Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations, 27504-27508 [2017-12443]
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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
finished products). Therefore, the total
recordkeeping burden for domestic
facilities is estimated to be 9,061 hours
(13 hours × 697), and the total
recordkeeping burden for foreign
facilities is estimated to be 11,908 hours
(13 hours × 916), as shown in table 2.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12448 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2495]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Technical Electronic
Product Radiation Safety Standards
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for members to serve on
the Technical Electronic Product
Radiation Safety Standards Committee
(TEPRSSC) in the Center for Devices
and Radiological Health.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Nominations received on or
before August 14, 2017 will be given
first consideration for membership on
TEPRSSC. Nominations received after
August 14, 2017 will be considered for
nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by accessing FDA’s
Advisory Committee Membership
Nomination Portal at https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s Web site at https://
pmangrum on DSK3GDR082PROD with NOTICES
SUMMARY:
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www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Shanika Craig, Office of Device
Evaluation, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G644, Silver Spring,
MD 20993–0002, 301–796–6639, email:
Shanika.Craig@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on TEPRSSC that include two
general public representatives and a
government representative.
I. General Description of the
Committee’s Duties
The committee provides advice and
consultation to the Commissioner of
Food and Drugs (Commissioner) on the
technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products, and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
II. Criteria for Voting Members
The committee consists of a core of 15
voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of science or engineering,
applicable to electronic product
radiation safety. Members will be
invited to serve for overlapping terms of
up to 4 years. Terms of more than 2
years are contingent upon the renewal
of the committee by appropriate action
prior to its expiration.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the committee. Selfnominations are also accepted.
Nominations must include a current and
´
´
complete resume or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available. Nominations must also
specify the advisory committee for
which the nominee is recommended.
Nominations must also acknowledge
that the nominee is aware of the
nomination unless self-nominated. FDA
will ask potential candidates to provide
detailed information concerning such
matters related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
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U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12354 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1155]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Labeling
Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
SUMMARY:
Fax written comments on the
collection of information by July 17,
2017.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0381. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
pmangrum on DSK3GDR082PROD with NOTICES
Food Labeling Regulations—21 CFR
Parts 101, 102, 104, and 105
OMB Control Number 0910–0381—
Extension
Our food labeling regulations require
food producers to disclose to consumers
and others specific information about
themselves or their products on the
label or labeling of their products.
Related regulations require that food
producers retain records establishing
the basis for the information contained
in the label or labeling of their products
and provide those records to regulatory
officials. Finally, certain regulations
provide for the submission of food
labeling petitions to us. We issued our
food labeling regulations under parts
101, 102, 104, and 105 (21 CFR parts
101, 102, 104, and 105) under the
authority of sections 4, 5, and 6 of the
Fair Packaging and Labeling Act (the
FPLA) (15 U.S.C. 1453, 1454, and 1455)
and sections 201, 301, 402, 403, 409,
411, 701, and 721 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 321, 331, 342, 343, 348, 350,
371, and 379e). Most of these
regulations derive from section 403 of
the FD&C Act, which provides that a
food product shall be deemed to be
misbranded if, among other things, its
label or labeling fails to bear certain
required information concerning the
food product, is false or misleading in
any particular, or bears certain types of
unauthorized claims. The disclosure
requirements and other collections of
information in the regulations in parts
101, 102, 104, and 105 are necessary to
ensure that food products produced or
sold in the United States are in
compliance with the labeling provisions
of the FD&C Act and the FPLA.
Section 101.3 of our food labeling
regulations requires that the label of a
food product in packaged form bear a
statement of identity (i.e., the name of
the product), including, as appropriate,
the form of the food or the name of the
food imitated. Section 101.4 prescribes
requirements for the declaration of
ingredients on the label or labeling of
food products in packaged form. Section
101.5 requires that the label of a food
product in packaged form specify the
name and place of business of the
manufacturer, packer, or distributor
and, if the food producer is not the
manufacturer of the food product, its
connection with the food product.
