annual Responses: 10; Total Annual Hours:
160. (For policy questions regarding this collection contact Barry Levi
at 410-786-4529).
[[Page 11793]]
Dated: February 26, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2014-04613 Filed 2-28-14; 8:45 am]
BILLING CODE 4120-01-P