Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents, 58721-58722 [2019-23934]
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Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Notices
Any routes of administration for all
drug classes are included.
• Bronchodilators
a. Beta-adrenergic receptor agonists:
Albuterol, arformoterol, formoterol,
indaceterol, levalbuterol,
olodaterol, terbutaline, vilanterol
b. Antimuscarinics: Aclidinium,
atropine, glycopyrrolate,
ipratropium, scopolamine,
tiotropium, umeclidinium
c. Methylxanthines: Theophylline,
aminophylline, caffeine
• Nebulized saline
• Corticosteroids: Beclomethasone,
betamethasone, budesonide,
ciclesonide, dexamethasone,
flunisolide, fluticasone,
hydrocortisone, methylprednisolone,
mometasone, prednisone
• Diuretics: Amiloride, bumetanide,
ethacrynic acid, furosemide,
hydrochlorothiazide, indapinide,
metolazone, spironolactone,
torsemide, triamterine
• Lidocaine
• Non-steroidal anti-inflammatory
agents: Celecoxib, diclofenac,
diflusinal, etodolac, fenoprofen,
flurbiprofen, ibuprofen,
indomethacin, ketoprofen, ketorolac,
meloxicam, nabumetone, naproxen,
oxaprozin, piroxicam, salsalate,
sulindac, tolmetin
• Phenothiazines: Promethazine,
prochlorperazine, chlorpromazine,
thioridazine
• Atypical antipsychotics: Aripiprazole,
asenapine, brexpiprazole, cariprazine,
clozapine, haloperidol, iloperidone,
lurasidone, olanzapine, paliperidone,
pimavanserin, quetiapine,
risperidone, ziprasidone
• Gamma-Aminobutyric acid (GABA)
analog anticonvulsants: Gabapentin,
pregabalin
• Opioids: Buprenorphine, codeine,
dihydrocodeine, fentanyl,
hydrocodone, hydromorphone,
methadone, morphine, oxycodone,
oxymorphone, tapentadol, tramadol
• Anxiolytics
a. Benzodiazepines: Alprazolam,
clonazepam, diazepam, lorazepam,
midazolam, oxazepam, temazepam
b. Serotonin-norepinephrine reuptake
inhibitors (SNRIs)/Selective
serotonin reuptake inhibitors
(SSRIs): Citalopram,
desvenlafaxine, duloxetine,
escitalopram, fluoxetine,
fluvoxamine, levomilnacipran,
milnacipran, paroxetine, sertraline,
venlafaxine
c. Other: Bupropion, buspirone,
mirtazapine
• Combinations of any of the above
VerDate Sep<11>2014
19:23 Oct 31, 2019
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Combinations of Nonpharmacologic
and Pharmacologic or Multimodal
Interventions
Comparators
• KQ 1: Placebo, usual care, other nonpharmacological intervention or a
combination of non-pharmacological
interventions
• KQ 2: Placebo, usual care, other
pharmacological intervention or dose
or route, or a combination of
pharmacological interventions
• KQ 3: Placebo, usual care, nonpharmacological interventions,
pharmacologic interventions, or
multimodal interventions (e.g.,
opioids versus respiratory training, or
acupuncture versus morphine versus
combination acupuncture and
morphine)
• KQ 4: Any of the comparators for KQ
1, KQ 2, or KQ 3
Outcomes
Patient- or Caregiver-Reported, or
Observational Symptom-Related
Outcomes (KQ1–3)
Caregiver-Reported or Observational
Symptom-Related Only if Patients are
Unable to Self-Report
• Gastrointestinal (constipation, nausea,
vomiting)
• Pruritus
• Urinary retention, dry mouth
• Opioid use disorder
• Discomfort or distress from
equipment, e.g., oxygen or masks
• Death
• Dropouts
Timing: Any Duration of Follow-up
Setting: Any Setting
Study Design: RCTs for all KQ
• For KQ1–3: RCTs, nonrandomized
controlled trials, and observational
studies with a concurrent comparison
group, with at least 10 patients in
each group
• For KQ 4: RCTs, nonrandomized
controlled trials, observational studies
with a concurrent comparison group,
and prospective or retrospective
cohort studies where the primary
objective of the study is to evaluate
harms from dyspnea treatments
Dated: October 28, 2019.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director,
AHRQ.
