4164 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations
EFFECTIVE DATE: January 29, 1997.
FOR FURTHER INFORMATION CONTACT:
Dianne T. McRae, Center for Veterinary
Medicine (HFV–102), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–594–1623.
SUPPLEMENTARY INFORMATION: Solvay
Animal Health, Inc., 1201 Northland
Dr., Mendota Heights, MN 55120, is
sponsor of NADA 6–417. The
application provides for intravenous or
intramuscular use of tripelennamine
hydrochloride injection in cattle and
intramuscular use in horses for treating
conditions in which antihistaminic
therapy may be expected to lead to
alleviation of some signs of disease.
FDA is amending the regulations to
reflect additional limitations currently
in the approved drug labeling and
publishing tolerances for drug residues
in cattle tissues and in milk. The
product is for veterinary prescription
use only. The regulations are amended
in 21 CFR 522.2615(c) to reflect the
required withdrawal period and milk
discard time and in 21 CFR part 556 to
reflect the tolerance for residues in
cattle tissues and in milk.
List of Subjects
21 CFR Part 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 522 and 556 are amended as
follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
Authority: Sec. 512 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b).
2. Section 522.2615 is amended by
redesignating paragraph (c) as paragraph
(d), adding new paragraph (c), and
revising newly redesignated paragraph
(d)(3) to read as follows:
§ 522.2615 Tripelennamine hydrochloride
injection.
* * * * *
(c) Related tolerances. See § 556.741
of this chapter.
(d) * * *
(3) Limitations. Do not use in horses
intended for food purposes. Treated
cattle must not be slaughtered for food
during treatment and for 4 days
following the last treatment. Milk that
has been taken during treatment and for
24 hours (two milkings) after the last
treatment must not be used for food. A
withdrawal period has not been
established for this product in
preruminating calves. Do not use in
calves to be processed for veal. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
3. The authority citation for 21 CFR
part 556 continues to read as follows:
Authority: Secs. 402, 512, 701 of the
Federal Food, Drug, and Cosmetic Act (21
U.S.C. 342, 360b, 371).
4. New § 556.741 is added to read as
follows:
§ 556.741 Tripelennamine.
A tolerance of 200 parts per billion
(ppb) is established for residues of
tripelennamine in uncooked edible
tissues of cattle and 20 ppb in milk.
Dated: January 7, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 97–2140 Filed 1–28–97; 8:45 am]
BILLING CODE 4160–01–F
21 CFR Parts 812 and 813
[Docket No. 91N–0292]
Investigational Device Exemptions;
Intraocular Lenses
AGENCY: Food and Drug Administration,
HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is issuing a final
rule to remove the regulations on
investigational device exemptions
(IDE’s) for intraocular lenses (IOL’s). An
IOL is an implant intended to surgically
replace the natural lens of the human
eye. FDA believes it is no longer
necessary to maintain particularized
regulations on IOL investigations
because approved IOL’s are now widely
available and investigations of IOL’s can
be conducted under the investigational
device regulations applicable to medical
devices generally. This action is
intended to eliminate confusion within
the clinical research community and to
provide uniformity to investigational
device studies.
EFFECTIVE DATE: March 31, 1997.
FOR FURTHER INFORMATION CONTACT:
Joanne R. Less, Center for Devices and
Radiological Health (HFZ–403), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–594–1190.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has two regulations on
investigational use of medical devices.
Part 812 (21 CFR part 812) covers
investigational devices generally, and
part 813 (21 CFR part 813) applies only
to IOL’s. The existence of a separate
regulation for investigational use of
IOL’s is due to provisions of the Medical
Device Amendments of 1976 (1976
amendments) (Pub. L. 94–295) that
addressed IOL’s and to particular issues
surrounding IOL products at that time.
FDA has determined that maintaining
two closely related sets of
investigational device regulations is no
longer necessary. Thus, FDA has
reexamined the need to retain part 813,
and the agency has concluded that
maintaining a regulatory distinction
between IOL studies and studies of
other medical devices is no longer
justified. Therefore, in order to
eliminate confusion within the clinical
research community and to provide
uniformity to investigational device
studies, FDA is removing the IOL
regulations in their entirety and
removing § 812.2(c)(8) to exempt IOL’s
from part 812 when the IOL’s are the
subject of an approved premarket
approval application under section 515
of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360e).
In the Federal Register of October 6,
1993 (58 FR 52142), FDA published a
proposed rule to remove the regulations
on IOL’s. In that same issue, FDA also
proposed procedures for
disqualification of clinical investigators
for inclusion in the current general
investigational device regulations. FDA
provided an opportunity for interested
persons to submit comments on the
proposed removal of the IOL regulations
by December 6, 1993. Subsequently, in
the Federal Register of December 6,
1993 (58 FR 64209), FDA extended the
comment period to January 5, 1994. In
a future issue of the Federal Register,
FDA will issue final procedures for
disqualification of clinical investigators
as part of the current general
investigational device regulations in
part 812.
