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Federal Register / Vol. 71, No.

155 / Friday, August 11, 2006 / Notices 46231

ANNUAL BURDEN ESTIMATES


Number of re- Average bur-
Number of re- Total burden
Instrument sponses per den hours per
spondents hours
respondent response

Intermediary survey ......................................................................................... 60 1 .5 30

Estimated Total Annual Burden in cooperation with the Society of & Suites (see Location) before October
Hours: Clinical Research Associates (SoCRA), is 22, 2006. The registration fee will be
In compliance with the requirements announcing a workshop on FDA clinical used to offset the expenses of hosting
of Section 3506(c)(2)(A) of the trial statutory and regulatory the conference, including meals,
Paperwork Reduction Act of 1995, the requirements. This 2-day workshop for refreshments, meeting rooms, and
Administration for Children and the clinical research community targets materials.
Families is soliciting public comment sponsors, monitors, clinical
Space is limited, therefore interested
on the specific aspects of the investigators, institutional review
information collection described above. boards, and those who interact with parties are encouraged to register early.
Copies of the proposed collection of them for the purpose of conducting Limited onsite registration may be
information can be obtained and FDA-regulated clinical research. The available. Please arrive early to ensure
comments may be forwarded by writing workshop will include both industry prompt registration. If you need special
to the Administration for Children and and FDA perspectives on proper accommodations due to a disability,
Families, Office of Administration, conduct of clinical trials regulated by please contact Nancy Bellamy (see
Office of Information Services, 370 FDA. Contact) at least 7 days in advance of
L’Enfant Promenade, SW., Washington, Date and Time: The public workshop the workshop.
DC 20447. Attn: ACF Reports Clearance is scheduled for Wednesday, November
SUPPLEMENTARY INFORMATION: The
Office. E-mail address: 15, 2006, from 8:30 a.m. to 5 p.m. and
workshop on FDA clinical trials
infocollection@acf.hhs.gov. All requests Thursday, November 16, 2006, from
statutory and regulatory requirements
should be identified by the title of the 8:30 a.m. to 4:30 p.m.
Location: The public workshop will helps fulfill the Department of Health
information collection.
The Department specifically requests be held at the Sheraton Indianapolis and Human Services’ and FDA’s
comments on: (a) Whether the proposed Hotel & Suites, 8787 Keystone Crossing, important mission to protect the public
collection of information is necessary Indianapolis, IN 46240, 317–846–2700, health by educating researchers on
for the proper performance of the FAX: 317–574–6775. proper conduct of clinical trials. Topics
functions of the agency, including Contact: Nancy Bellamy, Food and for discussion include the following: (1)
whether the information shall have Drug Administration, 300 River Pl., FDA regulation of the conduct of
practical utility; (b) the accuracy of the suite 5900, Detroit, MI, 48207, 313–393– clinical research; (2) medical device,
agency’s estimate of the burden of the 8143, FAX: 313–393–8139, e-mail: drug, biological product and food
proposed collection of information; (c) nancy.bellamy@fda.hhs.gov. aspects of clinical research; (3)
the quality, utility, and clarity of the Registration: Send registration investigator initiated research; (4) pre-
information to be collected; and (d) information (including name, title, firm investigational new drug application
ways to minimize the burden of the name, address, telephone, and fax meetings and FDA meeting process; (5)
collection of information on number) and the registration fee of $575 informed consent requirements; (6)
respondents. Consideration will be (member), $650 (nonmember), or $525 ethics in subject enrollment; (7) FDA
given to comments and suggestions (Government employee nonmember). regulation of institutional review
submitted within 60 days of this (Registration fee for nonmembers
boards; (8) electronic records
publication. includes a 1-year membership.) The
requirements; (9) adverse event
registration fee for FDA employees is
Dated: August 4, 2006. reporting; (10) how FDA conducts
waived. Make the registration fee
Robert Sargis, payable to SoCRA, 530 West Butler bioresearch inspections; and (11) what
Reports Clearance Officer. Ave., suite 109, Chalfont, PA, 18914. To happens after the FDA inspection. FDA
[FR Doc. 06–6841 Filed 8–10–06; 8:45 am] register via the Internet go tohttp:// has made education of the research
BILLING CODE 4184–01–M www.socra.org/html/ community a high priority to ensure the
FDAlConference.htm (FDA has quality of clinical data and protect
verified the Web site address, but is not research subjects. The workshop helps
DEPARTMENT OF HEALTH AND responsible for subsequent changes to to implement the objectives of section
HUMAN SERVICES the Web site after this document 406 of the FDA Modernization Act (21
publishes in the Federal Register). U.S.C. 393) and the FDA Plan for
Food and Drug Administration The registrar will also accept payment Statutory Compliance, which includes
by major credit cards. For more working more closely with stakeholders
Industry Exchange Workshop on Food
information on the meeting, or for and ensuring access to needed scientific
and Drug Administration Clinical Trial
questions on registration, contact 800– and technical expertise. The workshop
Requirements; Public Workshop
SoCRA92 (800–762–7292), or 215–822– also furthers the goals of the Small
hsrobinson on PROD1PC67 with NOTICES1

