Administrative Detention; Corrections, 9412-9413 [2014-03582]
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Federal Register / Vol. 79, No. 33 / Wednesday, February 19, 2014 / Rules and Regulations
upgrade UI Benefits and Tax Systems by
SWAs using Federal funds.
(b) The standard designated in
paragraph (a) of this section is effective
March 21, 2014.
Eric M. Seleznow,
Acting Assistant Secretary, Employment and
Training Administration.
2. On page 8055, in the second
column, ‘‘FDA–1995–N–0036’’ is
corrected to read ‘‘FDA–1995–N–0063’’.
3. On page 8058, in the third column,
‘‘FDA–1995–N–0036’’ is corrected to
read ‘‘FDA–1995–N–0063’’.
[FR Doc. 2014–03496 Filed 2–18–14; 8:45 am]
Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
BILLING CODE 4510–FN–P
[FR Doc. 2014–03588 Filed 2–18–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
21 CFR Parts 106 and 107
21 CFR Part 800
[Docket No. FDA–1995–N–0063 (formerly
95N–0309)]
[Docket No. FDA–1977–N–0222]
RIN 0910–AF27
Administrative Detention; Corrections
Current Good Manufacturing Practices,
Quality Control Procedures, Quality
Factors, Notification Requirements,
and Records and Reports, for Infant
Formula; Correction
AGENCY:
AGENCY:
Food and Drug Administration,
HHS.
Interim final rule; request for
comments; correction.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
document that appeared in the Federal
Register of February 10, 2014. The
document revised our infant formula
regulations to establish requirements for
current good manufacturing practices,
including audits; to establish
requirements for quality factors; and to
amend FDA’s quality control
procedures, notification, and record and
reporting requirements for infant
formula. FDA took the action to improve
the protection of infants who consume
infant formula products. The document
was published with an incorrect docket
number. This document corrects that
error.
DATES: Effective Date: This correction is
effective February 19, 2014.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 3208,
Silver Spring, MD 20993, 301–796–
9148.
SUPPLEMENTARY INFORMATION: In FR Doc.
2014–02148, appearing on page 7934 in
the Federal Register of February 10,
2014 (79 FR 7934), the following
corrections are made:
1. On page 7934, ‘‘FDA–1995–N–
0036’’ is corrected to read ‘‘FDA–1995–
N–0063’’ each time it appears.
ehiers on DSK2VPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
14:22 Feb 18, 2014
Jkt 232001
Food and Drug Administration,
HHS.
Final rule; correcting
amendment.
ACTION:
The Food and Drug
Administration (FDA) published a
document in the Federal Register on
Friday, March 9, 1979 (44 FR 13239).
The document established
administrative detention procedures for
devices intended for human use
believed to be adulterated or
misbranded. The document was
published with a citation in the first
column on page 13240 that
subsequently was changed by the
Nutrition Labeling and Education Act
Amendments of 1993. In addition, the
document was published with one
typographical error in the first column
on page 13241. This document corrects
these errors.
DATES: This correction is effective
February 19, 2014.
FOR FURTHER INFORMATION CONTACT: Jan
B. Welch, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3412, 301–796–
5776, FAX: 301–847–8136, jan.welch@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
correcting a final rule that appeared in
the Federal Register on Friday, March 9,
1979 (44 FR 13239). The final rule
established administrative detention
procedures for devices intended for
human use believed to be adulterated or
misbranded. The document was
published with a citation to section
201(y) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(y)) (the
FD&C Act) in the first column on page
13240 (§ 800.55(g)(1) (21 CFR
SUMMARY:
PO 00000
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Fmt 4700
Sfmt 4700
800.55(g)(1)) that subsequently was
changed to section 201(x) of the FD&C
Act by section 3(b) of the Nutrition
Labeling and Education Act
Amendments of 1993 (Pub. L. 103–80).
In addition, the document was
published with one typographical error
in the first column on page 13241
(§ 800.55(k)(1)) in which the word ‘‘is’’
should have been the word ‘‘in’’. This
document updates the statutory
reference in § 800.55(g)(1) and corrects
the typographical error in § 800.55(k)(1).
