Medical Devices; Reports of Corrections and Removals; Technical Amendment, 9413 [2014-03581]
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Federal Register / Vol. 79, No. 33 / Wednesday, February 19, 2014 / Rules and Regulations
the devices, if seized, may appeal a
detention order. Any appeal shall be
submitted in writing to the FDA District
Director in whose district the devices
are located within 5 working days of
receipt of a detention order. If the
appeal includes a request for an
informal hearing, as defined in section
201(x) of the act, the appellant shall
request either that a hearing be held
within 5 working days after the appeal
is filed or that the hearing be held at a
later date, which shall not be later than
20 calendar days after receipt of a
detention order.
*
*
*
*
*
(k) Recordkeeping requirements. (1)
After issuance of a detention order
under paragraph (d) of this section, the
owner, operator, or agent in charge of
any factory, warehouse, other
establishment, or consulting laboratory
where detained devices are
manufactured, processed, packed, or
held shall have, or establish, and
maintain adequate records relating to
how the detained devices may have
become adulterated or misbranded,
records on any distribution of the
devices before and after the detention
period, records on the correlation of any
in-process detained devices that are put
in final form under paragraph (h) of this
section to the completed devices,
records of any changes in, or processing
of, the devices permitted under the
detention order, and records of any
other movement under paragraph (h) of
this section. * * *
*
*
*
*
*
Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03582 Filed 2–18–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 806
[Docket No. FDA–2014–N–0011]
Medical Devices; Reports of
Corrections and Removals; Technical
Amendment
AGENCY:
Food and Drug Administration,
ehiers on DSK2VPTVN1PROD with RULES
HHS.
devices to address a minor change as a
result of the enactment of the Food and
Drug Administration Amendments Act
of 2007 (FDAAA). This action is
technical in nature and is intended to
provide accuracy to the Agency’s
regulation.
This rule is effective February
19, 2014.
DATES:
Jkt 232001
§ 806.1
[Amended]
2. Amend § 806.1(a) by removing
‘‘section 519(f)’’ and adding in its place
‘‘section 519(g)’’.
Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03581 Filed 2–18–14; 8:45 am]
BILLING CODE 4160–01–P
Section
806.1(a) (21 CFR 806.1(a)) refers to a
subsection of the Federal Food, Drug,
and Cosmetic Act that was redesignated
as a result of FDAAA (Pub. L. 110–85).
FDA is amending § 806.1(a) to update
the obsolete reference.
FDA is publishing the document as a
final rule under the Administrative
Procedures Act (5 U.S.C. 551, et seq.).
FDA has determined that good cause
exists to dispense with prior notice and
public comment under 5 U.S.C.
553(b)(3)(B) and 21 CFR 10.40(e)(1)
since such notice and comment are
unnecessary because this amendment to
the regulation provides only a technical
change to update an obsolete citation. In
addition, FDA finds good cause to
provide for this regulation to be
effective immediately upon publication
under 5 U.S.C. 553(d)(3).
FDA has determined under 21 CFR
25.30(i) that this final rule 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.
This final rule contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 806 have been approved
under OMB control number 0910–0359,
which expires May 31, 2014.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 806
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 806 is
amended as follows:
14:22 Feb 18, 2014
Authority: 21 U.S.C. 352, 360, 360i, 360j,
371, 374.
Deborah Yoder, Office of Compliance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 2676, Silver Spring, MD 20993–
0002, 301–796–6109, Deborah.Yoder@
fda.hhs.gov.
The Food and Drug
Administration (FDA) is amending its
regulation regarding reports of
corrections to and removals of medical
VerDate Mar<15>2010
1. The authority citation for 21 CFR
part 806 continues to read as follows:
■
FOR FURTHER INFORMATION CONTACT:
Imports, Medical devices, Reporting
and recordkeeping requirements.
SUMMARY:
PART 806—MEDICAL DEVICES;
REPORTS OF CORRECTIONS AND
REMOVALS
■
ACTION:
Final rule; technical
amendment.
9413
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
NATIONAL FOUNDATION ON THE
ARTS AND THE HUMANITIES
National Endowment for the
Humanities
45 CFR Part 1171
RIN 3136–AA32
Public Access to NEH Records Under
the Freedom of Information Act
National Endowment for the
Humanities.
ACTION: Final rule.
AGENCY:
The National Endowment for
the Humanities (NEH) is unilaterally
rescinding its joint Freedom of
Information Act (FOIA) regulations with
the National Endowment for the Arts
(NEA) and the Institute of Museum and
Library Services (IMLS), and issuing its
own FOIA regulations. This final rule
provides the NEH’s procedures for
disclosure of its records, as required by
the FOIA, 5 U.S.C. 552, as amended.
These regulations also provide the
procedures for disclosing records of the
Federal Council on the Arts and the
Humanities (FCAH), an agency for
which NEH provides legal counsel.
DATES: The final rule will be effective
March 21, 2014.
FOR FURTHER INFORMATION CONTACT:
Mara Campbell, Office of the General
Counsel, National Endowment for the
Humanities, at 202–606–8322, or
mcampbell@neh.gov.
SUPPLEMENTARY INFORMATION: The NEH
along with the NEA, the IMLS, and the
FCAH make up the National Foundation
on the Arts and Humanities
(Foundation). The Foundation was
established by the National Foundation
on the Arts and Humanities Act of 1965,
20 U.S.C. 951 et seq. The NEH along
SUMMARY:
E:\FR\FM\19FER1.SGM
19FER1
]]>Agencies
[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Rules and Regulations]
[Page 9413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03581]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 806
[Docket No. FDA-2014-N-0011]
Medical Devices; Reports of Corrections and Removals; Technical
Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulation regarding reports of corrections to and removals of medical
devices to address a minor change as a result of the enactment of the
Food and Drug Administration Amendments Act of 2007 (FDAAA). This
action is technical in nature and is intended to provide accuracy to
the Agency's regulation.
DATES: This rule is effective February 19, 2014.
FOR FURTHER INFORMATION CONTACT: Deborah Yoder, Office of Compliance,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2676, Silver
Spring, MD 20993-0002, 301-796-6109, Deborah.Yoder@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section 806.1(a) (21 CFR 806.1(a)) refers to
a subsection of the Federal Food, Drug, and Cosmetic Act that was
redesignated as a result of FDAAA (Pub. L. 110-85). FDA is amending
Sec. 806.1(a) to update the obsolete reference.
FDA is publishing the document as a final rule under the
Administrative Procedures Act (5 U.S.C. 551, et seq.). FDA has
determined that good cause exists to dispense with prior notice and
public comment under 5 U.S.C. 553(b)(3)(B) and 21 CFR 10.40(e)(1) since
such notice and comment are unnecessary because this amendment to the
regulation provides only a technical change to update an obsolete
citation. In addition, FDA finds good cause to provide for this
regulation to be effective immediately upon publication under 5 U.S.C.
553(d)(3).
FDA has determined under 21 CFR 25.30(i) that this final rule 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.
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 806 have been approved under
OMB control number 0910-0359, which expires May 31, 2014.
List of Subjects in 21 CFR Part 806
Imports, Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
806 is amended as follows:
PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
0
1. The authority citation for 21 CFR part 806 continues to read as
follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Sec. 806.1 [Amended]
0
2. Amend Sec. 806.1(a) by removing ``section 519(f)'' and adding in
its place ``section 519(g)''.
Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03581 Filed 2-18-14; 8:45 am]
BILLING CODE 4160-01-P
