Submission for OMB Review; Comment Request, 63987-63988 [2013-25128]
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Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
emcdonald on DSK67QTVN1PROD with NOTICES
medical ethics or other relevant
professions.
The MEDCAC works from an agenda
provided by the Designated Federal
Official. The MEDCAC reviews and
evaluates medical literature, technology
assessments, and hears public testimony
on the evidence available to address the
impact of medical items and services on
health outcomes of Medicare
beneficiaries. The MEDCAC may also
advise Centers for Medicare and
Medicaid Services (CMS) as part of
Medicare’s ‘‘coverage with evidence
development’’ initiative.
II. Provisions of the Notice
As of June 2014, there will be 30
membership terms expiring. Of the 30
memberships expiring, 1 is nonvoting
industry representative, 3 are voting
patient advocates and the remaining 26
membership openings are for the
general MEDCAC voting membership.
Accordingly, we are requesting
nominations for both voting and
nonvoting members to serve on the
MEDCAC. Nominees are selected based
upon their individual qualifications and
not as representatives of professional
associations or societies. We wish to
ensure adequate representation of the
interests of both women and men,
members of all ethnic groups and
physically challenged individuals.
Therefore, we encourage nominations of
qualified candidates from these groups.
All nominations must be
accompanied by curricula vitae.
Nomination packages must be sent to
Maria Ellis at the address listed in the
ADDRESSES section of this notice.
Nominees for voting membership must
also have expertise and experience in
one or more of the following fields:
• Clinical medicine including
subspecialties
• Administrative medicine
• Public health
• Biological and physical sciences
• Epidemiology and biostatistics
• Clinical trial design
• Health care data management and
analysis
• Patient advocacy
• Health care economics
• Medical ethics
• Other relevant professions
We are looking particularly for
experts in a number of fields. These
include cancer screening, genetic
testing, clinical epidemiology;
psychopharmacology; screening and
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diagnostic testing analysis; and vascular
surgery. We also need experts in
biostatistics in clinical settings,
dementia treatment, minority health,
observational research design, stroke
epidemiology, and women’s health.
The nomination letter must include a
statement that the nominee is willing to
serve as a member of the MEDCAC and
appears to have no conflict of interest
that would preclude membership. We
are requesting that all curricula vitae
include the following:
• Date of birth
• Place of birth
• Social security number
• Title and current position
• Professional affiliation
• Home and business address
• Telephone and fax numbers
• Email address
• List of areas of expertise
In the nomination letter, we are
requesting that the nominee specify
whether they are applying for a voting
patient advocate position, for another
voting position or a nonvoting industry
representative. Potential candidates will
be asked to provide detailed information
concerning such matters as financial
holdings, consultancies, and research
grants or contracts in order to permit
evaluation of possible sources of
conflict of interest.
Members are invited to serve for
overlapping 2-year terms. A member
may serve after the expiration of the
member’s term until a successor is
named. Any interested person may
nominate one or more qualified persons.
Self-nominations are also accepted. The
current Secretary’s Charter for the
MEDCAC is available on the CMS Web
site at: https://www.cms.hhs.gov/FACA/
Downloads/medcaccharter.pdf, or you
may obtain a copy of the charter by
submitting a request to the contact listed
in the FOR FURTHER INFORMATION
CONTACT section of this notice.
Authority: 5 U.S.C. App. 2, section 10(a)(1)
and (a)(2).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program.)
Dated: October 18, 2013.
Patrick Conway,
CMS Chief Medical Officer and Director,
Center for Clinical Standards and Quality,
Centers for Medicare & Medicaid Services.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Parents and Children Together
(PACT) Evaluation.
OMB No.: 0970–0403.
Description: The Office of Planning,
Research and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
proposing data collection activity as
part of the Parents and Children
Together (PACT) Evaluation. The
objective of the PACT evaluation is to
document and provide initial
assessment of selected Responsible
Fatherhood and Healthy Marriage grant
programs that were authorized under
the 2010 Claims Resolution Act. This
information will be critical to informing
decisions related to future investments
in programming as well as the design
and operation of such services.
PACT is utilizing three major,
interrelated evaluation strategies:
Impact evaluation; implementation
evaluation; and qualitative evaluation.
To collect data for these strategies,
eighteen instruments have been
approved to-date. This 30-Day Federal
Register Notice covers two new
instruments:
(19) Follow-up Survey (for Responsible
Fatherhood study participants)
(20) Follow-up Survey (for Healthy
Marriage study participants)
A more thorough description of the
study and instruments was provided in
a 60 Day Federal Register Notice posted
in Vol. 78, No. 102, p. 31942 on May 28,
2013.
Respondents: Program applicants,
program participants, program staff, and
staff at referral agencies.
Annual Burden Estimates
This current 30-Day Federal Register
Notice covers two new instruments:
[FR Doc. 2013–25008 Filed 10–24–13; 8:45 am]
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Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
ANNUAL BURDEN: CURRENT REQUEST
Number of
responses
per
respondent
Annual
number of
respondents
Activity/respondent
Average
burden per
response
(hours)
Total annual
burden hours
Responsible Fatherhood Grantee Impact Evaluation
(19) RF Follow-up survey
Study participants .....................................................................................
1,600
1
0.75
1,200
Healthy Marriage Grantee Impact Evaluation
(20) HM Follow-up survey
Study participants .....................................................................................
3,200
1
0.75
2,400
Total ...................................................................................................
........................
........................
........................