Section 101.7 specifies requirements for
the declaration of the net quantity of
contents on the label of a food in
packaged form and prescribes
conditions under which a food whose
label does not accurately reflect the
actual quantity of contents may be sold,
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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
§§ 101.9 and 105.66 for the purpose of
conducting food labeling experiments
with our authorization. Section 101.9
requires that nutrition information be
provided for all food products intended
for human consumption and offered for
sale, unless an exemption in § 101.9(j)
applies to the product. In particular,
§ 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,
§ 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
§ 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 § 101.9 for any food product for
which a nutrient content claim is made.
Under some circumstances, § 101.13
also requires the disclosure of other
types of information as a condition for
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27505
the use of a nutrient content claim. For
example, under § 101.13(j), if the claim
compares the level of a nutrient in the
food with the level of the same nutrient
in another ‘‘reference’’ food, the claim
must also disclose the identity of the
reference food, the amount of the
nutrient in each food, and the
percentage or fractional amount by
which the amount of the nutrient in the
labeled food differs from the amount of
the nutrient in the reference food. It also
requires that when this comparison is
based on an average of food products,
this information must be provided to
consumers or regulatory officials upon
request. Section 101.13(q)(5) requires
that restaurants document and provide
to appropriate regulatory officials, upon
request, the basis for any nutrient
content claims they have made for the
foods they sell.
Section 101.14(d)(2) and (3) provides
for the disclosure of nutrition
information in accordance with § 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 § 101.36(h) applies. In
particular, § 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-
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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
references the provisions in § 101.9(g)(9)
for the submission to us of requests for
alternative approaches to nutrition
labeling requirements. Also,
§ 101.36(h)(2) cross-references the
provisions in § 101.9(j)(18) for the
submission of small business exemption
notices. As noted previously, we
developed Form FDA 3570 to assist
small businesses in claiming the small
business exemption from nutrition
labeling. The form contains all the
elements required by § 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
§ 101.45 contains guidelines for
providing such information. Also,
§ 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 (§ 101.4) and disclosure of
information concerning performance
characteristics (§ 101.13(d)). Section
101.69 provides for the submission of a
petition requesting that we authorize a
particular nutrient content claim by
regulation. Section 101.70 provides for
the submission of a petition requesting
that we authorize a particular health
claim by regulation. Section
101.77(c)(2)(ii)(D) requires the
disclosure of soluble fiber per serving in
the nutrition labeling of a food bearing
a health claim about the relationship
between soluble fiber and a reduced risk
of coronary heart disease. Section
101.79(c)(2)(iv) requires the disclosure
of the amount of folate in the nutrition
label of a food bearing a health claim
about the relationship between folate
and a reduced risk of neural tube
defects.
Section 101.100(d) provides that any
agreement that forms the basis for an
exemption from the labeling
requirements of section 403(c), (e), (g),
(h), (i), (k), and (q) of the FD&C Act be
in writing and that a copy of the
agreement be made available to us upon
request. Section 101.100 also contains
reporting and disclosure requirements
as conditions for claiming certain
labeling exemptions (e.g., 101.100(h)).
Regulations in part 102 define the
information that must be included as
part of the statement of identity for
particular foods and prescribe related
labeling requirements for some of these
foods. For example, § 102.22 requires
that the name of a protein hydrolysate
will include the identity of the food
source from which the protein was
derived.
Part 104, which pertains to nutritional
quality guidelines for foods, cross
references several labeling provisions in
part 101 but contains no separate
information collection requirements.
Part 105 contains special labeling
requirements for hypoallergenic foods,
infant foods, and certain foods
represented as useful in reducing or
maintaining body weight.
The purpose of our food labeling
requirements is to allow consumers to
be knowledgeable about the foods they
purchase. Nutrition labeling provides
information for use by consumers in
selecting a nutritious diet. Other
information enables a consumer to
comparison shop. Ingredient
information also enables consumers to
avoid substances to which they may be
sensitive. Petitions or other requests
submitted to us provide the basis for us
to permit new labeling statements or to
grant exemptions from certain labeling
requirements. Recordkeeping
requirements enable us to monitor the
basis upon which certain label
statements are made for food products
and whether those statements are in
compliance with the requirements of the
FD&C Act or the FPLA.
Description of Respondents:
Respondents to this information
collection are manufacturers, packers,
and distributors of food products.
