Federal. Register / Vol. 44, No.
171 / Friday, August 31, 1979 / Notices
Dated: August 23,1979.
Joseph P. Rile,
Associate CommissonerforRegulatery
Affais.
[FR Doe. 79-2=83 Filed 8-30-7 8.-45am]
BlUNG CODE 4110-3-U
Immunoglobulin Workshop; Public
Meeting
AGENCY: Food and Drug Administration.
ACTION Notice.
SUMMARY: This document'announces a
public meeting to discuss the clinical
characteristics and current and potential
uses of immunoglobulin preparations for
intramuscular (i.m.) and intravenous
(i.v.) administration. The causes and
prevention of clinical reactions to these
products will be presented.
DATE: The meeting will be held from 8:30
a.m. to 3 p.m., October 30 and 31,1979.
ADDRESS: The meeting will be held in
the Wilson Hall (Bldg. 1) auditorium,
National Institutes of Health, 9000
Rockville Pike, Bethesda, MD 20205.
FOR FURTHER INFORMATION CONTACT:
Barbara Alving, Bureau of Biologics
(HFB-250), Food and Drug
Administration, Department of Health,
Education, and Welfare, 8800 Rockville
Pike, Bethesda, MD 20205, 301-496-4833.
SUPPLEMENTARY INFORMATION:
Immunoglobulins are plasma derivatives
used for the prophylaxis or modification
of various infectious diseases and as
replacement therapy for patients with
an immune deficiency. Both public and
private organizations are engaged in
efforts to develop immunoglobulin
preparations that are safe and effective
for i.v. administration. Currently, only
preparations for i.m. administration are
generally available.
The Bureau of Biologics, Food and
Drug Administration, in conjunction
with the Division of Blood Diseases and
Resources, National Heart, Lung, and
Blood Institute, will hold a public
meeting to discuss the clinical
characteristics and current and potential
uses of i.m. and i.v. preparations. The
causes and prevention of clinical
reactions to-these products will also be
presented.
The workshop will be held from 8:30
a.m. to 3 p.m., October 30 and 31,1979,
in the Wilson Hall (Bldg. 1) auditorium,
National Institutes of Health, 9000
Rockville Pike, Bethesda, MD 20205.
Persons planning to attend are
requested to contact Barbara Alving,
Bureau of Biologics (address above), by
October 17,1979.
51335
Dated. August 23,1979.
Joseph P. Rile,
Associate CommissionerforRegulatory
Affairs.
[FR Doc . Filed o -,0me:5 am]
BlUING CODE 4110-03-4
Consumer Participation; Open Meeting
AGENCY: Food and Drug Administration.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) announces a
forthcoming consumer exchange meeting
to be chaired by George Gerstenberg,
District Director, New York District,
New York, NY.
DATE: The meeting will be held 10 a.m.
to 12 m., Wednesday, September 26,
1979.
ADDRESS: The meeting will be held at
the Syosset Public Library, the meeting
rn., 225 S. Oyster Bay Rd., Syosset. NY
11791.
FUR FURTHER INFORMATION CONTACT:
Alicia Martinez, Consumer Affairs
Officer, Food and Drug Administration,
Department of Health, Education, and
Welfare, 850 Third Ave., Brooklyn, NY
11232, 212-965-5754.
SUPPLEMENATRY INFORMATION: The
purpose of this meeting is to encourage
dialogue between consumers and FDA
officials, to identify and set priorities for
current and future health concerns, to
enhance relationships between local
consumers and FDA's New York District
Office, and to contribute to the agency's
policymaking decision on vital issues.
Datedh August 23,1979.
Joseph P. Ifle,
Associate CommissionerforRegulatory
Affairs.
tFRDoe. 7-Z-00 Filed 6-3G- V:845 am)
BILUING CODE 4110-03-M
[Docket No. 76N-0400]
Good Laboratory Practice for
Nonclinical Laboratory Studies;
Availability of the Post Conference
Report
AGENCY: Food and Drug Administration.
ACTION: Notice.
SUMMARY: The agency announces the
availability of the post conference report
prepared from the recently conducted
management briefing sessions on the
final regulations regarding good
laboratory practice in the conduct of
nonclinical laboratory studies. The
sessions were held on May 1, 2, and 3,
1979 in Washington, Chicago, and San
Francisco. The purpose of the
conferences was to provide the
regulated industry with information
required to understand and comply with
the regulations.
