National Institute for Occupational Safety and Health (NIOSH); Request for Nominations To Serve on the World Trade Center Health Program Science/Technical Advisory Committee (WTCHP-STAC), 36926-36927 [2011-15684]
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Federal Register / Vol. 76, No. 121 / Thursday, June 23, 2011 / Notices
Because there is not a public
comment period, written comments may
be submitted. Any written comments
received will be included in the official
record of the meeting and should be
submitted to the contact person below
in advance of the meeting.
Contact Person for more Information:
Theodore M. Katz, M.P.A., Executive
Secretary, NIOSH, CDC, 1600 Clifton
Road, NE., Mailstop: E–20, Atlanta, GA
30333, Telephone (513) 533–6800, Toll
Free 1–800–CDC–INFO, E-mail
ocas@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention, and the Agency for Toxic
Substances and Disease Registry.
Dated: June 16, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–15681 Filed 6–22–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
erowe on DSK5CLS3C1PROD with NOTICES
National Institute for Occupational
Safety and Health (NIOSH); Request for
Nominations To Serve on the World
Trade Center Health Program Science/
Technical Advisory Committee
(WTCHP–STAC)
The Centers for Disease Control and
Prevention (CDC) is soliciting
nominations for possible membership
on the WTCHP–STAC. This committee
was established by Public Law 111–347
(The James Zadroga 9/11 Health and
Compensation Act of 2010), enacted on
January 2, 2011, Section 3302(a). The
Advisory Committee is governed by the
provisions of Public Law 92–463, the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of advisory committees in the
Executive Branch.
Section 3302(a)(1) of the James
Zadroga 9/11 Health and Compensation
Act of 2010 (the Act) establishes that the
WTCHP–STAC will review scientific
and medical evidence and make
recommendations to the WTC Program
Administrator on additional program
eligibility criteria and additional health
conditions for program inclusion. The
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15:02 Jun 22, 2011
Jkt 223001
committee will be consulted on other
matters as related to and outlined in the
Act at the discretion of the WTC
Program Administrator. In accordance
with Public Law 111–347, Section
3302(a)(2), the WTC Program
Administrator will appoint the members
of the committee and include at least:
• 4 occupational physicians, at least
two of whom have experience treating
WTC rescue and recovery workers;
• 1 physician with expertise in
pulmonary medicine;
• 2 environmental medicine or
environmental health specialists;
• 2 representatives of WTC
responders;
• 2 representatives of certifiedeligible WTC survivors;
• 1 industrial hygienist;
• 1 toxicologist;
• 1 epidemiologist; and, at least
• 1 mental health professional.
For the mental health professional
category, specific expertise is sought in
trauma-related psychiatry or psychology
and psychiatric epidemiology. Other
members may be appointed at the
discretion of the WTC Program
Administrator.
A WTCHP–STAC member’s term
appointment may last four years. If a
vacancy occurs, the WTC Program
Administrator may appoint a new
member who represents the same
interest as the predecessor. WTCHP–
STAC members may be appointed to
successive terms. The frequency of
committee meetings shall be determined
by the WTC Program Administrator
based on program needs. Meetings may
occur up to four times a year. Members
are paid the Special Government
Employee rate of $250 per day, and
travel costs and per diem are included
and based on the Federal Travel
Regulations.
Any interested person or organization
may self-nominate or nominate one or
more qualified persons for membership.
Nominations must include the following
information:
• The nominee’s contact information
and current occupation or position;
• The nominee’s resume or
curriculum vitae, including prior or
current membership on other NIOSH,
CDC, HHS advisory committees or other
relevant organizations, associations, and
committees;
• The category of membership
(occupational, pulmonary or
environmental medicine physician,
environmental health specialist,
representative of responder or survivor
beneficiary group, industrial hygienist,
toxicologist, epidemiologist, or mental
health) that the candidate is qualified to
represent;
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
• A summary of the background,
experience, and qualifications that
demonstrates the nominee’s suitability
for each of the nominated membership
categories;
• Articles or other documents the
nominee has authored that indicate the
nominee’s knowledge, and experience
in relevant subject categories; and
• A statement that the nominee is
aware of the nomination, is willing to
regularly attend and participate in
WTCHP–STAC meetings, and has no
known conflicts of interest that would
preclude membership on WTCHP–
STAC.
WTCHP–STAC members will be
selected upon the basis of their relevant
experience and competence in their
respective categorical fields. The
information received through this
nomination process, in addition to other
relevant sources of information, will
assist the WTC Program Administrator
in appointing members to serve on
WTCHP–STAC. In selecting members,
the WTC Program Administrator will
consider individuals nominated in
response to this Federal Register notice,
as well as other qualified individuals.
