Agency Information Collection Activities; Proposed Collection; Public Comment Request, 45931-45932 [2013-18310]
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Federal Register / Vol. 78, No. 146 / Tuesday, July 30, 2013 / Notices
constitutes new safety information;
what procedures are involved in
requiring safety labeling changes; and
how FDA will enforce the requirements
for safety labeling changes.
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 implementation of
section 505(o)(4) of the FD&C Act. 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 statutes
and regulations.
pmangrum on DSK3VPTVN1PROD with NOTICES
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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, and
will be posted to the docket at https://
www.regulations.gov.
III. Paperwork Reduction Act of 1995
This guidance contains collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (the PRA) (44 U.S.C. 3501–
3520). The collections of information
have been approved under OMB control
number 0910–0734. This guidance also
refers to previously approved
collections of information. Specifically,
the guidance describes: Labeling
supplements for NDAs, ANDAs, and
BLAs submitted under 21 CFR 314.70,
314.71, 314.97, and 601.12; and the
content and format of prescription drug
labeling submitted under 21 CFR 201.56
and 201.57. These collections of
information are subject to review by
OMB under the PRA and are approved
under OMB control numbers 0910–
0001, 0910–0338, and 0910–0572.
Section V of the guidance refers to the
guidance entitled ‘‘Formal Dispute
Resolution: Appeals Above the Division
Level,’’ which describes collections of
information approved under OMB
control number 0910–0430.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
VerDate Mar<15>2010
14:32 Jul 29, 2013
Jkt 229001
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: July 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–18236 Filed 7–29–13; 8:45 am]
BILLING CODE 4160–01–P
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
within 60 days of this notice.
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:
Nurse Anesthetist Traineeship (NAT)
Program Application.
OMB No. 0915–XXXX—New.
Abstract: The Health Resources and
Services Administration (HRSA)
SUMMARY:
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
45931
provides advanced education nursing
training grants to educational
institutions to increase the numbers of
Nurse Anesthetists through the NAT
Program. The NAT Program is governed
by Title VIII, Section 811(a)(2) of the
Public Health Service Act, (42 U.S.C.
296j(a)(2)), as amended by Section 5308
of the Patient Protection and Affordable
Care Act, Public Law 111–148. The NAT
application will use the SF–424 R&R
Short Form which includes the Project
Abstract, Program Narrative, NAT
Attachments and the NAT Tables. The
application and proposed NAT Tables
will request information on program
participants such as the number of
enrollees, number of enrollees/trainees
supported, number of graduates,
number of graduates supported,
projected data on enrollees/trainees and
graduates for the previous fiscal year,
the types of programs they are enrolling
into and/or from which enrollees/
trainees are graduating, and the
distribution of Nurse Anesthetists to
practice in underserved, rural, or public
health practice settings.
Need and Proposed Use of the
Information: Funds appropriated for the
NAT Program are distributed among
eligible institutions based on a formula.
NAT award amounts are based on
enrollment and graduate data and two
funding factors (Statutory Funding
Preference and Special Consideration)
reported on the NAT Tables. HRSA will
use the data from the application,
specifically the NAT Tables to
determine the award, ensure
programmatic compliance, and provide
information to the public and Congress.
Likely Respondents: Eligible
applicants are schools of nursing,
nursing centers, academic health
centers, state or local governments, and
other public or private nonprofit entities
determined appropriate by the Secretary
that submit an application and are
accredited for the provision of nurse
anesthesia educational program by
designated accrediting organizations.
Eligible applicants must be accredited
by the Council on Accreditation (COA)
of Nurse Anesthesia Educational
Programs of the American Association
of Nurse Anesthetists. The school must
be located in the 50 states, the District
of Columbia, Guam, the Commonwealth
of Puerto Rico, the Northern Mariana
Islands, the Virgin Islands, American
Samoa, Guam, the U.S. Virgin Islands,
the Federated States of Micronesia, the
Republic of the Marshall Islands, or the
Republic of Palau.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
E:\FR\FM\30JYN1.SGM
30JYN1
45932
Federal Register / Vol. 78, No. 146 / Tuesday, July 30, 2013 / Notices
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
Number of
respondents
Form name
Number of
responses per
respondent
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
NAT Application including the NAT Attachments and NAT
Tables ...............................................................................
100
1
100
6
600
Total ..............................................................................
100
1
100
6
600
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: July 24, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–18310 Filed 7–29–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
pmangrum on DSK3VPTVN1PROD with NOTICES
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), announcement is
made of the following National
Advisory body scheduled to meet
during the month of September 2013.
The National Advisory Committee on
Rural Health will convene its seventyfourth meeting in the time and place
specified below:
Name: National Advisory Committee
on Rural Health and Human Services.
Dates and Time: September 4, 2013,
9:00 a.m.–5 p.m. September 5, 2013,
9:00 a.m.–5 p.m. September 6, 2013,
8:45 a.m.–11:00 a.m.
Place: Holiday Inn Bozeman, 5 East
Baxter Lane, Bozeman, MT 59715, (406)
587–4561.
