Advisory Committee: Bone, Reproductive and Urologic Drugs Advisory Committee, 20094-20095 [2014-08151]
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20094
Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations
Attorney General and the Chairman of
the Federal Trade Commission (FTC)
concerning the impact of the
commercial or industry standards on
competition.
The modifications to regulatory
definitions addressed by this action do
not incorporate testing methods
contained in any new commercial
standards not already referenced by the
test procedures.
IV. Approval of the Office of the
Secretary
The Secretary of Energy has approved
publication of today’s final rule.
List of Subjects in 10 CFR Part 430
Administrative practice and
procedure, Energy conservation,
Household appliances.
Issued in Washington, DC, on April 7,
2014.
David T. Danielson,
Assistant Secretary, Energy Efficiency and
Renewable Energy.
For the reasons stated in the
preamble, DOE amends part 430 of
chapter II, subchapter D, of title 10, of
the Code of Federal Regulations, as set
forth below:
PART 430—ENERGY CONSERVATION
PROGRAM FOR CONSUMER
PRODUCTS
1. The authority citation for part 430
continues to read as follows:
■
Authority: 42 U.S.C. 6291–6309; 28 U.S.C.
2461 note.
2. Section 430.2 is amended by
removing the definition of ‘‘through-thewall air conditioner and heat pump’’
and by adding, in alphabetical order,
definitions for ‘‘through-the-wall central
air conditioner’’ and ‘‘through-the-wall
central air conditioning heat pump’’ to
read as follows:
■
§ 430.2
Definitions.
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Through-the-wall central air
conditioner means a central air
conditioner that is designed to be
installed totally or partially within a
fixed-size opening in an exterior wall,
and:
(1) Is not weatherized;
(2) Is clearly and permanently marked
for installation only through an exterior
wall;
(3) Has a rated cooling capacity no
greater than 30,000 Btu/hr;
(4) Exchanges all of its outdoor air
across a single surface of the equipment
cabinet; and
(5) Has a combined outdoor air
exchange area of less than 800 square
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inches (split systems) or less than 1,210
square inches (single packaged systems)
as measured on the surface described in
paragraph (4) of this definition.
Through-the-wall central air
conditioning heat pump means a heat
pump that is designed to be installed
totally or partially within a fixed-size
opening in an exterior wall, and:
(1) Is not weatherized;
(2) Is clearly and permanently marked
for installation only through an exterior
wall;
(3) Has a rated cooling capacity no
greater than 30,000 Btu/hr;
(4) Exchanges all of its outdoor air
across a single surface of the equipment
cabinet; and
(5) Has a combined outdoor air
exchange area of less than 800 square
inches (split systems) or less than 1,210
square inches (single packaged systems)
as measured on the surface described in
paragraph (4) of this definition.
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■ 3. Section 430.32 is amended by:
■ a. Revising the introductory text to
paragraph (c);
■ b. Removing paragraph (c)(1);
■ c. Redesignating paragraphs (c)(2)
through (c)(6) as (c)(1) through (c)(5)
respectively;
■ d. Removing footnote 1 to the table in
newly redesignated paragraph (c)(1);
■ e. Removing newly redesignated
paragraphs (c)(1)(v)(A) and (v)(B);
■ f. Further redesignating newly
redesignated paragraph (c)(1)(vi) as
paragraph (c)(1)(v);
■ g. Further redesignating newly
redesignated paragraphs (c)(1)(vii)(A)
and (vii)(B) as paragraphs (c)(1)(vi)(A)
and (vi)(B) respectively;
■ h. Removing footnote 1 to the table in
newly redesignated paragraph (c)(2);
■ i. Amending newly redesignated
paragraph (c)(3) by removing the
reference to ‘‘(c)(3)’’ and adding in its
place ‘‘(c)(2)’’; and
■ j. Amending newly redesignated
paragraph (c)(4), by removing the
references to ‘‘(c)(3)’’ in both places and
adding in their places, ‘‘(c)(2)’’.
The revision reads as follows:
§ 430.32 Energy and water conservation
standards and their compliance dates.
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(c) Central air conditioners and heat
pumps. The energy conservation
standards defined in terms of the
heating seasonal performance factor are
based on Region IV, the minimum
standardized design heating
requirement, and the sampling plan
stated in § 429.16 of this chapter.
