Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 21380-21381 [2013-08348]
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21380
Federal Register / Vol. 78, No. 69 / Wednesday, April 10, 2013 / Notices
FDA announced the availability of a
guidance on this collection in the
Federal Register of April 20, 2010 (75
FR 20606), and requested tobacco health
documents that were created during the
period from June 23, 2009, through
December 31, 2009. The guidance stated
that information required under section
904(a)(4) must be submitted to FDA
beginning December 22, 2009. Further,
FDA stated it would publish a revised
guidance specifying the timing of
subsequent reporting. FDA is in the
process of revising the April 2010
guidance but will continue collecting
documents created during the specified
period for any manufacturers, importers,
or their agents who still have documents
to submit.
FDA has been collecting the
information submitted pursuant to
section 904(a)(4) through a facilitative
electronic form and through a paper
form (Form FDA 3743) for those
individuals who choose not to use the
electronic method. In both forms, FDA
is requesting the following information
from firms that have not already
reported or still have documents to
report:
• Submitter identification: Submitter
type, company name, address, country,
company headquarters Dun and
Bradstreet number, and company
headquarters Facility Establishment
Identifier number;
• Submitter point of contact: Contact
name, title, position title, email,
telephone, and fax; and
• Submission format and contents (as
applicable):
Æ Electronic documents: Media type,
media quantity, size of submission,
quantity of documents, file type, and
file software;
Æ Paper documents: Quantity of
documents, quantity of volumes, and
quantity of boxes; and
Æ Whether or not a submission is
being provided.
• Confirmation statement (with
identification and signature of submitter
including name, company name,
address, position title, email, telephone,
and fax); and
• Document categorization (as
applicable): Relationship of the
document or set of documents to the
following:
Æ Health, behavioral, toxicological, or
physiological effects;
Æ Specific current or future tobacco
product(s);
Æ Class of current or future tobacco
product(s);
Æ Specific ingredient(s),
constituent(s), component(s), or
additive(s);
Æ Class of ingredient(s),
constituent(s), component(s), or
additive(s).
• Document readability and
accessibility: Keywords; glossary or
explanation of any abbreviations, jargon,
or internal (e.g., code) names; special
instructions for loading or compiling
submission; and
• Document metadata: Date document
was created, document author(s),
document recipient(s), document
custodian, document title or
identification number, beginning and
ending Bates numbers, and Bates
number ranges for documents attached
to a submitted email.
In addition to the electronic and
paper forms, the guidance that FDA
issued in April 2010 (75 FR 20606) was
intended to assist persons making
tobacco health document submissions.
For further assistance, FDA is providing
a technical guide, embedded hints, and
a Web tutorial on the electronic portal.
The estimated 50 hours per response
burden is based on the average burden
estimate among all 4 respondents.
Therefore, on an individual basis, the
actual burden per respondent may be
higher or lower than the 50 hours
estimate because it is an average value.
FDA currently is evaluating the
classification/coding recommendations
and will revisit this issue in future
guidance. The number of documents
received each year since the original
collection period has fallen to less than
5 percent of the number received in the
original collection period. FDA expects
this is because documents created
within the specified period have already
been submitted. Also, the number of
respondents who still have documents
to submit has decreased. Therefore, FDA
estimates the biannual burden of the
continuation of this collection to be at
most, 5 percent of the original burden.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Tobacco Health Document Submissions and Form FDA
3743 ..................................................................................
1 There
Number of
responses per
respondent
Number of
respondents
Activity
4
2
8
50
Total hours
400
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–08315 Filed 4–9–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
BILLING CODE 4160–01–P
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
TKELLEY on DSK3SPTVN1PROD with NOTICES
Average
burden per
response
Total annual
responses
ACTION:
Notice.
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the Health Resources and
Services Administration (HRSA) will
SUMMARY:
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17:59 Apr 09, 2013
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submit an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB).
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.
To request a copy of the clearance
requests submitted to OMB for review,
email paperwork@hrsa.gov or call the
HRSA Reports Clearance Office at (301)
443–1984.
