National Advisory Council on Migrant Health; Notice of Meeting, 19294-19295 [2012-7613]
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Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices
systems for the UK population (Ref. 3).
This peer-reviewed journal article
presented the following findings
regarding primary MoM THR: (1)
Increased failure rate at 5 years for MoM
THR related to larger head sizes; (2)
significantly higher risk for revision in
female patients (Note: In the United
States, labeling discourages use of MoM
hips in females of child bearing age with
warnings in MoM THR labeling and
contraindications in MoM hip
resurfacing labeling); and (3) revisions
for dislocation in men with MoM
replacements were slightly lower,
showing some benefit to larger head
sizes.
The committee will be asked to
discuss the following as it pertains to
these devices in the U.S. population:
Device mechanisms of failure, metal ion
testing, imaging methods, local and
systemic complications, preoperative
and postoperative patient risk factors, as
well as clinical followup considerations
for patients with MoM hip systems
(total and resurfacing).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: FDA will work with
affected industry, professional
organizations, and societies that have an
interest in the MoM hip arthroplasty
systems and who wish to make a
presentation separate from the general
open public hearing; time slots on June
28, 2012, between approximately 9 a.m.
and 10 a.m. Representatives from
industry, professional organizations and
societies interested in making formal
presentations to the committee should
notify the contact person on or before
May 1, 2012.
Interested persons may present data,
information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
May 9, 2012. On June 27, 2012 oral
presentations from the public will be
scheduled between approximately 9
a.m. and 10 a.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
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arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before May 1,
2012. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by May 2, 2012.
Comments: FDA is opening a docket
to allow for public comments to be
submitted to the Agency on the issues
before the Orthopaedic and
Rehabilitation Devices Panel of the
Medical Devices Advisory Committee
beginning on March 30, 2012, and
closing on May 9, 2012. Interested
persons are encouraged to use the
docket to submit electronic or written
comments regarding this meeting.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management, Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Divisions
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact James Clark,
James.Clark@fda.hhs.gov or 301–796–
5293 at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
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I. References
The following references have been
placed on display in the Division of
Dockets Management (see Comments)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but FDA is not
responsible for any subsequent changes
to the Web site after this document
publishes in the Federal Register.)
1. American Academy of Orthopedic
Surgeons, ‘‘Modern Metal-on-Metal Hip
Implants: A Technology Overview’’ (July
15, 2011), accessed online at https://
www.aaos.org/research/overviews/
Metal_On_Metal.pdf.
2. Adelaide: Australian Orthopaedic
Association, Australian Orthopaedic
Association National Joint Replacement
Registry: Annual Report 2010, 2010.
3. Smith, A.J., P. Dieppe, K. Vernon, et al.,
‘‘Failure Rates of Stemmed Metal-onMetal Hip Replacements: Analysis of
Data From the National Joint Registry of
England and Wales,’’ Lancet (March 13,
2012), accessed online at https://
www.thelancet.com/journals/lancet/
article/PIIS0140–6736(12)60353-5/
fulltext#article_upsell (doi:10.1016/
S0140–6736(12)60353–5).
Dated: March 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–7767 Filed 3–29–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Migrant
Health; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: National Advisory Council on
Migrant Health.
Dates and Times: May 7, 2012, 8:30 a.m.
to 5 p.m., May 8, 2012, 8:30 a.m. to 5 p.m.
Place: Westin Denver Downtown Hotel,
1672 Lawrence Street, Denver, Colorado
80202. Telephone: (303) 572–9100.
Fax: (303) 572–7288.
Status: The meeting will be open to the
public.
Purpose: The purpose of the meeting is to
discuss services and issues related to the
health of migrant and seasonal farmworkers
and their families and to formulate
recommendations for the Secretary of Health
and Human Services.
Agenda: The agenda includes an overview
of the National Advisory Council on Migrant
Health’s (The Council) general business
activities. The Council will also hear
presentations from experts on farmworker
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Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices
issues, including the status of farmworker
health at the local and national levels.
Agenda items are subject to change as
priorities indicate.
For Further Information Contact: Gladys
Cate, Office of Special Population Health,
Bureau of Primary Health Care, Health
Resources and Services Administration, 5600
Fishers Lane, Room 15–62, Rockville,
Maryland 20857; telephone (301) 594–0367.
Dated: March 22, 2012.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2012–7613 Filed 3–29–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Privacy Act of 1974; Report of an
Altered System of Records
Department of Health and
Human Services (HHS), Health
Resources and Services Administration
(HRSA).
ACTION: Notice of an Altered System of
Records (SOR).
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974
(5 U.S.C. 552a), as amended, the Health
Resources and Services Administration
(HRSA) is publishing a notice to alter
the system of records for the National
Practitioner Data Bank for Adverse
Information on Physicians and Other
Health Care Practitioners, HHS/HRSA/
BHPR. The System of Records Notice
(SORN) 09–15–0054 was last published
on October 1, 2010 (75 FR 60763). The
Health Care Quality Improvement Act of
1986, as amended, title IV of Public Law
99–660 (42 U.S.C. 11101 et seq.)
authorized the Secretary to establish a
National Practitioner Data Bank (NPDB)
to collect and release certain
information relating to the professional
competence and conduct of physicians,
dentists, and other health care
practitioners. By law, the information is
releasable only to the specific entities
described in the SORN. The law
requires the maintenance of records
such as medical malpractice payments,
adverse licensure and clinical privilege
actions, disciplinary actions taken by
Boards of Medical Examiners, and
professional review actions taken by
entities against physicians, dentists, and
other healthcare practitioners. Section
1921 of the Social Security Act, as
amended, expands reporting to the
NPDB to authorize maintenance of
records of adverse licensure actions and
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negative actions or findings taken by a
State licensing authority, peer review
organization, or private accreditation
entity against all health care
practitioners or healthcare entities.