NIOSH is committed to bringing
greater diversity of thought, perspective
and experience to its advisory
committees. Nominees from all races,
gender, age and persons living with
disabilities are encouraged to apply.
Nominees must be U.S. citizens.
Candidates invited to serve will be
asked to submit the ‘‘Confidential
Financial Disclosure Form for Special
Government Employees Serving on
Federal Advisory Committees at the
Centers for Disease Control and
Prevention.’’ This form allows CDC to
determine whether there is a statutory
conflict between that person’s public
responsibilities as a Special Government
Employee and private interests and
activities, or the appearance of a lack of
impartiality, as defined by Federal
regulation. The form may be viewed and
downloaded at https://www.usoge.gov/
forms/oge450_pdf/
oge450_accessible.pdf. This form
should not be submitted as part of a
nomination.
Nominations should be submitted
(postmarked or received) by July 7,
2011.
You may submit nominations for
WTCHP–STAC, identified by NIOSH
Docket No. NIOSH–229, by any of the
following methods:
• Electronic submissions: You may
submit nominations, including
attachments, electronically to the
NIOSH Docket No. NIOSH–229 located
at https://www.cdc.gov/niosh/docket/.
Follow the instructions for submitting
E:\FR\FM\23JNN1.SGM
23JNN1
Federal Register / Vol. 76, No. 121 / Thursday, June 23, 2011 / Notices
electronic comments. Attachments
should be in Microsoft Word,
WordPerfect, or Excel; however,
Microsoft Word is preferred.
• Regular, Express, or Overnight Mail:
Written nominations may be submitted
(one original and two copies) to the
following address only: NIOSH Docket
229 or Zaida Burgos, Committee
Management Specialist, National
Institute for Occupational Safety and
Health, Centers for Disease Control and
Prevention, 1600 Clifton Road, NE., M/
S E–20, Atlanta, Georgia 30333.
Telephone and facsimile submissions
cannot be accepted.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the Agency for Toxic Substances and
Disease Registry.
Dated: June 16, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–15684 Filed 6–22–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0315]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Fusilev, Levoleucovorin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for Fusilev
(Levoleucovorin) and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
erowe on DSK5CLS3C1PROD with NOTICES
SUMMARY:
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15:02 Jun 22, 2011
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Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product Fusilev
(levoleucovorin calcium), a folate
analog. Levoleucovorin rescue is
indicated after high-dose methotrexate
therapy in osteosarcoma and is also
indicated to diminish the toxicity and
counteract the effects of impaired
methotrexate elimination and/or
inadvertent overdosage of folic acid
antagonists. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for Fusilev (U.S. Patent No.
6,500,829) from the University of
Strathclyde, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration
and that FDA determine the product’s
regulatory review period. In a letter
dated June 1, 2011, FDA advised the
Patent and Trademark Office that this
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36927
human drug product had undergone a
regulatory review period and that the
approval of Fusilev represented the first
permitted commercial marketing or use
of the product.
FDA has determined that the
applicable regulatory review period for
Fusilev is 6,993 days. Of this time, 703
days occurred during the testing phase
of the regulatory review period, while
6,290 days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: January
15, 1989. The applicant claims
December 15, 1988, as the date the
investigational new drug application
(IND) became effective. However, FDA
records indicate that the IND effective
date was January 15, 1989, which was
30 days after FDA receipt of the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: December 18,
1990. The applicant claims December
14, 1990, as the date the new drug
application (NDA) for FUSILEV (NDA
20–140) was initially submitted.
However, FDA records indicate that
NDA 20–140 was submitted on
December 18, 1990.
3. The date the application was
approved: March 7, 2008. FDA has
verified the applicant’s claim that NDA
20–140 was approved on March 7, 2008.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 797 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by August 22,
2011. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by December 20, 2011. To meet
its burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
E:\FR\FM\23JNN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Pages 36926-36927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health (NIOSH);
Request for Nominations To Serve on the World Trade Center Health
Program Science/Technical Advisory Committee (WTCHP-STAC)
The Centers for Disease Control and Prevention (CDC) is soliciting
nominations for possible membership on the WTCHP-STAC. This committee
was established by Public Law 111-347 (The James Zadroga 9/11 Health
and Compensation Act of 2010), enacted on January 2, 2011, Section
3302(a). The Advisory Committee is governed by the provisions of Public
Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C.
App.), which sets forth standards for the formation and use of advisory
committees in the Executive Branch.
