Supplemental Evidence and Data Request on Management of Primary Headache During Pregnancy, 64523-64527 [2019-25414]

Download as PDF Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices FEDERAL COMMUNICATIONS COMMISSION FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies Radio Broadcasting Services; AM or FM Proposals To Change the Community of License Federal Communications Commission. AGENCY: ACTION: Notice. The agency must receive comments on or before January 21, 2020. DATES: Federal Communications Commission, 445 12th Street SW, Washington, DC 20554. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Rolanda F. Smith, 202–418–2054. The following applicants filed AM or FM proposals to change the community of license: OMNI BROADCASTING, LLC, WTKP(FM), Fac. ID No. 67579, Channel 229C3, From: YOUNGSTOWN, FL, To: PORT ST. JOE, FL, File No. 0000082907; SUN MEDIA, INC., WJLI(FM), Fac. ID No. 63817, Channel 252C1, From: PADUCAH, KY, To: METROPOLIS, IL, File No. 0000082340; HI-LINE RADIO FELLOWSHIP INC., KZLM(FM), Fac. 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The full text of these applications is available for inspection and copying during normal business hours in the Commission’s Reference Center, 445 12th Street SW, Washington, DC 20554 or electronically via the Media Bureau’s Consolidated Data Base System, http:// licensing.fcc.gov/prod/cdbs/pubacc/ prod/app_sear.htm. and the Licensing and Management System (LMS), https:// apps2int.fcc.gov/dataentry/public/tv/ publicAppSearch.html. khammond on DSKJM1Z7X2PROD with NOTICES SUPPLEMENTARY INFORMATION: The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. 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[FR Doc. 2019–25396 Filed 11–21–19; 8:45 am] BILLING CODE 6712–01–P VerDate Sep<11>2014 16:57 Nov 21, 2019 Jkt 250001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 64523 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Management of Primary Headache During Pregnancy Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for supplemental evidence and data submissions. AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Management of Primary Headache during Pregnancy, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. DATES: Submission Deadline on or before 30 days after date of publication. ADDRESSES: Email submissions: epc@ ahrq.hhs.gov. Print submissions: Mailing Address: Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857. Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857. SUMMARY: FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301–427–1496 or Email: epc@ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence Management of Primary Headache during Pregnancy. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies E:\FR\FM\22NON1.SGM 22NON1 khammond on DSKJM1Z7X2PROD with NOTICES 64524 Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices conducted). We are looking for studies that report on Management of Primary Headache during Pregnancy, including those that describe adverse events. The entire research protocol is available online at: https://effective healthcare.ahrq.gov/products/ headaches-pregnancy/protocol. This is to notify the public that the EPC Program would find the following information on Management of Primary Headache during Pregnancy helpful: D A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number. D For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements: Study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results. D A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. D Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file. Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. The draft of this review will be posted on AHRQ’s EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://www.effective healthcare.ahrq.gov/email-updates. The systematic review will answer the following questions. This information is VerDate Sep<11>2014 16:57 Nov 21, 2019 Jkt 250001 provided as background. AHRQ is not requesting that the public provide answers to these questions. Key Questions (KQ) KQ 1: What are the (comparative) benefits and harms of interventions to prevent attacks of primary headache in women who are pregnant (or attempting to become pregnant), postpartum, or breastfeeding? KQ 1a. Do the (comparative) benefits and harms vary by phase (i.e., preconception, first trimester of pregnancy, second trimester of pregnancy, third trimester of pregnancy, postpartum, breastfeeding)? KQ 1b. Do the (comparative) benefits and harms vary by type of primary headache (i.e., migraine, tension headache, cluster headache, and other trigeminal autonomic cephalgias)? KQ 2: What are the (comparative) benefits and harms of interventions to treat acute attacks of primary headache in women who are pregnant (or attempting to become pregnant), postpartum, or breastfeeding? KQ 2a. Do the (comparative) benefits and harms vary by phase (i.e., preconception, first trimester of pregnancy, second trimester of pregnancy, third trimester of pregnancy, postpartum, breastfeeding)? KQ 2b. Do the (comparative) benefits and harms vary by type of primary headache (i.e., migraine, tension