Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections, 55215-55216 [2012-22103]
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Federal Register / Vol. 77, No. 174 / Friday, September 7, 2012 / Notices
on Code Sets, Operating Rules and
Administrative Simplification. In
addition, a status update will be given
on NCVHS’s Working Group on Data
Access and Use; and the Committee will
deliberate briefly on follow-up from the
August 9th Executive Subcommittee
Strategic Planning Session.
The agenda for the morning of the
second day will consist of a review of
the final action items discussed on the
first day; and reports from the
Subcommittees. After lunch, the
Committee will be briefed on deidentification methods for Open Health
data. Once the full Committee adjourns,
NCVHS’s Working Group on Data
Access and Use will convene to discuss
anticipated work products and logistical
plans. Further information will be
provided on the NCVHS Web site at
https://www.ncvhs.hhs.gov/.
The times shown above are for the full
Committee meeting. Subcommittee
breakout sessions are scheduled for late
in the afternoon on the first day and in
the morning prior to the full Committee
meeting on the second day. Agendas for
these breakout sessions will be posted
on the NCVHS Web site (URL below)
when available.
Contact Person for More Information:
Substantive program information as
well as summaries of meetings and a
roster of committee members may be
obtained from Marjorie S. Greenberg,
Executive Secretary, NCVHS, National
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Disease Control and Prevention, 3311
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Maryland 20782, telephone (301) 458–
4245. Information also is available on
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site: https://www.ncvhs.hhs.gov/, where
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srobinson on DSK4SPTVN1PROD with NOTICES
Dated: August 29, 2012.
James Scanlon,
Deputy Assistant Secretary for Planning and
Evaluation, Office of the Assistant Secretary
for Planning and Evaluation.
[FR Doc. 2012–22102 Filed 9–6–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Membership on the Secretary’s
Advisory Committee on Human
Research Protections
Office for Human Research
Protections, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended. The Committee is governed
by the provisions of Public Law 92–463,
as amended (5 U.S.C. appendix 2),
which sets forth standards for the
formation and use of advisory
committees.
SUMMARY: The Office for Human
Research Protections (OHRP), a program
office in the Office of the Assistant
Secretary for Health, Department of
Health and Human Services (HHS), is
seeking nominations of qualified
candidates to be considered for
appointment as members of the
Secretary’s Advisory Committee on
Human Research Protections (SACHRP).
SACHRP provides advice and
recommendations to the Secretary, HHS,
and the Assistant Secretary for Health
on matters pertaining to the continuance
and improvement of functions within
the authority of HHS directed toward
protections for human subjects in
research. SACHRP was established by
the Secretary, HHS, on October 1, 2002.
OHRP is seeking nominations of
qualified candidates to fill two positions
on the Committee membership that will
be vacated during the 2013 calendar
year.
AUTHORITY:
Nominations for membership on
the Committee must be received no later
than October 9, 2012.
ADDRESSES: Nominations should be
mailed or delivered to Dr. Jerry
Menikoff, Director, Office for Human
Research Protections, Department of
Health and Human Services, 1101
Wootton Parkway, Suite 200; Rockville,
MD 20852. Nominations will not be
accepted by email or by facsimile.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, Executive Director, SACHRP,
Office for Human Research Protections,
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852, telephone: 240–
453–8141. A copy of the Committee
charter and list of the current members
can be obtained by contacting Ms.
Gorey, accessing the SACHRP Web site
at www.hhs.gov/ohrp/sachrp, or
DATES:
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55215
requesting via email at
sachrp@osophs.dhhs.gov.
The
Committee provides advice on matters
pertaining to the continuance and
improvement of functions within the
authority of HHS directed toward
protections for human subjects in
research. Specifically, the Committee
provides advice relating to the
responsible conduct of research
involving human subjects with
particular emphasis on special
populations such as neonates and
children, prisoners, the decisionally
impaired, pregnant women, embryos
and fetuses, individuals and
populations in international studies,
investigator conflicts of interest and
populations in which there are
individually identifiable samples, data
or information.
In addition, the Committee is
responsible for reviewing selected
ongoing work and planned activities of
the OHRP and other offices/agencies
within HHS responsible for human
subjects protection. These evaluations
may include, but are not limited to, a
review of assurance systems, the
application of minimal research risk
standards, the granting of waivers,
education programs sponsored by
OHRP, and the ongoing monitoring and
oversight of institutional review boards
and the institutions that sponsor
research.
Nominations: The OHRP is requesting
nominations to fill two positions for
voting members of SACHRP. Two
positions will become vacant in March,
2013. Nominations of potential
candidates for consideration are being
sought from a wide array of fields,
including, but not limited to: Public
health and medicine, behavioral and
social sciences, health administration,
and biomedical ethics. To qualify for
consideration of appointment to the
Committee, an individual must possess
demonstrated experience and expertise
in any of the several disciplines and
fields pertinent to human subjects
protection and/or clinical research.
