Advisory Committee for Reproductive Health Drugs; Notice of Meeting, 46021-46022 [E8-18131]
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Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices
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written or electronic comments on the
draft guidance by October 6, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of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.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Larry Ouderkirk, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4125,
Silver Spring, MD 20993, 301–796–
1585.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Residual Solvents in Drug Products
Marketed in the United States.’’
Beginning July 1, 2008, FDA will
require that drug products marketed in
the United States with an official USP
monograph meet the residual solvents
requirements in the revised General
Chapter <467> ‘‘Residual Solvents.’’
For compendial drug products
approved under a new drug application
(NDA) or abbreviated new drug
application (ANDA), changes made to
the specifications in the approved
application regarding the revised
General Chapter <467> should be in
accordance with applicable regulations
described in 21 CFR 314.70 and the
recommendations in the guidance for
industry on ‘‘Changes to an Approved
NDA or ANDA, April 2004.’’ FDA
expects that in most cases, an annual
report can be used to report changes.
FDA recommends that applicants who
have submitted NDAs or ANDAs to the
agency for drug products that are not the
subject of an official USP monograph
control and limit the presence of
residual solvents in the subject drug
product as described in the guidance on
‘‘Q3C Impurities: Residual Solvents.’’
Marketed compendial drug products
that are not approved under an NDA or
ANDA (for example, over-the-counter
(OTC) drug products that are marketed
under an FDA OTC monograph) are also
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subject to the provisions of the Federal
Food, Drug, and Cosmetic Act, the
revised General Chapter <467>, and
current good manufacturing practice
requirements in 21 CFR 211.165(e) and
211.194(a)(2).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on control of residual solvents in drug
products marketed in the United States.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed 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 seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://
www.regulations.gov.
Dated: July 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–18127 Filed 8–6–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Advisory Committee for Reproductive
Health Drugs; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory
Committee for Reproductive Health
Drugs.
General Function of the Committee:
To provide advice and
recommendations to theagency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 8, 2008, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Rockville, Plaza Ballrooms I and II, 1750
Rockville Pike, Rockville, MD. The hotel
phone number is 301–468–1100.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail:
kalyani.bhatt@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code 301–451–
2537. Please call the Information Line
for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The committee will discuss
new drug application (NDA) 22–242,
proposed trade name FABLYN
(lasofoxifene tartrate) Tablets, 0.5
milligrams (mg), Pfizer Inc., for the
proposed indication of the treatment of
osteoporosis in postmenopausal women
at increased risk of fracture.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
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46022
Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 27, 2008.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 19, 2008. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 20, 2008.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Kalyani
Bhatt (301) 827–7001 at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–18131 Filed 8–6–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0416]
Consideration of FDA-Regulated
Products That May Contain Nanoscale
Materials; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting and a request for
comments including available data to
gather information that will assist the
agency in further implementing the
recommendations of the
Nanotechnology Task Force Report (the
Report) relating to the development of
agency guidances. The Report’s
recommendations covered foods
(including dietary supplements), food
and color additives (including food
contact substances), animal drugs and
feeds, cosmetics, human drugs and
biologics, and medical devices. In
addition to requesting comments in
response to the questions in this notice
and those that will be discussed at the
public meeting, FDA is announcing a
request for available data and
information on the effects of nanoscale
materials on quality, safety, and, where
relevant, effectiveness of products
subject to FDA oversight.
DATES: The public meeting will be held
on September 8, 2008, from 8:30 a.m. to
5 p.m. Anyone who wishes to speak at
the meeting must register and submit a
summary of the presentation and an
electronic copy of the presentation by
Tuesday, September 2, 2008. See section
IV of the SUPPLEMENTARY INFORMATION
section of this document for details on
how to register. Submit written or
electronic comments by Friday, October
24, 2008.
ADDRESSES: The public meeting will be
held at the University Systems of
Maryland Shady Grove Center/
Universities, 9630 Gudelsky Dr.,
Rockville, MD 20850 (https://
www.shadygrove.umd.edu/conference).1
There is parking near the building.
Submit written comments, available
data, and other information to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
1 FDA has verified the Web site address, but FDA
is not responsible for any subsequent changes to the
Web site after this document publishes in the
Federal Register.
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MD 20852. Submit electronic comments
to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Megan Clark, Office of Policy, Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
3360, e-mail: megan.clark@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Nanotechnology allows scientists to
work on the scale of molecules to create,
explore, and manipulate materials
measured in nanometers; billionths of a
meter. In July 2007, FDA issued the
Report analyzing scientific and
regulatory considerations relating to the
safety and effectiveness of FDAregulated products containing nanoscale
materials regulated by FDA, and making
recommendations regarding these
considerations. Additionally, the Report
summarized the state of the science for
biological interactions with nanoscale
materials. The Report also
recommended that FDA coordinate with
other Federal agencies and the private
sector in research and other activities to
increase general scientific
understanding and facilitate assessment
of data needs for regulated products.
This coordination includes developing
an infrastructure to share and leverage
knowledge and build upon information
from individual studies of nanoscale
materials.
The agency has been considering
development of guidances
recommended in the Report and
believes that holding a public meeting
and announcing this request for
comments and available data will
provide information that will assist in
this task. In addition, FDA is working
with the National Institutes of Health
(particularly the NanoHealth Enterprise)
to explore methods for receiving and
sharing data relating to, for example,
general product development, including
research on failed product candidates,
and biological interactions of certain
characteristics of nanoscale materials.
Such a data repository could allow FDA
and other stakeholders to share data and
methods, and to develop models of
biological interaction that could then
inform product development and
review.
II. Meeting Agenda
The primary purpose of the meeting is
to determine what factors the agency
should consider in providing guidance
on:
1. The information and data that may
be needed to demonstrate the safety and
effectiveness of FDA-regulated products
containing nanoscale materials and
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[Federal Register Volume 73, Number 153 (Thursday, August 7, 2008)]
[Notices]
[Pages 46021-46022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18131]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
Advisory Committee for Reproductive Health Drugs; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Advisory Committee for Reproductive Health
Drugs.
General Function of the Committee: To provide advice and
recommendations to theagency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 8, 2008, from
8 a.m. to 5 p.m.
Location: Hilton Washington DC/Rockville, Plaza Ballrooms I and II,
1750 Rockville Pike, Rockville, MD. The hotel phone number is 301-468-
1100.
Contact Person: Kalyani Bhatt, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX: 301-827-6776, e-mail: kalyani.bhatt@fda.hhs.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 301-451-2537. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: The committee will discuss new drug application (NDA) 22-
242, proposed trade name FABLYN (lasofoxifene tartrate) Tablets, 0.5
milligrams (mg), Pfizer Inc., for the proposed indication of the
treatment of osteoporosis in postmenopausal women at increased risk of
fracture.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the
[[Page 46022]]
meeting, the background material will be made publicly available at the
location of the advisory committee meeting, and the background material
will be posted on FDA's Web site after the meeting. Background material
is available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click
on the year 2008 and scroll down to the appropriate advisory committee
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 27, 2008. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before August 19, 2008. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by August
20, 2008.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kalyani Bhatt (301)
827-7001 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-18131 Filed 8-6-08; 8:45 am]
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