Medical Device Regulations; Disqualification of a Clinical Investigator; Technical Amendment, 76902 [E6-21952]
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76902
Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations
(2) No. 058005 for use of 5 mg/mL
solution in swine as in paragraph (d)(4)
of this section.
(3) No. 000010 for use of 50 mg/mL
solution in dogs as in paragraph (d)(5)
of this section.
(4) No. 059130 for use of 100 mg/mL
solution in turkeys as in paragraph
(d)(2) and in chickens as in paragraph
(d)(3) of this section.
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Dated: December 13, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–21951 Filed 12–21–06; 8:45 am]
BILLING CODE 4160–01–S
List of Subjects in 21 CFR Part 812
Health records, Medical devices,
Medical research, Reporting and
recordkeeping requirements.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act, and Public
Health Service Act, and under authority
delegated to the Commissioner of Food
and Drugs, 21 CFR part 812 is amended
as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 812
[Docket No. 2006N–0494]
Medical Device Regulations;
Disqualification of a Clinical
Investigator; Technical Amendment
AGENCY:
has regulatory responsibility for the
medical device subject to this regulation
is responsible for corresponding with
the investigator of the study concerning
any possible violations of the applicable
requirements. Therefore, FDA is
updating this regulation to include the
references to CBER and CDER.
Publication of this document
constitutes final action under the
Administrative Procedure Act (5 U.S.C.
553). FDA has determined that notice
and public comment are unnecessary
because this amendment to the
regulations provides only a technical
change to update references in the Code
of Federal Regulations, and is
nonsubstantive.
Food and Drug Administration,
HHS.
PART 812—INVESTIGATIONAL
DEVICE EXEMPTIONS
Final rule; technical
amendment.
I
SUMMARY: The Food and Drug
Administration (FDA) is amending a
medical device regulation to include
references to the Center for Biologics
Evaluation and Research (CBER) and the
Center for Drug Evaluation and Research
(CDER). This regulation pertains to the
disqualification of a clinical
investigator. Currently, only a reference
to the Center for Devices and
Radiological Health is listed in this
regulation. This action is being taken to
ensure the accuracy of FDA’s
regulations.
DATES: This rule is effective December
22, 2006.
FOR FURTHER INFORMATION CONTACT:
Stephen M. Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
jlentini on PROD1PC65 with RULES
ACTION:
Authority: 21 U.S.C. 331, 351, 352, 353,
355, 360, 360c–360f, 360h–360j, 371, 372,
374, 379e, 381, 382, 383; 42 U.S.C. 216, 241,
262, 263b–263n.
1. The authority citation for 21 CFR
part 812 continues to read as follows:
I. Background
FDA is amending 21 CFR 812.119(a)
to include references to CBER and
CDER. This regulation pertains to the
disqualification of a clinical
investigator. Currently, only a reference
to the Center for Devices and
Radiological Health is listed in this
regulation. The appropriate Center that
VerDate Aug<31>2005
17:32 Dec 21, 2006
Jkt 211001
2. Section 812.119 is amended by
revising paragraph (a) to read as follows:
I
§ 812.119 Disqualification of a clinical
investigator.
(a) If FDA has information indicating
that an investigator has repeatedly or
deliberately failed to comply with the
requirements of this part, part 50, or
part 56 of this chapter, or has repeatedly
or deliberately submitted false
information either to the sponsor of the
investigation or in any required report,
the Center for Devices and Radiological
Health, the Center for Biologics
Evaluation and Research, or the Center
for Drug Evaluation and Research will
furnish the investigator written notice of
the matter under complaint and offer
the investigator an opportunity to
explain the matter in writing, or, at the
option of the investigator, in an informal
conference. If an explanation is offered
and accepted by the applicable Center,
the disqualification process will be
terminated. If an explanation is offered
but not accepted by the Center, the
investigator will be given an
opportunity for a regulatory hearing
under part 16 of this chapter on the
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
question of whether the investigator is
entitled to receive investigational
devices.
