Submission for OMB Review; Comment Request; CareerTrac, 59624-59625 [2012-23970]
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59624
Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
record-keepers
Number of
records per
record-keeper
Total annual
records
Average
burden per
record-keeping
Total hours
1140.32 (Format and content requirements for labeling
and advertising) ................................................................
1
1
1
1
1
........................
........................
........................
........................
1
Total ..............................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
1140.32 ................................................................................
1
1
1
1
1
srobinson on DSK4SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden hour estimates for this
collection of information were based on
industry-prepared data and information
regarding pharmaceutical advertising
and cigarette and smokeless tobacco
product advertising expenditures. The
burden collection does not include
reporting burdens associated with
providing established names on labels
and statements of intended use because
section 102 of the Tobacco Control Act
required that these provisions be struck
from the reissued final rule (previously
included in 897.24 and 897.32(c)).
Section 1140.30 (previously 897.30)
requires manufacturers, distributors,
and retailers to observe certain format
and content requirements for labeling
and advertising, and requires
manufacturers, distributors, and
retailers to notify FDA if they intend to
use an advertising medium that is not
listed in the regulations. The concept of
permitted advertising in 1140.30 is
sufficiently broad to encompass most
forms of advertising. FDA estimates that
approximately 300 respondents will
submit an annual notice of alternative
advertising, and the Agency has
estimated it should take 1 hour to
provide such notice.
For the recordkeeping and disclosure
requirements, 1140.32 (previously
897.32) requires competent and reliable
survey evidence to establish whether a
newspaper, magazine, periodical, or
other publication qualifies as an ‘‘adult’’
publication. Section 1140.32 also
requires the use of a black text on a
white background for labeling and
advertising. The respondent and hourly
burden for recordkeeping and disclosure
under this section (2 burden hours total)
reflect placeholders for the number of
manufacturers who would keep records
under this section.
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During the next 3 years, FDA does not
intend to enforce the recordkeeping and
disclosure requirements of 1140.32 and
has revised the burden to act as a
placeholder in the event FDA exercises
its authority to enforce the requirements
of this section in the future.
FDA estimates that the total time
required for this collection of
information is 302 hours.
Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
301–847–8533, email:
GIDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), or visit our Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: September 25, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–23885 Filed 9–27–12; 8:45 am]
BILLING CODE 4160–01–P
[FR Doc. 2012–23833 Filed 9–27–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Food and Drug Administration
Submission for OMB Review;
Comment Request; CareerTrac
[Docket No. FDA–2012–N–0001]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is postponing the
Gastrointestinal Drugs Advisory
Committee Meeting scheduled for
October 15, 2012. This meeting was
announced in the Federal Register of
August 16, 2012 (77 FR 49446). The
postponement is due to scheduling
issues.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, Fax:
PO 00000
Frm 00035
Fmt 4703
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Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Fogarty
International Center (FIC), National
Institute of General Medical Science
(NIGMS), National Cancer Institute
(NCI), and National Library of Medicine
(NLM) of the National Institutes of
Health (NIH), in conjunction with the
National Institute of Environmental
Health Sciences (NIEHS), including the
Intramural Research and Training
Award (IRTA) and Superfund Research
Program (SRP) within NIEHS, has
submitted to the Office of Management
and Budget (OMB) for review and
approval. This proposed information
collection was previously published in
the Federal Register, Vol. 77, No. 106,
on June 1, 2012, pages 32648–32649 and
allowed 60 days for public comment.
One public comment was received from
the Association for Research in Vision
and Ophthalmology (ARVO). The
SUMMARY:
Gastrointestinal Drugs Advisory
Committee; Notice of Postponement of
Meeting
E:\FR\FM\28SEN1.SGM
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59625
Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
purpose of this notice is to allow an
additional 30 days for public comment.
NIH 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.
Proposed Collection: Title:
CareerTrac. Type of Information
Collection Request: REVISION (OMB
NO.: 0925–0568). Need and Use of
Information Collection: This data
collection system is being developed to
track, evaluate and report short and
long-term outputs, outcomes, and
impacts of international trainees
involved in health research training
programs—specifically tracking this for
at least ten years following training by
having Principal Investigators enter data
after trainees have completed the
program. The data collection system
provides a streamlined, web-based
application permitting Principal
Investigators to record career
achievement progress by trainee on a
voluntary basis. FIC, NIEHS, NCI, NLM
and NIGMS management will use this
Number of
respondents
Type of respondents
data to monitor, evaluate, and adjust
grants to ensure desired outcomes are
achieved, comply with OMB Part
requirements, respond to congressional
inquiries, and guide future strategic and
management decisions regarding the
grant program.
Frequency of Response: Annual and
periodic. Affected Public: None. Type of
Respondents: Principal Investigators
and/or their administrators funded by
FIC, NIEHS, NCI, NIGMS, and NLM.
The annual reporting burden hours are
as follows:
Average time
per response
(in hrs)
Response
frequency
Total annual
hour burden
385
30
30/60
5,775
Total ..........................................................................................................
srobinson on DSK4SPTVN1PROD with NOTICES
Principal Investigators ......................................................................................
385
30
30/60
5,775
There are no capital, operating, or
maintenance costs.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
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: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Dr.
Rachel Sturke, Evaluation Officer,
Division of Science Policy, Planning,
and Evaluation, FIC, NIH, 16 Center
Drive, Bethesda, MD 20892, or call nontoll-free number (301) 480–6025 or
VerDate Mar<15>2010
17:28 Sep 27, 2012
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email your request, including your
address to: rachel.sturke@nih.gov.
