Agency Information Collection Activities: Proposed Collection: Public Comment Request, 24737-24738 [2014-09887]
Download as PDF
Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices
3. The date the application was
approved: May 20, 2011. FDA has
verified the applicant’s claim that NDA
202022 was approved on May 20, 2011.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the Patent and Trademark
Office applies several statutory
limitations in its calculations of the
actual period for patent extension. In its
application for patent extension, this
applicant seeks 768 days of patent term
extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by June 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
October 28, 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–
2013–S–0610.
Comments and petitions 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: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09911 Filed 4–30–14; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:30 Apr 30, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than June 30, 2014.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
National Health Service Corps Site
Application and Site Recertification
Application.
OMB No. 0915–0230—Revision.
Abstract: The National Health Service
Corps (NHSC) of the Bureau of Clinician
Recruitment and Service (BCRS), Health
Resources and Services Administration,
is committed to improving the health of
the nation’s underserved by uniting
communities in need with caring health
professionals, and by supporting their
efforts to build better systems of care.
NHSC-approved sites are health care
facilities that provide comprehensive
outpatient, ambulatory, primary health
care services to populations residing in
Health Professional Shortage Areas
SUMMARY:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
24737
(HPSAs). Related inpatient services may
be provided by NHSC-approved Critical
Access Hospitals (CAHs). In order to
become an NHSC-approved site, new
sites must submit a Site Application for
review and approval. Existing NHSCapproved sites are required to complete
a Site Recertification Application in
order to maintain their status as an
approved site. Both the NHSC Site
Application and Site Recertification
Application request information on the
clinical service site, sponsoring agency,
recruitment contact, staffing levels,
service users, charges for services,
employment policies, and fiscal
management capabilities. Assistance in
completing these applications may be
obtained through the appropriate State
Primary Care Offices and the NHSC. The
information collected on the
applications is used for determining the
eligibility of sites for the assignment of
NHSC health professionals and to verify
the need for NHSC clinicians. Approval
as an NHSC service site is valid for 3
years. Sites wishing to remain eligible
for the assignment of NHSC providers,
must submit a Site Recertification
Application every 3 years.
Need and Proposed Use of the
Information: The need and purpose of
this information collection is to obtain
information for NHSC site applicants.
The information obtained from the
NHSC Site Application and Site
Recertification Application will be
utilized to determine the eligibility of
sites to participate in the NHSC as an
approved service site.
Likely Respondents: Health care
facilities interested in participating in
the NHSC and becoming an approved
service site.
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 Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
E:\FR\FM\01MYN1.SGM
01MYN1
24738
Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
NHSC New Site Application ................................................
NHSC Site Recertification Application .................................
2,000
1,000
1
1
2,000
1,000
0.5
0.5
1,000
500
Total ..............................................................................
3,000
........................
3,000
........................
1,500
HRSA specifically requests comments
on (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.
Mental Health, National Institutes of Health,
6001 Executive Blvd., Room 6154, MSC 9606,
Bethesda, MD 20892–9606, 301–443–7861,
dsommers@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: April 25, 2014.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–09931 Filed 4–30–14; 8:45 am]
BILLING CODE 4140–01–P
Dated: April 23, 2014.
Jackie Painter,
Deputy Director, Division of Policy and
Information Coordination.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–09887 Filed 4–30–14; 8:45 am]
National Institutes of Health
BILLING CODE 4165–15–P
National Institute of Mental Health;
Notice of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health
Notice of Closed Meeting
tkelley on DSK3SPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Translational Research for the Development
of Novel Interventions.
Date: May 20, 2014.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: David I. Sommers, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
VerDate Mar<15>2010
17:30 Apr 30, 2014
Jkt 232001
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Mental Health
Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Mental Health Council.
Date: May 22 2014.
Open: 8:30 a.m. to 2:15 p.m.
Agenda: Presentation of NIMH Director’s
Report and discussion of NIMH program and
policy issues.
Place: National Institutes of Health (NIH),
Neuroscience Center, Conference Rooms C/
PO 00000
Frm 00072
Fmt 4703
Sfmt 9990
D/E, 6001 Executive Boulevard, Rockville,
MD 20852.
Closed: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, Conference Rooms C/
D/E, 6001 Executive Boulevard, Rockville,
MD 20852.
Contact Person: Jane A. Steinberg, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Mental Health, NIH,
Neuroscience Center, 6001 Executive Blvd.,
Room 6154, MSC 9609, Bethesda, MD 20892–
9609, 301–443–5047.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
In the interest of security, visitors will be
asked to show one form of identification (for
example, a government-issued photo ID,
driver’s license, or passport) and to state the
purpose of their visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: April 25, 2014.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–09930 Filed 4–30–14; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\01MYN1.SGM
01MYN1
Agencies
[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Pages 24737-24738]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09887]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
no later than June 30, 2014.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10-29, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: National Health Service Corps
Site Application and Site Recertification Application.
OMB No. 0915-0230--Revision.
Abstract: The National Health Service Corps (NHSC) of the Bureau of
Clinician Recruitment and Service (BCRS), Health Resources and Services
Administration, is committed to improving the health of the nation's
underserved by uniting communities in need with caring health
professionals, and by supporting their efforts to build better systems
of care. NHSC-approved sites are health care facilities that provide
comprehensive outpatient, ambulatory, primary health care services to
populations residing in Health Professional Shortage Areas (HPSAs).
Related inpatient services may be provided by NHSC-approved Critical
Access Hospitals (CAHs). In order to become an NHSC-approved site, new
sites must submit a Site Application for review and approval. Existing
NHSC-approved sites are required to complete a Site Recertification
Application in order to maintain their status as an approved site. Both
the NHSC Site Application and Site Recertification Application request
information on the clinical service site, sponsoring agency,
recruitment contact, staffing levels, service users, charges for
services, employment policies, and fiscal management capabilities.
Assistance in completing these applications may be obtained through the
appropriate State Primary Care Offices and the NHSC. The information
collected on the applications is used for determining the eligibility
of sites for the assignment of NHSC health professionals and to verify
the need for NHSC clinicians. Approval as an NHSC service site is valid
for 3 years. Sites wishing to remain eligible for the assignment of
NHSC providers, must submit a Site Recertification Application every 3
years.
Need and Proposed Use of the Information: The need and purpose of
this information collection is to obtain information for NHSC site
applicants. The information obtained from the NHSC Site Application and
Site Recertification Application will be utilized to determine the
eligibility of sites to participate in the NHSC as an approved service
site.
Likely Respondents: Health care facilities interested in
participating in the NHSC and becoming an approved service site.
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 Information Collection Request are summarized in the table below.
Total Estimated Annualized burden hours:
[[Page 24738]]
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
NHSC New Site Application....... 2,000 1 2,000 0.5 1,000
NHSC Site Recertification 1,000 1 1,000 0.5 500
Application....................
-------------------------------------------------------------------------------
Total....................... 3,000 .............. 3,000 .............. 1,500
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (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.
Dated: April 23, 2014.
Jackie Painter,
Deputy Director, Division of Policy and Information Coordination.
[FR Doc. 2014-09887 Filed 4-30-14; 8:45 am]
BILLING CODE 4165-15-P