[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Notices]
[Pages 65663-65667]
[FR Doc No: 2013-25975]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of our food labeling regulations and on Form FDA 3570, Model
Small Business Nutrition Labeling Exemption Notice, which small
businesses may use to claim the small business exemption from nutrition
labeling.

DATES: Submit either electronic or written comments on the collection
of information by December 31, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, we are publishing this notice of the proposed
collection of information set forth in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Food Labeling Regulations--21 CFR Parts 101, 102, 104, and 105 (OMB
Control Number 0910-0381)--Revision To Include Collections Previously
Approved by OMB, but Currently in Use Without Approval

    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.
    Upon review of the information collection requests supporting these
food labeling regulations, FDA found that the third party disclosure
burdens associated with the requirements found in Sec. Sec.
101.9(c)(2)(ii) and 101.36(b)(2) to declare the amount of trans fatty
acids present in a food, and with 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, are in use without current OMB approval. These
collections of information were previously approved by OMB under
control numbers 0910-0515 and 0910-0395 respectively, however the
approval periods for these collections have expired. To remedy this
oversight, to most appropriately streamline these information
collections, and to eliminate redundancy in our information collection
requests, we seek to revise the instant collection to include these
third party disclosure elements and have included them in the burden
estimates and discussion in this document in support of our approval
request for OMB control number 0910-0381.
    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 101.9 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 (d)(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 in this document, 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)).
    Section 101.105 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.
    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.
    We estimate the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third Party Disclosure Burden \1\
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                                                                                Number of
                             21 CFR section                                 Number of      disclosures    Total  annual  Average  burden    Total hours
                                                                           respondents   per respondent    disclosures   per  disclosure
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101.3, 101.22, 102, and 104; statement of identity labeling                      25,000            1.03          25,750            0.5            12,875
 requirements..........................................................
101.4, 101.22, 101.100, 102, 104, and 105; ingredient labeling                   25,000            1.03          25,750            1              25,750
 requirements..........................................................
101.5; requirement to specify the name and place of business of the              25,000            1.03          25,750            0.25            6,438
 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 104; labeling requirements           25,000            1.03          25,750            4             103,000
 for disclosure of nutrition information...............................
101.9(g)(9) and 101.36(f)(2); alternative means of compliance permitted              12            1                 12            4                  48
101.10; requirements for nutrition labeling of restaurant foods........         300,000            1.5          450,000            0.25          112,500
101.12(b); RACC for baking powder, baking soda and pectin..............              29            2.3               67            1                  67

101.12(e); adjustment to the RACC of an aerated food permitted.........              25            1                 25            1                  25
101.12(g); requirement to disclose the serving size that is the basis             5,000            1              5,000            1               5,000
 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 disclose nutrition information             200            1                200            1                 200
 for any food product for which a nutrient content claim is made.......
101.13(j)(2), 101.13(k), 101.54, 101.56, 101.60, 101.61, and 101.62;              5,000            1              5,000            1               5,000
 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 disclose the basis for               300,000            1.5          450,000            0.75          337,500
 nutrient content claims made for their food...........................
101.14(d)(2); general requirements for disclosure of nutrition                  300,000            1.5          450,000            0.75          337,500
 information related to health claims for food products................
101.15; requirements pertaining to prominence of required statements                160           10              1,600            8              12,800
 and use of foreign language...........................................
101.22(i)(4); supplier certifications for flavors designated as                      25            1                 25            1                  25
 containing no artificial flavors......................................
101.30 and 102.33; labeling requirements for fruit or vegetable juice             1,500            5              7,500            1               7,500
 beverages.............................................................
101.36; nutrition labeling of dietary supplements......................             300           40             12,000            4.025          48,300
101.42 and 101.45; nutrition labeling of raw fruits, vegetables, and              1,000            1              1,000            0.5               500
 fish..................................................................
101.45(c); databases of nutrient values for raw fruits, vegetables, and               5            4                 20            4                  80
 fish..................................................................
101.79(c)(2)(i)(D); disclosure requirements for food labels that                  1,000            1              1,000            0.25              250
 contain a folate/neural tube defect health claim......................
101.79(c)(2)(iv); disclosure of amount of folate for food labels that               100            1                100            0.25               25
 contain a folate/neural tube defect health claim......................
101.100(d); disclosure of agreements that form the basis for exemption            1,000            1              1,000            1               1,000
 from the labeling requirements of section 403(c), (e), (g), (h), (i),
 (k), and (q) of the FD&C Act..........................................
101.105 and 101.100(h); disclosure requirements for food not accurately          25,000            1.03          25,750            0.5            12,875
 labeled for quantity of contents and for claiming certain labeling
 exemptions............................................................
                                                                        --------------------------------------------------------------------------------
    Total..............................................................  ..............  ..............  ..............  ...............       1,029,258
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                Number of                        Average
                             21 CFR section                                  Number of      records per    Total  annual    burden per      Total hours
                                                                           recordkeepers   recordkeeper       records      recordkeeping
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101.12(e); recordkeeping to document the basis for density-adjusted RACC              25            1                 25            1                 25
101.13(q)(5); recordkeeping to document the basis for nutrient content           300,000            1.5          450,000            0.75         337,500
 claims.................................................................
101.14(d)(2); recordkeeping to document nutrition information related to         300,000            1.5          450,000            0.75         337,500
 health claims for food products........................................
101.22(i)(4); recordkeeping to document supplier certifications for                   25            1                 25            1                 25
 flavors designated as containing no artificial flavors.................
101.100(d)(2); recordkeeping pertaining to agreements that form the                1,000            1              1,000            1              1,000
 basis for an exemption from the labeling requirements of section
 403(c), (e), (g), (h), (i), (k), and (q) of the FD&C Act...............