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[FR Doc. 2014–08223 Filed 4–10–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA–2014–N–0355]
Advisory Committee: Bone,
Reproductive and Urologic Drugs
Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
standing advisory committees’
regulations to change the name and
function of the Advisory Committee for
Reproductive Health Drugs. This action
is being taken to reflect changes made
to the charter for this advisory
committee.
DATES: This rule is effective April 11,
2014.
FOR FURTHER INFORMATION CONTACT:
Teresa Hays, Committee Management
Officer, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–8220.
SUPPLEMENTARY INFORMATION: FDA is
announcing that the name of the
Advisory Committee for Reproductive
Health Drugs, which was established on
March 23, 1978, has been changed. The
Agency decided that the name ‘‘Bone,
Reproductive and Urologic Drugs
Advisory Committee’’ more accurately
describes the subject areas for which the
committee is responsible. The
committee reviews and evaluates data
on the safety and effectiveness of
marketed and investigational human
drug products for use in the practice of
osteoporosis and metabolic bone
disease, obstetrics, gynecology, urology
and related specialties, and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
The Bone, Reproductive and Urologic
Drugs Advisory Committee name was
changed and its functions expanded in
the charter renewal dated March 23,
2014. In this final rule, FDA is revising
21 CFR 14.100(c)(9) to reflect these
changes.
Publication of this final rule
constitutes a final action on this change
under the Administrative Procedure
Act. Under 5 U.S.C. 553(b)(B) and (d)
and 21 CFR 10.40(d) and (e), the Agency
finds good cause to dispense with notice
and public procedure and to proceed to
an immediately effective regulation.
Such notice and procedures are
unnecessary and are not in the public
SUMMARY:
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Federal Register / Vol. 79, No. 70 / Friday, April 11, 2014 / Rules and Regulations
interest because the final rule is merely
codifying the new name and expanded
function of the advisory committee to
reflect the current committee charter.
List of Subjects in 21 CFR Part 14
Administrative practice and
procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 14 is
amended as follows:
PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE
1. The authority citation for 21 CFR
part 14 continues to read as follows:
■
Electronic Submissions
Authority: 5 U.S.C. App. 2; 15 U.S.C.
1451–1461, 21 U.S.C. 41–50, 141–149, 321–
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264, Pub. L. 107–109;
Pub. L. 108–155; Pub. L. 113–54.
2. Section 14.100 is amended by
revising the heading of paragraph (c)(9)
and paragraph (c)(9)(ii) to read as
follows:
■
§ 14.100 List of standing advisory
committees.
*
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(c) * * *
(9) Bone, Reproductive and Urologic
Drugs Advisory Committee.
(i) * * *
(ii) Function: Advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
the Food and Drug Administration has
regulatory responsibility.
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Dated: April 8, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–08151 Filed 4–10–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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21 CFR Part 73
[Docket No. FDA–2012–C–0900]
Listing of Color Additives Exempt
From Certification; Spirulina Extract
AGENCY:
ACTION:
Final rule.
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Submit electronic objections in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written objections in the
following ways:
• Mail/Hand Delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2012–C–0900 for this
rulemaking. All objections received will
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
detailed instructions on submitting
objections, see the ‘‘Objections’’ heading
of the SUPPLEMENTARY INFORMATION
section.
Docket: For access to the docket to
read background documents or
objections received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 240–402–1264.
SUPPLEMENTARY INFORMATION:
I. Introduction
Food and Drug Administration,
HHS.
The Food and Drug
Administration (FDA or we) is
amending the color additive regulations
to provide for the expanded safe use of
spirulina extract as a color additive in
food. This action is in response to a
petition filed by GNT USA, Inc.
DATES: This rule is effective May 13,
2014. See section X for further
information on the filing of objections.
Submit either electronic or written
objections and requests for a hearing by
May 12, 2014.
ADDRESSES: You may submit either
electronic or written objections and
requests for a hearing, identified by
Docket No. FDA–2012–C–0900, by any
of the following methods:
SUMMARY:
In a document published in the
Federal Register of September 6, 2012
(77 FR 54862), we announced that GNT
USA, Inc., c/o Hogan Lovells US LLP,
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20095
Columbia Square, 555 Thirteenth St.
NW., Washington, DC 20004, had filed
a color additive petition (CAP 2C0297).
The petition proposed to amend the
color additive regulations in part 73
Listing of Color Additives Exempt From
Certification (21 CFR part 73) to provide
for the safe use of spirulina concentrate,
prepared from a filtered aqueous extract
of the dried biomass of Arthrospira
platensis (A. platensis) (an edible bluegreen cyanobacterium also known as
Spirulina platensis), as a color additive
in food.
