[Federal Register Volume 65, Number 33 (Thursday, February 17, 2000)]
[Notices]
[Pages 8177-8180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3807]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food and Drug Administration/Industry Exchange Workshop on Fresh 
Air 2000-Medical Gas Requirements; Public Satellite Broadcast Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of workshop.

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SUMMARY: The Food and Drug Administration (FDA), Office of the 
Commissioner, Center for Drug Evaluation and Research, Office of 
Regulatory Affairs, and the Regional Small Business Assistance Offices 
is announcing a satellite broadcast workshop on FDA medical gas 
requirements. Through the workshop, FDA seeks to help ensure that the 
medical gas community understands existing FDA requirements for 
manufacturing, labeling, and distribution of medical gases and takes 
appropriate actions to establish effective manufacturing controls, thus 
preventing regulatory problems when inspections occur.
    Date and Time: See Table 1 following the Location section of this 
document.
    Location: See Table 1 below.

                                                     Table 1
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          Workshop Address                     Date and Local Time                        Registrar
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SAN JUAN, FDA San Juan District       Wednesday, March 15, 2000             Daniel Gonzalez, FDA San Juan
 Office,                                2 p.m. to 6. p.m.                    District Office, 466 Fernandez
466 Fernandez Juncos Ave., San Juan,    Atlantic time                        Juncos Ave., San Juan, PR 00901,
 PR 00901.                                                                   787-729-6894, FAX: 787-729-6658, e-
                                                                             mail: [email protected].
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AUGUSTA, Maine Department of          Wednesday, March 15, 2000             Becky Maxim, FDA, Capital West
 Agriculture, Agricultural Bldg.,       1 p.m. to 5 p.m.                     Business Center, 81 Leighton Rd.,
 333 Cony Rd., Augusta, ME 04330.       Eastern time                         suite 14, Augusta, ME 04330-9303,
                                                                             207-622-8268, ext. 13, FAX: 207-622-
                                                                             8273, e-mail: [email protected]
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WINCHESTER, FDA/Winchester            Wednesday, March 15, 2000             Herman B. Janiger, FDA Northeast
 Engineering and Analytical Center,     1 p.m. to 5 p.m.                     Region, 158-15 Liberty Ave.,
 109 Holton St., Winchester, MA         Eastern time                         Jamaica, NY 11433-1034, 718-662-
 01890.                                                                      5618, FAX: 718-662-5434, e-mail:
                                                                             [email protected].
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NEW YORK CITY/JAMAICA, NY, FDA        Wednesday, March 15, 2000             Herman B. Janiger, FDA Northeast
 Northeast Regional Office, 158-15      1 p.m. to 5 p.m.                     Region, 158-15 Liberty Ave.,
 Liberty Ave., Jamaica, NY 11433-       Eastern time                         Jamaica, NY 11433-1034, 718-662-
 1034.                                                                       5618, FAX: 718-662-5434, e-mail:
                                                                             [email protected].
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PHILADELPHIA, FDA Philadelphia        Wednesday, March 15, 2000             Anitra Brown-Reed, FDA Philadelphia
 District Office, 2d and Chestnut       1 p.m. to 5 p.m.                     District, 2d and Chestnut Sts., rm.
 Sts., rm. 900, U.S. Customhouse,       Eastern time                         900, U.S. Customhouse,
 Philadelphia, PA 19106.                                                     Philadelphia, PA 19106, 215-597-
                                                                             4390, ext. 4548, FAX: 215-597-4660,
                                                                             e-mail: [email protected].
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BALTIMORE, FDA Baltimore District     Wednesday, March 15, 2000             Valerie Matthews, FDA Baltimore
 Office, 900 Madison Ave.,              1 p.m. to 5 p.m.                     District, 900 Madison Ave.,
 Baltimore, MD 21201.                   Eastern time                         Baltimore, MD 21201, 410-962-3396,
                                                                             ext. 111, FAX: 410-962-0044, e-
                                                                             mail: [email protected].
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ROCKVILLE, FDA, Parklawn Conference   Wednesday, March 15, 2000             Erik Henrikson, FDA Center for Drug
 Center, 5600 Fishers Lane, 3d          1 p.m. to 5 p.m.                     Evaluation and Research (HFD-320),
 floor, rms. G and H, Rockville, MD     Eastern time                         7520 Standish Pl., Rockville, MD
 20857.                                                                      20855, 301-827-0072, FAX: 301-594-
                                                                             2202, e-mail:
                                                                             [email protected].
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CINCINNATI, FDA Cincinnati District   Wednesday, March 15, 2000             Mary Jane Jeffries, FDA Cincinnati
 Office, 6751 Steger Dr.,               1 p.m. to 5 p.m.                     District, 6751 Steger Dr.,
 Cincinnati, OH 45237.                  Eastern time                         Cincinnati OH 45237, 513-679-2700,
                                                                             ext. 115, FAX: 513-679-2771, e-
                                                                             mail: [email protected].
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[[Page 8178]]

