Agency Information Collection Activities: Proposed Collection: Comment Request, 20117-20118 [2013-07650]
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Federal Register / Vol. 78, No. 64 / Wednesday, April 3, 2013 / Notices
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the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on the draft guidance by July 2, 2013.
ADDRESSES: Submit written requests for
single printed copies of the draft
guidance to the Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5129; Silver Spring,
MD 20993. Send one self-addressed
adhesive label to assist the office in
processing your requests. The guidance
may also be obtained by mail by calling
the Office of Combination Products at
301–796–8930. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the 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draft guidance to https://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:
Patricia Y. Love, Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5129, Silver Spring,
MD 20993.
SUPPLEMENTARY INFORMATION:
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DATES:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Glass Syringes for Delivering Drug and
Biological Products: Technical
Information to Supplement
International Organization for
Standardization (ISO) Standard 11040–
4.’’ This document provides guidance to
sponsors seeking to rely on conformity
to ISO Standard 11040–4 in submissions
for glass syringes products. FDA has
become aware of adverse events and
product quality events related to
connectivity problems when certain
glass syringes are used with connecting
devices, including connecting devices to
conform to the FDA-recognized ISO
594–2 standard. Accordingly, FDA has
determined that, for glass syringes,
demonstrating conformity to the ISO
11040–4 standard alone does not ensure
that the glass syringe can be properly
connected to connecting devices.
Therefore, this guidance document
identifies additional, technical
information that should be included in
an investigational device exemption
(IDE), humanitarian device exemption
(HDE), 510(k), or postmarket application
(PMA) for a glass syringe product, or in
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an investigational new drug application
(IND), a biologics license application
(BLA), new drug application (NDA), or
abbreviated new drug application
(ANDA) for a drug or biological product
that is delivered with such a glass
syringe product, to demonstrate that the
glass syringe can be properly connected
to connecting devices.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on ‘‘Glass Syringes for Delivering Drug
and Biological Products: Technical
Information to Supplement
International Organization for
Standardization (ISO) Standard 11040–
4.’’ 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.
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. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 314 for
NDAs have been approved under OMB
control number 0910–0001. The
collections of information in 21 CFR
part 601 for BLAs have been approved
under OMB control number 0910–0338.
The collections of information in 21
CFR part 814 subpart B for PMAs have
been approved under OMB control
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20117
number 0910–0231. The collections of
information in FD&C Act subpart E for
510(k) notifications have been approved
under OMB control number 0901–0120.
Dated: March 28, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07685 Filed 4–2–13; 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:
Comment Request
ACTION:
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of Title
44, United States Code, as amended by
the Paperwork Reduction Act of 1995,
Pub. L. 104–13), the Health Resources
and Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. 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
Reports Clearance Officer at (301) 443–
1984.
HRSA especially 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.
Information Collection Request Title:
Primary Care Faculty Development
Initiative (OMB No. 0915-xxxx)—[New].
Abstract: HRSA’s Bureau of Health
Professions, Division of Medicine and
Dentistry, has contracted with Oregon
Health and Science University (OHSU),
contract HHSH250201200023C, to
conduct the planning, execution, and
evaluation of a nationally based,
longitudinal Primary Care Faculty
Development Initiative (PCFDI)
demonstration project. OHSU has
developed web-based survey
SUMMARY:
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Federal Register / Vol. 78, No. 64 / Wednesday, April 3, 2013 / Notices
instruments which will be used to
evaluate the effectiveness of the planned
curriculum and its implementation and
to make recommendations to improve
teaching and competency assessment in
primary care educational activities. The
two web-based surveys are Irvine’s
Leadership Behavior Survey and the
Faculty Skill & Program Feasibility
Survey. The objectives of the survey
instruments are to: assess the feasibility
and acceptability of an interdisciplinary faculty development pilot
program targeting primary care
physicians; to measure the leadership
skills of PCFDI faculty participants; and
to assess the initial impact of faculty
receiving training from an interdisciplinary faculty development pilot
program on their perception of skill
development in the core content areas of
leadership, change management,
teamwork, panel or population
management, competency assessment,
and clinical microsystems.