headache, cluster headache, and other trigeminal autonomic cephalgias)? Contextual Question What is the available evidence concerning levels in maternal serum/ blood, fetal/infant serum/blood, breast milk, amniotic fluid, meconium, cord blood, or child urine of drugs used to prevent or treat attacks of primary headache in women who are pregnant (or attempting to become pregnant), postpartum, or breastfeeding? Study Eligibility Criteria We had discussions with a Technical Expert Panel (TEP) during which we reviewed the specific eligibility criteria. As part of the discussions, we asked the TEP to provide guidance on prioritizing outcomes and selecting among harms/ adverse events of interest. KQ 1 (Prevention of Primary Headache) Population(s): • Women who are pregnant (or attempting to become pregnant/in the preconception phase), postpartum (defined as up to 12 months postdelivery), or breastfeeding (for any length of time) with history of primary headache PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 Æ Migraine, tension headache, cluster headache or other trigeminal autonomic cephalgia (TACs) Æ Women attempting to become pregnant include those actively planning pregnancy, by any method, who may wish to use only treatments found to be safe and effective during pregnancy. • Exclude: Women with history of secondary headache of any origin Interventions: • Pharmacologic interventions Æ Tricyclic antidepressants (e.g., amitriptyline, nortriptyline, imipramine) Æ Beta blockers (e.g., metoprolol, propranolol, nadolol, atenolol, timolol, nebivolol) Æ Calcium channel blockers (e.g., verapamil, nimodipine, nifedipine, nicardipine) Æ Other antihypertensive medications (e.g., lisinopril, candesartan, clonidine) Æ Antiepileptic drugs (e.g., divalproex sodium, sodium valproate, valproic acid, topiramate, gabapentin, carbamazepine, lamotrigine) Æ Serotonin and norepinephrine reuptake inhibitors (SSNRIs) (e.g., venlafaxine, duloxetine) Æ Benzodiazepines (e.g., clonazepam) Æ N-methyl-D-aspartate (NMDA) receptor antagonists (e.g., memantine) Æ Calcitonin gene-related peptide (CGRP) inhibitors (e.g., erenumab, fremanezumab, galcanezumab) Æ Antihistamines (e.g., cyproheptadine) Æ Antimanic agents (e.g., lithium) Æ Tetracyclic antidepressants (e.g., mirtazapine) Æ Corticosteroids (e.g., methylprednisolone, triamcinolone acetonide, combinations of local anesthetics and corticosteroids) Æ Other pharmacologic interventions used to prevent primary headache (whether or not available or approved in the United States) • Non-pharmacologic interventions Æ Supplements (e.g., riboflavin, magnesium, coenzyme Q10, melatonin, feverfew, butterbur, frankincense) Æ Nerve blocks (e.g., occipital nerve blocks, sphenopalantine ganglion blocks, trigger point injections) Æ Chemodenervation (e.g., onabotulinum toxin A, abobotulinum toxin A) Æ Physical therapy Æ Hydration Æ Noninvasive neuromodulation devices (e.g., transcutaneous E:\FR\FM\22NON1.SGM 22NON1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices electrical nerve stimulation, transcranial magnetic stimulation, transcutaneous vagal stimulation, remote electrical neurostimulation) Æ Behavioral therapy (e.g., cognitive behavioral therapy, diet therapy, sleep therapy, exercise therapy, support group therapy) Æ Complementary therapies (e.g., biofeedback, acupuncture, mindfulness-based stress reduction) Æ Other non-pharmacologic interventions used to prevent primary headache Comparators: • Pharmacologic interventions Æ Other class Æ Other drug within class Æ Same drug(s), different route, treatment duration, initiation time, or other aspect Æ As comparator to nonpharmacologic intervention • Nonpharmacologic interventions Æ Other nonpharmacologic intervention class Æ Other nonpharmacologic intervention, within class Æ As comparator to pharmacologic intervention • No pharmacologic or nonpharmacologic interventions Æ Placebo Æ No intervention Outcomes: (* denotes important outcomes that will be used when developing Strength of Evidence tables) • Acute headache attacks* Æ Occurrence of acute headache attacks Æ Frequency of acute headache attacks Æ Severity of acute headache attacks Æ Duration of acute headache attacks • Headache-related symptoms (e.g., nausea/vomiting, photosensitivity, dizziness)* Æ Occurrence of headache-related symptoms Æ Frequency of headache-related symptoms Æ Severity of headache-related symptoms Æ Duration of headache-related symptoms Æ Most bothersome symptom • Emergency department visits, clinic visits, or hospitalizations* • Quality of life* • Functional outcomes Æ Impact on family life Æ Employment/school attendance Æ Time spent managing disease • Resource use • Acceptability of intervention by patients • Patient satisfaction with intervention • Number of prescribed medications VerDate Sep<11>2014 16:57 Nov 21, 2019 Jkt 250001 • Number of days with acute medication use • Adverse events Æ Maternal D Serious maternal adverse events* • ‘‘Serious’’ adverse events (including those that are composite outcomes), as defined by study authors • Cardiovascular outcomes, such as stroke, myocardial infarction D Non-serious maternal adverse