Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 13288-13290 [2018-06154]
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Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
difference could lead to liability
concerns (e.g., for a pharmacy manager
who makes representations to an
outsourcing facility about how a drug
will be used) and scope of practice
concerns (if a doctor concludes he or
she should not be bound by the
representations).
FDA Response to Issue Two: For
certain drugs, one of the conditions to
qualify for exemptions under section
503B is that there is a change that
produces for an individual patient a
clinical difference, as determined by the
prescribing practitioner, between the
compounded drug and the comparable
approved drug. If a pharmacy manager
does not wish to document on the order
that such a drug will only be
administered after an appropriate
prescriber determination, the manager
could ask the prescriber to provide
documentation. If a prescriber, or
person able to make a representation for
a prescriber, refuses to confirm that a
compounded drug produces a clinical
difference for a patient, the
compounded drug may be considered
‘‘essentially a copy’’ of the
commercially-available product. The
outsourcing facility may decide in this
scenario to not compound the drug.
Issue Three: At least one commenter
recommended that the guidance
requires practitioners to provide
additional details regarding the patient
population in need of a compounded
drug as part of the prescriber
determination of clinical difference, and
that both a hospital and practitioner
should produce statements of clinical
difference.
FDA Response to Issue Three: FDA’s
draft guidance states that when an
outsourcing facility intends to rely on a
prescriber determination to establish
that a compounded drug is not
essentially a copy of an approved drug,
the outsourcing facility should ensure
that the determination is documented
on the prescription or order for the
compounded drug. This means the
determination is referenced in the
statute at section 503B(d)(2), which FDA
cannot change through guidance. FDA
cannot give exhaustive guidance
regarding what such documentation
may contain, but we did provide
appropriate examples. Under the
guidance, both a prescribing practitioner
and a person able to make a
representation for the practitioner, such
as, potentially, a hospital pharmacy
manager, would be able to produce a
statement of clinical difference.
Issue Four: At least one commenter
asked about the acceptability of specific
means of applying a determination
statement to a product order.
FDA Response to Issue Four: FDA
does not believe a particular format is
needed for a prescriber determination of
clinical difference, provided that the
determination clearly identifies the
relevant change made to the
compounded product and the clinical
difference that the change will produce
for patient(s), as determined by the
prescriber.
As none of the comments suggested
that we revise our estimated burden for
the information collection, we have
retained our original estimate as
follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Type of reporting recommendations in guidance
Number of
respondents
Consultation between the outsourcing facility and
prescriber or health care facility, and the notation
on the prescription or order documenting the prescriber’s determination of clinical difference.
Checking FDA’s drug shortage list and documenting
on the prescription that the drug is in shortage.
daltland on DSKBBV9HB2PROD with NOTICES
1 There
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
40
100
4,000
0.05 (3 minutes) .....
200
30
100
3,000
0.03 (2 minutes) .....
100
are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate that annually a total of
approximately 40 outsourcing facilities
(‘‘number of respondents’’ in table 1,
line 1) will consult a prescriber to
determine whether he or she has made
a determination that the compounded
drug has a change that produces a
clinical difference for an individual
patient as compared to the comparable
approved drug and that outsourcing
facilities will document this
determination on approximately 4,000
prescriptions or orders for compounded
drugs (‘‘total annual disclosures’’ in
table 1, line 1). We estimate that the
consultation between the outsourcing
facility and the prescriber or health care
facility contact adding a notation to
each prescription or order that does not
already document this determination
will take approximately 3 minutes per
prescription or order.
We estimate that a total of
approximately 30 outsourcing facilities
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(‘‘number of respondents’’ in table 1,
line 2) will document this information
on approximately 3,000 prescriptions or
orders for compounded drugs (‘‘total
annual disclosures’’ in table 1, line 2).
We estimate that checking FDA’s drug
shortage list and documenting this
information will take approximately 2
minutes per prescription or order.
Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06169 Filed 3–27–18; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6397]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Labeling;
Calorie Labeling of Articles of Food in
Vending Machines and Nutrition
Labeling of Standard Menu Items in
Restaurants and Similar Retail Food
Establishments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
SUMMARY:
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Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by April 27,
2018.
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 0910–0782. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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:
Calorie Labeling of Articles of Food in
Vending Machines and Nutrition
Labeling of Standard Menu Items in
Restaurants and Similar Retail Food
Establishments—21 CFR Part 101
OMB Control Numbers 0910–0782 and
0910–0783—Consolidation
This information collection supports
FDA regulations under 21 CFR 101. As
published in the Federal Register of
December 1, 2014 (79 FR 71156 and
71259), regulations at 21 CFR 101.8 and
101.11 were revised to provide for the
nutritional analysis of certain foods and
for the disclosure of that information on
applicable products purchased by
consumers. The regulations also provide
for the registration of certain individuals
who become subject to the
requirements, for which we developed
Form FDA 3757 entitled, ‘‘DHHS/FDA
Menu and Vending Machine Labeling
Voluntary Registration,’’ to assist
respondents in this regard. To keep the
registration active, respondents must
renew the registration every other year
within 60 days prior to the expiration of
the establishment’s current registration
with FDA, or it will automatically
expire.