101.105(t); recordkeeping pertaining to disclosure requirements for food             100            1                100            1                100
 not accurately labeled for quantity of contents........................
                                                                         -------------------------------------------------------------------------------
    Total...............................................................  ..............  ..............  ..............  ..............         676,150
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                     Table 3--Estimated Annual Reporting Burden \1\
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                                                                                Number of                        Average
                         21 CFR section/form No.                             Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
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101.9(j)(18) and 101.36(h)(2); procedure for small business nutrition             10,000               1          10,000               8          80,000
 labeling exemption notice using Form FDA 3570..........................
101.12(h); petitions to establish or amend a RACC.......................               5               1               5              80             400
101.69; petitions for nutrient content claims...........................               3               1               3              25              75
101.70; petitions for health claims.....................................               5               1               5              80             400
101.108; written proposal for requesting temporary exemptions from                     1               1               1              40              40
 certain regulations for the purpose of conducting food labeling
 experiments............................................................
                                                                         -------------------------------------------------------------------------------
    Total...............................................................  ..............  ..............  ..............  ..............          80,915
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\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.
    As noted, we are revising this collection to include previously
approved third party disclosure burdens associated with the requirement
to declare the amount of trans fatty acids present in a food, including
dietary supplements. The third party disclosure burden hours formerly
associated with OMB control number 0910-0515 (collection titled, ``Food
Labeling: Trans Fatty Acids in Nutrition Labeling'') are represented by
the citation to Sec.  101.9 on line 4 of table 1 and the citation to
Sec.  101.36 on line 17 of table 1. For this revision, we have not
added burden hours to line 4 or line 17 of table 1 because, based on
our experience with food labeling, the 4 hours estimated for meeting
the labeling requirements of Sec.  101.9 and the 4 hours estimated for
meeting the labeling requirements of Sec.  101.36 are appropriate
estimates of the total time it takes a respondent to meet our
requirements for nutrition labeling in Sec. Sec.  101.9 and 101.36.
    We are also revising this collection to include previously approved
third party disclosure burdens associated with 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. The third party disclosure burden hours
formerly associated with OMB control number 0910-0395 (collection
titled, ``Food Labeling: Nutrition Labeling of Dietary Supplements on a
`Per Day' Basis'') are represented by the citation to Sec.  101.36 on
line 17 of table 1 and the addition of 300 hours to our previous
estimate of 48,000 hours. For this revision, we added 300 burden hours
to line 17 of table 1 because voluntary labeling on a ``per day'' basis
is in addition to the required ``per serving'' basis. We estimate that
``per day'' information would generally be placed on at most 10 percent
of the estimated 12,000 disclosures, for a total of 1,200 annual
disclosures, and that a respondent will spend 15 minutes (0.25 hours)
per disclosure, for a total of 300 hours. Thus, the total estimated
burden on line 17 of table 1 is 48,300 hours and average burden per
disclosure on line 17 of table 1 has been increased from 4.0 to 4.025
hours, to represent an averaging of the burden hours across all of the
estimated 12,000 disclosures.
    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: October 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25975 Filed 10-31-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Proposed Rules]
[Pages 38581-38582]
[FR Doc No: 2011-16657]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0579; Airspace Docket No. 11-AEA-14]

Proposed Amendment of Class D and E Airspace and Revocation of
Class E Airspace; Manassas, VA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class D and Class E airspace
areas and remove Class E airspace at Manassas Municipal/Harry P. Davis
Airport, Manassas, VA. A Standard Instrument Approach Procedure has
been cancelled; therefore modification to the airspace areas is
required for the safety and airspace management of Instrument Flight
Rules (IFR) operations at the airport.

DATES: Comments must be received on or before August 15, 2011. The
Director of the Federal Register approves this incorporation by
reference action under title 1, Code of Federal Regulations, part 51,
subject to the annual revision of FAA, Order 7400.9 and publication of
conforming amendments.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2011-0579; Airspace Docket No. 11-AEA-14, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.
    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: John Fornito, Airspace Specialist,
Operations Support Group, Eastern Service Center, Air Traffic
Organization, Federal Aviation Administration, P.O. Box 20636, Atlanta,
Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this proposed rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal. Communications should identify
both docket numbers and be submitted in triplicate to the address
listed above. Those wishing the FAA to acknowledge receipt of their
comments on this notice must submit with those comments a self-
addressed, stamped postcard on which the following statement is made:
``Comments to Docket No. FAA-2011-0579; Airspace Docket No. 11-AEA-
14.'' The postcard will be date/time stamped and returned to the
commenter. All communications received before the specified closing
date for comments will be considered before taking action on the
proposed rule. The proposal contained in this notice may be changed in
light of the comments received. A report summarizing each substantive
public contact with FAA personnel concerned with this rulemaking will
be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/. Additionally, any person may obtain
a copy of this notice by submitting a

request to the Federal Aviation Administration (FAA), Office of Air
Traffic Airspace Management, ATA-400, 800 Independence Avenue, SW.,
Washington, DC 20591, or by calling<PHONE_NUMBER>. Communications must
identify both docket numbers for this notice. Persons interested in
being placed on a mailing list for future NPRM's should contact the
FAA's Office of Rulemaking,<PHONE_NUMBER>, to request a copy of
Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution
System, which describes the application procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class D and E surface airspace at
Manassas Municipal/Harry P. Davis Airport, Manassas, VA. Cancellation
of the VOR approach into the airport has made this action necessary.
Class E airspace designated as an extension to Class D airspace is no
longer needed and therefore, would be removed. This action would
enhance the safety and management of IFR operations at Manassas
Municipal/Harry P. Davis Airport.
    Class D and E airspace designations are published in Paragraphs
5000, 6002 and 6004, respectively, of FAA Order 7400.9U, dated August
18, 2010, and effective September 15, 2011, which is incorporated by
reference in 14 CFR 71.1. The Class D and E airspace designations
listed in this document would be published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it proposes to remove Class E airspace and amend
Class D and E airspace at Manassas, VA.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 will continue to read as
follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, signed August 15, 2010, and effective September 15,
2011, is amended as follows:

Paragraph 5000 Class D airspace.