AGENCY: Food and Drug Administration, 8644, or via e-mail: socramail@aol.com. Business Regulatory Enforcement
HHS. Attendees are responsible for their own Fairness Act (Public Law 104–121) by
ACTION: Notice of public workshop. accommodations. To make reservations providing outreach activities by
at the Sheraton Indianapolis Hotel & Government agencies directed to small
SUMMARY: The Food and Drug Suites, at the reduced conference rate, businesses.
Administration (FDA) Detroit District, contact the Sheraton Indianapolis Hotel

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46232 Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices

Dated: August 4, 2006. Division of Dockets Management (HFA– the areas of foods (including dietary
Jeffrey Shuren, 305), Food and Drug Administration, supplements), food and color additives,
Assistant Commissioner for Policy. 5630 Fishers Lane, rm. 1061, Rockville, animal feeds, cosmetics, drugs and
[FR Doc. E6–13114 Filed 8–10–06; 8:45 am] MD 20852. Submit electronic comments biologics, and medical devices, whether
BILLING CODE 4160–01–S
to http://www.fda.gov/dockets/ there are new or emerging scientific
ecomments. All comments should be issues that should be brought to FDA’s
identified with the docket number attention, including issues related to the
DEPARTMENT OF HEALTH AND found in brackets in the heading of this safety of nanotechnology materials, and
HUMAN SERVICES document. any other issues about which the
FOR FURTHER INFORMATION CONTACT: regulated industry, academia, and the
Food and Drug Administration Poppy Kendall, Food and Drug interested public may wish to inform
Administration (HF–11), 5600 Fishers FDA concerning the use of
[Docket No. 2006N–0107]
Lane, Rockville, MD 20857, 301–827– nanotechnology materials in FDA-
Food and Drug Administration- 3360, FAX: 301–594–6777, e-mail: regulated products.
Regulated Products Containing poppy.kendall@fda.hhs.gov. The public meeting will be chaired by
Nanotechnology Materials; Public SUPPLEMENTARY INFORMATION:
the FDA Nanotechnology Task Force.
Meeting Acting FDA Commissioner Andrew von
I. Why Are We Holding a Public Eschenbach created this internal task
AGENCY: Food and Drug Administration, Meeting? force to help the agency evaluate the
HHS. increasing use of nanotechnology
Nanotechnology is defined in a
ACTION: Notice of public meeting; variety of ways. The National materials in FDA-regulated products.
request for comments. Nanotechnology Initiative (a U.S. For more information about FDA’s
Government research and development role regarding nanotechnology products,
SUMMARY: The Food and Drug see our Web page at http://www.fda.gov/
coordinating program) refers to
Administration (FDA) will hold a public nanotechnology/.
nanotechnology as ‘‘the understanding
meeting October 10, 2006, on FDA-
and control of matter at dimensions of II. How Can You Participate?
regulated products containing
roughly 1 to 100 nanometers, where
nanotechnology materials, and has You can participate through oral
unique phenomena enable novel
opened a docket on FDA-regulated presentation at the meeting or through
applications’’ (http://www.nano.gov). A
products containing nanotechnology written or electronic material submitted
nanometer is a billionth of a meter, and
materials. The purpose of the meeting to the docket. In response to the first
is approximately the width of 10
will be to help FDA further its notice of this meeting (71 FR 19523,
hydrogen atoms lined up side by side.
understanding of developments in April 14, 2006) we received a large
(A human hair is about 80,000
nanotechnology materials that pertain to number of responses indicating interest
nanometers in width. Deoxyribonucleic
