Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children; Notice of Meeting, 76852-76853 [E5-7934]
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Federal Register / Vol. 70, No. 248 / Wednesday, December 28, 2005 / Notices
wwhite on PROD1PC65 with NOTICES
Medicine (CVM) (HFV–3), Food and
Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9004,
FAX: 240–276–9020, e-mail:
asindela@cvm.fda.gov.
Transcripts: Meeting transcripts will
be made available on CVM’s Web site
(https://www.fda.gov/cvm/adufa.htm)
approximately 30 working days after the
meeting. The transcript will also be
available for public examination at the
Division of Dockets Management (see
ADDRESSES), between 9 a.m. and 4 p.m.,
Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
In the language authorizing the
Animal Drug User Fee Act, Congress
directed the Secretary of Health and
Human Services (the Secretary) to
consult with the Committee on Energy
and Commerce of the House of
Representatives, the Committee on
Health, Education, Labor and Pensions
of the Senate, appropriate scientific and
academic experts, veterinary
professionals, representatives of
consumer advocacy groups, and the
regulated industry in developing
recommendations to Congress for the
reauthorization of ADUFA and for the
goals and plans for meeting the goals
associated with the process for review of
animal drug applications. As directed
by Congress, FDA is holding a public
meeting to gather information on what
features we should propose to include
in the ADUFA program (https://
www.fda.gov/cvm/4218.htm) and hear
stakeholder views on this subject.
We are offering the following two
general questions for consideration, and
we are interested in responses to these
questions and any other pertinent
information stakeholders would like to
share:
1. What is your assessment of the
overall performance of the ADUFA
program thus far?
2. What suggestions or changes would
you make relative to the reauthorization
of ADUFA?
ADUFA, amended the Federal Food,
Drug, and Cosmetic Act (the act) and
authorized FDA to collect fees for
certain animal drug applications,
establishments, products, and sponsors
in support of the review of animal
drugs. These additional resources
support FDA’s responsibilities under
the act to ensure that new animal drug
products are safe and effective for
animals as well as for the public with
respect to animals intended for food
consumption.
FDA’s animal drug user fee program
was authorized in 2003 and
implemented in 2004. A significant part
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of the preparations for the program
included determining the fee levels for
fiscal year (FY) 2004. ADUFA provides
for the following four fees: (1) A sponsor
fee, (2) an establishment fee, (3) a
product fee, and (4) an application fee.
The act also provides for specific
waivers and exemptions from fees. FDA
prepared guidance for the industry
regarding the fees, billings and
submission of fees, and waivers and
exemptions (https://www.fda.gov/cvm/
adufa.htm).
The total amounts of monies expected
for collection were as follows: $5
million for FY 2004; $8 million in FY
2005; and, $10 million in each FY 2006
through 2008. Each fee type was
expected to be 25 percent of the total
amount collected. Thus, in FY 2006, we
expect to receive $2,500,000 from
sponsor fees, establishment fees,
product fees, and application fees, for a
total of $10,000,000 dollars (figures are
subject to inflation and workload
adjustments). The user fees are used to
achieve shorter, more predictable
review times by increasing the review
staff at FDA and building better
management systems. As a result, we
anticipate substantial savings to the
industry in regulatory review and
developmental expenses.
FDA’s animal drug premarket review
program is making continual and
substantial improvements in the animal
drug review process as a result of user
fees. This helps ensure an adequate
supply of safe and effective therapeutic
and production animal drugs.
We have published a number of
reports that may help inform the public
about the ADUFA program. Key
documents such as ADUFA-related
guidance, legislation, performance
reports, and financial reports, can be
found at https://www.fda.gov/cvm/
adufa.htm.
II. Meeting
FDA will conduct the meeting on
February 24, 2006, at the DoubleTree
Hotel (see Location). In general, the
meeting format will include
presentations by FDA and a series of
panels representing different
stakeholder interest groups (scientific
and academic experts, veterinary
professionals, representatives of
consumer advocacy groups, and the
regulated industry). FDA and panel
presentations are planned from 9 a.m.
until 12 noon. The open public
comment portion of the meeting for
registered speakers is planned to begin
at 1 p.m. An opportunity for public
comments from meeting attendees will
commence following the registered
presentations, if time permits. The
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docket will remain open for written
comments through March 26, 2006, 30
days following the meeting.
If you wish to reserve time to make a
presentation at the meeting, please
contact Aleta Sindelar (see FOR FURTHER
INFORMATION CONTACT) by February 10,
2006. Your request to make a
presentation should include the
following information: Name, company,
company address, company phone
number, and e-mail address. We will try
to accommodate all persons who wish
to make a presentation. The time
allotted for presentations may depend
on the number of persons who wish to
speak.
If you require special
accommodations due to a disability,
please contact the DoubleTree Hotel (see
Location) at least 7 days in advance of
the meeting.
