[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Proposed Rules]
[Pages 57364-57366]
[FR Doc No: 2018-24854]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0643; Product Identifier 2018-NM-084-AD]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (SNPRM); reopening
of comment period.

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SUMMARY: We are revising an earlier proposal for certain Dassault
Aviation Model FALCON 7X airplanes. This action revises the notice of
proposed rulemaking (NPRM) by proposing to require the incorporation of
revised and more restrictive airworthiness limitations. We are
proposing this airworthiness directive (AD) to address the unsafe
condition on these products. Since these actions would impose an
additional burden over those in the NPRM, we are reopening the comment
period to allow the public the chance to comment on these changes.

DATES: The comment period for the NPRM published in the Federal
Register on August 10, 2018 (83 FR 39630), is reopened.
    We must receive comments on this SNPRM by December 31, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Dassault
Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South
Hackensack, NJ 07606; telephone<PHONE_NUMBER>; internet http://www.dassaultfalcon.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0643; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this SNPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0643;
Product Identifier 2018-NM-084-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this SNPRM. We will consider all
comments received by the closing date and may amend this SNPRM based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this SNPRM.

Discussion

    We issued an NPRM to amend 14 CFR part 39 by adding an AD that
would apply to certain Dassault Aviation Model FALCON 7X airplanes. The
NPRM published in the Federal Register on August 10, 2018 (83 FR
39630). The NPRM was prompted by a determination that more restrictive
maintenance requirements and airworthiness limitations are necessary.
The NPRM proposed to require revising the existing maintenance or
inspection program, as applicable, to incorporate new and more
restrictive maintenance requirements and airworthiness limitations for
airplane structures and systems.

Actions Since the NPRM Was Issued

    Since we issued the NPRM, additional airworthiness limitations have
been issued, and we have determined that it is necessary to revise the
existing maintenance or inspection program to incorporate the new and
more restrictive requirements in the revised service information. We
have changed paragraph (g) of this proposed AD to require revising the
existing maintenance or inspection program to incorporate the
information specified in Chapter 5-40-00, Airworthiness Limitations,
DGT 107838, Revision 7, dated August 24, 2018, of the Dassault Falcon
7X Maintenance Manual (MM).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2018-0101, dated May 3, 2018 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Dassault Aviation Model FALCON 7X
airplanes. The MCAI states:

    The airworthiness limitations and certification maintenance
instructions for Dassault Falcon 7X aeroplanes, which are approved
by EASA, are currently defined and published in Dassault Falcon 7X
AMM [airplane maintenance manual], Chapter 5-40. These instructions
have been identified as mandatory for continued airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition [i.e., reduced structural integrity and reduced
control of these airplanes due to the failure of system components].
    Previously, EASA issued AD 2015-0095 [which corresponds to FAA
AD 2016-16-09, Amendment 39-18607 (81 FR 52752, August 10, 2016)
(``AD 2016-16-09'')] to require accomplishment of the maintenance
tasks, and implementation of the airworthiness limitations, as
specified in Dassault Falcon 7X AMM, Chapter 5-40, at Revision 4.
    Since that [EASA] AD was issued, Dassault issued the ALS
[airworthiness limitations section], which introduces new and more
restrictive maintenance requirements and/or airworthiness
limitations.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2015-0095, which is superseded, and requires
accomplishment of the actions specified in the ALS.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0643.

Related Service Information Under 1 CFR Part 51

    Dassault Aviation has issued Chapter 5-40-00, Airworthiness
Limitations, DGT 107838, Revision 7, dated August 24, 2018, of the
Dassault Falcon 7X MM. This service information introduces new and more
restrictive maintenance requirements and airworthiness limitations for
airplane structures and systems. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

Comments

    We gave the public the opportunity to participate in developing
this proposed AD. We received no comments on the NPRM or on the
determination of the cost to the public.

FAA's Determination and Requirements of This SNPRM

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    Certain changes described above expand the scope of the NPRM. As a
result, we have determined that it is necessary to reopen the comment
period to provide additional opportunity for the public to comment on
this SNPRM.

Costs of Compliance

    We estimate that this proposed AD affects 67 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:
    We have determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although we recognize that this number may vary from operator to
operator. In the past, we have estimated that this action takes 1 work-
hour per airplane. Since operators incorporate maintenance or
inspection program changes for their affected fleet(s), we have
determined that a per-operator estimate is more accurate than a per-
airplane estimate. Therefore, we estimate the total cost per operator
to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes and associated appliances to the
Director of the System Oversight Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;

    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Dassault Aviation: Docket No. FAA-2018-0643; Product Identifier
2018-NM-084-AD.

(a) Comments Due Date

    We must receive comments by December 31, 2018.

(b) Affected ADs

    This AD affects AD 2014-16-23, Amendment 39-17947 (79 FR 52545,
September 4, 2014) (``AD 2014-16-23'') and AD 2016-16-09, Amendment
39-18607 (81 FR 52752, August 10, 2016) (``AD 2016-16-09'').

(c) Applicability

    This AD applies to Dassault Aviation Model FALCON 7X airplanes,
certificated in any category, with an original certificate of
airworthiness or original export certificate of airworthiness issued
on or before August 24, 2018.

    Note 1 to paragraph (c) of this AD: Dassault Aviation Model
FALCON 7X airplanes with modifications M1000 and M1254 incorporated
are commonly referred to as ``Model FALCON 8X'' airplanes as a
marketing designation.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time limits/
maintenance checks.

(e) Reason

    This AD was prompted by a determination that more restrictive
maintenance requirements and airworthiness limitations are
necessary. We are issuing this AD to address reduced structural
integrity and reduced control of airplanes due to the failure of
system components.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Maintenance or Inspection Program Revision

    Within 90 days after the effective date of this AD, revise the
existing maintenance or inspection program, as applicable, by
incorporating the information specified in Chapter 5-40-00,
Airworthiness Limitations, DGT 107838, Revision 7, dated August 24,
2018, of the Dassault Falcon 7X Maintenance Manual (MM). The initial
compliance times for the tasks specified in Chapter 5-40-00,
Airworthiness Limitations, DGT 107838, Revision 7, dated August 24,
2018, of the Dassault Falcon 7X MM are at the applicable compliance
times specified in Chapter 5-40-00, Airworthiness Limitations, DGT
107838, Revision 7, dated August 24, 2018, of the Dassault Falcon 7X
MM, or within 90 days after the effective date of this AD, whichever
occurs later.

(h) Terminating Action for Other ADs

    (1) Accomplishing the actions required by paragraph (g) of this
AD terminates the requirements of paragraph (q) of AD 2014-16-23.
    (2) Accomplishing the actions required by paragraph (g) of this
AD terminates all requirements of AD 2016-16-09.

