Proposed Information Collection Activity; Comment Request Proposed Projects, 18917-18918 [2014-07530]
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18917
Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Notices
verification is required for psychiatric
hospitals. Some verification is needed,
however, to ensure that other types of
hospitals and units meet the criteria for
exclusion. Consequently, we instructed
the Fiscal Intermediaries (FIs) and SAs
to perform certain verification activities,
beginning in October 1983 when PPS
was implemented. We originally
developed the CMS–437 as an SA
Worksheet for verifying exclusions from
PPS for psychiatric units.
Since April 9, 1994, PPS-excluded
psychiatric units already excluded from
the PPS have met CMS’s annual
requirement for PPS-exclusion by selfattesting that they remain in compliance
with the PPS exclusion criteria. Under
the current procedure, all psychiatric
units applying for first-time exclusion
are surveyed by the SAs. The SAs also
perform surveys to investigate
complaint allegations and conduct
annual sample reverification surveys on
5 percent of all psychiatric units. The
aforementioned exclusions continue to
exist and thus we propose to continue
to use the Criteria Worksheet, Forms
CMS–437, for verifying first-time
exclusions from the PPS, for complaint
surveys, for its annual 5 percent
validation sample, and for facility selfattestation. These forms are related to
the survey and certification and
Medicare approval of the PPS-excluded
units. Form Number: CMS–437 (OCN:
0938–0358); Frequency: Annually;
Affected Public: Private sector—
Business or other for-profits; Number of
Respondents: 1,614; Total Annual
Responses: 1,614; Total Annual Hours:
Dated: April 1, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
404. (For policy questions regarding this
collection contact Donald Howard at
410–786–6764.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Disclosure for
the In-Office Ancillary Services
Exception; Use: Physicians who provide
certain imaging services (magnetic
resonance imaging, computed
tomography, and positron emission
tomography) under the in-office
ancillary services exception to the
physician self-referral prohibition are
required to create the disclosure notice
as well as the list of other imaging
suppliers to be provided to the patient.
The patient will then be able to use the
disclosure notice and list of suppliers in
making an informed decision about his
or her course of care for the imaging
service. The physician must maintain a
record of the disclosure in the patient’s
medical record. If we were investigating
the referrals of a physician providing
advanced imaging services under the inoffice ancillary services exception, we
would review the written disclosure in
order to determine if the physician
satisfied the requirement. Form
Number: CMS–10332 (OCN: 0938–
1133); Frequency: Occasionally;
Affected Public: Private sector—
Business or other for-profits; Number of
Respondents: 71,000; Total Annual
Responses: 71,106; Total Annual Hours:
125,383. (For policy questions regarding
this collection contact Jacqueline
Proctor at 410–786–8852).
[FR Doc. 2014–07582 Filed 4–3–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request Proposed
Projects
Title: Family Violence Prevention and
Services: Grants to States; Native
American Tribes and Alaskan Native
Villages; and State Domestic Violence
Coalitions
OMB No.: 0970–0280
Description: The Family Violence
Prevention and Services Act (FVPSA),
42 U.S.C. 10401 et seq., authorizes the
Department of Health and Human
Services to award grants to States,
Tribes—and Tribal Organizations, and
State Domestic Violence Coalitions for
family violence prevention and
intervention activities. The proposed
information collection activities will be
used to make grant award decisions and
to monitor grant performance.
Respondents: State Agencies
Administering FVPSA Grants; Tribal
Governments and Tribal Organizations;
and State Domestic Violence Coalitions.
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
53
150
56
53
150
56
1
1
1
1
1
1
10
5
10
10
10
10
530
750
560
530
1,500
560
Estimated Total Annual Burden Hours .....................................................
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State Grant Application ....................................................................................
Tribal Grant Application ...................................................................................
State Domestic Violence Coalition Application ................................................
State FVPSA Grant Performance Progress Report ........................................
Tribal FVPSA Grant Performance Progress Report ........................................
State Domestic Violence Coalition Performance Progress Report .................
........................
........................
........................
4,430
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
VerDate Mar<15>2010
17:37 Apr 03, 2014
Jkt 232001
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
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Sfmt 4703
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
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04APN1
18918
Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Notices
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–07530 Filed 4–3–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0147]
Types of Communication During the
Review of Medical Device
Submissions; 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 guidance entitled
‘‘Types of Communication During the
Review of Medical Device
Submissions.’’ The purpose of this
guidance is to update the Agency’s
approach to Interactive Review and
other additional types of
communication, to reflect FDA’s
implementation of the Medical Device
User Fee Act of 2007 (MDUFA II)
Commitment Letters and of
undertakings agreed to in connection
with the Medical Device User Fee
Amendments of 2012 (MDUFA III).
