Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting, 19936-19937 [07-1952]
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19936
Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices
Estimated Total Annual Burden
Hours: 880.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@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, Fax: 202–395–6974,
Attn: Desk Officer for ACF.
Dated: March 15, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–1976 Filed 4–19–07; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Help America Vote Act (HAVA)
Voting Access Annual Report.
OMB No.: New Collection.
Description: An annual report is
required by Federal statute (the Help
America Vote Act (HAVA) of 2002,
Public Law 107–252, Section 291,
Payments for Protection and Advocacy
Systems, 42 U.S.C. 15461). Each State or
Unit of Local Government must prepare
and submit an annual report at the end
of every fiscal year. The report
addresses the activities conducted with
the funds provided during the year. The
information collected from the annual
report will be aggregated into an annual
profile of how States have utilized the
funds and establish best practices for
election officials. It will also provide an
overview of the State election goals and
accomplishment and permit the
Administration on Developmental
Disabilities to track voting progress to
monitor grant activities.
Respondents: Secretaries of State,
Directors, State Election Boards, State
Chief Election officials.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of responses per
respondent
Average
burden hours
per response
Total burden
hours
Help America Vote Act (HAVA) Voting Access Annual Report ......................
sroberts on PROD1PC70 with NOTICES
Instrument
55
1
24
1,320
Estimated Total Annual Burden
Hours: 1,320.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. E-mail
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after the 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 collected should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: March 15, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–1977 Filed 4–19–07; 8:45am]
BILLING CODE 4184–01–M
VerDate Aug<31>2005
18:52 Apr 19, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Preparation for International
Conference on Harmonization
Meetings in Brussels, Belgium; Public
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘Preparation for
ICH meetings in Brussels, Belgium’’ to
provide information and receive
comments on the International
Conference on Harmonization (ICH) as
well as the upcoming meetings in
Brussels, Belgium. The topics to be
discussed are the topics for discussion
at the forthcoming ICH Steering
Committee Meeting. The purpose of the
meeting is to solicit public input prior
to the next Steering Committee and
Expert Working Groups meetings in
Brussels, Belgium, May 5 through 10,
2007, at which discussion of the topics
underway and the future of ICH will
continue.
Date and Time: The meeting will be
held on Thursday, May 3, 2007, from
11:30 a.m. to 1 p.m.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Location: The meeting will be held at
5600 Fishers Lane, 3rd floor, Conference
Room D, Rockville, MD 20857. For
security reasons, all attendees are asked
to arrive no later than 11:20 a.m., as you
will be escorted from the front entrance
of 5600 Fishers Lane to Conference
Room D.
Contact Person: All participants must
register with Tammie Bell, Office of the
Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, e-mail:
Tammie.Bell2@fda.hhs.gov or fax: 301–
827–0003.
Registration and Requests for Oral
Presentations: Send registration
information (including name, title, firm
name, address, telephone, and fax
number), written material and requests
to make oral presentations, to the
contact person by April 20, 2007.
If you need special accommodations
due to a disability, please contact
Tammie Bell at least 7 days in advance.
Transcripts: Transcripts of the
meeting may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
12A–16, Rockville, MD 20857,
approximately 15 working days after the
meeting at a cost of 10 cents per page.
SUPPLEMENTARY INFORMATION: The ICH
was established in 1990 as a joint
E:\FR\FM\20APN1.SGM
20APN1
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices
regulatory/industry project to improve,
through harmonization, the efficiency of
the process for developing and
registering new medicinal products in
Europe, Japan and the United States
without compromising the regulatory
obligations of safety and effectiveness.
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for medical product
development among regulatory
agencies. ICH was organized to provide
an opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. ICH is concerned with
harmonization among three regions: The
European Union, Japan, and the United
States. The six ICH sponsors are the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labor and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and Health Canada, the
European Free Trade Area and the
World Health Organization. The ICH
process has achieved significant
harmonization of the technical
requirements for the approval of
pharmaceuticals for human use in the
three ICH regions.