3,600
Estimated Total Annual Burden
Hours (for instruments previously
approved and currently in use, and
those associated with this 30-Day
Notice): 16,716.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2013–25128 Filed 10–24–13; 8:45 am]
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emcdonald on DSK67QTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1214]
Clinical Investigator Training Course
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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The Food and Drug Administration’s
(FDA’s) Center for Drug Evaluation and
Research/Office of Medical Policy and
the Duke University Office of
Continuing Medical Education are
cosponsoring a 3-day training course for
clinical investigators on scientific,
ethical, and regulatory aspects of
clinical trials. This training course is
intended to provide clinical
investigators with expertise in the
design, conduct, and analysis of clinical
trials; improve the quality of clinical
trials; and enhance the safety of trial
participants. Senior FDA staff will
communicate directly with clinical
investigators on issues of greatest
importance for successful clinical
research.
Date and Time: The training course
will be held on November 12 and 13,
2013, from 8 a.m. to 5 p.m., and on
November 14, 2013, from 8 a.m. to 4
p.m.
Location: The course will be held at
the Holiday Inn College Park, 10000
Baltimore Ave., College Park, MD
20740.
Contact Person: Connie Wisner, Office
of Medical Policy, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6360,
Silver Spring, MD 20993, 301–796–
8509.
Registration: Register by November 1,
2013. The registration fee is $400 per
person. The fee includes course
materials and onsite lunch. Early
registration is recommended because
seating is limited. There will be no
onsite registration.
Register online for the training course
at the registration Web site: https://
continuingeducation.dcri.duke.edu/fdaclinical-investigators-training-courseregistration or download a full-size copy
of the registration form from the
registration site and mail a check and
completed form to: Duke University
PO 00000
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Conference and Event Services, FDA
Investigator Course, Box 90841, 101
Bryan Center, Durham, NC 27708. You
will receive an email that confirms your
registration. (FDA has verified the Web
site address, but FDA is not responsible
for subsequent changes to the Web site
after this document publishes in the
Federal Register.)
Attendees are responsible for their
own accommodations. A block of rooms
has been reserved under ‘‘FDA Clinical
Investigator Course’’ at the Holiday Inn
College Park at a reduced conference
rate. Reservations for these
accommodations can be made online
using the course registration Web site
mentioned previously. Click on
‘‘registration form.’’ You will see a
direct link to the hotel.
Registration materials, payment
procedures, accommodation
information, and a detailed description
of the course can be found at the
registration/information Web site
mentioned previously.
If you need special accommodations
due to a disability, please contact
Connie Wisner (see Contact Person) at
least 7 days in advance. Persons
attending the course are advised that
FDA is not responsible for providing
access to electrical outlets.
SUPPLEMENTARY INFORMATION:
I. Background
Clinical trial investigators play a
critical role in the development of
medical products. They bear the
responsibility for ensuring the safe and
ethical treatment of study subjects and
for acquiring adequate and reliable data
to support regulatory decisions. This
course is intended to assist clinical
investigators in understanding what
preclinical and clinical information is
needed to support the investigational
use of medical products, as well as the
scientific, regulatory, and ethical
considerations involved in the conduct
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[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Notices]
[Pages 63987-63988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25128]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Parents and Children Together (PACT) Evaluation.
OMB No.: 0970-0403.
Description: The Office of Planning, Research and Evaluation
(OPRE), Administration for Children and Families (ACF), U.S. Department
of Health and Human Services (HHS), is proposing data collection
activity as part of the Parents and Children Together (PACT)
Evaluation. The objective of the PACT evaluation is to document and
provide initial assessment of selected Responsible Fatherhood and
Healthy Marriage grant programs that were authorized under the 2010
Claims Resolution Act. This information will be critical to informing
decisions related to future investments in programming as well as the
design and operation of such services.
PACT is utilizing three major, interrelated evaluation strategies:
Impact evaluation; implementation evaluation; and qualitative
evaluation. To collect data for these strategies, eighteen instruments
have been approved to-date. This 30-Day Federal Register Notice covers
two new instruments:
(19) Follow-up Survey (for Responsible Fatherhood study participants)
(20) Follow-up Survey (for Healthy Marriage study participants)
A more thorough description of the study and instruments was
provided in a 60 Day Federal Register Notice posted in Vol. 78, No.
102, p. 31942 on May 28, 2013.
Respondents: Program applicants, program participants, program
staff, and staff at referral agencies.
Annual Burden Estimates
This current 30-Day Federal Register Notice covers two new
instruments:
[[Page 63988]]
Annual Burden: Current Request
----------------------------------------------------------------------------------------------------------------
Average
Annual number Number of burden per Total annual
Activity/respondent of responses per response burden hours
respondents respondent (hours)
----------------------------------------------------------------------------------------------------------------
Responsible Fatherhood Grantee Impact Evaluation
----------------------------------------------------------------------------------------------------------------
(19) RF Follow-up survey
Study participants.......................... 1,600 1 0.75 1,200
----------------------------------------------------------------------------------------------------------------
Healthy Marriage Grantee Impact Evaluation
----------------------------------------------------------------------------------------------------------------
(20) HM Follow-up survey
Study participants.......................... 3,200 1 0.75 2,400
---------------------------------------------------------------
Total................................... .............. .............. .............. 3,600
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours (for instruments previously
approved and currently in use, and those associated with this 30-Day
Notice): 16,716.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade
SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All
requests should be identified by the title of the information
collection. Email address: OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for
Children and Families.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2013-25128 Filed 10-24-13; 8:45 am]
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