Because of the existence of exemptions
and exceptions, not all of the
requirements apply to all food
producers or to all of their products.
Some of the regulations affect food
retailers, such as supermarkets and
restaurants.
In the Federal Register of December
30, 2016 (81 FR 96462), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. In this notice, FDA did not
accurately reflect amendments approved
in the final rule, technical amendments
for 21 CFR parts 1, 100, 101, and 104,
‘‘Food Labeling; Technical
Amendments,’’ dated August 29, 2016
(81 FR 59129), which changed section
101.105 to section 101.7. This has been
corrected in this notice. In addition,
FDA received two comments from the
60-day notice. One comment was not
related to the PRA and will not be
addressed here, and one comment was
PRA-related and is addressed in this
document.
(Comment) One commenter stated
that ensuring that food is labeled
accurately and correctly is important
because people should know exactly
what is inside of different foods.
Labeling food accurately and correctly
ensures no information about the food is
hidden because some people have
allergies, and people should be allowed
to provide feedback.
(Response) FDA agrees with this
comment, and this collection of
information reinforces that food should
be labeled accurately, with no hidden
ingredients, for the public’s health and
safety. In addition, the renewal of this
collection of information provides the
public the opportunity to comment and
provide feedback on this collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
respondents
pmangrum on DSK3GDR082PROD with NOTICES
21 CFR section/part
101.3, 101.22, 102, and 104; statement of identity labeling requirements ...
101.4, 101.22, 101.100, 102, 104 and 105; ingredient labeling requirements.
101.5; requirement to 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.
101.9, 101.13(n), 101.14(d)(3), 101.62, and 104; labeling requirements for
disclosure of nutrition information.
101.9(g)(9) and 101.36(f)(2); alternative means of compliance permitted ....
101.10; requirements for nutrition labeling of restaurant foods .....................
101.12(b); RACC for baking powder, baking soda and pectin ......................
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Number of
disclosures
per
respondent
Total annual
disclosures
Average burden
per disclosure
Total hours
25,000
25,000
1.03
1.03
25,750
25,750
.5 (30 minutes) .....
1 ...........................
12,875
25,750
25,000
1.03
25,750
.25 (15 minutes) ...
6,438
25,000
1.03
25,750
.40 (24 minutes) ...
103,000
12
300,000
29
1
1.5
2.3
12
450,000
67
4 ...........................
.25 (15 minutes) ...
1 ...........................
48
112,500
67
Sfmt 4703
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TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1—Continued
101.12(e); adjustment to the RACC of an aerated food permitted ...............
101.12(g); requirement to 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.
101.13(d)(1) and 101.67; requirements to disclose nutrition information for
any food product for which a nutrient content claim is made.
101.13(j)(2), 101.13(k), 101.54, 101.56, 101.60, 101.61, and 101.62; additional disclosure required if the nutrient content claim compares the level
of a nutrient in one food with the level of the same nutrient in another
food.
101.13(q)(5); requirement that restaurants disclose the basis for nutrient
content claims made for their food.
101.14(d)(2); general requirements for disclosure of nutrition information
related to health claims for food products.
101.15; requirements pertaining to prominence of required statements and
use of foreign language.
101.22(i)(4); supplier certifications for flavors designated as containing no
artificial flavors.
101.30 and 102.33; labeling requirements for fruit or vegetable juice beverages.
101.36; nutrition labeling of dietary supplements ..........................................
101.42 and 101.45; nutrition labeling of raw fruits, vegetables, and fish ......
101.45(c); databases of nutrient values for raw fruits, vegetables, and fish
101.79(c)(2)(i)(D); disclosure requirements for food labels that contain a
folate/neural tube defect health claim.
101.79(c)(2)(iv); disclosure of amount of folate for food labels that contain
a folate/neural tube defect health claim.
101.100(d); disclosure of agreements that form the basis for exemption
from the labeling requirements of section 403(c), (e), (g), (h), (i), (k), and
(q) of the FD&C Act.
101.7 and 101.100(h); disclosure requirements for food not accurately labeled for quantity of contents and for claiming certain labeling exemptions.
Total ........................................................................................................