These new Agency communication
commitments are to increase the
efficiency of the review process.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
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
single copies of the guidance document
entitled ‘‘Types of Communication
During the Review of Medical Device
Submissions’’ 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. 5431, Silver Spring,
MD 20993–0002 or the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Administration, 1401
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:37 Apr 03, 2014
Jkt 232001
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed 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
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:
Samie Allen, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1533, Silver Spring,
MD 20993–0002, 301–796–6055, or
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.
SUPPLEMENTARY INFORMATION:
I. Background
In the letters dated September 27,
2007, from the Secretary of Health and
Human Services to the Chairman of the
Committee on Health, Education, Labor,
and Pensions of the U.S. Senate and the
Chairman of the Committee on Energy
and Commerce of the U.S. House of
Representatives setting out the goals of
section 201(c) of MDUFA II, Title II of
the Food and Drug Administration
Amendments of 2007 (FDAAA) (21
U.S.C. 379i note), FDA committed to
developing a guidance document that
describes an interactive review process
between FDA and industry for specific
medical device premarket submissions.
Further, during discussions with
representatives of the medical device
industry in the development of the
Agency’s recommendations for MDUFA
III, Title II of the Food and Drug
Administration Safety and Innovation
Act, Public Law 112–144 (July 9, 2012)
(21 U.S.C. 301 note), the Agency
proposed process improvements to
provide further transparency into the
review process, including new
communication commitments.
In the Federal Register on March 5,
2013 (78 FR 14305), FDA announced the
availability of the draft guidance
document. Interested persons were
invited to comment by June 3, 2013.
Four comments were received and, in
general, were supportive of the
guidance. However, the comments
contained multiple recommendations
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pertaining to the content of the guidance
and the need for clarification,
particularly for the Interactive Review
section. In response to these comments,
FDA revised the guidance document to
restructure the Interactive Review
section to clarify how this process
works and to include references to
additional submission types for which
Interactive Review pertains. Although
several commenters expressed concern
about FDA’s intention to limit the last
round of Interactive Review to 7 days,
we did not modify the guidance because
this approach is needed in order to
appropriately balance the intent of
interactive review with FDA’s
commitment to meet the performance
goals agreed upon as part of MDUFA III.
In response to comments regarding our
intention to limit the issuance of second
Additional Information (AI) letters for
510(k) submissions, the guidance was
modified slightly to clarify the
circumstances in which a second AI
letter might be issued, but remains
unchanged in explaining that these
circumstances will remain limited and
at FDA’s discretion. FDA will
continually assess any impacts that the
limited use of a second AI letter may
have, and, if needed, may consider
modifications to this approach. In
addition to modifications to the
Interactive Review section, we clarified
other items throughout the guidance,
and included Pre-Submissions as a
submission type subject to Acceptance
Communication. This document
supersedes ‘‘Interactive Review for
Medical Device Submissions: 510(k)s,
Original PMAs, PMA Supplements,
Original BLAs, and BLA Supplements’’
dated February 28, 2008.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on communication
during a medical device premarket
submission review to provide further
transparency into, and to increase the
efficiency of, the review process. 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 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/
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04APN1
Agencies
[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Notices]
[Pages 18917-18918]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07530]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Family Violence Prevention and Services: Grants to States;
Native American Tribes and Alaskan Native Villages; and State Domestic
Violence Coalitions
OMB No.: 0970-0280
Description: The Family Violence Prevention and Services Act
(FVPSA), 42 U.S.C. 10401 et seq., authorizes the Department of Health
and Human Services to award grants to States, Tribes--and Tribal
Organizations, and State Domestic Violence Coalitions for family
violence prevention and intervention activities. The proposed
information collection activities will be used to make grant award
decisions and to monitor grant performance.
Respondents: State Agencies Administering FVPSA Grants; Tribal
Governments and Tribal Organizations; and State Domestic Violence
Coalitions.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
State Grant Application......................... 53 1 10 530
Tribal Grant Application........................ 150 1 5 750
State Domestic Violence Coalition Application... 56 1 10 560
State FVPSA Grant Performance Progress Report... 53 1 10 530
Tribal FVPSA Grant Performance Progress Report.. 150 1 10 1,500
State Domestic Violence Coalition Performance 56 1 10 560
Progress Report................................
---------------------------------------------------------------
Estimated Total Annual Burden Hours......... .............. .............. .............. 4,430
----------------------------------------------------------------------------------------------------------------
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
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. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to
[[Page 18918]]
comments and suggestions submitted within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014-07530 Filed 4-3-14; 8:45 am]
BILLING CODE 4184-01-P