NIH Evidence-Based Methodology Workshop on Polycystic Ovary; Syndrome, 59625-59626 [2012-23965]
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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
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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
Frm 00036
Fmt 4703
Sfmt 4703
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
E:\FR\FM\28SEN1.SGM
28SEN1
59626
Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
workshop in Rotterdam developed new
diagnostic criteria, the Rotterdam
Criteria.
The 2012 NIH Evidence-based
Methodology Workshop on PCOS will
seek to clarify:
• Benefits and drawbacks of using the
Rotterdam Criteria
• The condition’s causes, predictors,
and long-term consequences
• Optimal prevention and treatment
strategies.
The NIH workshop is sponsored by
the Office of Disease Prevention and the
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development. A multidisciplinary
steering committee developed the
workshop agenda. The NIH Library
created an extensive, descriptive
bibliography on PCOS to facilitate
workshop discussion. During the 21⁄2day workshop, invited experts will
discuss the body of evidence and
attendees will have opportunities to
provide comments during open
discussion periods. After weighing the
evidence, an unbiased, independent
panel will prepare a report that
summarizes the workshop and identifies
future research priorities.
Advance information about the
workshop and workshop registration
materials may be obtained by calling
888–644–2667, or by sending email to
prevention@mail.nih.gov. Registration
and workshop information are also
available on the NIH Office of Disease
Prevention Web site at https://
prevention.nih.gov.
Please Note: As part of the measures to
ensure the safety of NIH employees and
property, all visitors must be prepared to
show a photo ID upon request. Visitors may
be required to pass through a metal detector
and have bags, backpacks, or purses
inspected or x-rayed as they enter the NIH
campus. For more information about the
security measures at NIH, please visit the
Web site at https://www.nih.gov/about/
visitorsecurity.htm.
Dated: September 24, 2012.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2012–23965 Filed 9–27–12; 8:45 am]
BILLING CODE 4140–01–P
SUBSTANCE ABUSE AND MENTAL
HEALTH SERVICES ADMINISTRATION
Agency Information Collection
Activities: Proposed Collection;
Comment Request
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the information collection plans, call
the SAMHSA Reports Clearance Officer
on (240) 276–1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Site Visits With
Grantees Integrating HIV Primary Care,
Substance Abuse, and Behavioral
Health Services—NEW
The Substance Abuse and Mental
Health Services Administration
(SAMSHA) is requesting approval to
conduct in-person Site Visit Interviews
with Minority AIDS Initiative—Targeted
Capacity Expansion (MAI–TCE)
Grantees Integrating HIV Primary Care,
Substance Abuse, and Behavioral Health
Services. This is a new project request
targeting the collection of programmatic
level data (e.g., services provision,
program administration, consumer
involvement, evaluation planning,
organizational capacity) through one-onone and group interviews and site
assessment surveys with grantee
personnel.
The goals of the MAI–TCE project are
to facilitate the development and
expansion of culturally competent and
effective integrated behavioral health
and primary care, which include HIV
services and medical treatment within
11 of the 12 Metropolitan Statistical
Areas (MSAs) and Metropolitan
Divisions (MDs) most heavily impacted
by HIV/AIDS. The program also
supports the integration of behavioral
health services (i.e., prevention,
treatment, and substance abuse) into the
CDC’s Enhanced Comprehensive HIV
Prevention Plans (ECHPP). Interviews
conducted with MAI–TCE grantees
during site visits are an integral part of
efforts to evaluate: (1) The effectiveness
of program implementation across the
grantee sites; (2) grantee efforts to
integrate behavioral health, substance
abuse and HIV care; (3) the variety of
program models in use across the
grantee sites; and, (4) grantee efforts to
engage and successfully reach their
target populations.
SAMHSA will conduct a total of two
in-person site visits with each of the 11
MAI–TCE program grantees, with
surveys being administered prior to
each site visit.
SAMHSA will conduct interviews
with grantee staff who will provide
information on their program’s
integration of primary care and
behavioral health services. While
participating in the evaluation is a
condition of the grantees’ funding,
participating in the interview and
survey process is voluntary. Both
instruments are designed to collect
information about: Specific program
components; HIV testing integration
challenges, successes, and lessons
learned; HIV care and evidence-based
behavioral health services for their
specific populations of focus; and
engaging consumers in the Behavioral
Health and Primary Care Network
Committee and other aspects of the
project, including how cultural
competence is operationalized.
Below is the table of the estimated
total burden hours:
EXHIBIT 1—ESTIMATE OF REPORTING BURDEN: ONE SITE VISIT ROUND
Number of
respondents
srobinson on DSK4SPTVN1PROD with NOTICES
Data collection tool
Responses
per
respondent
Hour per
response
Total burden
hours
Interview Guide ............................................................................................
Assessment Form ........................................................................................
132
55
1
1
2.5
.3
330
18.3
Total ......................................................................................................
* 132
2
2.8
348.3
* Note: The 55 respondents identified for the self-assessment are included in the 132 overall participants listed for the site visit protocol.
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E:\FR\FM\28SEN1.SGM
28SEN1
Agencies
[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Pages 59625-59626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23965]
-----------------------------------------------------------------------
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)
Evidence-based 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-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
[[Page 59626]]
workshop in Rotterdam developed new diagnostic criteria, the Rotterdam
Criteria.
The 2012 NIH Evidence-based Methodology Workshop on PCOS will seek
to clarify:
Benefits and drawbacks of using the Rotterdam Criteria
The condition's causes, predictors, and long-term
consequences
Optimal prevention and treatment strategies.
The NIH workshop is sponsored by the Office of Disease Prevention
and the Eunice Kennedy Shriver National Institute of Child Health and
Human Development. A multidisciplinary steering committee developed the
workshop agenda. The NIH Library created an extensive, descriptive
bibliography on PCOS to facilitate workshop discussion. During the 2\1/
2\-day workshop, invited experts will discuss the body of evidence and
attendees will have opportunities to provide comments during open
discussion periods. After weighing the evidence, an unbiased,
independent panel will prepare a report that summarizes the workshop
and identifies future research priorities.
Advance information about the workshop and workshop registration
materials may be obtained by calling 888-644-2667, or by sending email
to prevention@mail.nih.gov. Registration and workshop information are
also available on the NIH Office of Disease Prevention Web site at
https://prevention.nih.gov.
Please Note: As part of the measures to ensure the safety of
NIH employees and property, all visitors must be prepared to show a
photo ID upon request. Visitors may be required to pass through a
metal detector and have bags, backpacks, or purses inspected or x-
rayed as they enter the NIH campus. For more information about the
security measures at NIH, please visit the Web site at https://www.nih.gov/about/visitorsecurity.htm.
Dated: September 24, 2012.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2012-23965 Filed 9-27-12; 8:45 am]
BILLING CODE 4140-01-P