(i) No Alternative Actions, Intervals, and Critical Design
Configuration Control Limitations (CDCCLs)

    After the existing maintenance or inspection program, as
applicable, has been revised as required by paragraph (g) of this
AD, no alternative actions (e.g., inspections), intervals, or CDCCLs
may be used unless the actions, intervals, and CDCCLs are approved
as an alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (j)(1) of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, 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 Section, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to: [email protected]. 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.
    (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
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Dassault Aviation's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2018-0101, dated May 3, 2018, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0643.
    (2) For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; phone and
fax:<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000,
South Hackensack, NJ 07606; phone:<PHONE_NUMBER>; internet: http://www.dassaultfalcon.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on November 6, 2018.
Chris Spangenberg,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-24854 Filed 11-14-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27504-27508]
[FR Doc No: 2017-12443]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1155]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling
Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by July
17, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0381.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Food Labeling Regulations--21 CFR Parts 101, 102, 104, and 105

OMB Control Number 0910-0381--Extension

    Our food labeling regulations require food producers to disclose to
consumers and others specific information about themselves or their
products on the label or labeling of their products. Related
regulations require that food producers retain records establishing the
basis for the information contained in the label or labeling of their
products and provide those records to regulatory officials. Finally,
certain regulations provide for the submission of food labeling
petitions to us. We issued our food labeling regulations under parts
101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) under the
authority of sections 4, 5, and 6 of the Fair Packaging and Labeling
Act (the FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301,
402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350,
371, and 379e). Most of these regulations derive from section 403 of
the FD&C Act, which provides that a food product shall be deemed to be
misbranded if, among other things, its label or labeling fails to bear
certain required information concerning the food product, is false or
misleading in any particular, or bears certain types of unauthorized
claims. The disclosure requirements and other collections of
information in the regulations in parts 101, 102, 104, and 105 are
necessary to ensure that food products produced or sold in the United
States are in compliance with the labeling provisions of the FD&C Act
and the FPLA.
    Section 101.3 of our food labeling regulations requires that the
label of a food product in packaged form bear a statement of identity
(i.e., the name of the product), including, as appropriate, the form of
the food or the name of the food imitated. Section 101.4 prescribes
requirements for the declaration of ingredients on the label or
labeling of food products in packaged form. Section 101.5 requires that
the label of a food product in packaged form specify the name and place
of business of the manufacturer, packer, or distributor and, if the
food producer is not the manufacturer of the food product, its
connection with the food product. Section 101.7 specifies requirements
for the declaration of the net quantity of contents on the label of a
food in packaged form and prescribes conditions under which a food
whose label does not accurately reflect the actual quantity of contents
may be sold, with appropriate disclosures, to an institution operated
by a Federal, State, or local government. Section 101.108 provides for
the submission to us of a written proposal requesting a temporary
exemption from certain requirements of Sec. Sec.  101.9 and 105.66 for
the purpose of conducting food labeling experiments with our
authorization. Section 101.9 requires that nutrition information be
provided for all food products intended for human consumption and
offered for sale, unless an exemption in Sec.  101.9(j) applies to the
product. In particular, Sec.  101.9(c)(2)(ii) requires that the amount
of trans fatty acids present in a food must be declared on the
nutrition label on a separate line immediately under the line for the
declaration of saturated fat. Section 101.9(g)(9) provides that
interested parties may submit to us requests for alternative approaches
to nutrition labeling requirements. Finally, Sec.  101.9(j)(18)
provides that firms claiming the small business exemption from
nutrition labeling must submit notice to us supporting their claim
exemption. We developed Form FDA 3570 to assist small businesses in
claiming the small business exemption from nutrition labeling. The form
contains all the elements required by Sec.  101.9(j)(18).
    Section 101.10 requires that restaurants provide nutrition
information, upon request, for any food or meal for which a nutrient
content claim or health claim is made. Section 101.12(b) provides the
reference amount that is used for determining the serving sizes for
specific products, including baking powder, baking soda, and pectin.
Section 101.12(e) provides that a manufacturer that adjusts the
reference amount customarily consumed (RACC) of an aerated food for the
difference in density of the aerated food relative to the density of
the appropriate nonaerated reference food must be prepared to show us
detailed protocols and records of all data that were used to determine
the density-adjusted RACC. Section 101.12(g) requires that the label or
labeling of a food product disclose the serving size that is the basis
for a claim made for the product if the serving size on which the claim
is based differs from the RACC. Section 101.12(h) provides for the
submission of petitions requesting that we change the reference amounts
defined by regulation.
    Section 101.13 requires that nutrition information be provided in
accordance with Sec.  101.9 for any food product for which a nutrient
content claim is made. Under some circumstances, Sec.  101.13 also
requires the disclosure of other types of information as a condition
for the use of a nutrient content claim. For example, under Sec.
101.13(j), if the claim compares the level of a nutrient in the food
with the level of the same nutrient in another ``reference'' food, the
claim must also disclose the identity of the reference food, the amount
of the nutrient in each food, and the percentage or fractional amount
by which the amount of the nutrient in the labeled food differs from
the amount of the nutrient in the reference food. It also requires that
when this comparison is based on an average of food products, this
information must be provided to consumers or regulatory officials upon
request. Section 101.13(q)(5) requires that restaurants document and
provide to appropriate regulatory officials, upon request, the basis
for any nutrient content claims they have made for the foods they sell.
    Section 101.14(d)(2) and (3) provides for the disclosure of
nutrition information in accordance with Sec.  101.9 and, under some
circumstances, certain other information as a condition for making a
health claim for a food product. Section 101.15 provides that, if the
label of a food product contains any representation in a foreign
language, all words, statements, and other information required by or
under authority of the FD&C Act to appear on the label must appear in
both the foreign language and in English. Section 101.22 contains
labeling requirements for the disclosure of spices, flavorings,
colorings, and chemical preservatives in food products. Section
101.22(i)(4) sets forth disclosure and recordkeeping requirements
pertaining to certifications for flavors designated as containing no
artificial flavors. Section 101.30 specifies the conditions under which
a beverage that purports to contain any fruit or vegetable juice must
declare the percentage of juice present in the beverage and the manner
in which the declaration is to be made.
    Section 101.36 requires that nutrition information be provided for
dietary supplements offered for sale, unless an exemption in Sec.
101.36(h) applies. In particular, Sec.  101.36(b)(2) requires that the
amount of trans fatty acids present in dietary supplements must be
declared on the nutrition label on a separate line immediately under
the line for the declaration of saturated fat. Section 101.36(e)
permits the voluntary declaration of the quantitative amount and the
percent of Daily Value of a dietary ingredient on a ``per day'' basis
in addition to the required ``per serving'' basis, if a dietary
supplement label recommends that the dietary supplement be consumed
more than once per day. Section 101.36(f)(2) cross-