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
Number of
respondents
Form name
Number of
responses per
respondent
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.
The annual estimate of burden is as
follows:
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Irvine’s Leadership Behavior Survey ...................................
Faculty Skill & Program Feasibility Survey ..........................
36
36
1
1
36
36
.167
.167
6.01
6.01
Total ..............................................................................
72
........................
72
........................
12.02
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857.
Deadline: Comments on this
Information Collection Request must be
received within 60 days of this notice.
ADDRESSES:
Dated: March 27, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–07650 Filed 4–2–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
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 Board
of Scientific Counselors, NIAMS.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Arthritis and
Musculoskeletal and Skin Diseases,
including consideration of personnel
qualifications and performance, and the
competence of individual investigators,
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18:16 Apr 02, 2013
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the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIAMS.
Date:April 23–24, 2013.
Time: 6:00 p.m. to 5:20 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 4C32, Bethesda, MD 20892.
Contact Person: John J. O’Shea, MD, Ph.D.,
Scientific Director, National Institute of
Arthritis & Musculoskeletal and Skin
Diseases, Building 10, Room 9N228, MSC
1820, Bethesda, MD 20892, (301) 496–2612,
osheaj@arb.niams.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: March 28, 2013.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–07659 Filed 4–2–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed 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 following meeting.
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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 Cancer
Institute Special Emphasis Panel; Cancer
Biology and Therapy.
Date: April 17, 2013.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 9609
Medical Center Drive, 7–W–106, Rockville,
MD, (Telephone Conference Call).
Contact Person: Eun Ah Cho, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, 7–W–106,
Bethesda, MD 20892, 240–276–6342,
choe@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting date due to
scheduling conflicts.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
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[Federal Register Volume 78, Number 64 (Wednesday, April 3, 2013)]
[Notices]
[Pages 20117-20118]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07650]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. 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 Reports Clearance Officer at (301) 443-1984.
HRSA especially 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.
Information Collection Request Title: Primary Care Faculty
Development Initiative (OMB No. 0915-xxxx)--[New].
Abstract: HRSA's Bureau of Health Professions, Division of Medicine
and Dentistry, has contracted with Oregon Health and Science University
(OHSU), contract HHSH250201200023C, to conduct the planning, execution,
and evaluation of a nationally based, longitudinal Primary Care Faculty
Development Initiative (PCFDI) demonstration project. OHSU has
developed web-based survey
[[Page 20118]]
instruments which will be used to evaluate the effectiveness of the
planned curriculum and its implementation and to make recommendations
to improve teaching and competency assessment in primary care
educational activities. The two web-based surveys are Irvine's
Leadership Behavior Survey and the Faculty Skill & Program Feasibility
Survey. The objectives of the survey instruments are to: assess the
feasibility and acceptability of an inter-disciplinary faculty
development pilot program targeting primary care physicians; to measure
the leadership skills of PCFDI faculty participants; and to assess the
initial impact of faculty receiving training from an inter-disciplinary
faculty development pilot program on their perception of skill
development in the core content areas of leadership, change management,
teamwork, panel or population management, competency assessment, and
clinical microsystems.
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.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Irvine's Leadership Behavior 36 1 36 .167 6.01
Survey.........................
Faculty Skill & Program 36 1 36 .167 6.01
Feasibility Survey.............
-------------------------------------------------------------------------------
Total....................... 72 .............. 72 .............. 12.02
----------------------------------------------------------------------------------------------------------------
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857.
Deadline: Comments on this Information Collection Request must be
received within 60 days of this notice.
Dated: March 27, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-07650 Filed 4-2-13; 8:45 am]
BILLING CODE 4165-15-P