Information Collection Request Title:
Corps Community Day Event Form
(OMB No. 0915–xxxx)—[NEW]
Abstract: Corps Community Day was
created in 2011 and celebrates the
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10APN1
21381
Federal Register / Vol. 78, No. 69 / Wednesday, April 10, 2013 / Notices
National Health Service Corps (NHSC)
every October during National Primary
Care Week. The NHSC is a program
administered by the Bureau of Clinician
Recruitment and Service (BCRS) within
HRSA. The goals of Corps Community
Day encompass the following: increase
awareness of the NHSC to potential
applicants and the greater primary
health community; create a sense of
community and connectedness among
NHSC program participants, alumni,
partners, and staff; and underscore the
NHSC’s role in bringing primary health
care services to the nation’s neediest
communities. Current program
participants, alumni, NHSC
Ambassadors, sites, primary care
organizations, and professional
associations plan events and report the
details of their events to BCRS so that
they can be added to the state-by-state
map of events. In order to avoid
duplication of effort, eliminate
confusion regarding allowable event
dates, avoid data entry errors, and
implement a brief post-event
satisfaction survey, BCRS would like to
implement a standard form that event
planners will use to report to BCRS. The
fillable form will be available online
and will have less than 20 fields for
event planners to populate to submit for
inclusion on the map. There will also be
approximately 5 fields to populate
following the event to measure
satisfaction. Both the pre-event and
post-event data fields will be held in
one form.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
Number
of respondents
Form name
Responses
per
respondent
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.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
Corps Community Day Event Planning Form .....................
Corps Community Day Event Satisfaction Form .................
300
300
1
1
300
300
.066
.033
20
10
Total ..............................................................................
300
........................
300
........................
30 hours
Submit your comments to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Deadline: Comments on this ICR
should be received within 30 days of
this notice.
ADDRESSES:
Dated: April 4, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–08348 Filed 4–9–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
TKELLEY on DSK3SPTVN1PROD with NOTICES
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
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 meetings.
The meetings 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
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17:59 Apr 09, 2013
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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
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Glucose Regulation.
Date: June 5, 2013.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: D. G. Patel, PhD.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 756, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–7682,
pateldg@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Fellowships in
Digestive Diseases and Nutrition.
Date: June 13, 2013.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street
NW., Washington, DC 20036.
Contact Person: Thomas A. Tatham, PhD.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
PO 00000
Frm 00044
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Room 760, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–3993,
tathamt@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: April 4, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–08285 Filed 4–9–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Alternative Medicine; 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.
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
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10APN1
Agencies
[Federal Register Volume 78, Number 69 (Wednesday, April 10, 2013)]
[Notices]
[Pages 21380-21381]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08348]
-----------------------------------------------------------------------
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
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and
Services Administration (HRSA) will submit an Information Collection
Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests
submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA
Reports Clearance Office at (301) 443-1984.
Information Collection Request Title: Corps Community Day Event
Form (OMB No. 0915-xxxx)--[NEW]
Abstract: Corps Community Day was created in 2011 and celebrates
the
[[Page 21381]]
National Health Service Corps (NHSC) every October during National
Primary Care Week. The NHSC is a program administered by the Bureau of
Clinician Recruitment and Service (BCRS) within HRSA. The goals of
Corps Community Day encompass the following: increase awareness of the
NHSC to potential applicants and the greater primary health community;
create a sense of community and connectedness among NHSC program
participants, alumni, partners, and staff; and underscore the NHSC's
role in bringing primary health care services to the nation's neediest
communities. Current program participants, alumni, NHSC Ambassadors,
sites, primary care organizations, and professional associations plan
events and report the details of their events to BCRS so that they can
be added to the state-by-state map of events. In order to avoid
duplication of effort, eliminate confusion regarding allowable event
dates, avoid data entry errors, and implement a brief post-event
satisfaction survey, BCRS would like to implement a standard form that
event planners will use to report to BCRS. The fillable form will be
available online and will have less than 20 fields for event planners
to populate to submit for inclusion on the map. There will also be
approximately 5 fields to populate following the event to measure
satisfaction. Both the pre-event and post-event data fields will be
held in one form.
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.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form name respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Corps Community Day Event 300 1 300 .066 20
Planning Form..................
Corps Community Day Event 300 1 300 .033 10
Satisfaction Form..............
-------------------------------------------------------------------------------
Total....................... 300 .............. 300 .............. 30 hours
----------------------------------------------------------------------------------------------------------------
ADDRESSES: Submit your comments to the desk officer for HRSA, either by
email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806. Please
direct all correspondence to the ``attention of the desk officer for
HRSA.''
Deadline: Comments on this ICR should be received within 30 days of
this notice.
Dated: April 4, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-08348 Filed 4-9-13; 8:45 am]
BILLING CODE 4165-15-P