III. Comments
If you would like to submit written
comments to the docket regarding
ADUFA, please send your comments to
the Division of Dockets Management
(See ADDRESSES). Submit a single copy
of electronic comments or two paper
copies of any written comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Received comments may be
reviewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: December 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–7876 Filed 12–27–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Heritable
Disorders and Genetic Diseases in
Newborns and Children; 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: Advisory Committee on Heritable
Disorders and Genetic Diseases in Newborns
and Children (ACHDGDNC).
Dates and Times: February 13, 2006, 9 a.m.
to 5 p.m.; February 14, 2006, 8:30 a.m. to 3
p.m.
Place: Ronald Reagan Building and
International Trade Center, Rotunda Room,
E:\FR\FM\28DEN1.SGM
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Federal Register / Vol. 70, No. 248 / Wednesday, December 28, 2005 / Notices
wwhite on PROD1PC65 with NOTICES
1300 Pennsylvania Avenue, NW.,
Washington, DC 20004.
Status: The meeting will be open to the
public with attendance limited to space
availability.
Purpose: The Advisory Committee
provides advice and recommendations
concerning the grants and projects authorized
under the Heritable Disorders Program and
technical information to develop policies and
priorities for this program. The Heritable
Disorders Program was established to
enhance the ability of State and local health
agencies to provide for newborn and child
screening, counseling and health care
services for newborns and children having or
at risk for heritable disorders. The Committee
was established specifically to advise and
guide the Secretary regarding the most
appropriate application of universal newborn
screening tests, technologies, policies,
guidelines and programs for effectively
reducing morbidity and mortality in
newborns and children having or at risk for
heritable disorders.
Agenda: The first day will be devoted to a
presentation on the National Coordination
Center for the Regional Genetics and
Newborn Screening Collaboratives,
presentations on newborn screening projects
of the Regional Collaboratives, and reports
from the Committee’s subcommittees on
laboratory standards and procedures, followup and treatment and education and training.
The second day will include discussions on
the nomination process for candidate
conditions on the Newborn Screening Panel
and presentations by organizations
representing policy makers and legislation.
Proposed agenda items are subject to change.
Time will be provided each day for public
comment. Individuals who wish to provide
public comment or who plan to attend the
meeting and need special assistance, such as
sign language interpretation or other
reasonable accommodations, should notify
the ACHDGDNC Executive Secretary,
Michele A. Lloyd-Puryear, M.D., Ph.D.
(contact information provided below).
Contact Person: Anyone interested in
obtaining a roster of members or other
relevant information should write or contact
Michele A. Lloyd-Puryear, M.D., Ph.D.,
Maternal and Child Health Bureau, Health
Resources and Services Administration,
Room 18A–19, Parklawn Building, 5600
Fishers Lane, Rockville, Maryland 20857,
Telephone (301) 443–1080. Information on
the Advisory Committee is available at
https://mchb.hrsa.gov/programs/genetics/
committee.
Dated: December 20, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. E5–7934 Filed 12–27–05; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2005–23333]
Random Drug Testing Rate for
Covered Crewmembers
Coast Guard, DHS.
Notice of minimum random
drug testing rate.
AGENCY:
ACTION:
SUMMARY: The Coast Guard has set the
calendar year 2006 minimum random
drug testing rate at 50 percent of
covered crewmembers. Based upon an
evaluation of the 2004 Management
Information System (MIS) data
collection forms submitted by marine
employers, we will maintain the
minimum random drug testing at 50
percent of covered crewmembers for the
calendar year 2006. The purpose of
setting a minimum random drug testing
rate is to establish a measure of
deterrence for the illegal use of
controlled substances.
DATES: The minimum random drug
testing rate is effective January 1, 2006
through December 31, 2006. You must
submit your 2005 MIS reports no later
than March 15, 2006.
ADDRESSES: The annual MIS report may
be submitted in writing to Commandant
(G–MOA), U.S. Coast Guard
Headquarters, 2100 Second Street, SW.,
Room 2404, Washington, DC 20593–
0001 or by electronic submission to the
following Internet address: https://
www.uscg.mil/hq/g-m/moa/dapip.htm.
FOR FURTHER INFORMATION CONTACT: For
questions about this notice, please
contact Mr. Robert C. Schoening, Drug
and Alcohol Program Manager, Office of
Investigations and Analysis (G–MOA),
U.S. Coast Guard Headquarters,
telephone 202–267–0684. If you have
questions on viewing the docket, call
Renee V. Wright, Program Manager,
Dockets Operations, Department of
Transportation, telephone 202–366–
0402.
