Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 18037-18038 [2014-06999]
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18037
Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices
this applicant seeks 789 days of patent
term extension.
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submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by May 30, 2014.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 29, 2014. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. 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. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
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that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: March 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07060 Filed 3–28–14; 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
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 within 30 days of this notice.
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:
Reconciliation Tool for the Teaching
Health Center Graduate Medical
Education Program.
OMB No.: 0915–0342–Extension.
Abstract: The Teaching Health Center
Graduate Medical Education (THCGME)
program, Section 340H of the Public
Health Service (PHS) Act, was
established by Section 5508 of Public
Law 111–148. The program supports
training for primary care residents
(including residents in family medicine,
internal medicine, pediatrics, internal
SUMMARY:
medicine pediatrics, obstetrics and
gynecology, psychiatry, general
dentistry, pediatric dentistry, and
geriatrics) in community based
ambulatory patient care settings.
The statute provides that eligible
Teaching Health Centers receive
payment for both direct and indirect
expenses associated with training
residents in community-based
ambulatory patient care centers. Direct
medical expenses payments are
designed to compensate eligible
teaching health centers for those
expenses directly associated with
resident training, while indirect medical
expenses payments are intended to
compensate for the additional costs of
training residents in such programs.
Need and Proposed Use of the
Information: THCGME program
payments are prospective payments and
the statute provides for a reconciliation
process, through which overpayments
may be recouped and underpayments
may be adjusted at the end of the fiscal
year. This data collection instrument
will gather information relating to the
numbers of residents in THCGME
training programs in order to reconcile
payments for both direct and indirect
expenses.
Likely Respondents: The likely
respondents to the THCGME
Reconciliation Tool are existing
THCGME program award recipients.
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.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
tkelley on DSK3SPTVN1PROD with NOTICES
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
THCGME Reconciliation Tool ..............................................
44
1
44
2
88
Total ..............................................................................
44
1
44
2
88
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18038
Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices
Dated: March 11, 2014.
Jackie Painter,
Deputy Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–06999 Filed 3–28–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: Generic Clearance
To Support the Safe to Sleep
Campaign at the Eunice Kennedy
Shriver National Institute for Child
Health and Human Development
(NICHD)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Child Health and Human
Development, the National Institutes of
Health, has submitted to the Office of
Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on December 30, 2013, pages
79472–79473 and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institute of Child Health and Human
Development, National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact: Dr. Sarah L. Glavin, Deputy
Director, Office of Science Policy,
Analysis and Communication, Eunice
Kennedy Shriver National Institute of
Child Health and Human Development,
National Institutes of Health, 31 Center
Drive, Room 2A18, Bethesda, Maryland
20892, or call a non-toll free number
(301) 496–1877 or Email your request,
including your address to glavins@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Generic
Clearance to Support the Safe to Sleep
Campaign at the Eunice Kennedy
Shriver National Institute for Child
Health and Human Development
(NICHD), 0925—NEW, Eunice Kennedy
Shriver National Institute of Child
Health and Human Development
(NICHD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This is a request for a new
generic clearance that would be used for
submissions specific to the Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
(NICHD) Safe to Sleep (STS) public
education campaign. Submissions for
the STS campaign will be used to assess
the understanding and reach of STS
campaign materials and messages, and
to monitor and improve campaign
activities such as training workshops
and overall implementation. The
purpose of this information collection is
to monitor and modify campaign
activities, to plan future campaign
activities, to develop messages and
materials, and to develop distribution
and outreach strategies that are effective
at communicating their message to bring
about the intended response, awareness,
and/or behavioral change for the target
audiences. This generic clearance will
enable the NICHD to: (1) More
efficiently assess the implementation of
campaign activities; (2) better
understand the target audiences’
knowledge, attitudes, and beliefs toward
STS messages and materials; (3) better
understand how the campaign activities
have influenced the target audiences’
behaviors and practices; and (4) monitor
and improve activities such as trainings,
and material/message development.
Having a way to gather feedback on the
FOR FURTHER INFORMATION CONTACT:
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STS campaign activities is critical to
assessing the reach and effect of
campaign efforts. Data collected for the
campaign can inform where future STS
campaign resources can produce the
most meaningful results.
Data collected for the STS campaign
generic clearance will be used by a
number of audiences, including STS
campaign staff, NICHD leadership, STS
campaign collaborators, Federal Sudden
and Unexpected Infant Deaths (SUID)/
Sudden Infant Death Syndrome (SIDS)
Workgroup members, SUID/SIDS
stakeholders, clinical and maternal/
child health professionals, parents and
caretakers, and the general public.
These audiences may use the
information collections to: (1) Develop
new campaign messages, materials, and/
or training curricula; (2) monitor and
improve campaign activities; (3) make
decisions about campaign activities; (4)
inform current campaign activities; and
(5) inform and/or change practices and
behaviors of program participants.
Examples of the types of information
collections that could be included under
this generic clearance include: Focus
groups and in-depth interviews with
parents/caregivers and/or health
professionals to get feedback on
distribution and outreach activities,
and/or campaign messages; and Surveys
with parents/caregivers and/or health
professionals to: (1) Assess the
usefulness of the new STS campaign
materials, including print and on-line
materials and a video, (2) track outreach
experiences of program participants, (3)
assess training participants’ changes in
knowledge related to safe infant sleep
behavior and implementation of
outreach methods taught, and (4) assess
program participants’ resource needs.
The sub-studies for this generic will
be small scale, designed to obtain
results frequently and quickly to guide
campaign development and
implementation, inform campaign
direction, and be used internally for
campaign management purposes.
NICHD’s current scope and capacity for
STS generic sub-studies is non-existent
and this request would fill this gap.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
3,000.
Estimated Annualized Burden Hours
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]]>Agencies
[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18037-18038]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06999]
-----------------------------------------------------------------------
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
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 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 within 30 days of this
notice.
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: Reconciliation Tool for the
Teaching Health Center Graduate Medical Education Program.
OMB No.: 0915-0342-Extension.
Abstract: The Teaching Health Center Graduate Medical Education
(THCGME) program, Section 340H of the Public Health Service (PHS) Act,
was established by Section 5508 of Public Law 111-148. The program
supports training for primary care residents (including residents in
family medicine, internal medicine, pediatrics, internal medicine
pediatrics, obstetrics and gynecology, psychiatry, general dentistry,
pediatric dentistry, and geriatrics) in community based ambulatory
patient care settings.
The statute provides that eligible Teaching Health Centers receive
payment for both direct and indirect expenses associated with training
residents in community-based ambulatory patient care centers. Direct
medical expenses payments are designed to compensate eligible teaching
health centers for those expenses directly associated with resident
training, while indirect medical expenses payments are intended to
compensate for the additional costs of training residents in such
programs.
Need and Proposed Use of the Information: THCGME program payments
are prospective payments and the statute provides for a reconciliation
process, through which overpayments may be recouped and underpayments
may be adjusted at the end of the fiscal year. This data collection
instrument will gather information relating to the numbers of residents
in THCGME training programs in order to reconcile payments for both
direct and indirect expenses.
Likely Respondents: The likely respondents to the THCGME
Reconciliation Tool are existing THCGME program award recipients.
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.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
THCGME Reconciliation Tool...... 44 1 44 2 88
-------------------------------------------------------------------------------
Total....................... 44 1 44 2 88
----------------------------------------------------------------------------------------------------------------
[[Page 18038]]
Dated: March 11, 2014.
Jackie Painter,
Deputy Director, Division of Policy and Information Coordination.
[FR Doc. 2014-06999 Filed 3-28-14; 8:45 am]
BILLING CODE 4165-15-P