FDA-regulated products. FDA is in attending and presenting, and the
acid (DNA) is about 2.5 nanometers in
interested in learning about the kinds of responses indicated interest in a variety
width.)
new nanotechnology material products of topics. Therefore, in order to provide
Due to their small size and extremely
under development in the areas of foods the most value to those attending who
high ratio of surface area to volume,
(including dietary supplements), food may be interested in a particular topic,
nanotechnology materials often have
and color additives, animal feeds, we are likely to divide the meeting into
chemical or physical properties that are
cosmetics, drugs and biologics, and topic areas (for separate, concurrent
different from those of their larger
medical devices, whether there are new sessions on those topics) and one
counterparts. Such differences include
or emerging scientific issues that should general session. Participants would be
altered magnetic properties, altered
be brought to FDA’s attention, and any asked to express a preference for either
electrical or optical activity, increased
other scientific issues about which the one of the concurrent sessions or the
structural integrity, and increased
regulated industry, academia, and the general session in which to make a
chemical and biological activity.
interested public may wish to inform presentation. Time allotted for each
Because of these properties,
FDA concerning the use of presentation will depend on the
nanotechnology materials have great
nanotechnology materials in FDA- presentation requests received for that
potential for use in a vast array of
regulated products. session. Furthermore, given the number
products. Also because of some of their
DATES AND TIMES: The public meeting special properties, they may pose of responses received, it is likely that it
will be held October 10, 2006, from 9 different safety issues than their larger will be necessary to limit presentations
a.m. to 5 p.m. counterparts. Of particular interest to to one per individual/organization.
REGISTRATION: You may register at FDA, nanotechnology materials may In addition to a session that has a
http://www.fda.gov/nanotechnology/. enable new developments in implants more general focus, we are considering
We will also post the agenda at http:// and prosthetics, drug delivery, and food the following three breakout sessions:
www.fda.gov/nanotechnology/ prior to processing, and may already be in use (1) Topically-administered drugs,
the meeting. in some cosmetics and sunscreens. As biologics, devices and cosmetics; (2)
ADDRESSES: The public workshop will part of its critical path initiative, FDA is other drugs, biologics and devices; (3)
be held at the Natcher Auditorium, interested in learning if there are foods (including dietary supplements)
National Institutes of Health Campus, opportunities for it to help overcome and food and color additives, and
9000 Rockville Pike, bldg. 45, Bethesda, scientific hurdles that may be inhibiting animal Feeds.
hsrobinson on PROD1PC67 with NOTICES1

MD. We will also post the address for the use of nanotechnology in medical We ask that you register early (see
the meeting at http://www.fda.gov/ product development. REGISTRATION) if you intend to provide
nanotechnology/. We will be holding this meeting an oral presentation. The information
Written or electronic comments may because we are interested in learning provided during registration will help
be submitted by November 10, 2006. about the kinds of new nanotechnology us determine further how to organize
Submit written comments to the material products under development in the day. The final agenda will depend

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