The individuals selected for
appointment to the Committee can be
invited to serve a term of up to four
years. Committee members receive a
stipend and reimbursement for per diem
and any travel expenses incurred for
attending Committee meetings and/or
conducting other business in the
interest of the Committee. Interested
applicants may self-nominate.
Nominations should be typewritten.
The following information should be
included in the package of material
submitted for each individual being
SUPPLEMENTARY INFORMATION:
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55216
Federal Register / Vol. 77, No. 174 / Friday, September 7, 2012 / Notices
nominated for consideration: (1) A letter
of nomination that clearly states the
name and affiliation of the nominee, the
basis for the nomination (i.e., specific
attributes which qualify the nominee for
service in this capacity), and a statement
that the nominee is willing to serve as
a member of the Committee; (2) the
nominator’s name, address, daytime
telephone number, and the home and/
or work address, telephone number, and
email address of the individual being
nominated; and (3) a current copy of the
nominee’s curriculum vitae. Federal
employees should not be nominated for
consideration of appointment to this
Committee.
The Department makes every effort to
ensure that the membership of HHS
Federal advisory committees is fairly
balanced in terms of points of view
represented and the committee’s
function. Every effort is made to ensure
that individuals from a broad
representation of geographic areas,
women and men, ethnic and minority
groups, and the disabled are given
consideration for membership on HHS
Federal advisory committees.
Appointment to this Committee shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and
cultural, religious, or socioeconomic
status.
Individuals who are selected to be
considered for appointment will be
required to provide detailed information
regarding their financial holdings,
consultancies, and research grants or
contracts. Disclosure of this information
is necessary in order to determine if the
selected candidate is involved in any
activity that may pose a potential
conflict with the official duties to be
performed as a member of SACHRP.
Dated: August 31, 2012.
Jerry Menikoff,
Director, Office for Human Research
Protections, Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. 2012–22103 Filed 9–6–12; 8:45 am]
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srobinson on DSK4SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10003]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
AGENCY:
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In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (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.
1. Type of Information Collection
Request: Revision of a currently
approved collection.
Title of Information Collection: Notice
of Denial of Medical Coverage (or
Payment); Use: In the July 6, 2012,
Federal Register (77 FR 40064), the
Centers for Medicare and Medicaid
Services (CMS) published a 60-day
notice regarding the information
collection request approved under
0938–0829. However, due to technical
difficulties, the documents associated
with the information collection request
were not made available to the public
until August 14, 2012. Because of the
technical difficulties, CMS is
republishing the notice to allow the
public to have a full 60-day comment
period.
Section 1852(g)(1)(B) of the Social
Security Act (SSA) requires Medicare
health plans to provide enrollees with a
written notice in understandable
language that explains the plan’s
reasons for denying a request for a
service or payment for a service the
enrollee has already received. The
written notice must also include a
description of the applicable appeals
processes. Regulatory authority for this
notice is set forth in Subpart M of Part
422 at 42 CFR 422.568, 422.572,
417.600(b), and 417.840.
Section 1932 of the Social Security
Act (SSA) sets forth requirements for
Medicaid managed care plans, including
beneficiary protections related to
appealing a denial of coverage or
payment. The Medicaid managed care
appeals regulations are set forth in
Subpart F of Part 438 of Title 42 of the
CFR. Rules on the content of the written
denial notice can be found at 42 CFR
438.404.
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This notice combines the existing
Notice of Denial of Medicare Coverage
with the Notice of Denial of Payment
and includes optional language to be
used in cases where a Medicare health
plan enrollee also receives full Medicaid
benefits that are being managed by the
Medicare health plan. Form Number:
CMS–10003 (OCN: 0938–0829).
Frequency: Occasionally. Affected
Public: Private Sector (business or other
for-profits, not-for-profit institutions).
Number of Respondents: 665. Total
Annual Responses: 6,960,410. Total
Annual Hours: 1,159,604. (For policy
questions regarding this collection
contact Gladys Wheeler at 410–786–
0273. For all other issues call 410–786–
1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by November 6, 2012:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ___, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: September 4, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–22087 Filed 9–6–12; 8:45 am]
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[Federal Register Volume 77, Number 174 (Friday, September 7, 2012)]
[Notices]
[Pages 55215-55216]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22103]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Nominations for Membership on the Secretary's
Advisory Committee on Human Research Protections
AGENCY: Office for Human Research Protections, Office of the Assistant
Secretary for Health, Office of the Secretary, Department of Health and
Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
AUTHORITY: 42 U.S.C. 217a, Section 222 of the Public Health Service
Act, as amended. The Committee is governed by the provisions of Public
Law 92-463, as amended (5 U.S.C. appendix 2), which sets forth
standards for the formation and use of advisory committees.
