National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting Rule-Making Proceedings, 19778-19779 [2011-8395]
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Federal Register / Vol. 76, No. 68 / Friday, April 8, 2011 / Notices
2011, with a 180-day approval period.
Written comments and
recommendations will be considered
from the public if received by the
individuals designated below by May 4,
2011.
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/
regulations/pra or E-mail 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.
Interested persons are invited to send
comments regarding the burden or any
other aspect of these collections of
information requirements. However, as
noted above, comments on these
information collection and
recordkeeping requirements must be
mailed and/or faxed to the designees
referenced below by May 4, 2011.
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.
3. By Facsimile or E-mail to OMB.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer. Fax Number: (202) 395–6974. Email: OIRA_submission@omb.eop.gov.
Dated: April 1, 2011.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2011–8459 Filed 4–7–11; 8:45 am]
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BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0544]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Application for Participation in the
Medical Device Fellowship Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Application for Participation in the
Medical Device Fellowship Program’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@FDA.HHS.GOV.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 27, 2011 (76
FR 4913), the Agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0551. The
approval expires on March 31, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUMMARY:
Dated: April 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8369 Filed 4–7–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: Statement of Reasons for
Not Conducting Rule-Making
Proceedings
Health Resources and Services
Administration, HHS.
AGENCY:
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16:41 Apr 07, 2011
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ACTION:
Notice.
In accordance with section
2114(c)(2)(B) of the Public Health
Service Act, notice is hereby given of
the reasons for not conducting a rulemaking proceeding for adding Guillain´
Barre Syndrome (GBS) to the Vaccine
Injury Table at this time.
DATES: Written comments are not being
solicited.
FOR FURTHER INFORMATION CONTACT:
Geoffrey Evans, M.D., Director, Division
of Vaccine Injury Compensation,
Healthcare Systems Bureau, Health
Resources and Services Administration
(HRSA), Room 11C–26, Parklawn
Building, 5600 Fishers Lane, Rockville,
Maryland 20857; telephone number
(301) 443–6593.
SUPPLEMENTARY INFORMATION: The
National Childhood Vaccine Injury Act
of 1986, title III of Public Law 99–660
(42 U.S.C. 300aa–10 et seq.) established
the National Vaccine Injury
Compensation Program (VICP) for
persons found to be injured by vaccines.
Under this Federal program, petitions
for compensation are filed with the
United States Court of Federal Claims
(Court). The Court, acting through
special masters, makes findings as to
eligibility for, and amount of,
compensation. In order to gain
entitlement to compensation under title
XXI of the Public Health Service (PHS)
Act for a covered vaccine, a petitioner
must establish a vaccine-related injury
or death, either by proving that the first
symptom of an injury/condition, as
defined by the Qualifications and Aids
to Interpretation, occurred within the
time period listed on the Vaccine Injury
Table (Table), and therefore presumed
to be caused by a vaccine (unless
another cause is found), or by proof of
vaccine causation, if the injury/
condition is not on the Table or did not
occur within the time period specified
on the Table.
The statute authorizing the VICP
provides for the inclusion of additional
vaccines in the VICP when they are
recommended by the Centers for Disease
Control and Prevention (CDC) for
routine administration to children. See
section 2114(e)(2) of the PHS Act, 42
U.S.C. 300aa–14(e)(2). Consistent with
section 13632(a)(3) of Public Law 103–
66, the regulations governing the VICP
provide that such vaccines will be
included in the Table as of the effective
date of an excise tax to provide funds
for the payment of compensation with
respect to such vaccines. 42 CFR
100.3(c)(5). The statute authorizing the
VICP also authorizes the Secretary to
create and modify a list of injuries,
SUMMARY:
E:\FR\FM\08APN1.SGM
08APN1
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:
VerDate Mar<15>2010
16:41 Apr 07, 2011
Jkt 223001
• 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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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
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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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]]>Agencies
[Federal Register Volume 76, Number 68 (Friday, April 8, 2011)]
[Notices]
[Pages 19778-19779]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8395]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Vaccine Injury Compensation Program: Statement of
Reasons for Not Conducting Rule-Making Proceedings
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with section 2114(c)(2)(B) of the Public Health
Service Act, notice is hereby given of the reasons for not conducting a
rule-making proceeding for adding Guillain-Barr[eacute] Syndrome (GBS)
to the Vaccine Injury Table at this time.
DATES: Written comments are not being solicited.
FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D., Director,
Division of Vaccine Injury Compensation, Healthcare Systems Bureau,
Health Resources and Services Administration (HRSA), Room 11C-26,
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857;
telephone number (301) 443-6593.
SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of
1986, title III of Public Law 99-660 (42 U.S.C. 300aa-10 et seq.)
established the National Vaccine Injury Compensation Program (VICP) for
persons found to be injured by vaccines. Under this Federal program,
petitions for compensation are filed with the United States Court of
Federal Claims (Court). The Court, acting through special masters,
makes findings as to eligibility for, and amount of, compensation. In
order to gain entitlement to compensation under title XXI of the Public
Health Service (PHS) Act for a covered vaccine, a petitioner must
establish a vaccine-related injury or death, either by proving that the
first symptom of an injury/condition, as defined by the Qualifications
and Aids to Interpretation, occurred within the time period listed on
the Vaccine Injury Table (Table), and therefore presumed to be caused
by a vaccine (unless another cause is found), or by proof of vaccine
causation, if the injury/condition is not on the Table or did not occur
within the time period specified on the Table.
The statute authorizing the VICP provides for the inclusion of
additional vaccines in the VICP when they are recommended by the
Centers for Disease Control and Prevention (CDC) for routine
administration to children. See section 2114(e)(2) of the PHS Act, 42
U.S.C. 300aa-14(e)(2). Consistent with section 13632(a)(3) of Public
Law 103-66, the regulations governing the VICP provide that such
vaccines will be included in the Table as of the effective date of an
excise tax to provide funds for the payment of compensation with
respect to such vaccines. 42 CFR 100.3(c)(5). The statute authorizing
the VICP also authorizes the Secretary to create and modify a list of
injuries,
[[Page 19779]]
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:
[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-Barr[eacute] 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:
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 VICP-covered 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 rule-making 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]
BILLING CODE 4165-15-P
