FEDERAL REGISTER
FDA
[U.S. Food and Drug Administration]
_Federal Register_
_________________________________________________________________
Display date 4/18/97; Publication date 4/21/97
ACTION: Notice.
ARTHRITIS ADVISORY COMMITTEE
DATE AND TIME: May 6 and 7, 8:30 a.m.
LOCATION: Holiday Inn -- Gaithersburg, Whetstone Room, Two
Montgomery Village Ave., Gaithersburg, MD.
CONTACT: Kathleen R. Reedy or LaNise Giles, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-443-5455, FAX:
301-443-0699, or FDA Advisory Committee Information Hotline,
1-800-741-8138 (301-443-0572 in the Washington, DC area), Arthritis
Advisory Committee, code 12532. Please call the hotline for
information concerning any possible changes.
Open public hearing. Interested persons may present data,
information, or views, orally or in writing, on issues pending
before the committee. Those desiring to make formal presentations
should notify the contact person before May 1, 1997, 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 required to
make their comments.
Closed presentation of data. On May 6 and 7, 1997, the committee
will hear trade secret and/or confidential commercial information
relevant to pending investigational new drug applications (IND's)
and new drug applications (NDA's). This portion of the meeting
will be closed to permit discussion of this information (5 U.S.C.
552b(c)(4)).
Display 4/22/97; Publication 4/23/97
BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE
DATE AND TIME: MAY 6, 1997, 3:00 P.M.
LOCATION: National Institutes of Health Campus, Bldg. 29,
conference room 121, 8800 Rockville Pike, Bethesda, MD 20852.
CONTACT: William Freas or Rosanna L. Harvey, Center for Biologics
Evaluation and Research (HFM-21), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA
Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Biological Response Modifiers
Advisory Connittee, code 12388.
This meeting will be held via a telephone conference call. A
speaker telephone will be provided in the conference room to allow
public participation in the meeting.
The committee will discuss the site visit review report for the
Laboratory of Molecular Medical Genetics and the research program
of an individual in the Division of Cellular and Gene Therapy.
DISPLAY DATE: 4/25/97 PUBLICATION DATE: 4/28/97
21 CFR Part 522
IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS; FLUNIXIN
MEGLUMINE
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the
animal drug regulations to reflect approval of an abbreviated new
animal drug application (ANADA) filed by Agri Laboratories, Ltd.
The ANADA provides for use of flunixin meglumine injection in
horses for alleviation of inflammation and pain associated with
musculoskeletal disorders and visceral pain associated with colic.
EFFECTIVE DATE: APRIL 28, 1997
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for
Veterinary Medicine (HFV-114), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1617.
DISPLAY DATE: 4/25/97 PUBLICATION DATE: 4/28/97
21 CFR Part 522
IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS; CHANGE OF
SPONSOR
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the
animal drug regulations to reflect a change of sponsor for a new
abbreviated animal drug application (ANADA) from Phoenix
Pharmaceutical, Inc., to Phoenix Scientific, Inc.
EFFECTIVE DATE: April 28, 1997
FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0213.
DISPLAY DATE: 4/25/97 PUBLICATION DATE: 4/28/97
21 CFR Part 529
CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS; GENTAMICIN SULFATE
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the
animal drug regulations to reflect approval of an abbreviated new
animal drug application (ANADA) filed by Med-Pharmex, Inc. The
ANADA provides for the use of gentamicin sulfate solution in the
dipping treatment of turkey hatching eggs as an aid in the
reduction or elimination of certain organisms.
EFFECTIVE DATE: April 28, 1997
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
DISPLAY DATE: 4/25/97 PUBLICATION DATE: 4/28/97
21 CFR Part 510
ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS; CHANGE OF SPONSOR
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the
animal drug regulations to reflect a change of sponsor for three
new animal drug applications (NADA's) from Ciba-Geigy Animal
Health, Ciba-Geigy Corp. to Novartis Animal Health US, Inc.
EFFECTIVE DATE: April 28, 1997
FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0213.
DISPLAY DATE: 4/25/97 PUBLICATION DATE: 4/28/97
[Docket No. 97N - 0138]
ENVIRONMENTAL ASSESSMENTS AND FINDINGS OF NO SIGNIFICANT IMPACT
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that
it has reviewed environmental assessments (EA's) and issued
findings of no significant impact (FONSI's) relating to the 141 new
drug applications (NDA's), abbreviated new drug applications
(ANDA's), and supplemental applications listed in this document.
FDA is publishing this notice because Federal regulations require
public notice of the availability of environmental documents.
ADDRESSES: The EA's and FONSI's may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, or a copy may be
requested by writing the Freedom of Information Staff (HFI-35),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug
Evaluation and Research (HFD-357), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-594-5721.