ADDRESSES: The report is available for
public examination in the office of the
Hearing Clerk (HFA-305), Food and
Drug Administration, Rm. 4-65,5600
Fishers Lane, Rockville, MD 20M57;
single copies are available from Linda
Grassie, Consumer Communications
Management Staff (HF-10), Food and
Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Paul D. Lepore, Bioresearch Monitoring
Staff HFC-30], Food and Drug
Administration, Department of Health.
Education, and Welfare, 5600 Fishers
Lane, Rockville, MD 2057,301-443-
2390.
SUPPLEMENTARY INFORMATION: The final
order on the goodlaboratory practice
regulations was published in the Federal
Register of December 22, 1978 (43 FR
59986) with an effective date of June 20,
1979. Because the regulations constitute
the first of aseries of regulations
concerning investigational requirements
which are being developed as a result of
the FDA Bioresearch Monitoring
Program, and the concepts are complex,
the agency elected to conduct briefing
sessions for interested persons. The
sessions were attended by some 800
persons representing product sponsors.
study contractors, universities, and
government. Approximately 300
questions were posed at the sessions
and these questions and their answers
were composited and serve as the basis
for the post conference report.
The report described in this notice is
available for public examination
between 9 a.m. and 4 p.m., Monday
through Friday, in the office of the
Hearing Clerk (HFA-3051, Food and
Drug Administration. Rm. 4-65. 5600
Fishers Lane, Rockville. MD 20857.
Requests in writing for a single copy of
the report titled "Good Laboratory
Practice Regulations Management
Briefings," Post Conference Report, -
August, 1979, may be made to Linda
Grassie, Consumer Communications
Management Staff (HFJ-10), address
above. Conference attendees will
receive a copy of the post conference
report. Thus, the agency asks that only
interested persons who did not register
at any of the conferences request a copy
of the report.
51336 Federal Register / Vol. 44, No. 171 / Friday, August 31, 1979 / Notices
Dated: August 24,1979.
Joseph P. Hile,
Associate Commissionerfor Regulatory
Affairs.
[FR Oo. 79-27008 Filed 8--30-79: 845 am]
BILLING CODE 4110-03-M
[Docket No. 79F-0247
Farbenfabriken Bayer AG; Withdrawal
of Petition for Food Additives
AGENCY: Food and Drug Administration.
ACTION: Notice.
SUMMARY: This document announces thi
withdrawal without prejudice of the
petition (FAP 2R0864) proposing the safi
use of certain optical brighteners in
food-contact paper and paperboard.
This action is taken because the
petitioner has failed to submit
additional requested information.
FOR FURTHER INFORMATION CONTACT:
Gerad L. McCowin, Bureau of Foods
(HFF-334), Food and Drug
Administration, Department of Health,
Education, and Welfare, 200 C St. SW.,
Washington, D.C. 20204, 202-472-5690.
SUPPLEMENTARY INFORMATION: Under
the Federal Food, Drug, and Cosmetic
Act (sec. 409(b), 72 Stat. 1786 (21 U.S.C.
384(b))), the following notice is issued:
A petitiop (FAP 2R0864) was filed by
Farbenfabriken Bayer
Aktiengesellschaft, Leverkusen,
Germany, notice of which was publishe(
in the Federal Register of May 13, 1967
(32 FR 7224), proposing the issuance of a
regulation to provide for the safe use of
any of the following substances as
optical brighteners in food-contact pape:r
and paperboard:
4,4'-Bis(2"-[3"'-sulfophenylamino]-4"-[NN-
dl(2."-hydroxyethyl)-amino]-l",3",5"-
triazinyI-6"-amino)-stilbene-2,2'-disulfonic
acid, tetrasodium salt.
4,4'-Bis(2"-[N,N-di(2'-
hydroxyethyl)amino]-4"-amino-l",3",5"-
triazinyl-6"-amino)-stilbene-2,2'-disulfonic
acid, disodium salt.
4,4'-Bis[2"-(4"'-sulfophenylamino)-4"-(N,V-
di(2""-hydroxyethyl-amino)-1",3",5"-
triazinyl-6"-amino]-stilbene-2,2'-disulfonic
acid, tetrasodium salt.
4,4'-Bis[2"-(NAN-di(2"'-hydroxyethyl)-.
amino)-4"-phenylamino-l",3",5"-triazinyl-6"-
amino]-stilbene-2,2'-disulfonic acid,
tetrasodium salt.
Subsequently, the Food and Drug
Administration requested the petitioner
to submit additional information as
provided for in § 171.10) (21 CFR
171.1(j)) of the procedural food additive
regulations. The requested information
has not been received; therefore, this
petition in regarded as having been
withdrawn without prejudice to a future
filing.
