Office of the Director; Notice of Charter Renewal, 19779 [2011-8440]
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Federal Register / Vol. 76, No. 68 / Friday, April 8, 2011 / Notices
disabilities, illnesses, conditions, and
deaths (and their associated time
frames) associated with each category of
vaccines included on the Table. See
sections 2114(c) and 2114(e)(2) of the
PHS Act, 42 U.S.C. 300aa–14(c) and
30aa–14(e)(2). Finally, section
2114(c)(2) of the PHS Act, 42 U.S.C.
300aa–14(c)(2) provides that:
srobinson on DSKHWCL6B1PROD with NOTICES
[a]ny person (including the Advisory
Commission on Childhood Vaccines) may
petition the Secretary to propose regulations
to amend the Vaccine Injury Table. Unless
clearly frivolous, or initiated by the
Commission, any such petition shall be
referred to the Commission for its
recommendations. Following—
(A) receipt of any recommendation of the
Commission, or
(B) 180 days after the date of the referral
to the Commission, whichever occurs first,
the Secretary shall conduct a rule-making
proceeding on the matters proposed in the
petition or publish in the Federal Register a
statement of reasons for not conducting such
proceeding.
On September 9, 2010, a private person
submitted a petition to amend the Table.
This petition was submitted to the Chief
Special Master, Sandra Lord, with a
copy to Dr. Geoffrey Evans, Director,
Division of Vaccine Injury
Compensation. Pursuant to the VICP
statute, Dr. Evans referred the petition to
the Commission on October 28, 2010.
The Commission discussed the petition
at its meeting on March 3, 2011. At the
conclusion of this discussion, the
Commission voted unanimously to
recommend that the Secretary not
proceed with rule-making to amend the
Table as requested in the petition.
The petition requests that the
Secretary amend the Table to include
´
Guillain-Barre Syndrome (GBS) as an
injury following certain vaccines. The
petition asserts that ‘‘[e]very drug
company admits that GBS is linked to
many different vaccines including
influenza, meningitis, and cervical
cancer [human papillomavirus].’’ The
petitioner asserts that her mother
received the seasonal influenza vaccine,
and was subsequently diagnosed with
GBS. Other than the assertion cited, the
petition does not cite scientific support,
nor indicate specifically for which
vaccines GBS should be added as an
injury, nor indicate any appropriate
time-frame.
Nonetheless, the Secretary takes very
seriously proposals to modify the Table.
Prior to receipt of the petition, in 2008,
the Secretary contracted with the
Institute of Medicine (IOM) to review
the epidemiological, clinical, and
biological evidence regarding adverse
health events associated with specific
vaccines covered by the VICP. The
vaccines to be reviewed are:
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• Varicella vaccines,
• influenza vaccines,
• hepatitis B vaccine,
• human papillomavirus vaccines,
• hepatitis A vaccines,
• meningococcal vaccines,
• measles-mumps rubella vaccines,
and
• diphtheria, tetanus, pertussis
vaccines.
The IOM committee will author a
consensus report with conclusions on
the evidence bearing on causality and
the evidence regarding the biological
mechanisms that underlie specific
theories for how a specific vaccine is
related to a specific adverse event. In
particular, the report will contain
updated findings on the possible causal
relationship between certain VICPcovered vaccines and GBS, as well as
other possible injuries/medical
conditions. The Secretary expects to
receive the IOM consensus report in
early summer. After receipt of the
consensus report, and a careful analysis
of the important scientific and policy
considerations raised by the findings in
the report, the Secretary will consider
whether to engage in a rule-making
proceeding to modify the Table. As
required by law, any such rule-making
proceeding would include notice and
opportunity for a public hearing and at
least 180 days of public comment. See
section 2114(c)(1) of the PHS Act, 42
U.S.C. 300aa–14(c)(1). Also as required
by law, the Secretary would provide to
the Commission a copy of the proposed
regulation or revision, request
recommendations and comments by the
Commission, and afford the
Commission at least 90 days to make
such recommendations. See section
2114(d) of the PHS Act, 42 U.S.C.
300aa–14(d).
The Secretary intends to consider
whether to engage in a rule-making
process with the benefit of the
important scientific information soon to
be provided by the IOM; to begin the
lengthy process without such additional
information would not result in rulemaking founded on the best and most
recent scientific knowledge. For these
reasons, it has been determined not to
conduct a rule-making proceeding based
on the petition received at this time.
Dated: April 1, 2011.
Mary K. Wakefield,
Administrator.
[FR Doc. 2011–8395 Filed 4–7–11; 8:45 am]
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19779
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Center for
Scientific Review Advisory Council
(CSRAC), formerly National Institutes of
Health Peer Review Committee, was
renewed for an additional two-year
period on March 31, 2011.
It is determined that the CSRAC is in
the public interest in connection with
the performance of duties imposed on
the National Institutes of Health by law,
and that these duties can best be
performed through the advice and
counsel of this group.
Inquiries may be directed to Jennifer
Spaeth, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or spaethj@od.nih.gov.
Dated: April 4, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–8440 Filed 4–7–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
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[Federal Register Volume 76, Number 68 (Friday, April 8, 2011)]
[Notices]
[Page 19779]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8440]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter Renewal
In accordance with Title 41 of the U.S. Code of Federal
Regulations, Section 102-3.65(a), notice is hereby given that the
Charter for the Center for Scientific Review Advisory Council (CSRAC),
formerly National Institutes of Health Peer Review Committee, was
renewed for an additional two-year period on March 31, 2011.
It is determined that the CSRAC is in the public interest in
connection with the performance of duties imposed on the National
Institutes of Health by law, and that these duties can best be
performed through the advice and counsel of this group.
Inquiries may be directed to Jennifer Spaeth, Director, Office of
Federal Advisory Committee Policy, Office of the Director, National
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda,
Maryland 20892 (Mail code 4875), Telephone (301) 496-2123, or
spaethj@od.nih.gov.
Dated: April 4, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-8440 Filed 4-7-11; 8:45 am]
BILLING CODE 4140-01-P
