The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft Guidance for Industry; Availability, 45465-45466 [2015-18655]
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Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Proposed Rules
FIGURE 1 TO PARAGRAPHS (h) AND (j)
OF THIS AD—PART NUMBERS AND
SERIAL NUMBERS OF AFFECTED
FORWARD ENGINE MOUNTS AND ATTACHMENT PINS—Continued
FIGURE 2 TO PARAGRAPH (i) OF THIS
AD—AIRPLANE MANUFACTURER SERIAL NUMBERS—Continued
Airplane manufacturer serial Nos.
4753
4754
4755
4757
4761
4762
4772
4773
4774
4775
4779
4782
4783
4784
4786
4788
4790
4791
4798
4804
4813
Serial No.
Attachment Pin
(P/N 740–2022–501)
Forward Engine
Mount
(P/N 745–2010–503)
1467SC
1445SC
1462SC
1464SC
1466SC
1470SC
1459SC
1463SC
1475SC
1458SC
1477SC
1474SC
1478SC
1479SC
1472SC
13813001
13755001
13789001
13793001
13811001
13819001
13783001
13791001
13829001
13781001
13833001
13827001
13835001
13837001
13823001
(i) Exception to Paragraph (g) of This AD
For airplanes with manufacturer serial
numbers identified in figure 2 to paragraph
(i) of this AD: If it can be conclusively
determined that an engine has not been
replaced after March 1, 2011 (the date of
manufacture of the first airplane with
affected engine mounts), the airplane is not
affected by the requirements of paragraphs (g)
and (h) of this AD.
FIGURE 2 TO PARAGRAPH (i) OF THIS
AD—AIRPLANE MANUFACTURER SERIAL NUMBERS
Lhorne on DSK7TPTVN1PROD with PROPOSALS
Airplane manufacturer serial Nos.
4593
4602
4620
4637
4638
4642
4643
4644
4660
4677
4690
4696
4700
4701
4703
4706
4707
4710
4716
4719
4725
4726
4731
4736
4737
4741
4746
4751
4752
VerDate Sep<11>2014
13:52 Jul 29, 2015
Jkt 235001
(k) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Branch, ANM–116, Transport Airplane
Directorate, FAA, has the authority to
approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
In accordance with 14 CFR 39.19, send your
request to your principal inspector or local
Flight Standards District Office, as
appropriate. If sending information directly
to the International Branch, send it to ATTN:
Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM–116, Transport
Airplane Directorate, FAA, 1601 Lind
Avenue SW., Renton, WA 98057–3356;
telephone 425–227–1405; fax 425–227–1149.
Information may be emailed to: 9-ANM-116AMOC-REQUESTS@faa.gov. Before using
any approved AMOC, notify your appropriate
principal inspector, or lacking a principal
inspector, the manager of the local flight
standards district office/certificate holding
district office. The AMOC approval letter
must specifically reference this AD.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective
actions from a manufacturer, the action must
be accomplished using a method approved
by the Manager, International Branch, ANM–
116, Transport Airplane Directorate, FAA; or
the EASA; or Airbus’s EASA DOA. If
approved by the DOA, the approval must
include the DOA-authorized signature.
(3) Required for Compliance (RC): If any
service information contains procedures or
tests that are identified as RC, those
Frm 00017
Fmt 4702
Sfmt 4702
procedures and tests must be done to comply
with this AD; any procedures or tests that are
not identified as RC are recommended. Those
procedures and tests that are not identified
as RC may be deviated from using accepted
methods in accordance with the operator’s
maintenance or inspection program without
obtaining approval of an AMOC, provided
the procedures and tests identified as RC can
be done and the airplane can be put back in
a serviceable condition. Any substitutions or
changes to procedures or tests identified as
RC require approval of an AMOC.
(l) Special Flight Permits Prohibited
Special flight permits, as described in
Section 21.197 and Section 21.199 of the
Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.
(j) Parts Installation Prohibition
As of the effective date of this AD, no
person may install on any airplane any
engine mount attachment pin having P/N
740–2022–501 with a serial number
identified in figure 1 to paragraphs (h) and
(j) of this AD.
