Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Notices 58721

Any routes of administration for all Combinations of Nonpharmacologic • Gastrointestinal (constipation, nausea, drug classes are included. and Pharmacologic or Multimodal vomiting) • Bronchodilators Interventions • Pruritus • Urinary retention, dry mouth a. Beta-adrenergic receptor agonists: Comparators Albuterol, arformoterol, formoterol, • Opioid use disorder • indaceterol, levalbuterol, KQ 1: Placebo, usual care, other non- • Discomfort or distress from olodaterol, terbutaline, vilanterol pharmacological intervention or a equipment, e.g., oxygen or masks b. Antimuscarinics: Aclidinium, combination of non-pharmacological • Death atropine, glycopyrrolate, interventions • Dropouts • KQ 2: Placebo, usual care, other ipratropium, scopolamine, Timing: Any Duration of Follow-up tiotropium, umeclidinium pharmacological intervention or dose c. Methylxanthines: Theophylline, or route, or a combination of Setting: Any Setting pharmacological interventions aminophylline, caffeine • Study Design: RCTs for all KQ • KQ 3: Placebo, usual care, non- Nebulized saline • For KQ1–3: RCTs, nonrandomized • pharmacological interventions, Corticosteroids: Beclomethasone, pharmacologic interventions, or controlled trials, and observational betamethasone, budesonide, multimodal interventions (e.g., studies with a concurrent comparison ciclesonide, dexamethasone, opioids versus respiratory training, or group, with at least 10 patients in flunisolide, fluticasone, acupuncture versus morphine versus each group hydrocortisone, methylprednisolone, combination acupuncture and • For KQ 4: RCTs, nonrandomized mometasone, prednisone controlled trials, observational studies • morphine) Diuretics: Amiloride, bumetanide, • KQ 4: Any of the comparators for KQ with a concurrent comparison group, ethacrynic acid, furosemide, 1, KQ 2, or KQ 3 and prospective or retrospective hydrochlorothiazide, indapinide, cohort studies where the primary metolazone, spironolactone, Outcomes objective of the study is to evaluate torsemide, triamterine Patient- or Caregiver-Reported, or harms from dyspnea treatments • Lidocaine Observational Symptom-Related Dated: October 28, 2019. • Non-steroidal anti-inflammatory Outcomes (KQ1–3) Virginia L. Mackay-Smith, agents: Celecoxib, diclofenac, diflusinal, etodolac, fenoprofen, Caregiver-Reported or Observational Associate Director, Office of the Director, AHRQ. flurbiprofen, ibuprofen, Symptom-Related Only if Patients are indomethacin, ketoprofen, ketorolac, Unable to Self-Report [FR Doc. 2019–23871 Filed 10–31–19; 8:45 am] meloxicam, nabumetone, naproxen, • Dyspnea as measured by a validated BILLING CODE 4160–90–P oxaprozin, piroxicam, salsalate, tool, which must include patient- or sulindac, tolmetin caregiver-reported or observational DEPARTMENT OF HEALTH AND • symptom-related measures of Phenothiazines: Promethazine, HUMAN SERVICES prochlorperazine, chlorpromazine, breathing difficulty or discomfort • thioridazine Anxiety as measured by a validated Food and Drug Administration • Atypical antipsychotics: Aripiprazole, tool. This tool must include patient- asenapine, brexpiprazole, cariprazine, or caregiver-reported measures of [Docket No. FDA–2012–N–0977] clozapine, haloperidol, iloperidone, anxiety Agency Information Collection lurasidone, olanzapine, paliperidone, • Functional status (measured by Activities; Submission for Office of pimavanserin, quetiapine, validated patient- or caregiver- Management and Budget Review; risperidone, ziprasidone reported tool) • • Health-related quality of life (general Comment Request; Regulations Gamma-Aminobutyric acid (GABA) Restricting the Sale and Distribution of analog anticonvulsants: Gabapentin, or disease-specific, measured by a validated patient- or caregiver- Cigarettes and Smokeless Tobacco To pregabalin Protect Children and Adolescents • Opioids: Buprenorphine, codeine, reported tool) dihydrocodeine, fentanyl, Clinical or Utilization Health Outcomes AGENCY: Food and Drug Administration, hydrocodone, hydromorphone, (KQ1–4) HHS. methadone, morphine, oxycodone, • Respiratory rate ACTION: Notice. oxymorphone, tapentadol, tramadol • Oxygen or carbon dioxide/bicarbonate • Anxiolytics SUMMARY: The Food and Drug levels Administration (FDA) is announcing a. Benzodiazepines: Alprazolam, • Heart rate clonazepam, diazepam, lorazepam, • that a proposed collection of Blood pressure information has been submitted to the midazolam, oxazepam, temazepam • Objective measure of functional Office of Management and Budget b. Serotonin-norepinephrine reuptake capacity, e.g., 6-minute walk test (OMB) for review and clearance under inhibitors (SNRIs)/Selective • Level of sedation the Paperwork Reduction Act of 1995. serotonin reuptake inhibitors • Utilization outcomes linked to (SSRIs): Citalopram, dyspnea: hospitalizations, intensive DATES: Fax written comments on the desvenlafaxine, duloxetine, care unit stays, emergency room visits collection of information by December escitalopram, fluoxetine, 2, 2019. fluvoxamine, levomilnacipran, Patient-Centered Adverse Effects of ADDRESSES: To ensure that comments on milnacipran, paroxetine, sertraline, Dyspnea Treatments (KQ4) the information collection are received, venlafaxine • Central nervous system (cognitive OMB recommends that written c. Other: Bupropion, buspirone, changes, dizziness, drowsiness, comments be faxed to the Office of mirtazapine fatigue, headache, respiratory Information and Regulatory Affairs, • Combinations of any of the above depression) OMB, Attn: FDA Desk Officer, Fax: 202–