references the provisions in Sec.  101.9(g)(9) for the submission to us
of requests for alternative approaches to nutrition labeling
requirements. Also, Sec.  101.36(h)(2) cross-references the provisions
in Sec.  101.9(j)(18) for the submission of small business exemption
notices. As noted previously, we developed Form FDA 3570 to assist
small businesses in claiming the small business exemption from
nutrition labeling. The form contains all the elements required by
Sec.  101.36(h)(2).
    Section 101.42 requests that food retailers voluntarily provide
nutrition information for raw fruits, vegetables, and fish at the point
of purchase, and Sec.  101.45 contains guidelines for providing such
information. Also, Sec.  101.45(c) provides for the submission to us of
nutrient databases and proposed nutrition labeling values for raw
fruit, vegetables, and fish for review and approval.
    Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify
information that must be disclosed as a condition for making particular
nutrient content claims. Section 101.67 provides for the use of
nutrient content claims for butter, and cross-references requirements
in other regulations for information declaration (Sec.  101.4) and
disclosure of information concerning performance characteristics (Sec.
101.13(d)). Section 101.69 provides for the submission of a petition
requesting that we authorize a particular nutrient content claim by
regulation. Section 101.70 provides for the submission of a petition
requesting that we authorize a particular health claim by regulation.
Section 101.77(c)(2)(ii)(D) requires the disclosure of soluble fiber
per serving in the nutrition labeling of a food bearing a health claim
about the relationship between soluble fiber and a reduced risk of
coronary heart disease. Section 101.79(c)(2)(iv) requires the
disclosure of the amount of folate in the nutrition label of a food
bearing a health claim about the relationship between folate and a
reduced risk of neural tube defects.
    Section 101.100(d) provides that any agreement that forms the basis
for an exemption from the labeling requirements of section 403(c), (e),
(g), (h), (i), (k), and (q) of the FD&C Act be in writing and that a
copy of the agreement be made available to us upon request. Section
101.100 also contains reporting and disclosure requirements as
conditions for claiming certain labeling exemptions (e.g., 101.100(h)).
    Regulations in part 102 define the information that must be
included as part of the statement of identity for particular foods and
prescribe related labeling requirements for some of these foods. For
example, Sec.  102.22 requires that the name of a protein hydrolysate
will include the identity of the food source from which the protein was
derived.
    Part 104, which pertains to nutritional quality guidelines for
foods, cross references several labeling provisions in part 101 but
contains no separate information collection requirements.
    Part 105 contains special labeling requirements for hypoallergenic
foods, infant foods, and certain foods represented as useful in
reducing or maintaining body weight.
    The purpose of our food labeling requirements is to allow consumers
to be knowledgeable about the foods they purchase. Nutrition labeling
provides information for use by consumers in selecting a nutritious
diet. Other information enables a consumer to comparison shop.
Ingredient information also enables consumers to avoid substances to
which they may be sensitive. Petitions or other requests submitted to
us provide the basis for us to permit new labeling statements or to
grant exemptions from certain labeling requirements. Recordkeeping
requirements enable us to monitor the basis upon which certain label
statements are made for food products and whether those statements are
in compliance with the requirements of the FD&C Act or the FPLA.
    Description of Respondents: Respondents to this information
collection are manufacturers, packers, and distributors of food
products. Because of the existence of exemptions and exceptions, not
all of the requirements apply to all food producers or to all of their
products. Some of the regulations affect food retailers, such as
supermarkets and restaurants.
    In the Federal Register of December 30, 2016 (81 FR 96462), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. In this notice, FDA did not accurately
reflect amendments approved in the final rule, technical amendments for
21 CFR parts 1, 100, 101, and 104, ``Food Labeling; Technical
Amendments,'' dated August 29, 2016 (81 FR 59129), which changed
section 101.105 to section 101.7. This has been corrected in this
notice. In addition, FDA received two comments from the 60-day notice.
One comment was not related to the PRA and will not be addressed here,
and one comment was PRA-related and is addressed in this document.
    (Comment) One commenter stated that ensuring that food is labeled
accurately and correctly is important because people should know
exactly what is inside of different foods. Labeling food accurately and
correctly ensures no information about the food is hidden because some
people have allergies, and people should be allowed to provide
feedback.
    (Response) FDA agrees with this comment, and this collection of
information reinforces that food should be labeled accurately, with no
hidden ingredients, for the public's health and safety. In addition,
the renewal of this collection of information provides the public the
opportunity to comment and provide feedback on this collection.
    FDA estimates the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
                                                    Number of      disclosures    Total annual
              21 CFR section/part                  respondents         per         disclosures        Average burden per disclosure         Total hours
                                                                   respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.3, 101.22, 102, and 104; statement of                25,000            1.03          25,750  .5 (30 minutes)........................          12,875
 identity labeling requirements.
101.4, 101.22, 101.100, 102, 104 and 105;                25,000            1.03          25,750  1......................................          25,750
 ingredient labeling requirements.
101.5; requirement to specify the name and               25,000            1.03          25,750  .25 (15 minutes).......................           6,438
 place of business of the manufacturer, packer,
 or distributor and, if the food producer is
 not the manufacturer of the food product, its
 connection with the food product.
101.9, 101.13(n), 101.14(d)(3), 101.62, and              25,000            1.03          25,750  .40 (24 minutes).......................         103,000
 104; labeling requirements for disclosure of
 nutrition information.
101.9(g)(9) and 101.36(f)(2); alternative means              12               1              12  4......................................              48
 of compliance permitted.
101.10; requirements for nutrition labeling of          300,000             1.5         450,000  .25 (15 minutes).......................         112,500
 restaurant foods.
101.12(b); RACC for baking powder, baking soda               29             2.3              67  1......................................              67
 and pectin.

101.12(e); adjustment to the RACC of an aerated              25               1              25  1......................................              25
 food permitted.
101.12(g); requirement to disclose the serving            5,000               1           5,000  1......................................           5,000
 size that is the basis for a claim made for
 the product if the serving size on which the
 claim is based differs from the RACC.
101.13(d)(1) and 101.67; requirements to                    200               1             200  1......................................             200
 disclose nutrition information for any food
 product for which a nutrient content claim is
 made.
101.13(j)(2), 101.13(k), 101.54, 101.56,                  5,000               1           5,000  1......................................           5,000
 101.60, 101.61, and 101.62; additional
 disclosure required if the nutrient content
 claim compares the level of a nutrient in one
 food with the level of the same nutrient in
 another food.
101.13(q)(5); requirement that restaurants              300,000             1.5         450,000  .75 (45 minutes).......................         337,500
 disclose the basis for nutrient content claims
 made for their food.
101.14(d)(2); general requirements for                  300,000             1.5         450,000  .75 (45 minutes).......................         337,500
 disclosure of nutrition information related to
 health claims for food products.
101.15; requirements pertaining to prominence               160              10           1,600  8......................................          12,800
 of required statements and use of foreign
 language.
101.22(i)(4); supplier certifications for                    25               1              25  1......................................              25
 flavors designated as containing no artificial
 flavors.
101.30 and 102.33; labeling requirements for              1,500               5           7,500  1......................................           7,500
 fruit or vegetable juice beverages.
101.36; nutrition labeling of dietary                       300              40          12,000  4.025..................................          48,300
 supplements.
101.42 and 101.45; nutrition labeling of raw              1,000               1           1,000  .5 (30 minutes)........................             500
 fruits, vegetables, and fish.
101.45(c); databases of nutrient values for raw               5               4              20  4......................................              80
 fruits, vegetables, and fish.
101.79(c)(2)(i)(D); disclosure requirements for           1,000               1           1,000  .25 (15 minutes).......................             250
 food labels that contain a folate/neural tube
 defect health claim.
101.79(c)(2)(iv); disclosure of amount of                   100               1             100  .25 (15 minutes).......................              25
 folate for food labels that contain a folate/
 neural tube defect health claim.
101.100(d); disclosure of agreements that form            1,000               1           1,000  1......................................           1,000
 the basis for exemption from the labeling
 requirements of section 403(c), (e), (g), (h),
 (i), (k), and (q) of the FD&C Act.
101.7 and 101.100(h); disclosure requirements            25,000            1.03          25,750  .5 (30 minutes)........................          12,875
 for food not accurately labeled for quantity
 of contents and for claiming certain labeling
 exemptions.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................       1,029,258
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
                 21 CFR section                     Number of      records per    Total annual       Average burden per recordkeeping       Total hours
                                                  recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.7(t); recordkeeping pertaining to                       100               1             100  1......................................             100
 disclosure requirements for food not
 accurately labeled for quantity of contents.
101.12(e); recordkeeping to document the basis               25               1              25  1......................................              25
 for density-adjusted RACC.
101.13(q)(5); recordkeeping to document the             300,000             1.5         450,000  .75 (45 minutes).......................         337,500
 basis for nutrient content claims.
101.14(d)(2); recordkeeping to document                 300,000             1.5         450,000  .75 (45 minutes).......................         337,500
 nutrition information related to health claims
 for food products.
101.22(i)(4); recordkeeping to document                      25               1              25  1......................................              25
 supplier certifications for flavors designated
 as containing no artificial flavors.
101.100(d)(2); recordkeeping pertaining to                1,000               1           1,000  1......................................           1,000
 agreements that form the basis for an
 exemption from the labeling requirements of
 section 403(c), (e), (g), (h), (i), (k), and
 (q) of the FD&C Act.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................         676,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     21 CFR section/form No.         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
101.9(j)(18) and 101.36(h)(2);            10,000               1          10,000               8          80,000
 procedure for small business
 nutrition labeling exemption
 notice using Form FDA 3570.....
101.12(h); petitions to                        5               1               5              80             400
 establish or amend a RACC......
101.69; petitions for nutrient                 3               1               3              25              75
 content claims.................
101.70; petitions for health                   5               1               5              80             400
 claims.........................
101.108; written proposal for                  1               1               1              40              40
 requesting temporary exemptions
 from certain regulations for
 the purpose of conducting food
 labeling experiments...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          80,915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated annual third party disclosure, recordkeeping, and
reporting burdens are based on our communications with industry and our
knowledge of and experience with food labeling and the submission of
petitions and requests to us.
    We expect that the burden hours for submissions under Sec.  101.108
will be insignificant. Section 101.108 was originally issued to provide
a procedure whereby we could grant exemptions from certain food
labeling requirements. Exemption petitions have infrequently been
submitted in the recent past; none have been submitted since
publication on January 6, 1993, of the final regulations implementing
section 403(q) and (r) of the FD&C Act. Thus, in order to maintain OMB
approval of Sec.  101.108 to accommodate the possibility that a food
producer may propose to conduct a labeling experiment on its own
initiative, we estimate that we will receive one or fewer submissions
under Sec.  101.108 in the next 3 years.

    Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12443 Filed 6-14-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 226 (Wednesday, November 23, 2011)]
[Notices]
[Page 72493]
[FR Doc No: 2011-30216]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

ITS Joint Program Office Webinar on Alternative Organizational
Structures for a Certificate Management Entity; Notice of Public
Meeting

AGENCY: Research and Innovative Technology Administration, U.S.
Department of Transportation.

ACTION: Notice.

-----------------------------------------------------------------------

    The U.S. Department of Transportation (USDOT) Intelligent
Transportation System Joint Program Office (ITS JPO) will host a free
public webinar on December 9, 2011 from 1:00-3 p.m. (EST) to seek input
on a set of high-level, alternative organizational structures for a
certificate management entity (CME) to support a trusted and secure
connected vehicle environment.
    Persons planning to attend the webinar should register by December
5, 2011 using the following link: http://www.itsa.org/policywebinarregistration. For additional questions, please contact
Adam Hopps at<PHONE_NUMBER>.
    The ITS JPO will present results from an early analysis of
organizational models. This analysis will describe the functions that
need to be performed by a CME; identify key constraints as well as
institutional and policy requirements; model how those functions may be
organized; and present a high level assessment of these organizational
models against a set of evaluation criteria. Draft documentation of the
analysis will be posted for comment at the following location on or
before December 9, 2011 at: http://www.its.dot.gov. Stakeholders are
asked to submit comments to<EMAIL_ADDRESS>by 8 p.m. (EST) on December
14, 2011. Written comments may be submitted to: ITS JPO, 1200 New
Jersey Ave., SE (E33-316) Washington, DC 20590. This is not an official
docket. Stakeholders will have additional opportunities to provide
input in to this project at later stages, including via a public
meeting planned for March 2012.

Background

    Through 2014, the primary focus of the ITS JPO is a research
initiative focused on developing rapid and secure wireless
communications and trusted data exchanges among vehicles, roadside
infrastructure, and passengers' personal communications devices. This
innovative use of wireless communications provides the foundation for a
connected environment for transportation that is intended to enable a
multitude of applications to enhance surface transportation safety,
mobility, and environmental performance.
    In the end state, users need to have assurance that the system
offers trusted and secure communications. That is the fundamental
purpose of the Certificate Management System (or CME): To ensure that
participants and their vehicles receive digital certificates that allow
them to be trusted actors within the system and to access meaningful
and trusted data that is generated by others. If trust in the
communications breaks down, then trust in the overall connected
environment erodes and users become reluctant to use it or rely on it.
Trust can be violated in several ways:
     Security of communications: If communications are not
considered secure, users will be less likely to trust the data that is
generated by or accessible through the system.
     Private data is compromised: If technical and policy
solutions are not in place to protect private data or users perceive
that their private data could be made available to unauthorized third
parties without their awareness and consent, they will not participate.
     Corrupt or inaccurate data: If the data can be altered or
corrupted through malicious misbehavior by hackers, it may cause more
safety problems than fixes.
    The current study aims to analyze alternative operational models
that describe potential organizational designs, institutional
capabilities, and policies of a Certificate Management System. It also
assesses the needs for operation, maintenance, and system enhancements
over time. (This study is an institutional analysis only, not a
technical analysis, and it is not intended to develop a system design.)

    Issued in Washington, DC, on the 16th day of November 2011.
John Augustine,
Managing Director, ITS Joint Program Office.
[FR Doc. 2011-30216 Filed 11-22-11; 8:45 am]
BILLING CODE 4910-HY-P


e Average number of affected sources over next three years.  This does not include sources subject to both Subpart RRR and the HON, which are assumed to be complying with the HON.

TABLE G-8:  ANNUAL BURDEN OF REPORTING AND RECORDKEEPING REQUIREMENTS FOR SUBPART BB

(A)

Hr/ Occurrence

(B)

Occurrences/

Respondent/yr

(C)a

Respondent/

yr

(D)

Technical

hr/yr

(E=D*.05)

Managerial

 hr/yr

(F=D*.10)

Clerical

hr/yr

(G) Cost/yrb

1. Applications

Application for approval of Construction/

Modification

N/A

2. Surveys and Studies

N/A

3. Reporting Requirements

A. Read Instruction

1

1

0

0

0

0

$0

B. Required Activities

Initial emission test

20

0

0

0

0

0

$0

Monitoring performance test

280

1

0

0

0

0

$0

Vapor-tightness test tank truck and railcars

11

1

3c

33

2

3

$2,814

Marine vessels

80

1

66c

5,280

264

528

$444,880

Closed vent leak inspection

8

1

54c

432

22

43

$36,442

C. Create Information

Included in 3B

D. Gather Existing Information

Included in 3E

E. Write Report

Notification of anticipated startup

2

0

0

0

0

0

$0

Notification of actual startup

2

0

0

0

0

0

$0

Notification of emission test

2

0

0

0

0

0

$0

Report of emission test

8

0

0

0

0

0

$0

Notification of performance test ADVANCE \d2

2

0

0

0

0

0

$0

Report of performance test

8

0

0

0

0

0

$0

Report facilities below cut-offd

8

0

0

0

0

0

$0

Quarterly parameter excesses

4 ADVANCE \d2

4

54

864

43

86

$72,759

Total Annual Responses

(Block 13b)

216

SUBTOTAL

4. Recordkeeping

Requirements

A. Read Instructions

Included in 3A

B. Plan Activities

Included in 4C

C. Implement Activities

Included in 3B

D. Develop Record

System

N/A

E. Time to Enter

Information

  i. Facilities above cut-off

1.5 ADVANCE \d2

52

54

4,212

211

421

$354,936

  ii. Facilities below cut-offd

0.5

52

0

0

0

0

$0

F. Train Personnel

N/A

G. Audits

N/A

TOTAL ANNUAL HOURS

10,821

542

1,081

TOTAL ANNUAL BURDEN

12,444

$911,831

a Expect that there will be no new sources covered by these standards over the next three years.

b United States Department of Labor, Bureau of Labor Statistics, May 2006 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 325000 Chemical Manufacturing.  The wages are for Environmental Engineers, General and Operations Managers, and Office and Administrative Support Occupations.  The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.  Technical - $74.36/hr; Managerial - $125.87/hr; Clerical - $36.04/hr.

c Estimate that there are 54 facilities subject to this standard.  Estimate there are 3 tank truck and railcars and 131 marine vessels subject  to the standards.  All other transfer racks subject to Subpart BB are assumed to be complying with the HON.  Assume 50 percent of the marine vessels (66) operate at negative pressure and do not conduct annual vapor-tightness tests.

d For sources below the low quantity applicability for control requirements, a report is only required the first year of operation.  It is assumed that this report has been submitted.