Status: The meeting will be open to
the public.
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14:32 Jul 29, 2013
Jkt 229001
Purpose: The National Advisory
Committee on Rural Health and Human
Services provides counsel and
recommendations to the Secretary with
respect to the delivery, research,
development, and administration of
health and human services in rural
areas.
Agenda: Wednesday morning,
September 4, at 9:00 a.m., the meeting
will be called to order by the
Chairperson of the Committee: the
Honorable Ronnie Musgrove. The
Committee will be examining outreach,
enrollment and education efforts for the
rural population in regards to the Health
Insurance Marketplaces which will
open this fall. The Committee will also
examine the intersection of human
service delivery and poverty in rural
communities. The day will conclude
with a period of public comment at
approximately 5:00 p.m.
Thursday morning, September 5, at
approximately 9:00 a.m., the Committee
will break into Subcommittees and
depart for site visits to health care and
human services providers in Montana.
One panel from the Health
Subcommittee will visit Community
Health Partners in Livingston, Montana.
Another panel from the Health
Subcommittee will visit Wheatland
Memorial Healthcare in Harlowton,
Montana. The Human Services
Subcommittee will visit the Human
Resource Development Council, in
Bozeman, Montana. The day will
conclude at the Holiday Inn Bozeman
with a period of public comment at
approximately 4:30 p.m.
Friday morning, September 6, at 8:45
a.m., the Committee will summarize key
findings from the meeting and develop
a work plan for the next quarter and the
following meeting.
FOR FURTHER INFORMATION CONTACT:
Steve Hirsch, MSLS, Executive
Secretary, National Advisory Committee
on Rural Health and Human Services,
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
Health Resources and Services
Administration, Parklawn Building,
Room 5A–05, 5600 Fishers Lane,
Rockville, MD 20857, telephone (301)
443–0835, or fax (301) 443–2803.
Persons interested in attending any
portion of the meeting should contact
Kristen Lee at the Office of Rural Health
Policy (ORHP) via telephone at (301)
443–0835 or by email at klee1@hrsa.gov.
The Committee meeting agenda will be
posted on ORHP’s Web site https://
www.hrsa.gov/advisorycommittees/
rural/.
Dated: July 24, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–18308 Filed 7–29–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the National Advisory
Neurological Disorders and Stroke
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
E:\FR\FM\30JYN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 146 (Tuesday, July 30, 2013)]
[Notices]
[Pages 45931-45932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18310]
-----------------------------------------------------------------------
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
within 60 days of this notice.
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: Nurse Anesthetist Traineeship
(NAT) Program Application.
OMB No. 0915-XXXX--New.
Abstract: The Health Resources and Services Administration (HRSA)
provides advanced education nursing training grants to educational
institutions to increase the numbers of Nurse Anesthetists through the
NAT Program. The NAT Program is governed by Title VIII, Section
811(a)(2) of the Public Health Service Act, (42 U.S.C. 296j(a)(2)), as
amended by Section 5308 of the Patient Protection and Affordable Care
Act, Public Law 111-148. The NAT application will use the SF-424 R&R
Short Form which includes the Project Abstract, Program Narrative, NAT
Attachments and the NAT Tables. The application and proposed NAT Tables
will request information on program participants such as the number of
enrollees, number of enrollees/trainees supported, number of graduates,
number of graduates supported, projected data on enrollees/trainees and
graduates for the previous fiscal year, the types of programs they are
enrolling into and/or from which enrollees/trainees are graduating, and
the distribution of Nurse Anesthetists to practice in underserved,
rural, or public health practice settings.
Need and Proposed Use of the Information: Funds appropriated for
the NAT Program are distributed among eligible institutions based on a
formula. NAT award amounts are based on enrollment and graduate data
and two funding factors (Statutory Funding Preference and Special
Consideration) reported on the NAT Tables. HRSA will use the data from
the application, specifically the NAT Tables to determine the award,
ensure programmatic compliance, and provide information to the public
and Congress.
Likely Respondents: Eligible applicants are schools of nursing,
nursing centers, academic health centers, state or local governments,
and other public or private nonprofit entities determined appropriate
by the Secretary that submit an application and are accredited for the
provision of nurse anesthesia educational program by designated
accrediting organizations. Eligible applicants must be accredited by
the Council on Accreditation (COA) of Nurse Anesthesia Educational
Programs of the American Association of Nurse Anesthetists. The school
must be located in the 50 states, the District of Columbia, Guam, the
Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin
Islands, American Samoa, Guam, the U.S. Virgin Islands, the Federated
States of Micronesia, the Republic of the Marshall Islands, or the
Republic of Palau.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information
[[Page 45932]]
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:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
NAT Application including the 100 1 100 6 600
NAT Attachments and NAT Tables.
-------------------------------------------------------------------------------
Total....................... 100 1 100 6 600
----------------------------------------------------------------------------------------------------------------
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: July 24, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-18310 Filed 7-29-13; 8:45 am]
BILLING CODE 4165-15-P