* * * * *

AEA VA D Manassas, VA [Amended]

Manassas Municipal/Harry P. Davis Airport, VA
    (Lat. 38[deg]43'17'' N., long. 77[deg]30'56'' W.)

    That airspace extending upward from the surface to but not
including 2,000 feet MSL within a 5-mile radius of the Manassas
Municipal/Harry P. Davis Airport, excluding that airspace within the
Washington Tri-Area Class B airspace area. This Class D airspace
area is effective during the specific dates and times established in
advance by a Notice to Airmen. The effective date and time will
thereafter be continuously published in the Airport/Facility
Directory.

Paragraph 6002 Class E airspace designated as surface areas.

* * * * *

AEA VA E2 Manassas, VA [Amended]

Manassas Municipal/Harry P. Davis Airport, VA
    (Lat. 38[deg]43'17'' N., long. 77[deg]30'56'' W.)

    That airspace extending upward from the surface to but not
including 2,000 feet MSL within a 5-mile radius of the Manassas
Municipal/Harry P Davis Municipal Airport, excluding that airspace
within the Washington Tri-Area Class B airspace area. This Class E
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

Paragraph 6004 Class E airspace designated as an extension to a
Class D surface area.

* * * * *

AEA VA E4 Manassas, VA [Removed]

    Issued in College Park, Georgia, on June 27, 2011.
Barry A. Knight,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2011-16657 Filed 6-30-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Notices]
[Pages 21256-21257]
[FR Doc No: 2014-08552]

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

DEPARTMENT OF HOMELAND SECURITY

United States Coast Guard

[Docket No. USCG-2010-0455]

Availability of Final Environmental Impact Statement for the
Proposed Construction of a Highway Bridge Across the Manatee River at
Parrish, Manatee County, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability.

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

SUMMARY: The Coast Guard announces the availability of the final
environmental impact statement (FEIS) for the proposed construction of
a

highway bridge across the Manatee River at Parrish, Manatee County,
Florida. As a structure over navigable waters of the United States, the
proposed bridge would require a Coast Guard bridge permit. The FEIS
presents an analysis of the potential for impact to the natural, human
and cultural environment of the proposed bridge.

ADDRESSES: The FEIS is available online at http://www.regulations.gov.
It can also be viewed at the Coast Guard's Seventh District Bridge
Office, 909 SE 1st Avenue, Brickell Plaza Federal Building, Ste 432,
Miami, Florida, 33131, between 8 a.m. and 4 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For information about this document
call or email Randall Overton, Bridge Management Specialist, Seventh
Coast Guard District, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This notice is issued under the authority of
5 U.S.C. 552(a) and the regulations governing NEPA (40 CFR 1501, et.
seq.). Under the General Bridge Act of 1946 (33 U.S.C. 525-533),
construction of a bridge over a navigable U.S. waterway requires the
Coast Guard to grant a bridge permit. Such a permit would be needed for
the proposed Manatee River highway bridge, and under the National
Environmental Policy Act of 1969 (NEPA, 42 U.S.C. 4321 et seq.), a FEIS
is necessary before the permit can be issued. The environmentally
preferred alternative is identified as a bridge connecting Upper
Manatee River Road and Fort Hamer Road near mile 15.0 of the Manatee
River at Parrish, Florida. The purpose of the proposed bridge is to
facilitate local transportation east of Interstate 75 due to the high
population growth in this area. It would provide vertical clearance of
at least 26 feet. Public comments on a draft environmental impact
statement were received and are discussed in section 5.4 of the FEIS.
    In addition to making the FEIS available as noted under ADDRESSES,
copies of the FEIS are available from the Manatee County Chamber of
Commerce (telephone<PHONE_NUMBER>) and at county library locations
(Central Library telephone<PHONE_NUMBER> and Rocky Bluff Library
telephone<PHONE_NUMBER>). Also, the U.S. Environmental Protection Agency
(EPA) will issue its own notice of the FEIS's availability. The FEIS
will be considered final 30 days after publication of the EPA notice,
and the Coast Guard will thereafter issue its Record of Decision,
completing its NEPA analysis.

    Dated: April 7, 2014.
Brian L. Dunn,
Chief, Office of Bridge Programs, U.S. Coast Guard.
[FR Doc. 2014-08552 Filed 4-14-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Pages 12461-12464]
[FR Doc No: 2022-04637]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1825 and FDA-2020-D-1136]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidances have been implemented

without prior comment, but they remain subject to comment in accordance
with the Agency's good guidance practices.

DATES: The announcement of the guidances is published in the Federal
Register on March 4, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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 name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) 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,<PHONE_NUMBER>.
     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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of these guidances to the
address noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911, or Kimberly Thomas, Center for Drug Evaluation and Research
(CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6220, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, the
Secretary of Health and Human Services (HHS), pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists'' (originally issued on January 31,
2020, and subsequently renewed), available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at: https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021, there
was a Presidential Declaration continuing the national emergency
concerning the COVID-19 pandemic beyond March 1, 2021. See
Continuation of the National Emergency Concerning the Coronavirus
Disease 2019 (COVID-19) Pandemic (February 24, 2021), available at
https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
---------------------------------------------------------------------------

    In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making
available FDA guidances related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related
guidances. Therefore, FDA will issue COVID-19-related guidances for
immediate implementation without prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)) and Sec.  10.115(g)(2)). The guidances are available on
FDA's web pages entitled

