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Federal Register / Vol. 70, No.

31 / Wednesday, February 16, 2005 / Notices 7949

activities including updates on CDC response to Program Announcement 04038 FDA announced that a meeting of the
scientific and programmatic activities. and Program Announcement Request 05005. Cellular, Tissue and Gene Therapies
Agenda items are subject to change as Contact Person for More Information: Advisory Committee (formerly the
priorities dictate. Pamela J. Wilkerson, MPA, Scientific Review
Administrator, Office of Extramural
Biological Response Modifiers Advisory
FOR FURTHER INFORMATION CONTACT: Programs, National Institute for Occupational Committee) would be held on March 3
Robert Delaney,Executive Secretary, Safety and Health, CDC, 1600 Clifton Road, and 4, 2005. On page 3935, in the first
Advisory Committee to the NE., MS–E74, Atlanta, GA 30333, Telephone column, the introductory paragraph,
Director,CDC, 1600 Clifton Road, NE., 404–498–2556. Date and Time, Agenda, and Procedure
M/S D–14, Atlanta, Georgia 30333. The Director, Management Analysis and portions of the document are amended
Telephone 404/639–7000. Services Office has been delegated the to read as follows:
The Director, Management Analysis authority to sign Federal Register notices
and Services Office, has been delegated pertaining to announcements of meetings and This notice announces a forthcoming
the authority to sign Federal Register other committee management activities, for meeting of a public advisory committee
both the CDC and the Agency for Toxic of the Food and Drug Administration
notices pertaining to announcements of Substances and Disease Registry.
meetings and other committee (FDA). The meeting will be open to the
management activities, for both CDC Dated: February 8, 2005. public.
and the Agency for Toxic Substances Alvin Hall, Date and Time: The meeting will be
and Disease Registry. Director, Management Analysis and Services held on March 3, 2005, from 8 a.m. to
Office, Centers for Disease Control and approximately 6 p.m. and on March 4,
Dated: February 10, 2005.
Prevention CDC. 2005, from 8 a.m. to approximately 5
Alvin Hall,
[FR Doc. 05–2963 Filed 2–15–05; 8:45 am] p.m.
Director, Management Analysis and Services
BILLING CODE 4163–19–P
Office, Centers for Disease Control and Agenda: On March 3, 2005, all day
Prevention. and on March 4, 2005, in the morning,
[FR Doc. 05–2961 Filed 2–15–05; 8:45 am] the committee will discuss cellular
DEPARTMENT OF HEALTH AND
BILLING CODE 4163–18–P
HUMAN SERVICES therapies for repair and regeneration of
joint surfaces. Additionally, on March 4,
Food and Drug Administration 2005, the committee will discuss safety
DEPARTMENT OF HEALTH AND issues related to retroviral vector-
HUMAN SERVICES Cellular, Tissue and Gene Therapies mediated tumorigenesis in gene transfer
Advisory Committee (formerly the clinical trials.
Centers for Disease Control and Biological Response Modifiers
Prevention Advisory Committee); Amendment of Procedure: On March 3, 2005, from 8
Notice a.m. to approximately 6 p.m. and on
Disease, Disability, and Injury March 4, 2005, from 8 a.m. to
Prevention and Control Special AGENCY: Food and Drug Administration, approximately 5 p.m., the meeting is
Emphasis Panels: Occupational Health HHS. open to the public. Interested persons