Dated: August 21,1979
Sanford A. Miller,
Director,Bureauof Foods.
(FR Doc. 79-27196 Filed 8-30-79; 8:45 am]
BILLING CODE 4110-03-M
(Docket No. 79M-0203]
Paris Contact Lens Laboratory;
Premarket Approval of Softsite Tx
(Hefilcon A) Hydrophilic Contact Lens
PHP
-AGENCY: Food and Drug Administration.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) announces
approval of the application for
premarket approval under the Medical
Device Amendments of 1976 of the
Softsite Tm (hefilcon A) Hydrophilic
Contact Lens PHP sponsored by Paris
Contact Lens Laboratory, Coral Gables,
FL. After reviewing the Ophthalmology
Device Classification Panel's
recommendation, FDA notified the
sponsor that the application was
approved because the device had been
shown to be safe and effective for use as
recommended in the submitted labeling.
DATE: Petitions for administrative
review by October 1, 1979.
ADDRESS: Requests for copies of the
summary of safety and effectiveness
data and petitions for administrative
review may be sent to the Hearing Clerk
-(HFA305), Food and Drug
Administration, Rm. 4-65, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Keith Lusted, Bureau of Medical Devices
(HFK-402), Food and Drug
Administration, Department of Health,
Education, and Welfare, 8757 Georgia
Ave., Silver Spring, MD 20910, 301-427-
7550.-
SUPPLEMENTARY INFORMATION: The
sponsor, Paris Contact Lens Laboratory,
Coral Gables, FL 33146, submitted a new
drug application for the Softsite Tb
(hefilcon A) Hydrophilic Contact Lens to
FDA on October 17, 1975. Ile
application was reviewed by the
Ophthalmology Device Classification
Panel, an FDA advisory committee,
which recommended approval of the
application. On April 23, 1979, FDA
approved the application by a letter to
the sponsor from the Director of the
Bureau of Medical Devices.
Before enactment of the Medical
Device Amendments of 1975 (Pub. L. 94-
295, 90 Stat. 539-583) (the amendments),
soft contact lenses and solutions were
regulated as new drugs. Because the
amendments broadened the definition of
the term "device" in section 201(h) of the
III1|
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(h)) (the act), soft contact
lenses and solutions are now regulated
as class III devices (premarket
approval). As FDA explained in a notice
published in the Federal Register of
December 16, 1977 (42 FR 63472), the
amendments provide transitional
provisions to ensure continuation of
premarket approval requirements for
class III devices formerly considered
new drugs. Furthermore, FDA requires,
as a condition to approval, that sponsors
of applications for premarket approval
of soft contact lenses or solutions
comply with the records and reports
provisions of 21 CFR Part 310, Subpart
D, until these provisions are replaced by
similar requirements under the
amendments.
A summary of the information upon
which the agency's approval is based is
available upon request from the Hearing
Clerk (address above). Requests should
be identified with the name of the
device and the Hearing Clerk docket
number found in brackets in the heading
of this document.
The labeling of the Softsite z'
(hefilcon A) lens, like that of other
approved soft contact lenses, states that
the lens is to be used only with certain
solutions for disinfection and other
purposes. The restrictive labeling helps
to inform new lens users that they must
avoid purchasing inappropriate
products, e.g., solutions for use with
hard contact lenses. However, the
restrictive labeling needs to be updated
periodically to refer to new solutions
that FDA approved for use with an
approved lens. A sponsor who does not
update the restrictive labeling may
violate the misbranding provisions of
section 502 of the act (21 U.S.C. 352) as
well as the Federal Trade Commission
Act (15 U.S.C. 41-58), as amended by the
Magnuson Moss Warranty-Fe4eral
'Trade Commission Improvement Act
(Pub. L. 93-637). Furthermore, failure to
update the restrictive labeling to refer to
new solutions that may be used with an
approved lens may be grounds for
withdrawing approval of the application
for the lens, under section 515(e)(1)(F) of
the act (21 U.S.C. 360e(e)(1)(F)).
AccordinglY,, whenever FDA publishes a
notice in the Federal Register of the
agency's approval of a new solution for
use with an approved lens, the sponsor
of the lens shall correct its labeling to
refer to the new solution at the next
printing or at any other time FDA
prescribes by letter to the sponsor.
Opportunity for Administrative Review
Section 515(d)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360e(d)(3)), authorizes any interested
+(,121/,1(
Citation:
44 Fed. Reg. 51335 (1979), Friday, August 31, 1979,
pages 51177 - 51548

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