``COVID-19-Related Guidance Documents for Industry, FDA Staff, and
Other Stakeholders'' (available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and ``Search for
FDA Guidance Documents'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents).
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

                       Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                         Contact information to request single
         Docket No.               Center         Title of guidance                      copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1825............  CBER...........  Investigational COVID-  Office of Communication, Outreach and
                                               19 Convalescent         Development, 10903 New Hampshire Ave.,
                                               Plasma (Revised         Bldg. 71, Rm. 3128, Silver Spring, MD
                                               January 7, 2022).       20993-0002, 1-800-835-4709 or 240-402-
                                                                       8010; email [email protected].
FDA-2020-D-1136............  CDER...........  COVID-19 Public Health  [email protected]. Please include the
                                               Emergency Policy on     docket number FDA-2020-D-1136 and
                                               COVID-19-Related        complete title of the guidance in the
                                               Sanitation Tunnels      request.
                                               (February 2022).
----------------------------------------------------------------------------------------------------------------

    Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CBER Guidance

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 2). Therefore, clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:

                                     Table 2--CBER Guidance and Collections
----------------------------------------------------------------------------------------------------------------
                                                                        Another guidance title
         COVID-19 guidance title            CFR cite referenced in      referenced  in COVID-19     OMB control
                                               COVID-19 guidance               guidance               No(s).
----------------------------------------------------------------------------------------------------------------
Investigational COVID-19 Convalescent     21 CFR part 312...........  ..........................       0910-0014
 Plasma (Updated: January 7, 2022).       21 CFR parts 606 and 630..                                   0910-0116
                                                                      Form FDA 3926.............       0910-0814
----------------------------------------------------------------------------------------------------------------

B. CDER Guidance

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA is not required for
this guidance. The previously approved collections of information are
subject to review by OMB under the PRA. The collections of information
in the following FDA regulations and guidances have been approved by
OMB as listed in the following table:

                                     Table 3--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                               CFR cite referenced in COVID-    Another guidance referenced in      OMB control
   COVID-19 guidance title              19 guidance                   COVID-19 guidance               No(s).
----------------------------------------------------------------------------------------------------------------
COVID-19 Public Health         21 CFR part 312.............  --Enforcement Policy for                  0910-0001
 Emergency Policy on COVID-19-                                Sterilizers, Disinfectant Devices,       0910-0014
 Related Sanitation Tunnels                                   and Air Purifiers During the
 (February 2022).                                             Coronavirus Disease 2019 (COVID-
                                                              19) Public Health Emergency (March
                                                              2020).
                                                             --COVID-19 Public Health Emergency:
                                                              General Considerations for Pre-IND
                                                              Meeting Requests for COVID-19
                                                              Related Drugs and Biological
                                                              Products (May 2020).
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     FDA web page entitled ``Search for FDA Guidance
Documents'' available at

https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: February 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04637 Filed 3-3-22; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF CHEMICAL SAFETY

	AND POLLUTION PREVENTION

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  		11/24/2010

SUBJECT:	Fluazinam.  Addendum to Previous Human Health Risk Assessment
for Petitions for the Establishment of Tolerances and Registration of
New Uses on Apples and Carrots.

PC Code:  129098	DP Barcodes:  D381528

Decision Nos.:  437290	Registration No.: 71512-1

Petitions:  9E7570  Carrots

                  9F7571  Apples	Regulatory Action:  Section 3
Registration

Risk Assessment Type:  Single Chemical

                                         Aggregate	Case No.:  NA

TXR No.:  NA	CAS No.:    SEQ CHAPTER \h \r 1 79622-59-6

MRID Nos.:  47949001, 48103501,

                       48103502, 48154701	40 CFR:  §180.574

FROM:  	Douglas Dotson, Ph.D., Chemist

		Risk Assessment Branch II

		Health Effects Division (7509P)	  SEQ CHAPTER \h \r 1

THROUGH:	Dennis McNeilly, Chemist

		Richard Loranger, Ph.D., Senior Scientist

		Risk Assessment Branch II

		Health Effects Division (7509P)

TO:		Laura Nollen/Barbara Madden, RM Team 5, RIMUERB

		John Bazuin/Tony Kish, PM Team 22, Fungicide Branch

		Registration Division (7505P)		  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h
\r 1

Executive Summary

In early 2010, HED completed a human health risk assessment for proposed
uses of the fungicide fluazinam,
3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoro
methyl)-2-pyridinamine, on apples, carrots, head lettuce, leaf lettuce,
and the Bulb onion subgroup (13-07B) (Memo, D365940, D. Dotson, et al.,
3/31/2010).  HED recommended in favor of tolerances for head lettuce,
leaf lettuce, and the Bulb onion subgroup; however, because of major
data deficiencies, HED was not able to recommend in favor of tolerances
on apple and carrot commodities.  These data deficiencies are discussed
in detail in the residue chemistry summary document (Memo, D360840, D.
Dotson, 3/31/2010) that was written in support of the risk assessment.
In addition, the deficiencies are discussed in a 75-day letter that the
Agency provided to the registrant, ISK Biosciences.  The deficiencies
related to an apple processing study, a cattle feeding study, and the
analytical method for the metabolites AMPA and DAPA in fat, liver, and
kidney.  The previous residue chemistry summary document addressed all
residue chemistry aspects associated with the tolerance petitions.  HED
also prepared a response to the data deficiencies that can be referred
to for more details concerning the deficiencies (Memo, D381302, D.
Dotson, 11/24/2010).  This current risk assessment addresses ISK’s
responses to the cited data deficiencies and HED’s conclusions to
those responses.

This risk assessment for the proposed uses on apples and carrots is
being performed as a joint review with Canada’s Pest Management
Regulatory Agency (PMRA).