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Dated: December 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–21952 Filed 12–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9278]
RIN 1545–BB31, 1545–AY38, 1545–BC52
Treatment of Services Under Section
482; Allocation of Income and
Deductions From Intangibles;
Stewardship Expense; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendments.
AGENCY:
SUMMARY: This document contains
corrections to final and temporary
regulations (TD 9278) that was
published in the Federal Register on
Friday, August 4, 2006 (71 FR 44466)
regarding the treatment of controlled
services transactions under section 482
and the allocation of income from
intangibles, in particular with respect to
contributions by a controlled party to
the value of an intangible owned by
another controlled party. This document
also contains corrections to final and
temporary regulations that modify the
regulations under section 861
concerning stewardship expenses to be
consistent with the changes made to the
regulations under section 482.
DATES: Effective Date: The amendments
are effective on January 1, 2007.
FOR FURTHER INFORMATION CONTACT:
Thomas A. Vidano, (202) 435–5265, or
Carol B. Tan (202) 435–5159, for matters
relating to section 482, and David F.
Bergkuist, (202) 622–3850, for matters
relating to stewardship expenses (not
toll-free numbers).
SUPPLEMENTARY INFORMATION:
Background
The final and temporary regulations
that are the subject of these corrections
are under sections 482 and 861 of the
Internal Revenue Code.
Need for Correction
As published, the final and temporary
regulations (TD 9278) contains errors
that may prove to be misleading and are
in need of clarification.
E:\FR\FM\22DER1.SGM
22DER1
]]>Agencies
[Federal Register Volume 71, Number 246 (Friday, December 22, 2006)]
[Rules and Regulations]
[Page 76902]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21952]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 812
[Docket No. 2006N-0494]
Medical Device Regulations; Disqualification of a Clinical
Investigator; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending a medical
device regulation to include references to the Center for Biologics
Evaluation and Research (CBER) and the Center for Drug Evaluation and
Research (CDER). This regulation pertains to the disqualification of a
clinical investigator. Currently, only a reference to the Center for
Devices and Radiological Health is listed in this regulation. This
action is being taken to ensure the accuracy of FDA's regulations.
DATES: This rule is effective December 22, 2006.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is amending 21 CFR 812.119(a) to include references to CBER and
CDER. This regulation pertains to the disqualification of a clinical
investigator. Currently, only a reference to the Center for Devices and
Radiological Health is listed in this regulation. The appropriate
Center that has regulatory responsibility for the medical device
subject to this regulation is responsible for corresponding with the
investigator of the study concerning any possible violations of the
applicable requirements. Therefore, FDA is updating this regulation to
include the references to CBER and CDER.
Publication of this document constitutes final action under the
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that
notice and public comment are unnecessary because this amendment to the
regulations provides only a technical change to update references in
the Code of Federal Regulations, and is nonsubstantive.
List of Subjects in 21 CFR Part 812
Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and Public
Health Service Act, and under authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 812 is amended as follows:
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
0
1. The authority citation for 21 CFR part 812 continues to read as
follows:
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241,
262, 263b-263n.
0
2. Section 812.119 is amended by revising paragraph (a) to read as
follows:
Sec. 812.119 Disqualification of a clinical investigator.
(a) If FDA has information indicating that an investigator has
repeatedly or deliberately failed to comply with the requirements of
this part, part 50, or part 56 of this chapter, or has repeatedly or
deliberately submitted false information either to the sponsor of the
investigation or in any required report, the Center for Devices and
Radiological Health, the Center for Biologics Evaluation and Research,
or the Center for Drug Evaluation and Research will furnish the
investigator written notice of the matter under complaint and offer the
investigator an opportunity to explain the matter in writing, or, at
the option of the investigator, in an informal conference. If an
explanation is offered and accepted by the applicable Center, the
disqualification process will be terminated. If an explanation is
offered but not accepted by the Center, the investigator will be given
an opportunity for a regulatory hearing under part 16 of this chapter
on the question of whether the investigator is entitled to receive
investigational devices.
* * * * *
Dated: December 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21952 Filed 12-21-06; 8:45 am]
BILLING CODE 4160-01-S