In the Federal Register of December
12, 2017 (82 FR 58425), we published a
60-day notice requesting public
comment on the proposed information
13289
collection. A number of comments were
received in response to the notice. The
comments were generally supportive of
the information collection, but included
concerns about the potential effect the
ongoing or delayed rulemaking to
establish specific packaging
requirements (e.g., font-size of labeling,
compliance dates) might have on the
associated third-party disclosure
burden. Other comments questioned
whether FDA needed all data currently
being sought by the applicable
regulations and suggested the
registration schedule be relaxed,
especially given the small number of
respondents.
We are very appreciative of these
comments. At the same time, upon our
own review of the information
collection, we are seeking to consolidate
the burden currently approved under
OMB control number 0910–0783 with
0910–0782 because it is intended to
account for similar collection activities
and is supported by the same collection
instrument (Form FDA 3757) identified
above. Also, as neither the public
comments we received nor our own
evaluation suggested we revise our
original figures, we are retaining the
currently approved estimated burden for
the information collection, which is as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR 101.8 and 101.11
registration using form FDA 3757
Number of
responses
per
respondent
Number of
respondents
Total
annual
responses
§ 101.8(d); initial registration .............
§ 101.8(d); registration renewal ........
§ 101.11(d) initial registration ............
§ 101.11(d) registration reviewal .......
13
19
3,559
5,340
1
1
1
1
13
19
3,559
5,340
Total ...........................................
........................
........................
........................
1 There
Average burden per response
(in hours)
2
.5
2
.5
Total hours
.......................................................
(30 minutes) .................................
.......................................................
(30 minutes) .................................
26
9.5
7,118
2,670
...........................................................
9,823.5
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part 101
Annual
frequency
per
recordkeeper
Total
annual
records
Hours per record
Total hours
Initial Burden (Annualized over 3 years)
daltland on DSKBBV9HB2PROD with NOTICES
§ 101.8(c)(2)(i)(A);
analysis.
Initial
nutrition
69,017
1
69,017
.25 (15 minutes) ...............................
17,254
Annual Burden
§ 101.8(c)(2)(i)(A); Recurring nutrition analysis.
30,059
1
30,059
.25 (15 minutes) ...............................
7,515
Total ...........................................
........................
........................
........................
...........................................................
24,769
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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13290
Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR part 101
Total annual
disclosures
Average burden per disclosure
(in hours)
Total hours
§ 101.8(c)(2)(i); calorie analysis ........
§ 101.8(c)(2)(ii); calorie declaration
signage.
§ 101.8(e)(1); vending operator contact information.
282
3,279
11
2,122
3,102
6,958,038
1 .......................................................
.21 (12.5 minutes) ............................
3,102
1,461,188
3,279
125
409,875
.025 (1.5 minutes) ............................
10,247
Total ...........................................
........................
........................
........................
...........................................................
1,474,537
1 There
are no capital costs or operating and maintenance costs associated with the information collection.
These figures are based on our
analyses in support of the underlying
rulemaking cited above and there is no
burden increase since the previous OMB
approvals. Because these are newly
established information collection
provisions, we continue to evaluate the
collection burden and solicit public
comment, noting that the effective dates
and/or compliance dates for certain
provisions have not yet been realized.
Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06154 Filed 3–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and, (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: 2019 National Survey
on Drug Use and Health OMB No.
0930–0110—Revision
The National Survey on Drug Use and
Health (NSDUH) is a survey of the U.S.
civilian, non-institutionalized
population aged 12 years old or older.
The data are used to determine the
prevalence of use of tobacco products,
alcohol, illicit substances, and illicit use
of prescription drugs. The results are
used by SAMHSA, the Office of
National Drug Control Policy (ONDCP),
federal government agencies, and other
organizations and researchers to
establish policy, to direct program
activities, and to better allocate
resources.
While NSDUH must be updated
periodically to reflect changing
substance use and mental health issues,
and to continue producing current data,
only the following minor changes are
planned for the 2019 NSDUH: (1)
Adding a brief series of questions on
medication-assisted treatment (MAT) for
opioids and alcohol; and, (2) including
other minor wording changes to
improve the flow of the interview, to
increase respondent comprehension, or
to be consistent with text in other
questions.
The series of MAT questions seeks to
identify medications prescribed by
health professionals to help reduce or
stop the use of opioids and alcohol.
Including these questions in NSDUH
will allow SAMHSA to provide the first
known national-level estimates on the
use of MAT for opioid use disorder and
alcohol use disorder.
As with all NSDUH surveys
conducted since 1999, including those
prior to 2002 when the NSDUH was
referred to as the National Household
Survey on Drug Abuse, the sample size
of the survey for 2019 will be sufficient
to permit prevalence estimates for each
of the 50 states and the District of
Columbia. The total annual burden
estimate is shown below in Table 1.
TABLE 1—ANNUALIZED ESTIMATED BURDEN FOR 2019 NSDUH
Number of
respondents
daltland on DSKBBV9HB2PROD with NOTICES
Instrument
Responses
per
respondent
Total number
of responses
Hours per
response
Total burden
hours
Household Screening ...........................................................