and Safety Research, Program ACTION: Notice. may present data, information, or views,
Announcement (PA) 04038, and NIOSH orally or in writing, on issues pending
Support for Conferences and Scientific The Food and Drug Administration before the committee. Written
Meetings, Program Announcement (FDA) is announcing an amendment to submissions may be made to the contact
Request (PAR) 05005 the notice of meeting of the Cellular, person by February 23, 2005. Oral
Tissue and Gene Therapies Advisory presentations from the public will be
In accordance with section 10(a)(2) of Committee (formerly the Biological
the Federal Advisory Committee Act scheduled on March 3, 2005, between
Response Modifiers Advisory approximately 11 a.m. and 11:30 a.m.
(Pub. L. 92–463), the Centers for Disease Committee). This meeting was
Control and Prevention (CDC) and on March 4, 2005, between
announced in the Federal Register of
announces the following meeting: approximately 12 noon and 12:30 p.m.
January 27, 2005 (70 FR 3934). The
Time allotted for each presentation may
Name: Disease, Disability, and Injury amendment is being made to reflect the
Prevention and Control Special Emphasis be limited. Those desiring to make
cancellation of the closed portion of the
Panels (SEP): Occupational Health and Safety formal oral presentations should notify
meeting and the following portions of
Research, Program Announcement 04038, the document: Date and Time, Agenda, the contact person before February 23,
and NIOSH Support for Conferences and 2005, and submit a brief statement of
Scientific Meetings, Program Announcement Procedure, and Closed Committee
Deliberations. There are no other the general nature of the evidence or
Request 05005. arguments they wish to present, the
Times and Dates: 5 p.m.–5:30 p.m., March changes.
9, 2005 (Open); 5:30 p.m.–7:30 p.m., March
names and addresses of proposed
FOR FURTHER INFORMATION CONTACT: Gail participants, and an indication of the
9, 2005 (Closed); 8:30 a.m.–6:30 p.m., March
Dapolito or Rosanna L. Harvey, Center approximate time requested to make
10, 2005 (Closed).
Place: Royal Sonesta Hotel New Orleans, for Biologics Evaluation and Research their presentation.
300 Bourbon Street, New Orleans, LA 70140– (HFM–71), Food and Drug
Administration, 1401 Rockville Pike, On page 3935, in the second column,
1014 telephone 504–586–0300.
Status: Portions of the meeting will be Rockville, MD 20852, 301–827–0314, or the Closed Committee Deliberations
closed to the public in accordance with FDA Advisory Committee Information portion of the document is deleted to
provisions set forth in section 552b(c)(4) and Line, 1–800–741–8138 (301–443–0572 reflect the cancellation of the closed
(6), Title 5 U.S.C., and the Determination of in the Washington, DC area), code portion of the meeting on March 3,
the Director, Management Analysis and 3014512389. Please call the Information 2005.
Services Office, CDC, pursuant to Public Law
Line for up-to-date information on this This notice is issued under the
92–463.
Matters to be Discussed: The meeting will meeting. Federal Advisory Committee Act (5
include the review, discussion, and SUPPLEMENTARY INFORMATION: In the U.S.C. app. 2) and 21 CFR part 14,
evaluation of applications received in Federal Register of January 27, 2005, relating to the advisory committees.