The primary purpose of this alteration
is to publish the Privacy Act exemptions
that became necessary after
implementation of Section 1921, which
entitles law enforcement agencies to
access NPDB information and which
therefore requires a similar exemption
from certain provisions of the Privacy
Act that the Healthcare Integrity and
Protection Data Bank (HIPDB) has for
investigative materials. Because some of
the records may be queried by law
enforcement agencies for investigative
purposes (i.e., as opposed to
employment or other purposes), the
system will be exempt from certain
Privacy Act requirements to the extent
necessary to avoid revealing law
enforcement investigative interest and
compromising law enforcement
investigations. Another purpose of this
alteration is to add a new routine use
pertaining to system security, which is
being added to other SORNs published
by HHS.
DATES: As required by the Privacy Act
(5 U.S.C. 552a(r)), HRSA filed an altered
system of records report with the Chair
of the House Committee on Oversight
and Government Reform, the Chair of
the Senate Committee on Homeland
Security and Governmental Affairs, and
the Administrator, Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB), on
1/25/12. To ensure all parties have
adequate time in which to comment, the
altered system will become effective 30
days from the publication of this notice
or 40 days from the date it was
submitted to OMB and Congress,
whichever is later, unless HRSA
receives comments that require
alterations to this notice.
ADDRESSES: Please address comments to
Associate Administrator, Bureau of
Health Professions, Health Resources
and Services Administration, 5600
Fishers Lane, Room 8–103, Rockville,
Maryland 20857. Comments received
will be available for inspection at this
same address from 9 a.m. to 3 p.m.
(Eastern Standard Time Zone), Monday
through Friday.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Practitioner Data
Banks, Bureau of Health Professions,
5600 Fishers Lane, Room 8–103,
Rockville, Maryland 20857; Telephone:
(301) 443–2300. This is not a toll-free
number.
SUPPLEMENTARY INFORMATION: The
National Practitioner Data Bank (NPDB)
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19295
is primarily an alert or flagging system
intended to facilitate a comprehensive
review of health care practitioners’
professional credentials for the purpose
of protecting the public from unfit
practitioners. On January 28, 2010, the
Health Resources and Services
Administration published a final rule in
the Federal Register (75 FR 4656)
designed to implement section 1921 of
the Social Security Act (herein referred
to as section 1921). Section 1921
expands the scope of the NPDB. Section
1921 requires each state to adopt a
system of reporting to the Secretary
certain adverse licensure actions taken
against health care practitioners and
health care entities by any authority of
the state responsible for the licensing of
such practitioners or entities. It also
requires each state to report any
negative action or finding that a state
licensing authority, a peer review
organization, or a private accreditation
entity has finalized against a health care
practitioner or entity. Practically
speaking, Section 1921 resulted in,
among other consequences, the
inclusion of the vast majority of
information contained in the Healthcare
Integrity and Protection Data Bank
(HIPDB), a companion data bank, in the
NPDB.
The HIPDB was created by the Health
Insurance Portability and
Accountability Act (HIPAA) of 1996,
Public Law (Pub. L. 104–191), which
required the Secretary of HHS, acting
through the Office of Inspector General
(OIG) and the United States Attorney
General, to establish a new health care
fraud and abuse control program to
combat health care fraud and abuse.
Although their purposes are different,
together the HIPDB and NPDB serve to
facilitate review of health care
practitioners’ and entities’ backgrounds.
The HIPDB is exempt from certain
provisions of the Privacy Act (see 45
CFR 5b.11(b)(2)(ii)(F)). In order to
maintain the exemption for the HIPDB
investigative materials, which are now
also available through the NPDB, and
other expanded information which law
enforcement agencies can access, it was
necessary to extend similar Privacy Act
exemptions for the HIPDB to the NPDB.
The new routine use that is being added
for this system pertains to system
security. It is not specific to the NPDB
system; it is being added to new,
existing, and updated SORNs published
by HHS for other systems that are
affected by the same security
requirement.
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]]>Agencies
[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Notices]
[Pages 19294-19295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7613]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Council on Migrant Health; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: National Advisory Council on Migrant Health.
Dates and Times: May 7, 2012, 8:30 a.m. to 5 p.m., May 8, 2012,
8:30 a.m. to 5 p.m.
Place: Westin Denver Downtown Hotel, 1672 Lawrence Street,
Denver, Colorado 80202. Telephone: (303) 572-9100.
Fax: (303) 572-7288.
Status: The meeting will be open to the public.
Purpose: The purpose of the meeting is to discuss services and
issues related to the health of migrant and seasonal farmworkers and
their families and to formulate recommendations for the Secretary of
Health and Human Services.
Agenda: The agenda includes an overview of the National Advisory
Council on Migrant Health's (The Council) general business
activities. The Council will also hear presentations from experts on
farmworker
[[Page 19295]]
issues, including the status of farmworker health at the local and
national levels. Agenda items are subject to change as priorities
indicate.
For Further Information Contact: Gladys Cate, Office of Special
Population Health, Bureau of Primary Health Care, Health Resources
and Services Administration, 5600 Fishers Lane, Room 15-62,
Rockville, Maryland 20857; telephone (301) 594-0367.
Dated: March 22, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-7613 Filed 3-29-12; 8:45 am]
BILLING CODE 4165-15-P