[FR Doc. 2019–23871 Filed 10–31–19; 8:45 am]
• Dyspnea as measured by a validated
tool, which must include patient- or
caregiver-reported or observational
symptom-related measures of
breathing difficulty or discomfort
• Anxiety as measured by a validated
tool. This tool must include patientor caregiver-reported measures of
anxiety
• Functional status (measured by
validated patient- or caregiverreported tool)
• Health-related quality of life (general
or disease-specific, measured by a
validated patient- or caregiverreported tool)
BILLING CODE 4160–90–P
Clinical or Utilization Health Outcomes
(KQ1–4)
AGENCY:
• Respiratory rate
• Oxygen or carbon dioxide/bicarbonate
levels
• Heart rate
• Blood pressure
• Objective measure of functional
capacity, e.g., 6-minute walk test
• Level of sedation
• Utilization outcomes linked to
dyspnea: hospitalizations, intensive
care unit stays, emergency room visits
ACTION:
Patient-Centered Adverse Effects of
Dyspnea Treatments (KQ4)
• Central nervous system (cognitive
changes, dizziness, drowsiness,
fatigue, headache, respiratory
depression)
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58721
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0977]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) 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.
DATES: Fax written comments on the
collection of information by December
2, 2019.
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–
SUMMARY:
E:\FR\FM\01NON1.SGM
01NON1
58722
Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Notices
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0312. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10 a.m.–12 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–8867, 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:
Regulations Restricting the Sale and
Distribution of Cigarettes and
Smokeless Tobacco To Protect Children
and Adolescents—21 CFR 1140.30
OMB Control Number 0910–0312—
Extension
This is a request for an extension of
OMB approval for the information
collection requirements contained in
FDA’s regulations for cigarettes and
smokeless tobacco containing nicotine.
The regulations that are codified at 21
CFR part 1140 are authorized by section
102 of the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31). Section
102 of the Tobacco Control Act required
FDA to publish a final rule regarding
cigarettes and smokeless tobacco
identical in its provisions to the
regulation issued by FDA in 1996 (61 FR
44396, August 28, 1996), with certain
specified exceptions including that
subpart C (which included 21 CFR
897.24) and 21 CFR 897.32(c) be
removed from the reissued rule (section
102(a)(2)(B)). The reissued final rule
was published in the Federal Register of
March 19, 2010 (75 FR 13225).
This collection includes reporting
information requirements for § 1140.30
(21 CFR 1140.30), which directs persons
to notify FDA if they intend to use a
form of advertising that is not addressed
in the regulations and not originally
described in the March 19, 2010, final
rule. Section 1140.30 requires
manufacturers, distributors, and
retailers to (1) observe certain format
and content requirements for labeling
and advertising and (2) notify FDA if
they intend to use an advertising
medium that is not listed in the
regulations. The concept of permitted
advertising in § 1140.30 is sufficiently
broad to encompass most forms of
advertising.
In the Federal Register of May 17,
2019 (84 FR 22496), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
that was PRA related. The commenter
stated that this program is ineffective
and has no effect on whether Americans
smoke. FDA disagrees. Section 1140.30
is intended to help protect children and
adolescents by reducing the appeal of
cigarettes and smokeless tobacco to
them. Section 1140.30, in part, contains
a comprehensive list of permissible
forms of advertising and labeling; in the
unlikely event that a person wishes to
use a form of advertising or labeling that
is not described in § 1140.30, the section
directs respondents to notify FDA of the
form of advertising or labeling they
intend to use.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
1140.30—Scope of permissible forms of labeling and advertising ............................................................................
1 There
Number of
responses per
respondent
25
Total annual
responses
1
25
Average
burden per
response
Total hours
1
25
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden hour estimates for this
collection of information were based on
industry-prepared data and information
regarding cigarette and smokeless
tobacco product advertising
expenditures.
FDA estimates that approximately 25
respondents will submit an annual
notice of alternative advertising, and the
Agency has estimated it should take 1
hour to provide such notice. Therefore,
FDA estimates that the total time
required for this collection of
information is 25 hours.