II. Comments
The agency received two comments in
response to the proposal of October 6,
1993, with respect to IOL’s. One of the
comments was submitted by a trade
association. The other comment was
submitted by a manufacturer. A
4165Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Rules and Regulations
summary of the comments and the
agency’s response to them is provided
below:
(1) One comment concurred with
FDA’s proposal to remove the separate
regulation on IDE’s for IOL’s contained
in part 813. However, because part 813
contains some provisions that are not
reflected in part 812, the comment
suggested that FDA identify what, if
any, additional information FDA would
require IDE submissions for IOL’s to
include.
Under the final rule, any requirements
unique to part 813 would no longer
apply. The content of IDE submissions
for IOL’s only need to include
information required in IDE
submissions for investigational devices
generally. For example, with respect to
institutional review boards (IRB’s)
(referred to in part 813 as institutional
review committees), the sponsor will
only be required to submit the
information required by § 812.20(b)(6)
and not that required by § 813.20(b)(7).
(2) Both comments recommended that
FDA provide in the final rule a
mechanism for IOL clinical
investigations that are in progress before
the final rule becomes effective to
continue under part 813 until those
investigations are completed or
terminated. One comment also noted
that, because investigators have not
signed statements agreeing to conform
to part 812, application of the
requirements of part 812 to ongoing IOL
studies would create confusion and add
to the cost of the ongoing studies.
FDA does not believe that the
continuation of part 813 requirements
for existing studies is necessary. The
differences between parts 812 and 813
are relatively minor. Investigators who
are in compliance with part 813 will
also generally be in compliance with
part 812. Sponsors may seek a waiver
under part 812, if there are any
difficulties as a result of the change
from part 813 to part 812. FDA, however
does not anticipate any difficulties.
(3) Both comments emphasized that
part 812 has certain requirements that
are not included in part 813. For
example, § 812.150(b)(4) requires the
sponsor to submit a semi-annual
investigator list to FDA; § 812.150(b)(5)
requires the sponsor to submit annual
progress reports to all reviewing IRB’s;
and § 812.150(b)(8) requires the sponsor
to submit to FDA a copy of any report
by an investigator under § 812.150(a)(5)
within 5 working days of receipt. Both
comments requested that these
additional rules not be imposed on IOL
studies conducted under part 812.
FDA does not believe that
maintaining this type of distinction is
necessary. Experience over the past 15
years has shown that the requirements
of part 812 are reasonable and that
sponsors of investigations under part
812 have not had undue difficulty
complying with these provisions. As
noted in section II (2) of this document,
part 812 contains a waiver provision
that can be utilized on a case-by-case
basis, if needed.
(4) One comment asked how IRB’s
would be notified of the new rule.
FDA will send letters to sponsors of
all active IOL IDE investigations, and
the agency will request that sponsors
inform investigators and IRB’s of the
change. Additionally, FDA will
publicize the new rule at the regional
IRB meetings and at other appropriate
forums.
III. Environmental Impact
The agency has determined under 21
CFR 25.24(a)(8) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
IV. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act (5
U.S.C. 601–612). Executive Order 12866
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The agency
believes that this final rule is consistent
with the regulatory philosophy and
principles identified in the Executive
Order. In addition, the final rule is not
a significant regulatory action as defined
by the Executive Order and so is not
subject to review under the Executive
Order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because the final rule removes
existing regulations on investigational
studies of IOL’s and requires such
investigations to be conducted under
the IDE regulations in part 812
applicable to medical devices generally,
the agency certifies that the final rule
will not impose any significant new
burdens on sponsors and investigators
of IOL’s and will not have a significant
economic impact on a substantial
number of small entities. Therefore,
under the Regulatory Flexibility Act, no
further analysis is required.
List of Subjects
21 CFR Part 812
Health records, Medical devices,
Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 813
Medical devices, Medical research,
Reporting and recordkeeping
requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, chapter I of title 21
of the Code of Federal Regulations is
amended in 21 CFR parts 812 and 813
as follows:
PART 812—INVESTIGATIONAL
DEVICE EXEMPTIONS
1. The authority citation for 21 CFR
part 812 continues to read as follows:
Authority: Secs. 301, 501, 502, 503, 505,
506, 507, 510, 513–516, 518–520, 701, 702,
704, 721, 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331, 351, 352, 353,
355, 356, 357, 360, 360c–360f, 360h–360j,
371, 372, 374, 379e, 381); secs. 215, 301, 351,
354–360F of the Public Health Service Act
(42 U.S.C. 216, 241, 262, 263b–263n).
§ 812.2 [Amended]
2. Section 812.2 Applicability is
amended by removing paragraph (c)(8).
PART 813—INVESTIGATIONAL
EXEMPTIONS FOR INTRAOCULAR
LENSES
Part 813 [Removed and Reserved]
3. Part 813, consisting of §§ 813.1
through 813.170, is removed and
reserved.
Dated: January 22, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97–2169 Filed 1–28–97; 8:45 am]
BILLING CODE 4160–01–F
DEPARTMENT OF EDUCATION
34 CFR Part 75
RIN 1880–AA61
Direct Grant Programs
AGENCY: Department of Education.
ACTION: Final regulations.
SUMMARY: The Secretary amends the
Department’s regulations on direct grant
programs to expand the basis for
selecting applications for new grants to
include a recipient’s previous