SUMMARY: The Office for Human Research Protections (OHRP), a program
office in the Office of the Assistant Secretary for Health, Department
of Health and Human Services (HHS), is seeking nominations of qualified
candidates to be considered for appointment as members of the
Secretary's Advisory Committee on Human Research Protections (SACHRP).
SACHRP provides advice and recommendations to the Secretary, HHS, and
the Assistant Secretary for Health on matters pertaining to the
continuance and improvement of functions within the authority of HHS
directed toward protections for human subjects in research. SACHRP was
established by the Secretary, HHS, on October 1, 2002. OHRP is seeking
nominations of qualified candidates to fill two positions on the
Committee membership that will be vacated during the 2013 calendar
year.
DATES: Nominations for membership on the Committee must be received no
later than October 9, 2012.
ADDRESSES: Nominations should be mailed or delivered to Dr. Jerry
Menikoff, Director, Office for Human Research Protections, Department
of Health and Human Services, 1101 Wootton Parkway, Suite 200;
Rockville, MD 20852. Nominations will not be accepted by email or by
facsimile.
FOR FURTHER INFORMATION CONTACT: Julia Gorey, Executive Director,
SACHRP, Office for Human Research Protections, 1101 Wootton Parkway,
Suite 200, Rockville, MD 20852, telephone: 240-453-8141. A copy of the
Committee charter and list of the current members can be obtained by
contacting Ms. Gorey, accessing the SACHRP Web site at www.hhs.gov/ohrp/sachrp, or requesting via email at sachrp@osophs.dhhs.gov.
SUPPLEMENTARY INFORMATION: The Committee provides advice on matters
pertaining to the continuance and improvement of functions within the
authority of HHS directed toward protections for human subjects in
research. Specifically, the Committee provides advice relating to the
responsible conduct of research involving human subjects with
particular emphasis on special populations such as neonates and
children, prisoners, the decisionally impaired, pregnant women, embryos
and fetuses, individuals and populations in international studies,
investigator conflicts of interest and populations in which there are
individually identifiable samples, data or information.
In addition, the Committee is responsible for reviewing selected
ongoing work and planned activities of the OHRP and other offices/
agencies within HHS responsible for human subjects protection. These
evaluations may include, but are not limited to, a review of assurance
systems, the application of minimal research risk standards, the
granting of waivers, education programs sponsored by OHRP, and the
ongoing monitoring and oversight of institutional review boards and the
institutions that sponsor research.
Nominations: The OHRP is requesting nominations to fill two
positions for voting members of SACHRP. Two positions will become
vacant in March, 2013. Nominations of potential candidates for
consideration are being sought from a wide array of fields, including,
but not limited to: Public health and medicine, behavioral and social
sciences, health administration, and biomedical ethics. To qualify for
consideration of appointment to the Committee, an individual must
possess demonstrated experience and expertise in any of the several
disciplines and fields pertinent to human subjects protection and/or
clinical research.
The individuals selected for appointment to the Committee can be
invited to serve a term of up to four years. Committee members receive
a stipend and reimbursement for per diem and any travel expenses
incurred for attending Committee meetings and/or conducting other
business in the interest of the Committee. Interested applicants may
self-nominate.
Nominations should be typewritten. The following information should
be included in the package of material submitted for each individual
being
[[Page 55216]]
nominated for consideration: (1) A letter of nomination that clearly
states the name and affiliation of the nominee, the basis for the
nomination (i.e., specific attributes which qualify the nominee for
service in this capacity), and a statement that the nominee is willing
to serve as a member of the Committee; (2) the nominator's name,
address, daytime telephone number, and the home and/or work address,
telephone number, and email address of the individual being nominated;
and (3) a current copy of the nominee's curriculum vitae. Federal
employees should not be nominated for consideration of appointment to
this Committee.
The Department makes every effort to ensure that the membership of
HHS Federal advisory committees is fairly balanced in terms of points
of view represented and the committee's function. Every effort is made
to ensure that individuals from a broad representation of geographic
areas, women and men, ethnic and minority groups, and the disabled are
given consideration for membership on HHS Federal advisory committees.
Appointment to this Committee shall be made without discrimination on
the basis of age, race, ethnicity, gender, sexual orientation,
disability, and cultural, religious, or socioeconomic status.
Individuals who are selected to be considered for appointment will
be required to provide detailed information regarding their financial
holdings, consultancies, and research grants or contracts. Disclosure
of this information is necessary in order to determine if the selected
candidate is involved in any activity that may pose a potential
conflict with the official duties to be performed as a member of
SACHRP.
Dated: August 31, 2012.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary,
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2012-22103 Filed 9-6-12; 8:45 am]
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