SUPPLEMENTARY INFORMATION: Under 46
CFR 16.230, the Coast Guard requires
marine employers to establish random
drug testing programs for covered
crewmembers on inspected and
uninspected vessels. All marine
employers are required to collect and
maintain a record of drug testing
program data for each calendar year,
January 1 through December 31. You
must submit this data by 15 March of
the following year to the Coast Guard in
an annual MIS report.
You may either submit your own MIS
report or have a consortium or other
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76853
employer representative submit the data
in a consolidated MIS report. The
chemical drug testing data is essential to
analyze our current approach for
deterring and detecting illegal drug
abuse in the maritime industry.
Since 2004 MIS data indicates that the
positive random testing rate is greater
than one percent industry-wide (1.53
percent), the Coast Guard announces
that the minimum random drug testing
rate is set at 50 percent of covered
employees for the period of January 1,
2006 through December 31, 2006 in
accordance with 46 CFR 16.230(e).
Each year we will publish a notice
reporting the results of the previous
calendar year’s MIS data, and the
minimum annual percentage rate for
random drug testing for the next
calendar year.
Dated: December 20, 2005.
T.H. Gilmour,
Rear Admiral, U.S. Coast Guard, Assistant
Commandant for Marine Safety, Security and
Environmental Protection.
[FR Doc. E5–7897 Filed 12–27–05; 8:45 am]
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
Change in Regional Partners for
Southeast Alaska and the Kodiak
Archipelago for the Alaska Migratory
Bird Co-Management Council
Fish and Wildlife Service,
Interior.
ACTION: Notice.
AGENCY:
SUMMARY: The U.S. Fish and Wildlife
Service (Service) is announcing a
change in two regional partners, one
representing Southeast Alaska and the
other one representing the Kodiak
Archipelago, both on the Alaska
Migratory Bird Co-management Council
(Co-management Council). For
Southeast Alaska, the Central Council,
Tlingit and Haida Indian Tribes of
Alaska (Central Council), has elected to
step down, and the Co-management
Council has voted to replace that
partner with the Southeast Alaska InterTribal Fish and Wildlife Commission.
For Kodiak, the Kodiak Area Native
Association has elected to step down,
and the Co-Management Council has
voted to replace that partner with the
Shoonaq’ Tribe of Kodiak.
DATES: The decision described in this
notice became effective December 2,
2005.
Regional Director, Alaska
Region, U.S. Fish and Wildlife Service,
ADDRESSES:
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]]>Agencies
[Federal Register Volume 70, Number 248 (Wednesday, December 28, 2005)]
[Notices]
[Pages 76852-76853]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7934]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee on Heritable Disorders and Genetic Diseases in
Newborns and Children; 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: Advisory Committee on Heritable Disorders and Genetic
Diseases in Newborns and Children (ACHDGDNC).
Dates and Times: February 13, 2006, 9 a.m. to 5 p.m.; February
14, 2006, 8:30 a.m. to 3 p.m.
Place: Ronald Reagan Building and International Trade Center,
Rotunda Room,
[[Page 76853]]
1300 Pennsylvania Avenue, NW., Washington, DC 20004.
Status: The meeting will be open to the public with attendance
limited to space availability.
Purpose: The Advisory Committee provides advice and
recommendations concerning the grants and projects authorized under
the Heritable Disorders Program and technical information to develop
policies and priorities for this program. The Heritable Disorders
Program was established to enhance the ability of State and local
health agencies to provide for newborn and child screening,
counseling and health care services for newborns and children having
or at risk for heritable disorders. The Committee was established
specifically to advise and guide the Secretary regarding the most
appropriate application of universal newborn screening tests,
technologies, policies, guidelines and programs for effectively
reducing morbidity and mortality in newborns and children having or
at risk for heritable disorders.
Agenda: The first day will be devoted to a presentation on the
National Coordination Center for the Regional Genetics and Newborn
Screening Collaboratives, presentations on newborn screening
projects of the Regional Collaboratives, and reports from the
Committee's subcommittees on laboratory standards and procedures,
follow-up and treatment and education and training. The second day
will include discussions on the nomination process for candidate
conditions on the Newborn Screening Panel and presentations by
organizations representing policy makers and legislation. Proposed
agenda items are subject to change.
Time will be provided each day for public comment. Individuals
who wish to provide public comment or who plan to attend the meeting
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the ACHDGDNC
Executive Secretary, Michele A. Lloyd-Puryear, M.D., Ph.D. (contact
information provided below).
Contact Person: Anyone interested in obtaining a roster of
members or other relevant information should write or contact
Michele A. Lloyd-Puryear, M.D., Ph.D., Maternal and Child Health
Bureau, Health Resources and Services Administration, Room 18A-19,
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857,
Telephone (301) 443-1080. Information on the Advisory Committee is
available at https://mchb.hrsa.gov/programs/genetics/committee.
Dated: December 20, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. E5-7934 Filed 12-27-05; 8:45 am]
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