1 There
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section/part
Total annual
disclosures
Average burden
per disclosure
Total hours
25
5,000
1
1
25
5,000
1 ...........................
1 ...........................
25
5,000
200
1
200
1 ...........................
200
5,000
1
5,000
1 ...........................
5,000
300,000
1.5
450,000
.75 (45 minutes) ...
337,500
300,000
1.5
450,000
.75 (45 minutes) ...
337,500
160
10
1,600
8 ...........................
12,800
25
1
25
1 ...........................
25
1,500
5
7,500
1 ...........................
7,500
300
1,000
5
1,000
40
1
4
1
12,000
1,000
20
1,000
4.025 ....................
.5 (30 minutes) .....
4 ...........................
.25 (15 minutes) ...
48,300
500
80
250
100
1
100
.25 (15 minutes) ...
25
1,000
1
1,000
1 ...........................
1,000
25,000
1.03
25,750
.5 (30 minutes) .....
12,875
........................
........................
........................
...............................
1,029,258
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
101.7(t); recordkeeping pertaining to disclosure requirements for food not
accurately labeled for quantity of contents.
101.12(e); recordkeeping to document the basis for density-adjusted
RACC.
101.13(q)(5); recordkeeping to document the basis for nutrient content
claims.
101.14(d)(2); recordkeeping to document nutrition information related to
health claims for food products.
101.22(i)(4); recordkeeping to document supplier certifications for flavors
designated as containing no artificial flavors.
101.100(d)(2); recordkeeping pertaining to agreements that form the basis
for an exemption from the labeling requirements of section 403(c), (e),
(g), (h), (i), (k), and (q) of the FD&C Act.
Total ........................................................................................................
1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section
Total
annual
records
Average
burden per
recordkeeping
Total hours
100
1
100
1 ...........................
100
25
1
25
1 ...........................
25
300,000
1.5
450,000
.75 (45 minutes) ...
337,500
300,000
1.5
450,000
.75 (45 minutes) ...
337,500
25
1
25
1 ...........................
25
1,000
1
1,000
1 ...........................
1,000
........................
........................
........................
...............................
676,150
There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
pmangrum on DSK3GDR082PROD with NOTICES
101.9(j)(18) and 101.36(h)(2); procedure for small business nutrition labeling
exemption notice using Form FDA 3570 ..........................................................
101.12(h); petitions to establish or amend a RACC .............................................
101.69; petitions for nutrient content claims .........................................................
101.70; petitions for health claims ........................................................................
101.108; written proposal for requesting temporary exemptions from certain
regulations for the purpose of conducting food labeling experiments ..............
Total ...............................................................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section/form No.
Total
annual
responses
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Total hours
10,000
5
3
5
1
1
1
1
10,000
5
3
5
8
80
25
80
80,000
400
75
400
1
1
1
40
40
........................
........................
........................
........................
80,915
are no capital costs or operating and maintenance costs associated with this collection of information.
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burden per
response
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The estimated annual third party
disclosure, recordkeeping, and reporting
burdens are based on our
communications with industry and our
knowledge of and experience with food
labeling and the submission of petitions
and requests to us.
We expect that the burden hours for
submissions under § 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 § 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
§ 101.108 in the next 3 years.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12443 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0487]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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
‘‘Generic Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery.’’
DATES: Submit either electronic or
written comments on the collection of
pmangrum on DSK3GDR082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
information by August 14, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 14,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 14, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
ADDRESSES: You may submit comments
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–0487 for ‘‘Generic Clearance for
the Collection of Qualitative Feedback
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
on Agency Service Delivery.’’ Received
comments, those filed in a timely
manner (see DATES), will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ 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 Division of Dockets
Management. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@fda.hhs.gov, 301–796–
8867.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
E:\FR\FM\15JNN1.SGM
15JNN1
]]>Agencies
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27504-27508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12443]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1155]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling
Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (PRA).