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7950 Federal Register / Vol. 70, No. 31 / Wednesday, February 16, 2005 / Notices

Dated: February 8, 2005. the Web site after this document Dated: February 4, 2005.
Sheila Dearybury Walcoff, publishes in the Federal Register.) Jeffrey Shuren,
Associate Commissioner for External The registrar will also accept payment Assistant Commissioner for Policy.
Relations. by major credit cards. For more [FR Doc. 05–2922 Filed 2–15–05; 8:45 am]
[FR Doc. 05–2920 Filed 2–15–05; 8:45 am] information on the meeting, or for BILLING CODE 4160–01–S
BILLING CODE 4160–01–S questions on registration, contact 800–
SoCRA92 (800–762–7292), or 215–345–
7369, or via e-mail: socramail@aol.com. DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND Attendees are responsible for their own HUMAN SERVICES
HUMAN SERVICES accommodations. To make reservations
at the Sheraton University City Hotel at Food and Drug Administration
Food and Drug Administration
the reduced conference rate, contact the
Food and Drug Administration Drug
Industry Exchange Workshop on Food Sheraton University City Hotel (see
Educational Forum; Public Workshop;
and Drug Administration Clinical Trial Location) before March 13, 2005.
Correction
Requirements; Public Workshop The registration fee will be used to
offset the expenses of hosting the AGENCY: Food and Drug Administration,
AGENCY: Food and Drug Administration, conference, including meals, HHS.
HHS. refreshments, meeting rooms, and ACTION: Notice of public workshop;
ACTION: Notice of public workshop. materials. Space is limited, therefore correction.
SUMMARY: The Food and Drug interested parties are encouraged to
register early. Limited onsite registration SUMMARY: The Food and Drug
Administration (FDA) Philadelphia Administration (FDA) is correcting a
District, in cooperation with the Society may be available. Please arrive early to
ensure prompt registration. notice that appeared in the Federal
of Clinical Research Associates Register of February 3, 2005 (70 FR
(SoCRA), is announcing a workshop on If you need special accommodations
5686). The document announced a
FDA Clinical trial statutory and due to a disability, please contact Marie
public workshop. The document was
regulatory requirements. This 2-day Falcone (see Contact) at least 7 days in
published with a typographical error in
workshop for the clinical research advance of the workshop.
the SUPPLEMENTARY INFORMATION section.
community targets sponsors, monitors, SUPPLEMENTARY INFORMATION: The This document corrects that error.
clinical investigators, institutional workshop on FDA Clinical Trials FOR FURTHER INFORMATION CONTACT:
review boards, and those who interact Statutory and Regulatory Requirements,
with them for the purpose of conducting Joyce Strong, Office of Policy (HF–27),
helps fulfill the Department of Health Food and Drug Administration, 5600
FDA regulated clinical research. The and Human Services’ and FDA’s
workshop will include both industry Fishers Lane, Rockville, MD 20857,
important mission to protect the public 301–827–7010.
and FDA perspectives on proper health by educating researchers on
conduct of clinical trials regulated by SUPPLEMENTARY INFORMATION: In FR Doc.
proper conduct of clinical trials. Topics 05–2098, appearing on page 5686, in the
FDA. for discussion include the following: (1)
Date and Time: The public workshop Federal Register of Thursday, February
FDA and confidence in the conduct of 3, 2005, the following correction is
is scheduled for Wednesday, April 13,
clinical research; (2) medical device, made:
2005, from 8:15 a.m. to 5 p.m. and
drug, and biological product aspects of 1. On page 5687, in the second
Thursday, April 14, 2005, from 8:15
clinical research; (3) investigator column, the fifth line from the bottom
a.m. to 4 p.m.
Location: The public workshop will initiated research; (4) Pre-investigational should read ‘‘abbreviated new drug
be held at the Sheraton University City new drug (IND) application meetings applications (ANDAs)’’.
Hotel Philadelphia, 3549 Chestnut St., and FDA meeting process; (5) informed
Dated: February 8, 2005.
Philadelphia, PA 19104, 215–387–8000, consent requirements; (6) ethics in
subject enrollment; (7) FDA regulation Jeffrey Shuren,
FAX: 215–387–7920. Assistant Commissioner for Policy.
Contact: Marie Falcone, Food and of Institutional Review Boards; (8)
Drug Administration, U.S. electronic records requirements; (9) [FR Doc. 05–2921 Filed 2–15–05; 8:45 am]
Customhouse, 200 Chestnut St., rm. 900, adverse event reporting; (10) how FDA BILLING CODE 4160–01–S

Philadelphia, PA 19106, 215–597–2120 conducts bioresearch inspections, and


ext. 4003, FAX: 215–597–5798, e-mail: (11) what happens after the FDA
inspection. FDA has made education of DEPARTMENT OF HEALTH AND
mfalcone@ora.fda.gov.
Registration: Send registration the research community a high priority HUMAN SERVICES
information (including name, title, firm to assure the quality of clinical data and
protect research subjects. Food and Drug Administration
name, address, telephone, and fax
number) and the registration fee of $485 The workshop helps to implement the [Docket No. 2004N–0355]
(member), $560 (nonmember), or $460 objectives of section 406 of the FDA
(government employee nonmember). Modernization Act (21 U.S.C. 393) and Scientific Considerations Related to
(Registration fee for nonmemebers the FDA Plan for Statutory Compliance, Developing Follow-On Protein
includes a 1 year membership.) The which includes working more closely Products; Reopening of Comment
registration fee for FDA employees is with stakeholders and ensuring access Period
waived. Make the registration fee to needed scientific and technical AGENCY: Food and Drug Administration,
payable to SoCRA, P.O. Box 101, expertise. The workshop also furthers HHS.
Furlong, PA 18925. To register via the the goals of the Small Business ACTION: Notice; reopening of comment
Internet go to http://www.socra.org/ Regulatory Enforcement Fairness Act period.
FDA_Conference.htm. (FDA has verified (Public Law 104–121) by providing
the Web site address, but is not outreach activities by Government SUMMARY: The Food and Drug
responsible for subsequent changes to agencies directed to small businesses. Administration (FDA) is reopening until

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