Summary of Data Deficiencies Associated with PP#s 9E7570 and 9F7571
Cited in Previous Risk Assessment

In the previous risk assessment, HED concluded that an analytical method
was not available for enforcement of fluazinam tolerances in animal
commodities.  HED recommended that the registrant submit an adequate
enforcement method and an independent laboratory validation (ILV) for
the method.  The method needed to be adequate for analysis of parent
fluazinam as well as the metabolites AMPA and DAPA in animal commodities
for which tolerances would be established.  HED also recommended that
the registrant submit the results of an acceptable dairy cattle feeding
study.  Residues of the metabolites AMPA and DAPA in animal commodities
needed to be successfully quantified if they were present at levels
above the limit of quantitation.  HED recommended that the registrant
submit the results of an acceptable apple processing study.  The study
needed to be performed at a sufficiently high rate that residues of both
fluazinam and AMGT were quantifiable in the raw agricultural commodity
(RAC).  Finally, HED recommended that ISK submit multiresidue method
testing data for the regulated animal metabolites, AMPA and DAPA.

In response to these data deficiencies, ISK Biosciences submitted an
analytical method and ILV for the analysis of fluazinam, AMPA, and DAPA
in fat, liver, and kidney.  In addition, ISK submitted additional data
for the AMGT metabolite in apples in order that the apple processing
study could be upgraded to acceptable.  Finally, ISK submitted a
rebuttal to the data deficiencies cited in the cattle feeding study.
The multiresidue data for AMPA and DAPA remain outstanding.

Summary of Hazard and Risk Characterizations

When HED prepared the previous human health risk assessment for
fluazinam, it did so on the assumption that ISK Biosciences might
resolve the data deficiencies in the near future.  As a result, all of
the hazard and risk characterizations associated with the use of
fluazinam on apple and carrot commodities as well as the potential risk
resulting from exposure through consumption of animal commodities were
discussed and accounted for in the previous human health risk assessment
prepared for the proposed uses (Memo, D365940, D. Dotson, et al.,
3/31/2010).  For all exposure scenarios, risk estimates were not of
concern to HED for the current and proposed uses of fluazinam.

Ingredient Profile

The ingredient profile for the proposed uses was discussed in the
previous human health risk assessment prepared for the proposed uses.

Hazard Characterization/Assessment, FQPA Considerations

There have been no changes to the hazard characterization, endpoint
selection, or FQPA assessment.

Dietary Exposure/Risk Characterization

Apple, carrot, and livestock commodities were included in the dietary
exposure assessment performed in support of the previous risk
assessment.  There are no changes in the inputs to the dietary exposure
assessments (i.e., the estimated drinking water concentrations, percent
crop treated estimates, etc.) or in the acute or chronic dietary risk
estimates.  The cRfD is protective of cancer effects.  The dietary risk
estimates for the current and proposed uses of fluazinam are not of
concern to HED.

Residential Exposure/Risk Characterization

There are no residential/non-occupational uses for fluazinam; therefore,
risk assessments for these types of uses are not needed.

Aggregate Risk Assessments,

As there are no changes to the dietary exposure estimates and there are
no residential uses, there are no changes in the aggregate exposure and
risk estimates.  The cRfD is protective of cancer effects.  The
aggregate risk estimates for the current and proposed uses of fluazinam
are not of concern to HED.

Occupational Exposure/Risk Pathway

Occupational exposures resulting from uses on apples and carrots were
assessed in the previous risk assessment.  The occupational risk
estimates for the current and proposed uses of fluazinam are not of
concern to HED.

Data Needs and Label Recommendations

With the exception of the multiresidue method testing data for the
regulated animal metabolites, AMPA and DAPA, ISK Biosciences has
resolved the data deficiencies associated with the apple and carrot
tolerance petitions.  There are no outstanding data deficiencies that
would preclude establishment of tolerances and conditional registration
for apple, carrot, and livestock commodities.  Although analyte-specific
methods are available for AMPA and DAPA in animal commodities,
multiresidue method testing data continue to be required for these
regulated animal metabolites.

For any future uses that involve major feed items and significantly
higher dietary burdens, more vigorous extraction steps might be required
in the method for kidney and liver along with radiovalidation data to
demonstrate improved extractability.

HED recommends that the tolerances specified in Table 1 be established,
and that the multiresidue methods testing data for AMPA and DAPA be made
a condition of registration.

The registrant needs to submit a revised Section F in which the
recommended tolerances and correct commodity definitions listed in Table
1 are proposed.

α,α,α-trifluoro-2-nitro-p-toluidino)-3-chloro-5-(trifluoromethyl)
pyridine), DAPA
(3-chloro-2-(2,6-diamino-3-chloro-α,α,α.-trifluoro-p-toluidino)-5-(tr
ifluoromethyl)-pyridine), and their sulfamate conjugates.”

Analytical Methodology

Tolerance Enforcement Method for Animal Commodities

In response to the deficiency cited in the analytical method for AMPA
and DAPA in liver and kidney, ISK submitted an analytical method
entitled “Enforcement Method for the Analysis of Fluazinam and its
Metabolites AMPA and DAPA in Milk and Meat (Document Number
IB-2009-JLW-005-01).”  ISK also submitted an ILV for this method.  The
method is written for LC/MS/MS analysis of fluazinam, AMPA, and DAPA and
their sulfamate conjugates in bovine liver, fat, and milk.  The reported
method LOQ was 0.01 ppm for each analyte in liver, fat, and milk.

HED concludes that ISK’s analytical method entitled “Enforcement
Method for the Analysis of Fluazinam and its Metabolites AMPA and DAPA
in Milk and Meat” is adequate as an enforcement method for residues of
fluazinam, AMPA, and DAPA and their sulfamate conjugates in kidney,
liver, and fat.  The method was successfully validated based on the
Series 860.1340 Residue Chemistry Guidelines in one attempt for
fluazinam, AMPA, and DAPA in beef kidney and beef liver.  The beef fat
method was validated after two attempts with minor modification of the
method after the first method trial.