DATES: Fax written comments on the collection of information by July
17, 2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0381.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
[[Page 27505]]
Food Labeling Regulations--21 CFR Parts 101, 102, 104, and 105
OMB Control Number 0910-0381--Extension
Our food labeling regulations require food producers to disclose to
consumers and others specific information about themselves or their
products on the label or labeling of their products. Related
regulations require that food producers retain records establishing the
basis for the information contained in the label or labeling of their
products and provide those records to regulatory officials. Finally,
certain regulations provide for the submission of food labeling
petitions to us. We issued our food labeling regulations under parts
101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) under the
authority of sections 4, 5, and 6 of the Fair Packaging and Labeling
Act (the FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301,
402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350,
371, and 379e). Most of these regulations derive from section 403 of
the FD&C Act, which provides that a food product shall be deemed to be
misbranded if, among other things, its label or labeling fails to bear
certain required information concerning the food product, is false or
misleading in any particular, or bears certain types of unauthorized
claims. The disclosure requirements and other collections of
information in the regulations in parts 101, 102, 104, and 105 are
necessary to ensure that food products produced or sold in the United
States are in compliance with the labeling provisions of the FD&C Act
and the FPLA.
Section 101.3 of our food labeling regulations requires that the
label of a food product in packaged form bear a statement of identity
(i.e., the name of the product), including, as appropriate, the form of
the food or the name of the food imitated. Section 101.4 prescribes
requirements for the declaration of ingredients on the label or
labeling of food products in packaged form. Section 101.5 requires that
the label of a food product in packaged form specify the name and place
of business of the manufacturer, packer, or distributor and, if the
food producer is not the manufacturer of the food product, its
connection with the food product. Section 101.7 specifies requirements
for the declaration of the net quantity of contents on the label of a
food in packaged form and prescribes conditions under which a food
whose label does not accurately reflect the actual quantity of contents
may be sold, with appropriate disclosures, to an institution operated
by a Federal, State, or local government. Section 101.108 provides for
the submission to us of a written proposal requesting a temporary
exemption from certain requirements of Sec. Sec. 101.9 and 105.66 for
the purpose of conducting food labeling experiments with our
authorization. Section 101.9 requires that nutrition information be
provided for all food products intended for human consumption and
offered for sale, unless an exemption in Sec. 101.9(j) applies to the
product. In particular, Sec. 101.9(c)(2)(ii) requires that the amount
of trans fatty acids present in a food must be declared on the
nutrition label on a separate line immediately under the line for the
declaration of saturated fat. Section 101.9(g)(9) provides that
interested parties may submit to us requests for alternative approaches
to nutrition labeling requirements. Finally, Sec. 101.9(j)(18)
provides that firms claiming the small business exemption from
nutrition labeling must submit notice to us supporting their claim
exemption. We developed Form FDA 3570 to assist small businesses in
claiming the small business exemption from nutrition labeling. The form
contains all the elements required by Sec. 101.9(j)(18).
Section 101.10 requires that restaurants provide nutrition
information, upon request, for any food or meal for which a nutrient
content claim or health claim is made. Section 101.12(b) provides the
reference amount that is used for determining the serving sizes for
specific products, including baking powder, baking soda, and pectin.
Section 101.12(e) provides that a manufacturer that adjusts the
reference amount customarily consumed (RACC) of an aerated food for the
difference in density of the aerated food relative to the density of
the appropriate nonaerated reference food must be prepared to show us
detailed protocols and records of all data that were used to determine
the density-adjusted RACC. Section 101.12(g) requires that the label or
labeling of a food product disclose the serving size that is the basis
for a claim made for the product if the serving size on which the claim
is based differs from the RACC. Section 101.12(h) provides for the
submission of petitions requesting that we change the reference amounts
defined by regulation.
Section 101.13 requires that nutrition information be provided in
accordance with Sec. 101.9 for any food product for which a nutrient
content claim is made. Under some circumstances, Sec. 101.13 also
requires the disclosure of other types of information as a condition
for the use of a nutrient content claim. For example, under Sec.
101.13(j), if the claim compares the level of a nutrient in the food
with the level of the same nutrient in another ``reference'' food, the
claim must also disclose the identity of the reference food, the amount
of the nutrient in each food, and the percentage or fractional amount
by which the amount of the nutrient in the labeled food differs from
the amount of the nutrient in the reference food. It also requires that
when this comparison is based on an average of food products, this
information must be provided to consumers or regulatory officials upon
request. Section 101.13(q)(5) requires that restaurants document and
provide to appropriate regulatory officials, upon request, the basis
for any nutrient content claims they have made for the foods they sell.