TABLE G-9:  ANNUAL BURDEN OF REPORTING AND RECORDKEEPING REQUIREMENTS FOR SUBPART Y

(A)

Hr/ Occurrence

(B)

Occurrences/

Respondent/yr

(C)a

Respondent/

yr

(D)

Technical

hr/yr

(E=D*.05)

Managerial

 hr/yr

(F=D*.10)

Clerical

hr/yr

(G)

Cost/ yrb

1. Applications

Application for approval of Construction/Modification

N/A

2. Surveys and Studies

N/A

3. Reporting Requirements

A. Read Instructions

Included in 3C

B. Required Activities

Initial performance test

N/A

C. Create Information

Annual IFR Internal

Inspections and EFR

Seal Gap measurements (existing sources)

8

1

4

32

2

3

$2,739

D. Gather Existing Information

Included in 3C

E. Write Report

New Sources

  Notification of Construction/Reconstruction

Included in NSPS Kb

Notification of anticipated startup

Included in NSPS Kb

Notification of actual startup

Included in NSPS Kb

Notification of emission test

N/A

Report of emission test

N/A

Notification of Control

installation and refill at

1st IFR Degassingc

2

1

0

0

0

0

$0

Existing Sources

Annual Inspection Reports

2

2

4

16

1

2

$1,388

Supplemental Delay Reportd

2

1

0

0

0

0

$0

Quarterly Emission Report

None Expectede

Total Annual Responses (Block 13b)

8

4. Recordkeeping

Requirements

A. Read Instructions

Included in 3A

B. Plan Activities

Included in 4C

C. Implement Activities -

Filing and Maintaining Records

	2

1

4

8

0

1

$631

D. Develop Record System

Included in 4C

  E. Time to Enter Information

Included in 4C

F. Train Personnel

N/A

G. Audits

N/A

TOTAL ANNUAL HOURS

56

3

6

TOTAL ANNUAL BURDEN

65

$4,758

a Estimate that there will be 4 existing sources not covered by the HON.  All new source burden is included in the NSPS Subpart Kb regulation for storage vessels at 40 CFR Part 60

b United States Department of Labor, Bureau of Labor Statistics, May 2006 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 325000 Chemical Manufacturing.  The wages are for Environmental Engineers, General and Operations Managers, and Office and Administrative Support Occupations.  The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.  Technical - $74.36/hr; Managerial - $125.87/hr; Clerical - $36.04/hr.

c It is believed that all vessels have been degassed and all controls have been installed as they were to be installed within 10 years of promulgation.

d Estimate that two percent of existing sources will request delay of repair in the annual report.

e Assume that no sources will select the fixed roof vented to a control device option and, thus, have no quarterly reports of excess emissions.

TABLE G-10:  ANNUAL BURDEN OF REPORTING AND RECORDKEEPING REQUIREMENTS FOR SUBPART V

Activity

(A)

Hr/

Occurrence

(B)

Occurrences/

respondent/

yr

(C) ADVANCE \u2

Respondents/ yr

(D)

Technical

hr/yr

(E=D*.05)

Managerial

 hr/yr

(F=D*.10)

Clerical

hr/yr

(G)a

Cost/yr

1.	Applications

N/A

2.	Survey and Studies ADVANCE \d2

N/A

3.	Reporting Requirements

A. Read Instructions ADVANCE \d2

1

1

2b

2

0

0

$149

B. Required Activities

Initial Performance Test

20

1

2

40

2

4

$3,370

Reference Method 21/22 Tests

4

1

2

8

0

1

$631

Repeat Performance Test

20

0.2

2

8

0

1

$631

C. Create Information

See 3B

D. Gather Existing Information

See 3B

E. Write Report

Notification of Construction/ Reconstruction

2

1

2

4

0

0

$297

Notification of Anticipated Startup

2

1

2

4

0

0

$297

  Notification of Actual Startup

2

1

2

4

0

0

$297

  Notification of Initial Performance Test

2

1

2

4

0

0

$297

Report of Performance Test

See 3B

$0

Application for Alternative

10

1

0.5

5

0

1

$408

Initial Report

8

1

2

16

1

2

$1,388

  Semiannual Report

30

2

55c

3,300

165

330

$278,050

Total Annual Responses (Block 13b)

123

4.	Recordkeeping Requirements

A. Read Instructions

See 3A

B. Plan Activities

See 4C

C. Implement Activities

See 3B

D. Develop Record System

N/A

E. Time to Enter Information

Records of startups, shutdown, malfunction, etc.

1.5

1

2

3

0

0

$223

Records of operating, parameters and emissions

0.1

365d

55c

2,008

100

201

$169,109

Records of leak detected

0.4

52

55

1,144

57

114

$96,351

F. Train personnel

N/A

G. Audits

N/A

TOTAL ANNUAL HOURS

6,550

325

654

TOTAL ANNUAL BURDEN

7,529

$551,498

a United States Department of Labor, Bureau of Labor Statistics, May 2006 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 325000 Chemical Manufacturing.  The wages are for Environmental Engineers, General and Operations Managers, and Office and Administrative Support Occupations.  The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.  Technical - $74.36/hr; Managerial - $125.87/hr; Clerical - $36.04/hr.

b Assume one new facility per year comprising two new sources.

c Estimate 21 existing facilities comprising 55 sources.

TABLE G-11:  NEW SOURCE ANNUAL RESPONDENT BURDEN AND COST OF REPORTING AND

RECORDKEEPING REQUIREMENTS OF THE HON

Burden Item

Average Hours per Activity

(a)

Number of Activities per year per respondent

(b)

Technical Hours per year per respondent

(c)

Estimated. Number New respondents

(d)

Estimated Technical Hours per year

(e)

Estimated Managerial Hours per year

(f)

Estimated Clerical Hours per year

(g)

Annual Cost per year

(h)

1) Read Rule and Instructions

2.7

93

250

5

1,250

63

125

$105,385

2) Plan Activities

3.8

93

355

5

1,775

89

178

$149,607

3) Training

3.5

38

132

5

660

33

66

$55,610

4) Create, Test, Research and Development

2.4

1,778

4,266

5

21,330

1,067

2,133

$1,797,275

5) Gather Information, 	Monitor/Inspect

1.4

2,102

2,943

5

14,715

736

1,472

$1,239,899

6) Process/Compile and Review

0.8

50

40

5

200

10

20

$16,852

7) Complete Reports

11.4

49

557

5

2,785

139

279

$234,644

Total Annual Responses (Block 13b)

245

8) Record/Disclose

10.0

49

489

5

2,445

122

245

$205,996

9) Store/File

5.2

51

264

5

1,320

66

132

$111,220

TOTAL ANNUAL HOURS

46,480

2,325

4,650

TOTAL ANNUAL BURDEN

53,455

$3,916,488

(a) = (c)/(b)

(d) - From previously approved ICR.

See Attachment I for assumptions and further description of activities.