PO 00000
45465
(m) Related Information
(1) Refer to Mandatory Continuing
Airworthiness Information (MCAI) EASA
Airworthiness Directive 2015–0004, dated
January 13, 2015, for related information.
This MCAI may be found in the AD docket
on the Internet at https://www.regulations.gov
by searching for and locating Docket No.
FAA–2015–2963.
(2) For Airbus service information
identified in this AD, contact Airbus,
Airworthiness Office—EIAS, 1 Rond Point
Maurice Bellonte, 31707 Blagnac Cedex,
France; telephone +33 5 61 93 36 96; fax +33
5 61 93 44 51; email account.airworth-eas@
airbus.com; Internet https://www.airbus.com.
For Goodrich Aerostructures service
information identified in this AD, contact
UTC Aerospace Systems, ATTN: Christopher
Newth—V2500 A1/A5 Project Engineer,
Aftermarket—Aerostructures; 850 Lagoon
Drive, Chula Vista, CA; telephone 619–498–
7505; email christopher.newth@utas.utc.com.
You may view this service information at the
FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. For
information on the availability of this
material at the FAA, call 425–227–1221.
Issued in Renton, Washington, on July 17,
2015.
Michael Kaszycki,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2015–18533 Filed 7–29–15; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA–2015–D–1839]
The Food and Drug Administration’s
Policy on Declaring Small Amounts of
Nutrients and Dietary Ingredients on
Nutrition Labels; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\30JYP1.SGM
30JYP1
45466
ACTION:
Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Proposed Rules
Notification of availability.
The Food and Drug
Administration (FDA, we, or the
Agency) is announcing the availability
of a draft guidance for industry entitled
‘‘FDA’s Policy on Declaring Small
Amounts of Nutrients and Dietary
Ingredients on Nutrition Labels:
Guidance for Industry.’’ The draft
guidance, when finalized, will explain
to manufacturers of conventional foods
and dietary supplements our policy on
determining the amount to declare on
the nutrition label for certain nutrients
and dietary ingredients that are present
in a small amount.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on the draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 28,
2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Nutrition, Labeling, and
Dietary Supplements, Center for Food
Safety and Applied Nutrition (HFS–
820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740. Send two self-addressed
adhesive labels to assist the office in
processing your request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments on the draft guidance to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Carole Adler, Center for Food Safety and
Applied Nutrition (HFS–820), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2371.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Lhorne on DSK7TPTVN1PROD with PROPOSALS
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘FDA’s Policy on Declaring Small
Amounts of Nutrients and Dietary
Ingredients on Nutrition Labels:
Guidance for Industry.’’ We are issuing
the draft guidance consistent with our
good guidance practices regulation (21
CFR 10.115). The draft guidance
represents the current thinking of FDA
on our policy on declaring small
amounts of nutrients and dietary
ingredients on nutrition labels. It does
VerDate Sep<11>2014
13:52 Jul 29, 2015
Jkt 235001
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
The draft guidance, when finalized,
will explain our nutrition labeling
policy on declaring the nutrient values
in conventional foods and dietary
ingredient values in dietary
supplements in certain cases.
Specifically, declaring small amounts of
nutrients and dietary ingredients in the
nutrition labeling may result in a
conflict between 21 CFR 101.9(c)(1)
through (8) and 21 CFR 101.9(g)(4)(ii)
and 21 CFR 101.9(g)(5). In such cases,
we are recommending manufacturers
declare nutrients and dietary
ingredients in accordance with
§ 101.9(c)(1) through (8). If the draft
guidance is finalized, we intend to
consider the use of our enforcement
discretion with respect to the
compliance requirements in
§ 101.9(g)(4)(ii)) and § 101.9(g)(5) when
a conflict exists with § 101.9(c)(1)
through (8).
We also are considering whether
changes to our nutrition labeling
regulations are needed, including
changes to § 101.9(c) or (g), or both. If
we determine that rulemaking is
needed, we will consider whether to
revise or withdraw the draft guidance.
II. Paperwork Reduction Act of 1995
The draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information 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 § 101.9 have been
approved under OMB control number
0910–0381.