Food Residue Profile

Residues in Meat, Milk, Poultry, and Eggs

Because of the potential for residues to be present in animal
commodities, ISK submitted a dairy cattle feeding study with the
original submission.  Based on the poor recoveries of metabolites AMPA
and DAPA from liver and kidney and the mixed storage stability results,
the residue data from the cattle feeding study were not adequate to
satisfy data requirements.  HED determined that, in order to support
tolerances for apples and carrots, the registrant needed to submit a new
cattle feeding study in which a method with better recoveries of AMPA
and DAPA from liver and kidney was used.

In lieu of submitting a new cattle feeding study, ISK Biosciences
submitted a rebuttal to the data deficiency (MRID 47746605).  The
rebuttal is entitled “Rebuttal Response to Upgrade Magnitude of
Fluazinam Residues in Bovine Tissues and Milk from a 28-Day Feeding
Study.”  ISK explained that liver and kidney are metabolic matrices,
and as a result, residues are unstable during storage, and recoveries
are low when samples are analyzed.

The poor storage stability of AMPA and DAPA in liver and kidney, the
poor recovery from these matrices when the feeding study was performed,
and the results of the depuration study all support ISK’s assertion
that liver and kidney are metabolic matrices that cause the rapid
decline of AMPA and DAPA residues.  HED agrees with ISK Biosciences that
another animal feeding study does not need to be performed.

HED previously determined that a tolerance of 0.05 ppm would be adequate
to cover residues in the fat and meat byproducts of cattle, goat, horse,
and sheep (Memo, D360840, D. Dotson, 3/31/2010).  As a result, HED
recommends in favor of the establishment of tolerances of 0.05 ppm for
the fat and meat byproducts of cattle, goat, horse, and sheep.

Processing Studies

HED originally concluded that the apple processing study was not
adequate to satisfy data requirements.  In apples, the metabolite AMGT
is a residue of concern for risk assessment.  AMGT is not a residue of
concern for tolerance expression, however.  In the processing study
there were no quantifiable residues of AMGT in raw apples.  In several
of the field trials that were performed, however, raw apples contained
AMGT residues at, or above, the limit of quantitation.  Of the 42 field
trial values, 32 were below the LOQ of 0.01 ppm, 6 were 0.01 ppm, 3 were
0.02 ppm, and 1 was 0.03 ppm.  Canadian and U.S. residue chemistry
guidelines state that in the processing study, if residues in the RAC
are below the LOQ, but quantifiable residues occurred in the RAC in
field trials performed at the maximum requested label rate, that the
processing study should be conducted at exaggerated rates in order to
ensure that quantifiable residues will be present in the RAC.
Quantifiable residues are needed in the RAC in order to determine a
reliable concentration factor.

HED requested that the processing study be repeated at a sufficiently
high rate that residues of both parent and AMGT would be quantifiable in
the RAC.  Instead of performing a new processing study, however, the
registrant submitted additional data from the initial study.  When the
laboratory personnel originally analyzed the samples, they did not
quantitate samples in which the AMGT residue levels were below the LOQ.
As a result, it was not possible to determine processing factors.  ISK
Biosciences submitted an amended report in which the residue levels that
were between the LOD and LOQ were measured.  As stated above, the LOQ
was 0.01 ppm.  The original electronic data were not saved by the
performing laboratory.  As a result, residues were quantitated by
manually measuring peak heights.

AMGT is not a residue of concern for tolerance expression.  As a result,
the results of the processing study are not relevant to tolerance
enforcement.  AMGT is a residue of concern for risk assessment, however.
 As a result, the results of the processing study have the potential to
affect the dietary risk estimates.

Although the peak heights for AMGT in raw apples and the processed
commodities were small, HED believes that they are large enough compared
to the noise level in the chromatograms that they can be quantitated to
2-significant figure accuracy by manually measuring peak heights.
Because of the small peak heights and the fact that the AMGT residue
levels are below the LOQ, there is a higher degree of uncertainty in the
processing factors for AMGT than there is for the parent.  Regardless,
the results for AMGT in apple pomace are comparable to those of the
parent.  That is, in juice and cider, both compounds were reduced,
whereas in wet pomace and dry pomace, residues concentrated slightly.
The processing factors that were determined are consistent with what
would be expected based on separation of apples into components.  In the
Dietary Exposure Evaluation Model (DEEM, Version 7.81), the maximum
theoretical concentration factor for apple juice is only 1.3x.  This
default factor is based on the assumption that when the juice is
expressed from raw apples, all of the pesticide partitions into the
juice.  This is why it’s considered to be a maximum concentration
factor.  The 860 Residue Chemistry Guidelines provide factors of 1.2,
1.4, and 2 for the juices of grapes, tomatoes, and citrus, respectively.
 The Guidelines also provide a value of >14x as the maximum theoretical
concentration factor for apples, based on observed values for apple
pomace.  Although there is a higher degree of uncertainty in the AMGT
processing factors than in the fluazinam processing factors, HED
believes that the AMGT processing factors are sufficiently precise for
risk assessment purposes.  The factors were determined to 2-significant
figure accuracy, and they are consistent with what would be expected
based on separation of apples into components.

