Federal Register / Vol. 69, No. 44 / Friday, March 5, 2004 / Notices 10457
III. Comments Date and Time: The meeting will be Meeks, Conference Management Staff, at
held on March 25, 2004, from 8 a.m. to 301–594–1283, ext. 105, at least 7 days
The administrative record of this
5 p.m. in advance of the meeting.
public meeting will remain open for 30
Location: Hilton Washington, DC Notice of this meeting is given under
days after the public meeting. Interested North/Gaithersburg, Ballroom Salons A, the Federal Advisory Committee Act (5
persons may submit to the Division of B, C, and D, 620 Perry Pkwy., U.S.C. app. 2).
Dockets Management (HFA–305), Food Gaithersburg, MD.
and Drug Administration, 5630 Fishers Dated: March 1, 2004.
Contact Person: David Krause, Center
Lane, rm. 1061, Rockville, MD 20852, Peter J. Pitts,
for Devices and Radiological Health
written or electronic comments by June (HFZ–410), Food and Drug Associate Commissioner for External
11, 2004. You may also send comments Relations.
Administration, 9200 Corporate Blvd.,
to the Division of Dockets Management Rockville, MD 20850, 301–594–3090, [FR Doc. 04–4983 Filed 3–4–04; 8:45 am]
via e-mail to FDADockets@oc.fda.gov. ext. 141, or FDA Advisory Committee BILLING CODE 4160–01–S
Submit two paper copies of comments, Information Line, 1–800–741–8138
identified with the docket number (301–443–0572 in the Washington, DC
found in brackets in the heading of this area), code 3014512519. Please call the DEPARTMENT OF HEALTH AND
document. Individuals may submit one Information Line or access the Internet HUMAN SERVICES
paper copy. Received comments may be address of http://www.fda.gov/cdrh/
seen in the Division of Dockets Food and Drug Administration
panelmtg.html for up-to-date
Management between 9 a.m. and 4 p.m., information on this meeting. [Docket No. 2000D–1350]
Monday through Friday. Comments may Agenda: The committee will discuss,
be placed on the Internet and, if so, will make recommendations, and vote on a Draft Guidance for Industry on
be available for public viewing. premarket approval application (PMA) Labeling for Combined Oral
for an injectable device intended for use Contraceptives; Availability
IV. Meeting Notes
in the correction of lipoatrophy of the AGENCY: Food and Drug Administration,
You may request a copy of the notes face in human immunodeficiency virus HHS.
of the public meeting in writing from (HIV) positive patients. Background
the Freedom of Information Office (HFI– ACTION: Notice.
information for this PMA, including the
35), Food and Drug Administration, agenda and questions for the committee, SUMMARY: The Food and Drug
5600 Fishers Lane, rm. 12A–16, will be available to the public 1 Administration (FDA) is announcing the
Rockville, MD 20857, approximately 15 business day before the meeting on the availability of a draft guidance for
working days after the public meeting, Internet at http://www.fda.gov/cdrh/ industry entitled ‘‘Labeling for
at a cost of 10 cents per page. You may panelmtg.html. The material for this Combined Oral Contraceptives.’’ The
examine the notes of the public meeting meeting will be posted on March 24, draft guidance contains recommended
after June 11, 2004, at the Division of 2004. labeling for combined oral
Dockets Management between 9 a.m. Procedure: Interested persons may contraceptives. This is the second draft
and 4 p.m., Monday through Friday. present data, information, or views, of a guidance being issued on this topic.
Dated: February 27, 2004. orally or in writing, on issues pending
DATES: Submit written or electronic
before the committee. Written
Jeffrey Shuren, comments on the draft guidance by May
submissions may be made to the contact
Assistant Commissioner for Policy. 4, 2004. General comments on agency
person by March 15, 2004. On March
[FR Doc. 04–4888 Filed 3–4–04; 8:45 am] guidance documents are welcome at any
25, 2004, oral presentations from the
BILLING CODE 4160–01–S time.
public will be scheduled for
ADDRESSES: Submit written requests for
approximately 1 hour at the beginning
of committee deliberations and for single copies of the draft guidance to the
DEPARTMENT OF HEALTH AND approximately 1 hour near the end of Division of Drug Information (HFD–
HUMAN SERVICES the committee deliberations. Time 240), Center for Drug Evaluation and
allotted for oral public presentations Research, Food and Drug
Food and Drug Administration Administration, 5600 Fishers Lane,
may be limited. Those desiring to make
formal oral presentations should notify Rockville, MD 20857. Send one self-
General and Plastic Surgery Devices addressed adhesive label to assist that
Panel of the Medical Devices Advisory the contact person before March 15,
2004, and submit a brief statement of office in processing your requests.
Committee; Notice of Meeting Submit written comments on the draft
the general nature of the evidence or
AGENCY: Food and Drug Administration, arguments they wish to present, the guidance to the Division of Dockets
HHS. names and addresses of proposed Management (HFA–305), Food and Drug
ACTION: Notice. participants, and an indication of the Administration, 5630 Fishers Lane, rm.
approximate time requested to make 1061, Rockville, MD 20852. Submit
This notice announces a forthcoming their presentation. electronic comments to http://
meeting of a public advisory committee Persons attending FDA’s advisory www.fda.gov/dockets/ecomments. See
of the Food and Drug Administration committee meetings are advised that the the SUPPLEMENTARY INFORMATION section
(FDA). The meeting will be open to the agency is not responsible for providing for electronic access to the draft
public. access to electrical outlets. guidance document.
Name of Committee: General and FDA welcomes the attendance of the FOR FURTHER INFORMATION CONTACT:
Plastic Surgery Devices Panel of the public at its advisory committee Margaret Kober, Center for Drug
Medical Devices Advisory Committee. meetings and will make every effort to Evaluation and Research (HFD–580),
General Function of the Committee: accommodate persons with physical Food and Drug Administration, 5600
To provide advice and disabilities or special needs. If you Fishers Lane, Rockville, MD 20857,
recommendations to the agency on require special accommodations due to 301–827–4260.
FDA’s regulatory issues. a disability, please contact Shirley SUPPLEMENTARY INFORMATION:
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