The current ICH process and structure
can be found at the following Web site:
https://www.ich.org.
Interested persons may present data,
information, or views orally or in
writing, on issues pending at the public
meeting. Oral presentations from the
public will be scheduled between
approximately 4:30 p.m. and 5 p.m.
Time allotted for oral presentations may
be limited to 10 minutes. Those desiring
to make oral presentations should notify
the contact person by April 27, 2007,
and submit a brief statement of the
VerDate Aug<31>2005
18:52 Apr 19, 2007
Jkt 211001
general nature of the evidence or
arguments they which to present, the
names and addresses, phone number,
fax, and e-mail of proposed participants,
and an indication of the approximate
time requested to make their
presentation.
The agenda for the public meeting
will be made available via the internet
at https://www.fda.gov/cder/meeting/
ICH_20060508.htm.
Dated: April 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–1952 Filed 4–16–07; 3:25 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: Addition of Meningococcal
and Human Papillomavirus (HPV)
Vaccines to the Vaccine Injury Table
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: Through this notice, the
Secretary announces that
meningococcal (conjugate and
polysaccharide) and human
papillomavirus (HPV) vaccines are
covered vaccines under the National
Vaccine Injury Compensation Program
(VICP), which provides a system of nofault compensation for certain
individuals who have been injured by
covered childhood vaccines. This notice
serves to include meningococcal and
HPV vaccines as covered vaccines under
Category XIV (new vaccines) of the
Vaccine Injury Table (Table), which lists
the vaccines covered under the VICP.
This notice ensures that petitioners may
file petitions relating to meningococcal
and HPV vaccines with the VICP even
before such vaccines are added as
separate and distinct categories to the
Table through rulemaking.
DATES: This notice is effective on April
20, 2007. As described below,
meningococcal and HPV vaccines are
covered under the VICP as of February
1, 2007.
FOR FURTHER INFORMATION CONTACT:
Geoffrey Evans, M.D., Division Director,
Division of Vaccine Injury
Compensation, Healthcare Systems
Bureau, Health Resources and Services
Administration, Parklawn Building,
Room 11C–26, 5600 Fishers Lane,
Rockville, Maryland 20857; telephone
number (301) 443–6593.
PO 00000
Frm 00062
Fmt 4703
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19937
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 Public Health
Service (PHS) Act, 42 U.S.C. 300aa–
14(e)(2). Consistent with section
13632(a)(3) of Pub. L. 103–66, the
regulations governing the VICP provide
that such vaccines will be included as
covered vaccines 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 two prerequisites for adding
meningococcal (conjugate and
polysaccharide) and HPV vaccines to
the VICP as covered vaccines as well as
to the Table have been satisfied. In its
May 27, 2005, issue of the Morbidity
and Mortality Weekly Report (MMWR),
the CDC published its recommendation
that meningococcal conjugate vaccines
be routinely administered to young
adolescents at the pre-adolescent visit
(11–12 years olds). Additionally, for
those individuals who have not
previously received the meningococcal
conjugate vaccine, the CDC has
recommended vaccination before high
school entry to further reduce the
incidence of meningococcal disease in
adolescents and young adults. The CDC
also recommends routine vaccination
for college freshmen who live in
dormitories because they are at higher
risk for meningococcal disease when
compared with same aged cohorts. The
use of meningococcal conjugate vaccine
is preferred among persons aged 11–55
years. If meningococcal conjugate
vaccine is unavailable, meningococcal
polysaccharide vaccine is an acceptable
alternative for persons aged 11–55 years.
Meningococcal polysaccharide vaccine
is also recommended for children aged
2–10 years and persons aged 55 years
and older who are at increased risk for
meningococcal disease.