The processed apple commodities that impact the dietary risk estimates
are wet apple pomace and apple juice.  Wet apple pomace is an animal
feed item.  A conservative tolerance level of 5.0 ppm was used to
calculate the maximum expected dietary burden.  AMGT is not a residue of
concern in animal commodities, though.  The only way it would affect the
dietary burden is if it gets metabolized to AMPA and DAPA.  However,
AMGT residues in field trials were so low that any AMPA or DAPA that
would form would be negligible.  As for apple juice, HED believes that
the processing factor was determined precisely enough that AMGT residues
could be completely accounted for in this commodity.  In the acute
dietary exposure analysis, the recommended tolerance of 2.0 ppm was used
for apple juice along with the DEEM default processing factor of 1.3x.
In the chronic dietary exposure analysis, the average combined
(fluazinam + AMGT) residue value of 0.215 ppm was used for apple juice
along with the DEEM default processing factor of 1.3x.  The default
value of 1.3x is a conservative estimate of residue concentration, as
discussed above.

For the reasons discussed above, HED concludes that the residue data for
fluazinam and AMGT in the submitted apple processing study are
acceptable.  Residues of fluazinam concentrated in wet pomace
(processing factor of 2.8x) and dry pomace (processing factor of 3.6x),
but did not concentrate in juice and cider (processing factor of <0.4x
each).  Residues of AMGT concentrated in wet pomace (processing factor
of 1.3x) and dry pomace (processing factor of <2.8x), but did not
concentrate in juice and cider (processing factors of 0.5x and 0.7x,
respectively).  The submitted data satisfy the deficiency cited in the
previous residue chemistry summary document and risk assessment.

The highest average field trial value for fluazinam was 1.54 ppm.
Multiplying this value by the wet pomace processing factor of 2.8x
yields a residue value of 4.3 ppm.  Based on this value, a tolerance of
5.0 ppm needs to be established for apple, wet pomace.  AMGT is not
included in the tolerance expression for apples.  As a result, AMGT
residues do not need to be accounted for in the tolerance.  A separate
tolerance is not needed for juice based on the fact that fluazinam
residues are lower in juice than they are in the RAC.  Although ISK
Biosciences submitted processing data for dry pomace and cider, the
Agency does not establish tolerances for these commodities.

Tolerance Harmonization

There are currently no established Codex, Canadian, or Mexican maximum
residue limits (MRLs) for fluazinam on apples or carrots.  These
tolerance petitions are being evaluated as a joint review with
Canada’s PMRA.  The USEPA and PMRA will be harmonizing the tolerances
for the apple and carrot commodities.  The recommended tolerance for
carrot, roots is 0.70 ppm.  The NAFTA-harmonized tolerance generator
directs that the tolerance for apple should be 1.5 ppm.  The USEPA and
PMRA have agreed to establish the tolerance at 2.0 ppm.  Canada does not
establish tolerances for livestock feed items.  As a result, only the
U.S. will be establishing a tolerance for apple, wet pomace.  The U.S.
is establishing tolerances of 0.05 ppm for the fat and meat byproducts
of cattle, goats, horses, and sheep.  Canada is not establishing
tolerances for livestock commodities.

Data Needs

With the exception of the multiresidue method testing data for the
regulated animal metabolites, AMPA and DAPA, ISK Biosciences has
resolved the data deficiencies associated with the apple and carrot
tolerance petitions.  There are no outstanding data deficiencies that
would preclude establishment of tolerances and conditional registration
for apple, carrot, and livestock commodities.  Although analyte-specific
methods are available for AMPA and DAPA in animal commodities,
multiresidue method testing data continue to be required for these
regulated animal metabolites.

The registrant needs to submit a revised Section F in which the
recommended tolerances and correct commodity definitions listed in Table
1 are proposed.

For any future uses that involve major feed items and significantly
higher dietary burdens, more vigorous extraction steps may be required
in the method for kidney and liver along with radiovalidation data to
demonstrate improved extractability.

Recommended Tolerances

Although the NAFTA-harmonized tolerance generator recommends a tolerance
of 1.5 ppm for apples, the USEPA and PMRA have agreed to establish the
tolerance at 2.0 ppm.  This increase is being made because in one of the
field trials, residue values were 1.31 and 1.49 ppm and in another field
trial, residues were 1.39 and 1.67 ppm.  These field trials were
performed in arid regions (Toppenish, Washington and Eckert, Colorado,
respectively).  The next highest field trial value after these four was
0.17 ppm.  The U.S. and Canada agreed that a tolerance of 2.0 ppm might
be needed to protect farmers who grow apples in arid regions.  Although
the NAFTA-harmonized tolerance generator recommends a tolerance of 1.5
ppm, the OECD tolerance generator recommends a tolerance of 2.0 ppm for
this same data set.  The recommended tolerance for apple, wet pomace is
5.0 ppm.  The recommended tolerance for carrot, roots is 0.70 ppm.

HED recommends in favor of the establishment of tolerances of 0.05 ppm
for the fat and meat byproducts of cattle, goats, horses, and sheep.
Although ISK Biosciences proposed tolerances of 0.03 ppm for the meat of
cattle, goat, horse, and sheep, these tolerances are not needed based on
the results of the cattle feeding study and the calculated dietary
burden for dairy cattle.  Although ISK Biosciences proposed tolerances
of 0.03 ppm for the liver and kidney of cattle, goat, horse, and sheep,
these tolerances are not needed either, because tolerances are being
established for the meat byproducts of cattle, goat, horse, and sheep.
HED’s Chemistry Science Advisory Council (ChemSAC) determined that
individual tolerances are not needed for liver and kidney when a
tolerance is being established for meat byproducts (ChemSAC Minutes,
7/18/2007).

The recommended tolerances and correct commodity definitions are listed
in Table 1.