TABLE G-12:  EXISTING SOURCE ANNUAL RESPONDENT BURDEN AND COST OF REPORTING AND

RECORDKEEPING REQUIREMENTS OF THE HON PROVISIONS

Burden Item

Average Hours per Activity

(a)

Number of Activities per year per respondent

(b)

Total Technical Hours per year per respondent

(c)

Technical Hours per year per respondent for wastewater

(d)

Estimated Technical Hours per year

(e)

Estimated Managerial Hours per year

(f)

Estimated Clerical Hours per year

(g)

Annual Cost

 $per year

(h)

1) Read Rule and Instructions

3.6

23

69

14

17,680

884

1,768

$1,489,673

2) Plan Activities

6.1

13

61

18

16,080

804

1,608

$1,354,861

3) Training

5.3

4

17

4

4,400

220

440

$370,733

4) Create, Test, Research and Development

17.8

99

1617

150

400,080

20,004

40,008

$33,709,741

5) Gather Information, Monitor/Inspect

2.5

677

1693

0

406,320

20,316

40,632

$34,235,507

6) Process/Compile and Review

20.0

1

20

0

4,800

240

480

$404,436

7) Complete Reports

81.2

5

388

18

94,560

4,728

9,456

$7,967,389

Total Annual Responses (Block 13b)a

1,600

8) Record/Disclose

17.5

26

442

12

107,040

5,352

10,704

$9,018,923

9) Store/File

6.8

35

222

15

54,480

2,724

5,448

$4,590,349

TOTAL ANNUAL HOURS

1,105,440

55,272

110,544

TOTAL ANNUAL BURDEN

1,271,256

$93,141,612

(a) = (c + d)/(b)

(c) - there are 240 existing sources out of the 320 total that will continue to comply with the HON.

(d) - the 80 facilities complying with the CAR will still be required to comply with the HON for wastewater.

a Total number of respondents is 320 (240 for HON + 80 CAR still complying with HON Wastewater).

See Attachment I for assumptions and further description of activities.

TABLE G-13:  ANNUAL BURDEN OF REPORTING AND RECORDKEEPING REQUIREMENTS FOR SUBPART VVa

Activity

(A)

Hours/

Occurrence

(B)

Occurrences/

respondent/

yr

(C)a

Respondents/ yr

(D)

Technical

 hr/yr

(E=D*.05)

Managerial

hr/yr

(F=D*.10)

Clerical

hr/yr

(G)

$

Cost/yrb

1.	Applications

N/A

2.	Survey and Studies ADVANCE \d2

N/A

3.	Reporting Requirements

A. Read Instructions ADVANCE \d2

1

1

38

38

2

4

$3,222

B. Required Activities

Initial Performance Test Report

48

1

38

1,824

91

182

$153,646

Repeat Performance Test Report

48

1

8 ADVANCE \u2 c

384

19

38

$32,315

C. Create Information

Included in 3B

D. Gather Existing Information

Included in 3E

E. Write Report

New Sources

 Notification of Construction

2

1

23

46

2

5

$3,853

Notification of Reconstruction/ Modification

2

1

15

30

2

3

$2,591

  Notification of Actual Startup

2

1

38

76

4

8

$6,443

Notification of Initial/Repeat Performance Test

2

1

46

92

5

9

$7,795

  Existing Sources Semiannual Report

4.5

2

38

342

17

34

$28,796

Total Annual Responses (Block 13b)

244

4.	Recordkeeping Requirements

A. Read Instructions

Included in 3A

B. Plan Activities

Included in 4C

C. Implement Activities

Included in 3B

D. Develop Record System

N/A

E. Time to Enter Informationd

Average Facilities - Records of Operating Parameters

89.5

1

34

3,043

152

304

$256,366

Small Facilities - Records of Operating Parameters

95.2

1

4

381

19

38

$32,077

F. Train personnel

N/A

G. Audits

N/A

TOTAL ANNUAL HOURS

6,256

313

625

TOTAL ANNUAL BURDEN

7,146

$527,104

a Assume that there will be an average 38 new, modified, or reconstructed facilities each year over the next 3 years.  Estimate that 23 of new affected sources will be due to construction, and 15 will be reconstructed or modified.  There are an average of 38 new affected sources each year after promulgation of VVa.  Assume 10 percent are small facilities that will record instrument readings manually, and 90 percent of facilities use automated equipment to capture instrument readings electronically.  Assume that costs are being calculated for the second of the three years after promulgation of VVa, so that the 38 new sources in the first year are existing sources in the second year.  Since subpart VVa is more stringent than the HON and MON, no sources are assumed to be complying with the HON or MON instead of subpart VVa.

b United States Department of Labor, Bureau of Labor Statistics, May 2006 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 325000 Chemical Manufacturing.  The rates are for General and Operations Managers, Environmental Engineers, and Office and Administrative Support Occupations.  The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.  Technical - $74.36/hr; Managerial - $125.87/hr; Clerical - $36.04/hr.

c Assume 20 percent of initial performance tests must be repeated due to failure.

d Details of the additional hours relative to the hours for a source subject to subpart VV are provided in section 6(f) of Part A of the Supporting Statement.

Attachment H

Assumptions and Item Descriptions for Attachment F:  Table F-11

(A) That all existing and new sources must submit an initial report within 120 days of promulgation and an implementation plan or permit application within 12 or 18 months of the compliance date.  It is assumed that initial reports and implementation plans have been submitted for existing sources and these reports are only required for new sources.  The new sources are most likely to be collocated within existing plants and be included in those existing source reports.

(B) That semiannual reports of results from equipment leak detection and repair programs are required by the equipment leak standard.  Sources are required to comply with the equipment leak standard by 6 months after promulgation.  It is assumed that an average of 320 facilities will submit reports semiannually (320 x 2 = 640) (even those that use the CAR will still have to submit reports under the HON for wastewater).

Item Descriptions:

(a) Average Hours per Activity are estimates of the specific activities and are the basis for estimating the overall burden.

(b) Number of Activities per year represents the number of reports expected to be reviewed and other related activities during the course of the year.  Under the performance test headings, these numbers are based upon assumptions (A) and (B), above.  For one-time reports, the total number of reports expected over the three-year period was divided by three to get an annual average incorporating assumption (C), above.

(c) Estimated Technical Hours per year is the product of (a) and (b).

(d) Estimated Managerial Hours per year is 5 percent of (c).

(e) Estimated Clerical Hours per year is 10 percent of (c).

(f) Estimated Annual Cost per year is the sum of costs for technical, managerial, and clerical hours based on rates from the Office of Personnel Management (OPM) “2006 General Schedule” which excludes locality rates of pay.

Technical - $42.45 (GS-12, Step 1, $26.53 x 1.6)

Managerial - $57.20 (GS-13, Step 5, $35.75 x 1.6)

Clerical - $22.96 (GS-6, Step 3, $14.35 x 1.6)

(Ht x $42.45/hour)+(Hm x $57.20/hour)+(Hc x $14.35/hour) = (G)

Where:

Ht is (c), or technical hours

Hm is (d), or managerial hours, and

Hc is (e), clerical hours

Report Review:

1) Initial represents the EPA review of all initial reports received.

2) Implementation Plan or Permit Applications represents the EPA review of all implementation plans, or permit applications if submitted in lieu of an implementation plan.

3) Compliance Status represents compliance status verification by the EPA for the portions of the standard which a source must comply with before the compliance date (see assumption (D) above).

4) Review equipment leak monitoring represents the review and screening of periodic reports received as a result of the equipment leaks standard.

5) Notification of construction/reconstruction represents the EPA review of this notification from new sources.

6) Notification of anticipated startup represents the EPA review of this notification from new sources.

7) Notification of actual startup represents the EPA review of this notification from new sources.

8) Notification of performance test represents the EPA review of this notification from new sources.

9) Review of test results represents the EPA review of performance test results for new sources.

10) Review periodic reports represents the EPA review of periodic reports.

TOTAL BURDEN AND COST is the sum of each of the columns (d), (e), (f) and (g).