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395–7285, or emailed to oira_ FDA’s regulations for cigarettes and and advertising and (2) notify FDA if [email protected]. All smokeless tobacco containing nicotine. they intend to use an advertising comments should be identified with the The regulations that are codified at 21 medium that is not listed in the OMB control number 0910–0312. Also CFR part 1140 are authorized by section regulations. The concept of permitted include the FDA docket number found 102 of the Family Smoking Prevention advertising in § 1140.30 is sufficiently in brackets in the heading of this and Tobacco Control Act (Tobacco broad to encompass most forms of document. Control Act) (Pub. L. 111–31). Section advertising. 102 of the Tobacco Control Act required In the Federal Register of May 17, FOR FURTHER INFORMATION CONTACT: FDA to publish a final rule regarding Amber Sanford, Office of Operations, 2019 (84 FR 22496), FDA published a cigarettes and smokeless tobacco 60-day notice requesting public Food and Drug Administration, Three identical in its provisions to the White Flint North, 10 a.m.–12 p.m., comment on the proposed collection of regulation issued by FDA in 1996 (61 FR information. One comment was received 11601 Landsdown St., North Bethesda, 44396, August 28, 1996), with certain MD 20852, 301–796–8867, PRAStaff@ that was PRA related. The commenter specified exceptions including that stated that this program is ineffective fda.hhs.gov. subpart C (which included 21 CFR and has no effect on whether Americans 897.24) and 21 CFR 897.32(c) be SUPPLEMENTARY INFORMATION: In smoke. FDA disagrees. Section 1140.30 removed from the reissued rule (section compliance with 44 U.S.C. 3507, FDA is intended to help protect children and 102(a)(2)(B)). The reissued final rule has submitted the following proposed adolescents by reducing the appeal of was published in the Federal Register of collection of information to OMB for cigarettes and smokeless tobacco to review and clearance. March 19, 2010 (75 FR 13225). This collection includes reporting them. Section 1140.30, in part, contains Regulations Restricting the Sale and information requirements for § 1140.30 a comprehensive list of permissible Distribution of Cigarettes and (21 CFR 1140.30), which directs persons forms of advertising and labeling; in the Smokeless Tobacco To Protect Children to notify FDA if they intend to use a unlikely event that a person wishes to and Adolescents—21 CFR 1140.30 form of advertising that is not addressed use a form of advertising or labeling that in the regulations and not originally is not described in § 1140.30, the section OMB Control Number 0910–0312— directs respondents to notify FDA of the Extension described in the March 19, 2010, final rule. Section 1140.30 requires form of advertising or labeling they This is a request for an extension of manufacturers, distributors, and intend to use. OMB approval for the information retailers to (1) observe certain format FDA estimates the burden of this collection requirements contained in and content requirements for labeling collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response

1140.30—Scope of permissible forms of labeling and ad- vertising ...... 25 1 25 1 25 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden hour estimates for this Dated: October 23, 2019. (mexiletine hydrochloride) capsules, collection of information were based on Lowell J. Schiller, 150 milligrams (mg), 200 mg, and 250 industry-prepared data and information Principal Associate Commissioner for Policy. mg, were not withdrawn from sale for regarding cigarette and smokeless [FR Doc. 2019–23934 Filed 10–31–19; 8:45 am] reasons of safety or effectiveness. This tobacco product advertising BILLING CODE 4164–01–P determination will allow FDA to expenditures. approve abbreviated new drug FDA estimates that approximately 25 applications (ANDAs) for MEXITIL respondents will submit an annual DEPARTMENT OF HEALTH AND (mexiletine hydrochloride) capsules, notice of alternative advertising, and the HUMAN SERVICES 150 mg, 200 mg, and 250 mg, if all other Agency has estimated it should take 1 legal and regulatory requirements are hour to provide such notice. Therefore, Food and Drug Administration met. FDA estimates that the total time [Docket No. FDA–2019–P–2982] FOR FURTHER INFORMATION CONTACT: required for this collection of Carlarease Hunter, Center for Drug information is 25 hours. Determination That MEXITIL Evaluation and Research, Food and We have adjusted our burden estimate (Mexiletine Hydrochloride) Capsules, Drug Administration, 10903 New to approximately 25 notifications 150 Milligrams, 200 Milligrams, and 250 Hampshire Ave., Bldg. 51, Rm. 6213, annually, which more accurately Milligrams, Were Not Withdrawn From Silver Spring, MD 20993–0002, 301– reflects the current number of Sale for Reasons of Safety or 796–3702, Carlarease.Hunter@ submissions under this regulation. This Effectiveness fda.hhs.gov. is a decrease to the currently approved AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: In 1984, burden. The decrease in notifications is HHS. Congress enacted the Drug Price not unexpected given that the regulation ACTION: Notice. Competition and Patent Term applies to cigarettes and smokeless Restoration Act of 1984 (Pub. L. 98–417) tobacco and many of the alternative SUMMARY: The Food and Drug (the 1984 amendments), which media notifications have been made in Administration (FDA, Agency, or we) authorized the approval of duplicate previous years. has determined that MEXITIL versions of drug products under an

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