In its March 23, 2007, issue of the
MMWR, the CDC published its
recommendation that the HPV vaccine
be routinely administered to females
aged 11–12 years. The HPV vaccine can
be administered to females as young as
9 years. Vaccination is recommended
for females aged 13–26 years who have
not previously received the vaccine or
who have not completed the full series.
On December 20, 2006, the excise tax
legislation for meningococcal and HPV
vaccines was enacted by Pub. L. 109–
432, the ‘‘Tax Relief and Health Care
Act of 2006 (the Act).’’ Section 408 of
this Act adds all meningococcal and
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 72, Number 76 (Friday, April 20, 2007)]
[Notices]
[Pages 19936-19937]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1952]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Preparation for International Conference on Harmonization
Meetings in Brussels, Belgium; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Preparation for ICH meetings in Brussels, Belgium''
to provide information and receive comments on the International
Conference on Harmonization (ICH) as well as the upcoming meetings in
Brussels, Belgium. The topics to be discussed are the topics for
discussion at the forthcoming ICH Steering Committee Meeting. The
purpose of the meeting is to solicit public input prior to the next
Steering Committee and Expert Working Groups meetings in Brussels,
Belgium, May 5 through 10, 2007, at which discussion of the topics
underway and the future of ICH will continue.
Date and Time: The meeting will be held on Thursday, May 3, 2007,
from 11:30 a.m. to 1 p.m.
Location: The meeting will be held at 5600 Fishers Lane, 3rd floor,
Conference Room D, Rockville, MD 20857. For security reasons, all
attendees are asked to arrive no later than 11:20 a.m., as you will be
escorted from the front entrance of 5600 Fishers Lane to Conference
Room D.
Contact Person: All participants must register with Tammie Bell,
Office of the Commissioner, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, e-mail: Tammie.Bell2@fda.hhs.gov or fax:
301-827-0003.
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax number), written material and requests to make oral presentations,
to the contact person by April 20, 2007.
If you need special accommodations due to a disability, please
contact Tammie Bell at least 7 days in advance.
Transcripts: Transcripts of the meeting may be requested in writing
from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page.
SUPPLEMENTARY INFORMATION: The ICH was established in 1990 as a joint
[[Page 19937]]
regulatory/industry project to improve, through harmonization, the
efficiency of the process for developing and registering new medicinal
products in Europe, Japan and the United States without compromising
the regulatory obligations of safety and effectiveness.
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for medical product development among regulatory agencies.
ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. ICH is concerned with harmonization among
three regions: The European Union, Japan, and the United States. The
six ICH sponsors are the European Commission; the European Federation
of Pharmaceutical Industries Associations; the Japanese Ministry of
Health, Labor and Welfare; the Japanese Pharmaceutical Manufacturers
Association; the Centers for Drug Evaluation and Research and Biologics
Evaluation and Research, FDA; and the Pharmaceutical Research and
Manufacturers of America. The ICH Secretariat, which coordinates the
preparation of documentation, is provided by the International
Federation of Pharmaceutical Manufacturers Associations (IFPMA). The
ICH Steering Committee includes representatives from each of the ICH
sponsors and Health Canada, the European Free Trade Area and the World
Health Organization. The ICH process has achieved significant
harmonization of the technical requirements for the approval of
pharmaceuticals for human use in the three ICH regions.
The current ICH process and structure can be found at the following
Web site: https://www.ich.org.
Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Oral
presentations from the public will be scheduled between approximately
4:30 p.m. and 5 p.m. Time allotted for oral presentations may be
limited to 10 minutes. Those desiring to make oral presentations should
notify the contact person by April 27, 2007, and submit a brief
statement of the general nature of the evidence or arguments they which
to present, the names and addresses, phone number, fax, and e-mail of
proposed participants, and an indication of the approximate time
requested to make their presentation.
The agenda for the public meeting will be made available via the
internet at https://www.fda.gov/cder/meeting/ICH_20060508.htm.
Dated: April 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-1952 Filed 4-16-07; 3:25 pm]
BILLING CODE 4160-01-S