The spirulina concentrate that is
manufactured by the petitioner is a blue
colored powder or liquid produced by
extracting the water soluble components
of A. platensis, namely phycocyanins
and other proteins, polysaccharides,
lipids, and minor amounts of
components such as vitamins, minerals,
and water, followed by evaporation and
the addition of sugars and other foodgrade carriers (and water, if liquid
form). The principal coloring
components in the concentrate are the
phycocyanins (not more than 2 percent),
with lesser amounts of chlorophyll and
carotenoids.
II. Background
In the Federal Register of August 13,
2013, we issued a final rule in response
to a color additive petition (CAP
2C0293) approving the use of a filtered
aqueous extract of the dried biomass of
A. platensis as a color additive in candy
and chewing gum (78 FR 49117). We
established spirulina extract as the
common or usual name for the color
additive and listed it in § 73.530 (21
CFR 73.530). In addition to the identity
of the color additive, the regulation in
§ 73.530 includes specifications that
must be met for lead, arsenic, mercury,
and microcystin toxin; however, the
regulation does not impose a specific
upper limit for spirulina extract in food
or for the phycocyanin content of the
color additive because FDA determined
that the amount of the color additive
used in food was self-limiting. Instead,
FDA limited the use of spirulina extract
in candy and chewing gum to amounts
consistent with good manufacturing
practice.
The primary difference between the
spirulina extract that was the subject of
CAP 2C0293 and spirulina concentrate
that is the subject of CAP 2C0297 is the
concentration of the components.
Although spirulina concentrate is
produced with an evaporation step to
concentrate the components, the color
additive has a lower level of
phycocyanins (i.e., not more than 2
percent) than the spirulina extract that
was the subject of CAP 2C0293 (i.e., not
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]]>Agencies
[Federal Register Volume 79, Number 70 (Friday, April 11, 2014)]
[Rules and Regulations]
[Pages 20094-20095]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08151]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA-2014-N-0355]
Advisory Committee: Bone, Reproductive and Urologic Drugs
Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
standing advisory committees' regulations to change the name and
function of the Advisory Committee for Reproductive Health Drugs. This
action is being taken to reflect changes made to the charter for this
advisory committee.
DATES: This rule is effective April 11, 2014.
FOR FURTHER INFORMATION CONTACT: Teresa Hays, Committee Management
Officer, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993, 301-796-8220.
SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the
Advisory Committee for Reproductive Health Drugs, which was established
on March 23, 1978, has been changed. The Agency decided that the name
``Bone, Reproductive and Urologic Drugs Advisory Committee'' more
accurately describes the subject areas for which the committee is
responsible. The committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational human drug products for
use in the practice of osteoporosis and metabolic bone disease,
obstetrics, gynecology, urology and related specialties, and makes
appropriate recommendations to the Commissioner of Food and Drugs.
The Bone, Reproductive and Urologic Drugs Advisory Committee name
was changed and its functions expanded in the charter renewal dated
March 23, 2014. In this final rule, FDA is revising 21 CFR 14.100(c)(9)
to reflect these changes.
Publication of this final rule constitutes a final action on this
change under the Administrative Procedure Act. Under 5 U.S.C. 553(b)(B)
and (d) and 21 CFR 10.40(d) and (e), the Agency finds good cause to
dispense with notice and public procedure and to proceed to an
immediately effective regulation. Such notice and procedures are
unnecessary and are not in the public
[[Page 20095]]
interest because the final rule is merely codifying the new name and
expanded function of the advisory committee to reflect the current
committee charter.
List of Subjects in 21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 14 is amended as follows:
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
0
1. The authority citation for 21 CFR part 14 continues to read as
follows:
Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264, Pub. L. 107-109; Pub. L. 108-155; Pub.
L. 113-54.
0
2. Section 14.100 is amended by revising the heading of paragraph
(c)(9) and paragraph (c)(9)(ii) to read as follows:
Sec. 14.100 List of standing advisory committees.
* * * * *
(c) * * *
(9) Bone, Reproductive and Urologic Drugs Advisory Committee.
(i) * * *
(ii) Function: Advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drugs for human use and, as required, any other product for which the
Food and Drug Administration has regulatory responsibility.
* * * * *
Dated: April 8, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-08151 Filed 4-10-14; 8:45 am]
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