Interview ...............................................................................
Screening Verification ..........................................................
Interview Verification ............................................................
137,231
67,507
4,116
10,126
1
1
1
1
137,231
67,507
4,116
10,126
0.083
1.000
0.067
0.067
11,390
67,507
276
678
Total ..............................................................................
137,231
........................
218,980
........................
79,851
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
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Room 15E57B, 5600 Fishers Lane,
PO 00000
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Sfmt 4703
Rockville, MD 20857 OR email a copy
to summer.king@samhsa.hhs.gov.
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]]>Agencies
[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13288-13290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06154]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6397]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling;
Calorie Labeling of Articles of Food in Vending Machines and Nutrition
Labeling of Standard Menu Items in Restaurants and Similar Retail Food
Establishments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget
[[Page 13289]]
(OMB) for review and clearance under the Paperwork Reduction Act of
1995.
DATES: Fax written comments on the collection of information by April
27, 2018.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0782.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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.
Calorie Labeling of Articles of Food in Vending Machines and Nutrition
Labeling of Standard Menu Items in Restaurants and Similar Retail Food
Establishments--21 CFR Part 101
OMB Control Numbers 0910-0782 and 0910-0783--Consolidation
This information collection supports FDA regulations under 21 CFR
101. As published in the Federal Register of December 1, 2014 (79 FR
71156 and 71259), regulations at 21 CFR 101.8 and 101.11 were revised
to provide for the nutritional analysis of certain foods and for the
disclosure of that information on applicable products purchased by
consumers. The regulations also provide for the registration of certain
individuals who become subject to the requirements, for which we
developed Form FDA 3757 entitled, ``DHHS/FDA Menu and Vending Machine
Labeling Voluntary Registration,'' to assist respondents in this
regard. To keep the registration active, respondents must renew the
registration every other year within 60 days prior to the expiration of
the establishment's current registration with FDA, or it will
automatically expire.
In the Federal Register of December 12, 2017 (82 FR 58425), we
published a 60-day notice requesting public comment on the proposed
information collection. A number of comments were received in response
to the notice. The comments were generally supportive of the
information collection, but included concerns about the potential
effect the ongoing or delayed rulemaking to establish specific
packaging requirements (e.g., font-size of labeling, compliance dates)
might have on the associated third-party disclosure burden. Other
comments questioned whether FDA needed all data currently being sought
by the applicable regulations and suggested the registration schedule
be relaxed, especially given the small number of respondents.
We are very appreciative of these comments. At the same time, upon
our own review of the information collection, we are seeking to
consolidate the burden currently approved under OMB control number
0910-0783 with 0910-0782 because it is intended to account for similar
collection activities and is supported by the same collection
instrument (Form FDA 3757) identified above. Also, as neither the
public comments we received nor our own evaluation suggested we revise
our original figures, we are retaining the currently approved estimated
burden for the information collection, which is as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
21 CFR 101.8 and 101.11 Number of Average burden
registration using form FDA Number of responses per Total annual per response (in Total hours
3757 respondents respondent responses hours)
----------------------------------------------------------------------------------------------------------------
Sec. 101.8(d); initial 13 1 13 2............... 26
registration.
Sec. 101.8(d); registration 19 1 19 .5 (30 minutes). 9.5
renewal.
Sec. 101.11(d) initial 3,559 1 3,559 2............... 7,118
registration.
Sec. 101.11(d) registration 5,340 1 5,340 .5 (30 minutes). 2,670
reviewal.
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 9,823.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR part 101 Number of frequency per Total annual Hours per record Total hours
recordkeepers recordkeeper records
----------------------------------------------------------------------------------------------------------------
Initial Burden (Annualized over 3 years)
----------------------------------------------------------------------------------------------------------------
Sec. 101.8(c)(2)(i)(A); 69,017 1 69,017 .25 (15 minutes) 17,254
Initial nutrition analysis.
----------------------------------------------------------------------------------------------------------------
Annual Burden
----------------------------------------------------------------------------------------------------------------
Sec. 101.8(c)(2)(i)(A); 30,059 1 30,059 .25 (15 minutes) 7,515
Recurring nutrition analysis.
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 24,769
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 13290]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part 101 Number of disclosures Total annual per disclosure Total hours
respondents per respondent disclosures (in hours)
----------------------------------------------------------------------------------------------------------------
Sec. 101.8(c)(2)(i); calorie 282 11 3,102 1............... 3,102
analysis.
Sec. 101.8(c)(2)(ii); 3,279 2,122 6,958,038 .21 (12.5 1,461,188
calorie declaration signage. minutes).
Sec. 101.8(e)(1); vending 3,279 125 409,875 .025 (1.5 10,247
operator contact information. minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 1,474,537
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
These figures are based on our analyses in support of the
underlying rulemaking cited above and there is no burden increase since
the previous OMB approvals. Because these are newly established
information collection provisions, we continue to evaluate the
collection burden and solicit public comment, noting that the effective
dates and/or compliance dates for certain provisions have not yet been
realized.
Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06154 Filed 3-27-18; 8:45 am]
BILLING CODE 4164-01-P