 
MAITLAND, FDA Florida District        Wednesday, March 15, 2000             Frank Goodwin, FDA Florida District
 Office, 555 Winderly Pl., suite        1 p.m. to 5 p.m.                     Office, 555 Winderly Pl., suite
 200, Maitland, FL 32751.               Eastern time                         200, Maitland, FL 32751, 407-475-
                                                                             4707, FAX: 407-475-4768, e-mail:
                                                                             [email protected].
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ATLANTA, FDA Atlanta District         Wednesday, March 15, 2000             Teresa Thompson, FDA, 2302 West
 Office, 60 8th St. NE., Atlanta, GA    1 p.m. to 5 p.m.                     Meadowview Rd., suite 203,
 30309.                                 Eastern time                         Greensboro, NC 27407, 336-333-5419,
                                                                             FAX: 336-333-5563, e-mail:
                                                                             [email protected].
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DETROIT, FDA District Office, 1560    Wednesday, March 15, 2000             Evelyn DeNike, FDA Detroit District,
 East Jefferson Ave., Detroit, MI       1 p.m. to 5 p.m.                     1560 East Jefferson Ave., Detroit,
 48207 (attendance limited to one       Eastern time                         MI 48207-3179, 313-226-6260, ext.
 person per company).                                                        149, FAX: 313-226-3076, e-mail:
                                                                             [email protected].
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NASHVILLE, FDA Nashville Branch, 297  Wednesday, March 15, 2000             Kari Norton, FDA Nashville Branch,
 Plus Park Blvd., Nashville, TN         1 p.m. to 5 p.m.                     297 Plus Park Blvd., Nashville, TN
 37217.                                 Central time                         37217, 615-781-5388, ext. 112, FAX:
                                                                             615-781-5383, e-mail:
                                                                             [email protected].
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CHICAGO, FDA Chicago District         Wednesday, March 15, 2000             Patricia Lewis, FDA Chicago
 Office, 300 South Riverside Plaza,     12 m. to 4 p.m.                      District, 300 South Riverside
 suite 550 South Chicago, IL 60606.     Central time                         Plaza, suite 550 South Chicago, IL
                                                                             60606, 312-353-7379, FAX: 312-886-
                                                                             3280, e-mail: [email protected].
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MINNEAPOLIS/ST. PAUL, Fort Snelling,  Wednesday, March 15, 2000             Carrie Hoffman, FDA Minneapolis
 1 Federal Dr., rm. 196, Fort           12 m. to 4 p.m.                      District, 240 Hennepin Ave.,
 Snelling, MN 55111.                    Central time                         Minneapolis, MN 55401, 612-334-
                                                                             4100, ext. 159, FAX: 612-334-4142,
                                                                             e-mail: [email protected].
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LENEXA, FDA Kansas City District      Wednesday, March 15, 2000             Tywanna Paul, FDA Kansas City
 Office, 11630 West 80th St., P.O.      12 m. to 4 p.m.                      District, 11630 West 80th St.,
 Box 15905, Lenexa, KS 66285-5905.      Central time                         Lenexa, KS 66285-5905, 913-752-
                                                                             2141, FAX: 913-752-2111, e-mail:
                                                                             [email protected].
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NEW ORLEANS, FDA New Orleans          Wednesday, March 15, 2000             Kari Norton, FDA Nashville Branch,
 District Office, 6600 Plaza Dr.,       12 m. to 4 p.m.                      297 Plus Park Blvd., Nashville, TN
 suite 400, New Orleans, LA 70127.      Central time                         37217, 615-781-5388, ext. 112, FAX:
                                                                             615-781-5383, e-mail:
                                                                             [email protected].
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DENVER, FDA Denver District, Denver   Wednesday, March 15, 2000             Virlie Walker, FDA Denver District,
 Federal Center, Bldg. 20, 6th and      11 a.m. to 3 p.m.                    Federal Center, Bldg. 20, 6th and
 Kipling Sts., Denver, CO 80225-        Mountain time                        Kipling Sts., Denver, CO 80225-
 0087.                                                                       0087, 303-236-3018, FAX: 303-236-
                                                                             3551, e-mail: [email protected].
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DOWNEY, The Gas Company, Energy       Wednesday, March 15, 2000             Virgilio Pacio, FDA, 4510 Executive
 Resource Center, 9240 East             10 a.m. to 2 p.m.                    Dr., suite 225, San Diego, CA
 Firestone Blvd., Downey, CA 90241.     Pacific time                         92121, 858-550-3850, ext. 116, FAX:
                                                                             858-550-3860, e-mail:
                                                                             [email protected].
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BOTHELL, FDA Seattle District         Wednesday, March 15, 2000             Connie Rezendes, FDA Seattle
 Office, 22201 23d Dr. SE., Bothell,    10 a.m. to 2 p.m.                    District, 22201 23d Dr. SE.,
 WA 98021-4421.                         Pacific time                         Bothell, WA 98021-4421, 425-402-
                                                                             3178, FAX: 425-483-4996, e-mail:
                                                                             [email protected].
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ALAMEDA, FDA San Francisco District   Wednesday, March 15, 2000             Steven Gillenwater, FDA San
 Office, 1431 Harbor Bay Pkwy.,         10 a.m. to 2 p.m.                    Francisco District, 1431 Harbor Bay
 Alameda, CA 94502.                     Pacific time                         Pkwy., Alameda, CA 94502, 510-337-
                                                                             6802, FAX: 510-337-6702, e-mail:
                                                                             [email protected].
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    Contact: Erik N. Henrikson, Center for Drug Evaluation and Research 
(HFD-320), Food and Drug Administration, 7520 Standish Pl., Rockville, 
MD 20855, 301-827-0072, or e-mail [email protected].
    Registration: Send registration information, as listed in Table 1 
of this document, to the registrar for the site you wish to attend. 
Space is limited, therefore interested parties are encouraged to 
register early. The workshop is free of charge and open to the public, 
either through direct down-linking of the program or through attendance 
at one of the public meeting sites listed in Table 1 of this document. 
If you need special accommodations due to a disability, please inform 
the registrar for your site at least 7 days in advance of the workshop. 
Those who will be down-linking the program to their own locations and 
who will not