III. Comments
Interested persons may submit either
electronic comments regarding the draft
guidance to https://www.regulations.gov
or written comments regarding the draft
guidance to the Division of Dockets
Management (see ADDRESSES). It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance document
PO 00000
Frm 00018
Fmt 4702
Sfmt 4702
at https://www.fda.gov/FoodGuidances
or https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
Dated: July 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18655 Filed 7–29–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG–138526–14]
RIN 1545–BM46
Issue Price Definition for Tax-Exempt
Bonds; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Partial withdrawal of notice of
proposed rulemaking, notice of
proposed rulemaking, and notice of
public hearing; correction.
AGENCY:
This document contains
corrections to partial withdrawal of
notice of proposed rulemaking, notice of
proposed rulemaking, and notice of
public hearing; correction (REG–
138526–14) that were published in the
Federal Register on Wednesday, June
24, 2015 (80 FR 36301). The partial
withdrawal of notice of proposed
rulemaking, notice of proposed
rulemaking, and notice of public
hearing are relating to the definition of
issue price for purposes of the arbitrage
restrictions under section 148 of the
Internal Revenue Code (Code).
DATES: Written or electronic comments
and requests for a public hearing for the
notice of proposed rulemaking
published at 80 FR 36301, June 24,
2015, are still being accepted and must
be received by September 22, 2015.
FOR FURTHER INFORMATION CONTACT:
Lewis Bell at (202) 317–6980 (not a tollfree number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
The notice of proposed rulemaking
that is the subject of this correction is
under section 148 of the Internal
Revenue Code.
Need for Correction
As published in the Wednesday, June
24, 2015 (80 FR 36301) partial
withdrawal of notice of proposed
rulemaking, notice of proposed
E:\FR\FM\30JYP1.SGM
30JYP1
]]>Agencies
[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Proposed Rules]
[Pages 45465-45466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18655]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2015-D-1839]
The Food and Drug Administration's Policy on Declaring Small
Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 45466]]
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
announcing the availability of a draft guidance for industry entitled
``FDA's Policy on Declaring Small Amounts of Nutrients and Dietary
Ingredients on Nutrition Labels: Guidance for Industry.'' The draft
guidance, when finalized, will explain to manufacturers of conventional
foods and dietary supplements our policy on determining the amount to
declare on the nutrition label for certain nutrients and dietary
ingredients that are present in a small amount.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on the
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 28, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Nutrition, Labeling, and Dietary Supplements,
Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist the office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Carole Adler, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance for industry
entitled ``FDA's Policy on Declaring Small Amounts of Nutrients and
Dietary Ingredients on Nutrition Labels: Guidance for Industry.'' We
are issuing the draft guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The draft guidance represents the
current thinking of FDA on our policy on declaring small amounts of
nutrients and dietary ingredients on nutrition labels. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
The draft guidance, when finalized, will explain our nutrition
labeling policy on declaring the nutrient values in conventional foods
and dietary ingredient values in dietary supplements in certain cases.
Specifically, declaring small amounts of nutrients and dietary
ingredients in the nutrition labeling may result in a conflict between
21 CFR 101.9(c)(1) through (8) and 21 CFR 101.9(g)(4)(ii) and 21 CFR
101.9(g)(5). In such cases, we are recommending manufacturers declare
nutrients and dietary ingredients in accordance with Sec. 101.9(c)(1)
through (8). If the draft guidance is finalized, we intend to consider
the use of our enforcement discretion with respect to the compliance
requirements in Sec. 101.9(g)(4)(ii)) and Sec. 101.9(g)(5) when a
conflict exists with Sec. 101.9(c)(1) through (8).
We also are considering whether changes to our nutrition labeling
regulations are needed, including changes to Sec. 101.9(c) or (g), or
both. If we determine that rulemaking is needed, we will consider
whether to revise or withdraw the draft guidance.
II. Paperwork Reduction Act of 1995
The draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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. 101.9 have been approved under OMB
control number 0910-0381.
III. Comments
Interested persons may submit either electronic comments regarding
the draft guidance to https://www.regulations.gov or written comments
regarding the draft guidance to the Division of Dockets Management (see
ADDRESSES). It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
document at https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.
Dated: July 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18655 Filed 7-29-15; 8:45 am]
BILLING CODE 4164-01-P