HED recommends that 40CFR §180.574(a) be amended by adding the
following for the livestock commodity tolerances:  “Tolerances are
established for residues of fluazinam
(3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluor
omethyl)-2-pyridinamine), including its metabolites and degradates, in
or on the commodities in the table below.  Compliance with the tolerance
levels specified below is to be determined by measuring only fluazinam,
AMPA
(2-(6-amino-3-chloro-α,α,α-trifluoro-2-nitro-p-toluidino)-3-chloro-5-
(trifluoromethyl) pyridine), DAPA
(3-chloro-2-(2,6-diamino-3-chloro-α,α,α.-trifluoro-p-toluidino)-5-(tr
ifluoromethyl)pyridine), and their sulfamate conjugates.”

Table 1.  Tolerance Summary for Fluazinam.

Commodity	Proposed  Tolerance (ppm)	Recommended Tolerance (ppm)
Comments; Correct Commodity Definition

PP#9E7570

Carrot, roots	0.8	0.70	Adequate carrot residue data are available.  The
NAFTA-harmonized tolerance generator directs that the tolerance for this
data set should be 0.70 ppm.

PP#9F7571

Apples	1.7	2.0	Adequate apple residue data are available.  The
NAFTA-harmonized tolerance generator directs that the tolerance for this
data set should be 1.5 ppm.  The USEPA and PMRA agreed to establish the
tolerance at 2.0 ppm at such time as the data deficiencies were
resolved.

Apple

Apple, pomace, wet	5.0	5.0	Adequate apple processing data are available
for both fluazinam and AMGT.

Apple, wet pomace

Cattle, fat	0.03	0.05	An adequate cattle feeding study is available.
Based on the results of the study, the maximum expected residue in meat
byproducts and fat is 0.045 ppm.

Based on the results of the feeding study, tolerances are not needed for
milk and meat of cattle, goat, horse, and sheep.

Cattle, kidney	0.03	Not required

	Cattle, liver	0.03	Not required

	Cattle, meat	0.03	Not required

	Cattle, meat byproducts	0.03	0.05

	Goat, fat	0.03	0.05

	Goat, kidney	0.03	Not required

	Goat, liver	0.03	Not required

	Goat, meat	0.03	Not required

	Goat, meat byproducts	0.03	0.05

	Horse, fat	0.03	0.05

	Horse, kidney	0.03	Not required

	Horse, liver	0.03	Not required

	Horse, meat	0.03	Not required

	Horse, meat byproducts	0.03	0.05

	Milk	0.03	Not required

	Sheep, fat	0.03	0.05

	Sheep, kidney	0.03	Not required

	Sheep, liver	0.03	Not required

	Sheep, meat	0.03	Not required

	Sheep, meat byproducts	0.03	0.05

References

Fluazinam.  Human Health Risk Assessment for the Proposed Uses on
Apples, Carrots, Lettuce, and the Bulb Onion Subgroup (3-07A), and a
Request for a Reduced Tolerance on the Bushberry Subgroup (13-07B),
D365940, D. Dotson, et al., 3/31/2010

Fluazinam.  Petitions for the Establishment of Tolerances and
Registration of New Uses on Apples and Carrots.  HED’s Conclusions
Regarding Registrant’s Response to Data Deficiencies, D381302, D.
Dotson, 11/24/2010

Fluazinam.  Petitions for the Establishment of Tolerances and
Registration of New Uses on Apples, Carrots, Lettuce, and Bulb Onion
Subgroup (3-07A), and a Request for a Reduced Tolerance on Bushberry
Subgroup (13-07B).  Summary of Analytical Chemistry and Residue Data,
D360840, D. Dotson, 3/31/2010

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D374522, 3/31/2010

Fluazinam: Occupational and Residential Risk Assessment for Proposed Use
of Fluazinam on Apples, Carrots, Lettuce (Head and Leaf), and Onions
(Bulb), D371446, Z. Figueroa, 2/19/2010.

Page   PAGE  1  of   NUMPAGES  10


[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49393-49394]
[FR Doc No: 2017-23139]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2017-0219]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0078

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval for
reinstatement, without change, of the following collection of
information: 1625-0078, Credentialing and Manning Requirements for
Officers on Towing Vessels. Our ICR describes the information we seek
to collect from the public. Review and comments by OIRA ensure we only
impose paperwork burdens commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
November 24, 2017.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2017-0219] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email: [email protected].
    (2) Mail: OIRA, 725 17th Street NW., Washington, DC 20503,
attention Desk Officer for the Coast Guard.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr. Ave. SE., Stop 7710, Washington, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection. The Coast Guard invites comments on whether
this ICR should be granted based on the Collection being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the Collection; (2) the accuracy of the estimated burden of
the Collection; (3) ways to enhance the quality, utility, and clarity
of information subject to the Collection; and (4) ways to minimize the
burden of the Collection on respondents, including the use of automated
collection techniques or other forms of information technology. These
comments will help OIRA determine whether to approve the ICR referred
to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2017-0219], and must be received by November 24,
2017.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0078.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (82 FR 37461, August 10, 2017)
required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments.
Accordingly, no changes have been made to the Collections.

Information Collection Request

    Title: Credentialing and Manning Requirements for Officers on
Towing Vessels.
    OMB Control Number: 1625-0078.
    Summary: Credentialing and manning requirements ensure that towing
vessels operating on the navigable waters of the U.S. are under the
control of credentialed officers who meet certain qualification and
training standards.
    Need: Title 46 Code of Federal Regulations parts 10 and 11
prescribe regulations for the credentialing of maritime personnel. This
information collection is necessary to ensure that a mariner's training
information is available to assist in determining his or her overall
qualifications to hold certain credentials.
    Forms: None.
    Respondents: Owners and operators of towing vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from
15,869 hours to 18,635 hours a year due to an estimated increase in the
annual number of respondents.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: October 12, 2017.
James D. Roppel,
Acting Chief, Office of Information Management, U.S. Coast Guard.
[FR Doc. 2017-23139 Filed 10-24-17; 8:45 am]
 BILLING CODE 9110-04-P