[[Page 8179]]

attend one of FDA's public sites do not need register with FDA in 
advance.
    Additional meeting sites are available on the Internet at http://www.fda.gov/cder/workshop.htm.
    The broadcast is also available for down-linking, free of charge, 
to anyone with a steerable satellite dish capable of accessing c-band 
broadcast signals. Satellite coordinates and technical information will 
be posted on the Internet at http://www.fda.gov/cder/workshop.htm. 
Coordinates will not be available until 2 to 3 weeks prior to 
broadcast. Questions regarding satellite down-linking prior to day of 
broadcast should be directed to the Satellite Voicemail Line at 301-
594-2263.
    The workshop scheduled above will help implement the FDA Plan for 
Statutory Compliance (developed under section 406 of the FDA 
Modernization Act (21 U.S.C. 393)) through working more closely with 
stakeholders and ensuring access to needed scientific and technical 
expertise. This workshop also complies with the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121) that requires 
outreach activities by Government agencies directed to small 
businesses.
    The meeting announcement and registration form may also be accessed 
on the Internet at http://www.fda.gov/cder/workshop.htm.
    The following information is requested for registration:
BILLING CODE 4160-01-F

[[Page 8180]]

[GRAPHIC] [TIFF OMITTED] TN17FE00.012


    Dated: February 8, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-3807 Filed 2-16-00; 8:45 am]
BILLING CODE 4160-01-C