Advisory Committee; Risk Communication Advisory Committee; Establishment, 31075 [E7-10740]
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Federal Register / Vol. 72, No. 107 / Tuesday, June 5, 2007 / Notices
nominee, including current business
address, telephone number, and e-mail
address if available. Nominations must
also acknowledge that the nominee is
aware of the nomination, is willing to
serve as a member, and appears to have
no conflict of interest that would
preclude membership. FDA will ask the
potential candidates to provide detailed
information concerning matters related
to financial holdings, employment, and
research grants and/or contracts.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: May 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E7–10737 Filed 6–4–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Committee; Risk
Communication Advisory Committee;
Establishment
Food and Drug Administration
ACTION: Notice of establishment.
jlentini on PROD1PC65 with NOTICES
AGENCY:
Under the Federal Advisory
Committee Act, as amended (5 U.S.C.
Appendix 2), the Commissioner of Food
and Drugs (the Commissioner),
announces the establishment of the Risk
Communication Advisory Committee.
The Commissioner has determined that
it is in the public interest to establish
such a committee.
The Risk Communication Advisory
Committee shall provide advice to the
Commissioner or designee on strategies
and programs designed to communicate
with the public about both the risks and
benefits of Food and Drug
Administration (FDA)-regulated
products so as to facilitate optimal use
of these products. The committee also
reviews and evaluates research relevant
to such communication to the public by
both FDA and other entities. It also
facilitates interactively sharing risk and
benefit information with the public to
enable people to make informed
independent judgments about use of
FDA-regulated products. Duration of
this committee is 2 years from the date
the Charter is filed, unless the
Commissioner formally determines that
renewal is in the public interest.
The Risk Communication Advisory
Committee will be composed of a core
of 15 voting members including the
17:28 Jun 04, 2007
Jkt 211001
Lee
Zwanziger, Office of Planning, Office of
the Commissioner (HFP–1), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
2895, FAX: 301–827–5260, or
rcac@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
VerDate Aug<31>2005
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of risk
communication, social marketing,
health literacy, cultural competency,
journalism, bioethics, and other relevant
behavioral and social sciences. Some
members will be selected to provide
experience-based insights on the
communications needs of the various
groups who use FDA-regulated
products. The latter may include
patients and patients’ family members,
health professional, communicators in
health, medicine and science, persons
affiliated with consumer, specific
disease, or patient safety advocacy
groups. Depending on the meeting
topic(s), at least one nonvoting member
identified with relevant industry
interests may be invited from existing
members of other FDA Advisory
Committees.
Elsewhere
in this issue of the Federal Register,
FDA is publishing a request for
nominations for advisory committee
members and notice of a change to the
advisory committee telephone
information line adding the
establishment of the Risk
Communication Advisory Committee.
FDA plans to publish in the near future
a final rule adding the Risk
Communication Advisory Committee to
the list of FDA standing advisory
committees in 21 CFR 14.100.
SUPPLEMENTARY INFORMATION:
Dated: May 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E7–10740 Filed 6–4–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006E–0332 and 2006E–0333]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NAMENDA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00026
Fmt 4703
Sfmt 4703
31075
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
NAMENDA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of two applications to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of patents which claim that
human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 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 human drug
product 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, NAMENDA
E:\FR\FM\05JNN1.SGM
05JNN1
]]>Agencies
[Federal Register Volume 72, Number 107 (Tuesday, June 5, 2007)]
[Notices]
[Page 31075]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10740]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Risk Communication Advisory Committee;
Establishment
AGENCY: Food and Drug Administration
ACTION: Notice of establishment.
-----------------------------------------------------------------------
Under the Federal Advisory Committee Act, as amended (5 U.S.C.
Appendix 2), the Commissioner of Food and Drugs (the Commissioner),
announces the establishment of the Risk Communication Advisory
Committee. The Commissioner has determined that it is in the public
interest to establish such a committee.
The Risk Communication Advisory Committee shall provide advice to
the Commissioner or designee on strategies and programs designed to
communicate with the public about both the risks and benefits of Food
and Drug Administration (FDA)-regulated products so as to facilitate
optimal use of these products. The committee also reviews and evaluates
research relevant to such communication to the public by both FDA and
other entities. It also facilitates interactively sharing risk and
benefit information with the public to enable people to make informed
independent judgments about use of FDA-regulated products. Duration of
this committee is 2 years from the date the Charter is filed, unless
the Commissioner formally determines that renewal is in the public
interest.
The Risk Communication Advisory Committee will be composed of a
core of 15 voting members including the Chair. Members and the Chair
are selected by the Commissioner or designee from among authorities
knowledgeable in the fields of risk communication, social marketing,
health literacy, cultural competency, journalism, bioethics, and other
relevant behavioral and social sciences. Some members will be selected
to provide experience-based insights on the communications needs of the
various groups who use FDA-regulated products. The latter may include
patients and patients' family members, health professional,
communicators in health, medicine and science, persons affiliated with
consumer, specific disease, or patient safety advocacy groups.
Depending on the meeting topic(s), at least one nonvoting member
identified with relevant industry interests may be invited from
existing members of other FDA Advisory Committees.
FOR FURTHER INFORMATION CONTACT: Lee Zwanziger, Office of Planning,
Office of the Commissioner (HFP-1), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2895, FAX: 301-827-5260, or
rcac@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elsewhere in this issue of the Federal
Register, FDA is publishing a request for nominations for advisory
committee members and notice of a change to the advisory committee
telephone information line adding the establishment of the Risk
Communication Advisory Committee. FDA plans to publish in the near
future a final rule adding the Risk Communication Advisory Committee to
the list of FDA standing advisory committees in 21 CFR 14.100.
Dated: May 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-10740 Filed 6-4-07; 8:45 am]
BILLING CODE 4160-01-S