Publication of this rule constitutes
final action under the Administrative
Procedure Act (5 U.S.C. 553). This
amendment to the regulations provides
only a technical change and corrects a
nonsubstantive error. FDA therefore, for
good cause, finds under 5 U.S.C.
553(b)(3)(B) that notice and public
comment are unnecessary, and under 5
U.S.C. 553(d)(3) that the rule can
become effective upon publication.
FDA has determined under 21 CFR
25.30(i) that this final rule is of a type
that, as a class, 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
§ 800.55 have been approved under
OMB control number 0910–0114, which
expires April 30, 2016.
List of Subjects in 21 CFR Part 800
Administrative practice and
procedure; Medical devices;
Ophthalmic goods and services;
Packaging and containers; 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 800 is
amended as follows:
PART 800—GENERAL
1. The authority citation for 21 CFR
Part 800 continues to read as follows:
■
Authority: 21 U.S.C. 321, 334, 351, 352,
355, 360e, 360i, 360k, 361, 362, 371.
2. In § 800.55, revise paragraph (g)(1)
and the first sentence of paragraph (k)
to read as follows:
■
§ 800.55
Administrative detention.
*
*
*
*
*
(g) Appeal of a detention order. (1) A
person who would be entitled to claim
E:\FR\FM\19FER1.SGM
19FER1
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.
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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]
[Pages 9412-9413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03582]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 800
[Docket No. FDA-1977-N-0222]
Administrative Detention; Corrections
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correcting amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) published a document in
the Federal Register on Friday, March 9, 1979 (44 FR 13239). The
document established administrative detention procedures for devices
intended for human use believed to be adulterated or misbranded. The
document was published with a citation in the first column on page
13240 that subsequently was changed by the Nutrition Labeling and
Education Act Amendments of 1993. In addition, the document was
published with one typographical error in the first column on page
13241. This document corrects these errors.
DATES: This correction is effective February 19, 2014.
FOR FURTHER INFORMATION CONTACT: Jan B. Welch, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3412, 301-796-5776, FAX: 301-847-8136,
jan.welch@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is correcting a final rule that appeared
in the Federal Register on Friday, March 9, 1979 (44 FR 13239). The
final rule established administrative detention procedures for devices
intended for human use believed to be adulterated or misbranded. The
document was published with a citation to section 201(y) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(y)) (the FD&C Act) in the
first column on page 13240 (Sec. 800.55(g)(1) (21 CFR 800.55(g)(1))
that subsequently was changed to section 201(x) of the FD&C Act by
section 3(b) of the Nutrition Labeling and Education Act Amendments of
1993 (Pub. L. 103-80). In addition, the document was published with one
typographical error in the first column on page 13241 (Sec.
800.55(k)(1)) in which the word ``is'' should have been the word
``in''. This document updates the statutory reference in Sec.
800.55(g)(1) and corrects the typographical error in Sec.
800.55(k)(1).
Publication of this rule constitutes final action under the
Administrative Procedure Act (5 U.S.C. 553). This amendment to the
regulations provides only a technical change and corrects a
nonsubstantive error. FDA therefore, for good cause, finds under 5
U.S.C. 553(b)(3)(B) that notice and public comment are unnecessary, and
under 5 U.S.C. 553(d)(3) that the rule can become effective upon
publication.
FDA has determined under 21 CFR 25.30(i) that this final rule is of
a type that, as a class, 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 Sec. 800.55 have been approved under OMB
control number 0910-0114, which expires April 30, 2016.
List of Subjects in 21 CFR Part 800
Administrative practice and procedure; Medical devices; Ophthalmic
goods and services; Packaging and containers; 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
800 is amended as follows:
PART 800--GENERAL
0
1. The authority citation for 21 CFR Part 800 continues to read as
follows:
Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k,
361, 362, 371.
0
2. In Sec. 800.55, revise paragraph (g)(1) and the first sentence of
paragraph (k) to read as follows:
Sec. 800.55 Administrative detention.
* * * * *
(g) Appeal of a detention order. (1) A person who would be entitled
to claim
[[Page 9413]]
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