Attachment I

Assumptions and Item Descriptions for Attachment G:  Tables G-11 and G-12

Assumptions are:

(A) That there are 240 existing facilities out of 320 that will continue to comply with the HON, rather than the CAR.  The 80 facilities complying with the CAR will still be required to comply with the HON wastewater provisions, as the CAR does not include wastewater provisions.  The total number of facilities will increase by 5 new facilities per year.  Since new facilities must be in compliance at startup, the general periodic recordkeeping and reporting burdens are included, which accounts for the difference in the technical hours per facility.  No new facilities are expected to comply directly with the CAR.

(B) That the average representative source, new and existing, will consist of the following points of burden:

20 parameters to monitor at control devices throughout the facility

10 affected storage tanks of various capacities

3 affected major wastewater streams

4 affected transfer rack operations

3 overall leak detection and repair programs for 2,000 points

1 emissions averaging program that involves 10 emission points

1 facility wide inventory of emission points, Group 1 and Group 2

8 process vents per facility

(C) That there are 5 percent (0.05) managerial and 10 percent (0.10) clerical hours required for every technical hour.

(D) That some activities necessary to generate reports involve creating records in the process, and that these activities are assumed to be reports activities alone, to avoid double counting these as records activities as well.  Therefore, only items 8 and 9 are considered records burdens directly.

Item Descriptions:

(a) Average Hours per Activity is back-calculated by dividing (b) into (c).  Since the activities within each burden category can vary significantly, it is too inaccurate to assume an average to use to calculate (c).  Estimated activity technical hours are summarized to obtain (c) first, then back calculate for (a) with an estimated (b).

(b) Estimated Number of Activities per year per source represents the assumed typical number of separate activities a source may encounter during one year.  This number may vary from facility to facility, depending on consolidation of activities, collocated readings, etc.  Since so much variability exists, it is important to note that this is an estimate.  This number was only used to back-calculate (a).

(c) Technical Hours per year per source is the actual best estimate of the burden for each burden item.  The three-year separate activity burdens were divided by three, where appropriate, and then summarized to include in this column.  The technical hours for new sources is higher because some periodic compliance reports and records are required at startup.  Existing sources do not encounter these reports and record burdens for three years after promulgation.

(d) (Table G-11) Estimated Number of New Sources reflect the number given in assumption (A), above.  (Table G-12) Technical Hours Per Year Per Source for Wastewater are the annual technical hours associated with recordkeeping and reporting to ensure compliance with requirements for wastewater.  As discussed in assumption (A), facilities complying with the CAR will comply with the HON wastewater requirements.  Burden hours per source, per emission type are shown in Table B-1.

(e) Estimated Technical Hours per year is the product of (c) and (d) for new facilities (Table G-11).  For Table G-12, estimated technical hours are the product of (c) and the number of existing facilities complying with all of the HON (240) added to the product of (d) and the number of facilities complying with only the wastewater provisions (80).

(f) Estimated Managerial Hours per year is 5 percent of (e).

(g) Estimated Clerical Hours per year is 10 percent of (e).

(h) Estimated Annual Cost per year is from the United States Department of Labor, Bureau of Labor Statistics, May 2006 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 325000 Chemical Manufacturing.  The rates are for General and Operations Managers, Environmental Engineers, and Office and Administrative Support Occupations.  The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.

(Ht x $74.36/hour)+(Hm x $125.87/hour)+(Hc x $36.04/hour) = (G)

Where:

Ht is (e), or technical hours

Hm is (f), or managerial hours, and

Hc is (g), clerical hours

1) Read Rule and Instructions are the activities, less training, which involve comprehending the provisions in the standard and understanding how they apply to the respective points at a facility.

  2) Plan Activities represents such burdens as design, redesign, scheduling as well as drafting the implementation plan, and selecting methods of compliance.

3) Training represents the portion (assumed 40 percent) of activities from 1) Read Rule and Instruction for which an average facility would elect to provide class room instruction.  The standard does not require specific training itself.

4) Create, Test, Research and Development are the activities involving testing, retesting, establishing operating range for parameters and analyzing point by point applicability.  Monitor related refit, calibration and maintenance activities are also included under this heading.

5) Gather Information, Monitor and Inspect are the activities involving physical inspections of equipment, collection of monitored data and other related activities.

6) Process/Compile and Review are the activities that involve analysis of the information collected for accuracy, compliance, and appropriate reports and records required as a result.

7) Complete Reports represents the activities normally associated with filling out forms.  Since the standard requires no standard forms, these activities relate to the preparing of formal reports and cover letters as appropriate.

8) Record/Disclose are activities which are solely recordkeeping which occur once the appropriate report information has been extracted [see assumption (D)] above.  These activities involve software translation, duplication, or archival processes normally associated with data management and storage common to this industry.

9) Store/File are again activities which are solely recordkeeping which occur once the appropriate report information has been extracted (see assumption (D) above).  These activities involve the management life cycle of records, from the time they are filed and boxed up, to the time they are disposed.

TOTAL BURDEN AND COST is the sum of each of the columns (e), (f), (g) and (h).

Attachment J

Summary of Capital/Startup and Operation and Maintenance Costs for the CAR and the Referencing Subparts

NSPS Subpart Ka

a.	Total Capital/Startup Cost of Monitoring Equipment:

The total Capital/Start-up costs for this ICR are $0.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

The total Operating and Maintenance (O&M) Costs for this ICR is $0.

c.	Total Capital/Startup and O&M Cost:

The total Capital and O&M Costs are $0.

NSPS Subpart Kb

a.	Total Capital/Startup Cost of Monitoring Equipment:

The total Capital/Start-up costs for this ICR are $27,000.  This is the cost for 2 new storage tanks to install monitoring equipment associated with the CVS routed to a control device. The storage tanks will use equipment similar to that used for subparts NNN and III; therefore, the startup costs are approximately $13,500 per facility for a total of $27,000.  There are no capital/startup costs for the remaining 35 new storage tanks complying by either an IFR or EFR.

b. 	Total Cost of Operation and Maintenance of Monitoring Equipment:

 The average annualized burden is estimated to be $1,350 per year per affected facility ($13,500 discounted over 10 years by straight line depreciation method) for both new and existing affected sources using CVS to a control device (31), for a total of $41,850.

c.	Total Capital/Startup and O&M Cost:

The total Capital and O&M Costs are $68,850.

NSPS Subpart VV

a.	Total Capital/Startup Cost of Monitoring Equipment:

The capital/startup costs of this regulation are $0.  It is assumed that facilities that are already complying with subpart VV will not need to buy an additional monitor and no additional facilities will become subject to subpart VV in the future.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

The operation of the monitors is included in the monitoring costs.  Maintenance costs on these units is incidental, therefore no maintenance or operation costs incur.

c.	Total Capital/Startup and O&M Cost:

The total Capital and O&M Costs are $0.

NSPS Subpart VVa

a.	Total Capital/Startup Cost of Monitoring Equipment:

The capital/startup costs of this regulation are $4,200.  This is based on the average cost of a monitor ($7,000) with a 5-year expected life.  The equipment is not capitalized, so no discount rate applies.  The average annual cost is, therefore, $7,000/5, or $1,400/yr.  It is estimated that only area sources that construct new process units might purchase a monitoring instrument.  All other sources should have monitoring equipment because they are either subject to MACT rules or have been subject to NSPS subpart VV for other processes.  Assuming that 38 process units are subject to NSPS subpart VVa each year, 60 percent of new sources are newly constructed sources, and that 15 percent of all new sources are area sources, an estimated 3 facilities with a new process unit will buy a monitoring instrument to comply with NSPS subpart VVa.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

The operation of the monitors is included in the monitoring costs.  Maintenance costs on these units is incidental; therefore, no maintenance or operation costs incur.

c.	Total Capital/Startup and O&M Cost:

The total Capital and O&M Costs are $4,200.