Section 101.14(d)(2) and (3) provides for the disclosure of
nutrition information in accordance with Sec. 101.9 and, under some
circumstances, certain other information as a condition for making a
health claim for a food product. Section 101.15 provides that, if the
label of a food product contains any representation in a foreign
language, all words, statements, and other information required by or
under authority of the FD&C Act to appear on the label must appear in
both the foreign language and in English. Section 101.22 contains
labeling requirements for the disclosure of spices, flavorings,
colorings, and chemical preservatives in food products. Section
101.22(i)(4) sets forth disclosure and recordkeeping requirements
pertaining to certifications for flavors designated as containing no
artificial flavors. Section 101.30 specifies the conditions under which
a beverage that purports to contain any fruit or vegetable juice must
declare the percentage of juice present in the beverage and the manner
in which the declaration is to be made.
Section 101.36 requires that nutrition information be provided for
dietary supplements offered for sale, unless an exemption in Sec.
101.36(h) applies. In particular, Sec. 101.36(b)(2) requires that the
amount of trans fatty acids present in dietary supplements must be
declared on the nutrition label on a separate line immediately under
the line for the declaration of saturated fat. Section 101.36(e)
permits the voluntary declaration of the quantitative amount and the
percent of Daily Value of a dietary ingredient on a ``per day'' basis
in addition to the required ``per serving'' basis, if a dietary
supplement label recommends that the dietary supplement be consumed
more than once per day. Section 101.36(f)(2) cross-
[[Page 27506]]
references the provisions in Sec. 101.9(g)(9) for the submission to us
of requests for alternative approaches to nutrition labeling
requirements. Also, Sec. 101.36(h)(2) cross-references the provisions
in Sec. 101.9(j)(18) for the submission of small business exemption
notices. As noted previously, we developed Form FDA 3570 to assist
small businesses in claiming the small business exemption from
nutrition labeling. The form contains all the elements required by
Sec. 101.36(h)(2).
Section 101.42 requests that food retailers voluntarily provide
nutrition information for raw fruits, vegetables, and fish at the point
of purchase, and Sec. 101.45 contains guidelines for providing such
information. Also, Sec. 101.45(c) provides for the submission to us of
nutrient databases and proposed nutrition labeling values for raw
fruit, vegetables, and fish for review and approval.
Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify
information that must be disclosed as a condition for making particular
nutrient content claims. Section 101.67 provides for the use of
nutrient content claims for butter, and cross-references requirements
in other regulations for information declaration (Sec. 101.4) and
disclosure of information concerning performance characteristics (Sec.
101.13(d)). Section 101.69 provides for the submission of a petition
requesting that we authorize a particular nutrient content claim by
regulation. Section 101.70 provides for the submission of a petition
requesting that we authorize a particular health claim by regulation.
Section 101.77(c)(2)(ii)(D) requires the disclosure of soluble fiber
per serving in the nutrition labeling of a food bearing a health claim
about the relationship between soluble fiber and a reduced risk of
coronary heart disease. Section 101.79(c)(2)(iv) requires the
disclosure of the amount of folate in the nutrition label of a food
bearing a health claim about the relationship between folate and a
reduced risk of neural tube defects.
Section 101.100(d) provides that any agreement that forms the basis
for an exemption from the labeling requirements of section 403(c), (e),
(g), (h), (i), (k), and (q) of the FD&C Act be in writing and that a
copy of the agreement be made available to us upon request. Section
101.100 also contains reporting and disclosure requirements as
conditions for claiming certain labeling exemptions (e.g., 101.100(h)).
Regulations in part 102 define the information that must be
included as part of the statement of identity for particular foods and
prescribe related labeling requirements for some of these foods. For
example, Sec. 102.22 requires that the name of a protein hydrolysate
will include the identity of the food source from which the protein was
derived.
Part 104, which pertains to nutritional quality guidelines for
foods, cross references several labeling provisions in part 101 but
contains no separate information collection requirements.