Section 3302(a)(1) of the James Zadroga 9/11 Health and
Compensation Act of 2010 (the Act) establishes that the WTCHP-STAC will
review scientific and medical evidence and make recommendations to the
WTC Program Administrator on additional program eligibility criteria
and additional health conditions for program inclusion. The committee
will be consulted on other matters as related to and outlined in the
Act at the discretion of the WTC Program Administrator. In accordance
with Public Law 111-347, Section 3302(a)(2), the WTC Program
Administrator will appoint the members of the committee and include at
least:
4 occupational physicians, at least two of whom have
experience treating WTC rescue and recovery workers;
1 physician with expertise in pulmonary medicine;
2 environmental medicine or environmental health
specialists;
2 representatives of WTC responders;
2 representatives of certified-eligible WTC survivors;
1 industrial hygienist;
1 toxicologist;
1 epidemiologist; and, at least
1 mental health professional.
For the mental health professional category, specific expertise is
sought in trauma-related psychiatry or psychology and psychiatric
epidemiology. Other members may be appointed at the discretion of the
WTC Program Administrator.
A WTCHP-STAC member's term appointment may last four years. If a
vacancy occurs, the WTC Program Administrator may appoint a new member
who represents the same interest as the predecessor. WTCHP-STAC members
may be appointed to successive terms. The frequency of committee
meetings shall be determined by the WTC Program Administrator based on
program needs. Meetings may occur up to four times a year. Members are
paid the Special Government Employee rate of $250 per day, and travel
costs and per diem are included and based on the Federal Travel
Regulations.
Any interested person or organization may self-nominate or nominate
one or more qualified persons for membership. Nominations must include
the following information:
The nominee's contact information and current occupation
or position;
The nominee's resume or curriculum vitae, including prior
or current membership on other NIOSH, CDC, HHS advisory committees or
other relevant organizations, associations, and committees;
The category of membership (occupational, pulmonary or
environmental medicine physician, environmental health specialist,
representative of responder or survivor beneficiary group, industrial
hygienist, toxicologist, epidemiologist, or mental health) that the
candidate is qualified to represent;
A summary of the background, experience, and
qualifications that demonstrates the nominee's suitability for each of
the nominated membership categories;
Articles or other documents the nominee has authored that
indicate the nominee's knowledge, and experience in relevant subject
categories; and
A statement that the nominee is aware of the nomination,
is willing to regularly attend and participate in WTCHP-STAC meetings,
and has no known conflicts of interest that would preclude membership
on WTCHP-STAC.
WTCHP-STAC members will be selected upon the basis of their
relevant experience and competence in their respective categorical
fields. The information received through this nomination process, in
addition to other relevant sources of information, will assist the WTC
Program Administrator in appointing members to serve on WTCHP-STAC. In
selecting members, the WTC Program Administrator will consider
individuals nominated in response to this Federal Register notice, as
well as other qualified individuals.
NIOSH is committed to bringing greater diversity of thought,
perspective and experience to its advisory committees. Nominees from
all races, gender, age and persons living with disabilities are
encouraged to apply. Nominees must be U.S. citizens.
Candidates invited to serve will be asked to submit the
``Confidential Financial Disclosure Form for Special Government
Employees Serving on Federal Advisory Committees at the Centers for
Disease Control and Prevention.'' This form allows CDC to determine
whether there is a statutory conflict between that person's public
responsibilities as a Special Government Employee and private interests
and activities, or the appearance of a lack of impartiality, as defined
by Federal regulation. The form may be viewed and downloaded at https://www.usoge.gov/forms/oge450_pdf/oge450_accessible.pdf. This form
should not be submitted as part of a nomination.
Nominations should be submitted (postmarked or received) by July 7,
2011.
You may submit nominations for WTCHP-STAC, identified by NIOSH
Docket No. NIOSH-229, by any of the following methods:
Electronic submissions: You may submit nominations,
including attachments, electronically to the NIOSH Docket No. NIOSH-229
located at https://www.cdc.gov/niosh/docket/. Follow the instructions
for submitting
[[Page 36927]]
electronic comments. Attachments should be in Microsoft Word,
WordPerfect, or Excel; however, Microsoft Word is preferred.
Regular, Express, or Overnight Mail: Written nominations
may be submitted (one original and two copies) to the following address
only: NIOSH Docket 229 or Zaida Burgos, Committee Management
Specialist, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., M/S
E-20, Atlanta, Georgia 30333. Telephone and facsimile submissions
cannot be accepted.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities for
both CDC and the Agency for Toxic Substances and Disease Registry.
Dated: June 16, 2011.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2011-15684 Filed 6-22-11; 8:45 am]
BILLING CODE 4163-18-P