We have adjusted our burden estimate
to approximately 25 notifications
annually, which more accurately
reflects the current number of
submissions under this regulation. This
is a decrease to the currently approved
burden. The decrease in notifications is
not unexpected given that the regulation
applies to cigarettes and smokeless
tobacco and many of the alternative
media notifications have been made in
previous years.
VerDate Sep<11>2014
19:23 Oct 31, 2019
Jkt 250001
Dated: October 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23934 Filed 10–31–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–2982]
Determination That MEXITIL
(Mexiletine Hydrochloride) Capsules,
150 Milligrams, 200 Milligrams, and 250
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that MEXITIL
SUMMARY:
PO 00000
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(mexiletine hydrochloride) capsules,
150 milligrams (mg), 200 mg, and 250
mg, were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for MEXITIL
(mexiletine hydrochloride) capsules,
150 mg, 200 mg, and 250 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
Carlarease Hunter, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
796–3702, Carlarease.Hunter@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
E:\FR\FM\01NON1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Notices]
[Pages 58721-58722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23934]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0977]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco To Protect Children and Adolescents
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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.
DATES: Fax written comments on the collection of information by
December 2, 2019.
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-
[[Page 58722]]
395-7285, or emailed to [email protected]. All comments
should be identified with the OMB control number 0910-0312. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco To Protect Children and Adolescents--21 CFR 1140.30
OMB Control Number 0910-0312--Extension
This is a request for an extension of OMB approval for the
information collection requirements contained in FDA's regulations for
cigarettes and smokeless tobacco containing nicotine. The regulations
that are codified at 21 CFR part 1140 are authorized by section 102 of
the Family Smoking Prevention and Tobacco Control Act (Tobacco Control
Act) (Pub. L. 111-31). Section 102 of the Tobacco Control Act required
FDA to publish a final rule regarding cigarettes and smokeless tobacco
identical in its provisions to the regulation issued by FDA in 1996 (61
FR 44396, August 28, 1996), with certain specified exceptions including
that subpart C (which included 21 CFR 897.24) and 21 CFR 897.32(c) be
removed from the reissued rule (section 102(a)(2)(B)). The reissued
final rule was published in the Federal Register of March 19, 2010 (75
FR 13225).
This collection includes reporting information requirements for
Sec. 1140.30 (21 CFR 1140.30), which directs persons to notify FDA if
they intend to use a form of advertising that is not addressed in the
regulations and not originally described in the March 19, 2010, final
rule. Section 1140.30 requires manufacturers, distributors, and
retailers to (1) observe certain format and content requirements for
labeling and advertising and (2) notify FDA if they intend to use an
advertising medium that is not listed in the regulations. The concept
of permitted advertising in Sec. 1140.30 is sufficiently broad to
encompass most forms of advertising.
In the Federal Register of May 17, 2019 (84 FR 22496), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received that was PRA
related. The commenter stated that this program is ineffective and has
no effect on whether Americans smoke. FDA disagrees. Section 1140.30 is
intended to help protect children and adolescents by reducing the
appeal of cigarettes and smokeless tobacco to them. Section 1140.30, in
part, contains a comprehensive list of permissible forms of advertising
and labeling; in the unlikely event that a person wishes to use a form
of advertising or labeling that is not described in Sec. 1140.30, the
section directs respondents to notify FDA of the form of advertising or
labeling they intend to use.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
1140.30--Scope of permissible 25 1 25 1 25
forms of labeling and
advertising....................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden hour estimates for this collection of information were
based on industry-prepared data and information regarding cigarette and
smokeless tobacco product advertising expenditures.
FDA estimates that approximately 25 respondents will submit an
annual notice of alternative advertising, and the Agency has estimated
it should take 1 hour to provide such notice. Therefore, FDA estimates
that the total time required for this collection of information is 25
hours.
We have adjusted our burden estimate to approximately 25
notifications annually, which more accurately reflects the current
number of submissions under this regulation. This is a decrease to the
currently approved burden. The decrease in notifications is not
unexpected given that the regulation applies to cigarettes and
smokeless tobacco and many of the alternative media notifications have
been made in previous years.
Dated: October 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23934 Filed 10-31-19; 8:45 am]
BILLING CODE 4164-01-P