Part 105 contains special labeling requirements for hypoallergenic
foods, infant foods, and certain foods represented as useful in
reducing or maintaining body weight.
The purpose of our food labeling requirements is to allow consumers
to be knowledgeable about the foods they purchase. Nutrition labeling
provides information for use by consumers in selecting a nutritious
diet. Other information enables a consumer to comparison shop.
Ingredient information also enables consumers to avoid substances to
which they may be sensitive. Petitions or other requests submitted to
us provide the basis for us to permit new labeling statements or to
grant exemptions from certain labeling requirements. Recordkeeping
requirements enable us to monitor the basis upon which certain label
statements are made for food products and whether those statements are
in compliance with the requirements of the FD&C Act or the FPLA.
Description of Respondents: Respondents to this information
collection are manufacturers, packers, and distributors of food
products. Because of the existence of exemptions and exceptions, not
all of the requirements apply to all food producers or to all of their
products. Some of the regulations affect food retailers, such as
supermarkets and restaurants.
In the Federal Register of December 30, 2016 (81 FR 96462), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. In this notice, FDA did not accurately
reflect amendments approved in the final rule, technical amendments for
21 CFR parts 1, 100, 101, and 104, ``Food Labeling; Technical
Amendments,'' dated August 29, 2016 (81 FR 59129), which changed
section 101.105 to section 101.7. This has been corrected in this
notice. In addition, FDA received two comments from the 60-day notice.
One comment was not related to the PRA and will not be addressed here,
and one comment was PRA-related and is addressed in this document.
(Comment) One commenter stated that ensuring that food is labeled
accurately and correctly is important because people should know
exactly what is inside of different foods. Labeling food accurately and
correctly ensures no information about the food is hidden because some
people have allergies, and people should be allowed to provide
feedback.
(Response) FDA agrees with this comment, and this collection of
information reinforces that food should be labeled accurately, with no
hidden ingredients, for the public's health and safety. In addition,
the renewal of this collection of information provides the public the
opportunity to comment and provide feedback on this collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual
21 CFR section/part respondents per disclosures Average burden per disclosure Total hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.3, 101.22, 102, and 104; statement of 25,000 1.03 25,750 .5 (30 minutes)........................ 12,875
identity labeling requirements.
101.4, 101.22, 101.100, 102, 104 and 105; 25,000 1.03 25,750 1...................................... 25,750
ingredient labeling requirements.
101.5; requirement to specify the name and 25,000 1.03 25,750 .25 (15 minutes)....................... 6,438
place of business of the manufacturer, packer,
or distributor and, if the food producer is
not the manufacturer of the food product, its
connection with the food product.
101.9, 101.13(n), 101.14(d)(3), 101.62, and 25,000 1.03 25,750 .40 (24 minutes)....................... 103,000
104; labeling requirements for disclosure of
nutrition information.
101.9(g)(9) and 101.36(f)(2); alternative means 12 1 12 4...................................... 48
of compliance permitted.
101.10; requirements for nutrition labeling of 300,000 1.5 450,000 .25 (15 minutes)....................... 112,500
restaurant foods.
101.12(b); RACC for baking powder, baking soda 29 2.3 67 1...................................... 67
and pectin.
[[Page 27507]]
101.12(e); adjustment to the RACC of an aerated 25 1 25 1...................................... 25
food permitted.
101.12(g); requirement to disclose the serving 5,000 1 5,000 1...................................... 5,000
size that is the basis for a claim made for
the product if the serving size on which the
claim is based differs from the RACC.
101.13(d)(1) and 101.67; requirements to 200 1 200 1...................................... 200
disclose nutrition information for any food
product for which a nutrient content claim is
made.
101.13(j)(2), 101.13(k), 101.54, 101.56, 5,000 1 5,000 1...................................... 5,000
101.60, 101.61, and 101.62; additional
disclosure required if the nutrient content
claim compares the level of a nutrient in one
food with the level of the same nutrient in
another food.
101.13(q)(5); requirement that restaurants 300,000 1.5 450,000 .75 (45 minutes)....................... 337,500
disclose the basis for nutrient content claims
made for their food.