Comments 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.
Dated: September 14, 2012.
Dexter Collins,
Executive Officer, FIC, National Institutes of
Health.
[FR Doc. 2012–23970 Filed 9–27–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
NIH Evidence-Based Methodology
Workshop on Polycystic Ovary;
Syndrome
Notice
Notice is hereby given of the National
Institutes of Health (NIH) Evidencebased Methodology Workshop on
Polycystic Ovary Syndrome, to be held
December 3–5, 2012. The workshop’s
opening session will be on December 3,
from 6:30 p.m. to 9:00 p.m. at the
Bethesda Marriott Hotel, 5151 Pooks
Hill Road, Bethesda, Maryland 20814.
The workshop will continue December
4–5 at the NIH Natcher Conference
Center, 45 Center Drive, Bethesda,
Maryland 20892; beginning at 8:00 a.m.
on December 4 and at 8:30 a.m. on
December 5. The workshop will be open
to the public.
Polycystic ovary syndrome (PCOS) is
a common hormone disorder that affects
approximately 5 million reproductive-
PO 00000
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aged women in the United States.
Women with PCOS have difficulty
becoming pregnant (i.e., are infertile)
due to hormone imbalances that cause
or result from altered development of
ovarian follicles. One such imbalance is
high blood levels of androgens, which
can come from both the ovaries and
adrenal gland. Other organ systems that
are affected by PCOS include the
pancreas, liver, muscle, blood
vasculature, and fat.
In addition to fertility impairment,
other common symptoms of PCOS
include:
• Irregular or no menstrual periods
(for women of reproductive age)
• Acne
• Weight gain
• Excess hair growth on the face and
body
• Thinning scalp hair
• Ovarian cysts.
Women with PCOS are often resistant
to the biological effects of insulin and,
as a consequence, may have high
insulin levels. As such, women with
PCOS are at risk for type 2 diabetes,
high cholesterol, and high blood
pressure. Obesity also appears to worsen
the condition. Costs to the U.S. health
care system to identify and manage
PCOS are approximately $4 billion
annually; however, this estimate does
not include treatment of the serious
conditions associated with PCOS.
For most of the 20th century, PCOS
was a poorly understood condition. In
1990, the NIH held a conference on
PCOS to create both a working
definition of the disorder and diagnostic
criteria. The outcome of this conference,
the NIH Criteria, served as a standard
for researchers and clinicians for more
than a decade. In 2003, a consensus
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]]>Agencies
[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Pages 59624-59625]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23970]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; CareerTrac
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Fogarty International Center (FIC), National
Institute of General Medical Science (NIGMS), National Cancer Institute
(NCI), and National Library of Medicine (NLM) of the National
Institutes of Health (NIH), in conjunction with the National Institute
of Environmental Health Sciences (NIEHS), including the Intramural
Research and Training Award (IRTA) and Superfund Research Program (SRP)
within NIEHS, has submitted to the Office of Management and Budget
(OMB) for review and approval. This proposed information collection was
previously published in the Federal Register, Vol. 77, No. 106, on June
1, 2012, pages 32648-32649 and allowed 60 days for public comment. One
public comment was received from the Association for Research in Vision
and Ophthalmology (ARVO). The
[[Page 59625]]
purpose of this notice is to allow an additional 30 days for public
comment. NIH 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.
Proposed Collection: Title: CareerTrac. Type of Information
Collection Request: REVISION (OMB NO.: 0925-0568). Need and Use of
Information Collection: This data collection system is being developed
to track, evaluate and report short and long-term outputs, outcomes,
and impacts of international trainees involved in health research
training programs--specifically tracking this for at least ten years
following training by having Principal Investigators enter data after
trainees have completed the program. The data collection system
provides a streamlined, web-based application permitting Principal
Investigators to record career achievement progress by trainee on a
voluntary basis. FIC, NIEHS, NCI, NLM and NIGMS management will use
this data to monitor, evaluate, and adjust grants to ensure desired
outcomes are achieved, comply with OMB Part requirements, respond to
congressional inquiries, and guide future strategic and management
decisions regarding the grant program.
Frequency of Response: Annual and periodic. Affected Public: None.
Type of Respondents: Principal Investigators and/or their
administrators funded by FIC, NIEHS, NCI, NIGMS, and NLM. The annual
reporting burden hours are as follows:
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Number of Response per response Total annual
respondents frequency (in hrs) hour burden
----------------------------------------------------------------------------------------------------------------
Principal Investigators......................... 385 30 30/60 5,775
---------------------------------------------------------------
Total....................................... 385 30 30/60 5,775
----------------------------------------------------------------------------------------------------------------
There are no capital, operating, or maintenance costs.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) the
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
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: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Dr. Rachel Sturke, Evaluation Officer, Division of
Science Policy, Planning, and Evaluation, FIC, NIH, 16 Center Drive,
Bethesda, MD 20892, or call non-toll-free number (301) 480-6025 or
email your request, including your address to: rachel.sturke@nih.gov.
Comments 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.
Dated: September 14, 2012.
Dexter Collins,
Executive Officer, FIC, National Institutes of Health.
[FR Doc. 2012-23970 Filed 9-27-12; 8:45 am]
BILLING CODE 4140-01-P