NSPS Subpart DDD

a. 	Total Capital/Startup cost of Monitoring Equipment:

The capital/startup costs for this regulation are $300,000.  This is based on 10 new sources per year multiplied by $30,000 per source for monitoring equipment.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

The annual operation and maintenance costs are $630,000 dollars.  This is based on 80 existing sources plus 10 new sources over the life of the ICR multiplied by $7,000 for upkeep of the monitoring devices.

c.	Total Capital/Startup and O&M Cost:

The total Capital and O&M Costs are $930,000.

NSPS Subpart NNN/III

a.	Total Capital/Startup Cost of Monitoring Equipment:

The startup cost of monitoring equipment is approximately $13,500 per new affected facility for both Subpart III, Air Oxidation Operations and Subpart NNN, Distillation Operations, or a total of $2,403,000 (total of 178 new sources x $13,500/source).

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

The average annualized burden is estimated to be $1,350 per year per affected facility ($13,500 discounted over 10 years by straight line depreciation method) for Subpart III and for Subpart NNN for a total of $1,830,600 [($1,350 x 1,356) total number of new and existing affected sources under NNN and III].

c.	Total Capital/Startup and O&M Cost:

The total Capital and O&M Costs are $4,233,600.

NSPS Subpart RRR

a.	Total Capital/Startup cost of Monitoring Equipment:

The capital/startup costs for this regulation are $500,000 dollars per year.  This is based on 20 new sources per year multiplied by $25,000 for monitoring equipment discounted over 10 years at 7 percent.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

The annual operation and maintenance costs are $77,500 dollars.  This is based on 155 existing sources multiplied by $500 for upkeep of the monitoring device.

c.	Total Capital/Startup and O&M Cost:

The total Capital/startup and O&M Costs are $577,500.

NESHAP Subpart BB

a.	Total Capital/Startup cost of Monitoring Equipment:

Startup cost were identified in previous ICR.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

There are no O&M cost associated because no CEMs are employed.

c.	Total Capital/Startup and O&M Cost:

The total Capital and O&M Costs are $0.

NESHAP Subpart Y

a.	Total Capital/Startup Cost of Monitoring Equipment:

The only type of industry costs associated with the information collection activity in the standards is labor cost.  There are no capital/startup costs.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

There are no operation and maintenance costs.

c.	Total Capital/Startup and O&M Cost:

The total Capital and O&M Costs are $0.

NESHAP Subpart V

a.	Total Capital/Startup Cost of Monitoring Equipment:

Startup cost were identified in previous ICR.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

There are no O&M costs associated because no CEMs are employed.

c.	Total Capital and O&M Cost

The total Capital and O&M Costs are $0.

NESHAP HON:

Subpart G

a.	Total Capital/Startup Cost of Monitoring Equipment:

Estimate the cost to purchase monitoring equipment is approximately $20-30K for process vents and wastewater operations, or an average of $25K with a 10-year life expectancy and a 7 percent depreciation rate, or $2225 per year.  There are no associated costs for transfer racks and storage tanks.  Only new sources need to buy monitoring equipment; therefore, the total capital/startup cost is $25,000 x 5, or $125,000.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

The cost to industry associated with the operation and maintenance (O&M) is approximately $100-500K per year (capital/startup depreciation not included) for reactor process vents and wastewater operations.  The cost associated with the operation and maintenance is $50-100K per year (capital/startup depreciation not included) for distillation units process vents.  There are no associated costs for transfer racks and storage tanks.  The average O&M cost is assumed to be the average of the two ranges, or $275,000 per year.  Operation and maintenance incur for both new and existing sources.  The total O&M is, therefore, $275,000 x 245, or $67,375,000.

c.	Total Capital/Startup and O&M Cost:

The total Capital and O&M Costs are $67,500,000.

Subpart H

a.	Total Capital/Startup Cost of Monitoring Equipment:

Only new sources will buy an organic volatile analyzer.  Estimate the average cost of a monitor is $7,000 with a 5-year expected life. The equipment is not capitalized, so no discount rate applies.  The average annual cost is, therefore, $7,000/5, or $1,400/yr.  Estimate that 80 percent of facilities contract out LDAR services, and 20 percent perform in-house.  Those facilities which contract out (4 facilities) will purchase one unit as backup; the remaining facilities performing LDAR in-house (1 facility) will purchase 5 units to support the program.  The total annual capital/startup cost is, therefore, 9 units x 1400/unit, or $12,600/yr.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

The operation of the monitors is included in the monitoring costs.  Maintenance costs on these units is incidental; therefore, no maintenance or operation costs incur.

c.	Total Capital and O&M Cost for Subparts H, and I:

The total Capital and O&M Costs are $12,600.

Part 65 CAR

a.	Total Capital/Startup Cost of Monitoring Equipment:

Under the CAR, it is assumed all new sources start out under the referencing subpart.  Therefore, there is no capital/startup cost associated with this subpart.

b.	Total Cost of Operation and Maintenance of Monitoring Equipment:

The HON is the basis for determining O&M costs for the CAR.  The average cost per source, based on the HON is $275,000 per year, for a total of $22,000,000.

c.	Total Capital/Startup and O&M Cost:

The total Capital and O&M Costs are $22,000,000.

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[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Proposed Rules]
[Pages 21795-21796]
[FR Doc No: 2020-08182]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 130

[Docket No. FDA-1995-N-0062]

Food Standards; General Principles and Food Standards
Modernization; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the proposed rule that appeared in the Federal
Register of May 20, 2005. The proposed rule, entitled ``Food Standards;
General Principles and Food Standards Modernization,'' would establish
a set of general principles for food standards for FDA to use when
considering whether to establish, revise, or eliminate a food standard.
The proposed rule was issued jointly with the U.S. Department of
Agriculture (USDA) and, while FDA will continue to engage with USDA
regarding the proposed rule, we are extending the comment period to
allow interested persons additional time to submit comments.

DATES: We are extending the comment period on the proposed rule that
published in the Federal Register of May 20, 2005 (70 FR 29214). Submit
either electronic or written comments by July 20, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 20, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 20, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-1995-N-0062 for ``General Principles and Food Standards
Modernization; Reopening of the Comment Period.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://

www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rumana Yasmeen, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 20, 2005 (70
FR 29214), FDA and USDA jointly issued a proposed rule entitled ``Food
Standards; General Principles and Food Standards Modernization,'' as a
first step in instituting a process to modernize FDA definitions and
standards of identity (and standards of quality and fill of container)
consistent with section 401 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 341), and USDA's definitions and standards of identity or
composition under the Federal Meat Inspection Act and the Poultry
Products Inspection Act (21 U.S.C. 607(c) and 457(b)) (and standards of
fill of container). The proposed rule, if finalized, would establish
general principles that FDA and USDA would consider when determining
whether to establish, revise, or eliminate a food standard.
    Interested persons were originally given until August 18, 2005, to
comment on the proposed rule. In the Federal Register of February 21,
2020 (85 FR 10107), we announced that we were reopening the comment
period for an additional 60 days so that we could receive new data,
information, or further comments only on FDA-specific aspects of the
proposed rule, including 13 general principles which we would consider
when establishing, revising, or eliminating a food standard. The
reopened comment period was scheduled to end on April 21, 2020.
    We have received requests for an extension of the comment period
for the proposed rule, which conveyed concern that the current 60-day
comment period does not allow sufficient time to develop a meaningful
or thoughtful response to the proposed rule.
    FDA has considered the requests and is extending the comment period
for the proposed rule for 90 days, until July 20, 2020. We believe that
a 90-day extension allows adequate time for interested persons to
submit comments without significantly delaying rulemaking on these
important issues.

    Dated: April 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08182 Filed 4-17-20; 8:45 am]
 BILLING CODE 4164-01-P