101.14(d)(2); general requirements for 300,000 1.5 450,000 .75 (45 minutes)....................... 337,500
disclosure of nutrition information related to
health claims for food products.
101.15; requirements pertaining to prominence 160 10 1,600 8...................................... 12,800
of required statements and use of foreign
language.
101.22(i)(4); supplier certifications for 25 1 25 1...................................... 25
flavors designated as containing no artificial
flavors.
101.30 and 102.33; labeling requirements for 1,500 5 7,500 1...................................... 7,500
fruit or vegetable juice beverages.
101.36; nutrition labeling of dietary 300 40 12,000 4.025.................................. 48,300
supplements.
101.42 and 101.45; nutrition labeling of raw 1,000 1 1,000 .5 (30 minutes)........................ 500
fruits, vegetables, and fish.
101.45(c); databases of nutrient values for raw 5 4 20 4...................................... 80
fruits, vegetables, and fish.
101.79(c)(2)(i)(D); disclosure requirements for 1,000 1 1,000 .25 (15 minutes)....................... 250
food labels that contain a folate/neural tube
defect health claim.
101.79(c)(2)(iv); disclosure of amount of 100 1 100 .25 (15 minutes)....................... 25
folate for food labels that contain a folate/
neural tube defect health claim.
101.100(d); disclosure of agreements that form 1,000 1 1,000 1...................................... 1,000
the basis for exemption from the labeling
requirements of section 403(c), (e), (g), (h),
(i), (k), and (q) of the FD&C Act.
101.7 and 101.100(h); disclosure requirements 25,000 1.03 25,750 .5 (30 minutes)........................ 12,875
for food not accurately labeled for quantity
of contents and for claiming certain labeling
exemptions.
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. ....................................... 1,029,258
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.7(t); recordkeeping pertaining to 100 1 100 1...................................... 100
disclosure requirements for food not
accurately labeled for quantity of contents.
101.12(e); recordkeeping to document the basis 25 1 25 1...................................... 25
for density-adjusted RACC.
101.13(q)(5); recordkeeping to document the 300,000 1.5 450,000 .75 (45 minutes)....................... 337,500
basis for nutrient content claims.
101.14(d)(2); recordkeeping to document 300,000 1.5 450,000 .75 (45 minutes)....................... 337,500
nutrition information related to health claims
for food products.
101.22(i)(4); recordkeeping to document 25 1 25 1...................................... 25
supplier certifications for flavors designated
as containing no artificial flavors.
101.100(d)(2); recordkeeping pertaining to 1,000 1 1,000 1...................................... 1,000
agreements that form the basis for an
exemption from the labeling requirements of
section 403(c), (e), (g), (h), (i), (k), and
(q) of the FD&C Act.
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. ....................................... 676,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
101.9(j)(18) and 101.36(h)(2); 10,000 1 10,000 8 80,000
procedure for small business
nutrition labeling exemption
notice using Form FDA 3570.....
101.12(h); petitions to 5 1 5 80 400
establish or amend a RACC......
101.69; petitions for nutrient 3 1 3 25 75
content claims.................
101.70; petitions for health 5 1 5 80 400
claims.........................
101.108; written proposal for 1 1 1 40 40
requesting temporary exemptions
from certain regulations for
the purpose of conducting food
labeling experiments...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 80,915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 27508]]
The estimated annual third party disclosure, recordkeeping, and
reporting burdens are based on our communications with industry and our
knowledge of and experience with food labeling and the submission of
petitions and requests to us.
We expect that the burden hours for submissions under Sec. 101.108
will be insignificant. Section 101.108 was originally issued to provide
a procedure whereby we could grant exemptions from certain food
labeling requirements. Exemption petitions have infrequently been
submitted in the recent past; none have been submitted since
publication on January 6, 1993, of the final regulations implementing
section 403(q) and (r) of the FD&C Act. Thus, in order to maintain OMB
approval of Sec. 101.108 to accommodate the possibility that a food
producer may propose to conduct a labeling experiment on its own
initiative, we estimate that we will receive one or fewer submissions
under Sec. 101.108 in the next 3 years.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12443 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P