DISPLAY DATE: 4/25/97 PUBLICATION DATE: 4/28/97
21 CFR Part 177
[Docket No. 96F-0213]
INDIRECT FOOD ADDITIVES: POLYMERS
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the
food additive regulations to provide for the safe use of
1,4-benzenedicarboxylic acid, polymer with 1,4-butanediol,
(S)-2-butenedioic acid, 1,2-ethanediol, ethyl 2-propenoate,
hexanedioic acid and 2-propenoic acid, graft, in Nylon 6 and Nylon
6 modified with Nylon MXD - 6 articles intended for use in contact
with food. This action is in response to a petition filed by
Toyobo Co., Ltd.
DATES: Effective April 28, 1997; written objections and requests
for a hearing by May 28, 1997
ADDRESSES: Submit written objections to the Dockets Management
Branch (HFA - 305), Food and Drug Administration, 12420 Parklawn
Dr., rm. 1 - 23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food
Safety and Applied Nutrition (HFS - 216), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202 - 418 -
3081.
DISPLAY DATE: 4/29/97 PUBLICATION DATE: 4/30/97
[Docket No. 97C - 0171]
TOYO-MORTON, LTD.; FILING OF FOOD ADDITIVE PETITION
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that
Toyo-Morton, Ltd., has filed a petition proposing that the food
additive regulations be amended to provide for the safe use of
polyester-epoxy-urethane adhesive for use as a nonfood contact
layer of laminated articles intended for use in contact with food.
DATES: Written comments on the petitioner's environmental
assessment by MAY 30, 1997.
ADDRESSES: Submit written comments to the Dockets Management
Branch (HFA - 305), Food and Drug Administration, 12420 Parklawn
Dr., rm. 1 - 23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Daniel N. Harrison, Center for
Food Safety and Applied Nutrition (HFS - 215), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202 - 418 -
3084.
Display 4/30; Publication 5/1
[Docket No. 97C-0171]
CLOSURE MEDICAL CORP.; FILING OF COLOR ADDITIVE PETITION
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that
Closure Medical Corp. filed a petition proposing that the color
additive regulations be amended to provide for the safe use of D&C
Violet No. 2 to color 2-octyl cyanoacrylate topical tissue
adhesives.
DATES: Written comments on the petitioner's environmental
assessment by May 31, 1997.
ADDRESSES: Submit written comments to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr.,
rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Ellen M. Waldron, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug
Administration, 200 C St., SW., Washington, DC 20204, 202-418-3089.
DISPLAY DATE: 5/1/97 PUBLICATION DATE: 5/2/97; SEPARATE PART 9
[Docket No. 97D - 0159]
INTERNATIONAL CONFERENCE ON HARMONISATION; DRAFT GUIDELINE ON
QUALITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS: DERIVATION AND
CHARACTERIZATION OF CELL SUBSTRATES USED FOR PRODUCTION OF
BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS; AVAILABILITY
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is publishing a
draft guideline entitled ``Quality of Biotechnological/Biological
Products: Derivation and Characterization of Cell Substrates Used
for Production of Biotechnological/Biological Products.'' The
draft guideline was prepared under the auspices of the
International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH). The draft
guideline provides guidance on appropriate standards for the
derivation and characterization of cell substrates used in the
production of biotechnological/biological products, and provides
recommendations on the information in these areas that should be
presented in marketing applications.
DATES: Written comments by (insert date 45 days after date of
publication in the Federal Register).
ADDRESSES: Submit written comments on the draft guideline to the
Dockets Management Branch (HFA - 305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1 - 23, Rockville, MD
20857. Copies of the draft guideline are available from the Drug
Information Branch (HFD - 210), Center for Drug Evaluation and
Research, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301 - 827 - 4573. Single copies of the draft
guideline may be obtained by mail from the Office of Communication,
Training and Manufacturers Assistance (HFM - 40), Center for
Biologics Evaluation and Research (CBER), 1401 Rockville Pike,
Rockville, MD 20852 - 1448 or by calling the CBER Voice
Information System at 1 - 800 - 835 - 4709 or 301 - 827 - 1800.
Copies may be obtained from CBER's FAX Information System at 1 -
888 - CBER - FAX or 301 - 827 - 3844.
FOR FURTHER INFORMATION CONTACT:
Regarding the guideline: Ruth H. Wolff, Center for Biologics
Evaluation and Research (HFM - 594), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD 20852, 301 - 827 - 5103.
Regarding the ICH: Janet J. Showalter, Office of Health Affairs
(HFY - 20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301 - 827 - 0864.
Display 5/1/97; Publication 5/2/97
ACTION: Notice.
DRUG ABUSE ADVISORY COMMITTEE
DATE AND TIME: June 9 and 10, 1997, 8:30 a.m.
LOCATION: Holiday Inn-Bethesda, 8120 Wisconsin Ave., Bethesda, MD.
CONTACT: Karen M. Templeton-Somers or John Schupp, Center for Drug
Evaluation and Research (HFD-21) Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12535. Please call the Information Line
for up-to-date information on this meeting.
On June 9, 1997, the committee will discuss ways in which the
labeling for smoking cessation products could be made more
clinically useful. Public response to this topic is solicited.
_________________________________________________________________
[1][FDA HOME PAGE]
References