events • Nonobstetrical (e.g., maternal weight gain, tachycardia, hypertension, gastrointestinal) • Preterm labor, cesarean section • Reduced breast milk production • Symptoms related to withdrawal of medication D Discontinuation of intervention (or of study participation) due to maternal adverse events* Æ Fetal/infant D Serious fetal/infant adverse events* • ‘‘Serious’’ adverse events (including those that are composite outcomes), as defined by study authors • Death—spontaneous abortion, stillbirth, infant death • Preterm birth • Low birth weight for gestational age • Congenital anomalies or other newborn abnormalities • Perinatal complications, e.g., low APGAR score, respiratory distress, neonatal intensive care unit time • Neurodevelopmental—social, emotional, or cognitive delay or disability D Non-serious fetal/infant adverse events • Breastfeeding—delayed initiation, cessation, reduced frequency, reduced volume of breast milk • Poor infant attachment/bonding • Symptoms related to withdrawal of medication D Discontinuation of intervention (or of study participation) due to fetal/ infant adverse events* Potential Modifiers: • Phase Æ Preconception Æ First trimester Æ Second trimester Æ Third trimester Æ Postpartum Æ Breastfeeding • Type of primary headache Æ Migraine Æ Tension headache Æ Cluster headache Æ Other TACs Timing: • Any Setting: • Any PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 64525 Design: • Randomized controlled trials • Nonrandomized comparative studies, including pre-post studies • Single group studies • N-of-1 studies • Case-control studies • Case reports or series of case reports • Cross-sectional studies/surveys Æ Prospective or retrospective (all applicable study types) • For harms, we will start by searching for existing systematic reviews of interventions used during pregnancy, postpartum, or breastfeeding, regardless of their indication (i.e., for any disease/condition, not only primary headaches). We will not enforce a date restriction when screening for eligible systematic reviews, but when multiple eligible systematic reviews exist for a certain drug/class of drugs, we will use the most recent or most complete one. Æ We will subsequently search for, and include, large primary studies of interventions not adequately covered by the existing systematic reviews of harms. The specific eligibility criteria (particularly pertaining to study design, minimum sample size, and publication date) will be determined based on available EPC resources, the number of interventions without adequate existing systematic reviews, and the volume of potentially eligible studies. Æ For harms, we will also search the U.S. Food and Drug Administration, other international equivalent agencies, and pharmacopoeia. KQ 2 (Treatment of Primary Headache) Population(s): • Women who are pregnant (or attempting to become pregnant/in the preconception phase), postpartum (defined as up to 12 months postdelivery), or breastfeeding (for any length of time) with acute attacks of primary headache Æ Migraine, tension headache, cluster headache, or other trigeminal autonomic cephalgia (TACs) Æ Women attempting to become pregnant include those actively planning pregnancy, by any method, who may wish to use only treatments found to be safe and effective during pregnancy. • Exclude: Women with attacks of secondary headache of any origin Interventions: • Pharmacologic interventions Æ Analgesics/antipyretics (e.g., acetaminophen) E:\FR\FM\22NON1.SGM 22NON1 khammond on DSKJM1Z7X2PROD with NOTICES 64526 Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices Æ Nonsteroidal antiinflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, aspirin, celecoxib, ketorolac, indomethacin, ketoprofen, diclofenac, mefenamic acid) Æ Other over-the-counter analgesics (e.g., combination aspirin, acetaminophen, and caffeine; combination acetaminophen, isometheptene, and dichloralphenazone) Æ Antiemetics: dopamine receptor antagonists (e.g., metoclopramide, promethazine, prochlorperazine, droperidol, chlorpromazine) Æ Antiemetics: 5HT3 antagonists (e.g., ondansetron) Æ Antihistamines (e.g., meclizine, diphenhydramine, dimenhydrinate, promethazine) Æ Central nervous system stimulants (e.g., caffeine) Æ Muscle relaxants (e.g., baclofen, tizanidine, metaxalone, carisoprodol) Æ Corticosteroids (e.g., prednisolone, prednisolone, methylprednisolone, dexamethasone, betamethasone) Æ Triptans/Serotonin receptor agonists (e.g., sumatriptan, frovatriptan, naratriptan, rizatriptan, almotriptan, eletriptan, zolmitriptan, combination sumatriptan and naproxen) Æ Opioid containing analgesics (e.g., codeine, hydrocodone, oxycodone, morphine, meperidine, tramadol, butorphanol, nalbuphine) Æ Butalbital-containing analgesics (e.g., butalbital; combination butalbital and acetaminophen; combination butalbital, aspirin, and caffeine) Æ Ergot products (e.g., dihydroergotamine, ergotamine, combination ergotamine and caffeine) Æ Sympathomimetic amines (e.g., isometheptene) Æ Topical anesthetics (e.g., lidocaine) Æ Antipsychotics (e.g., chlorpromazine, olanzapine) Æ Somatostatin analogs (e.g., octreotide) Æ Intravenous magnesium Æ Other pharmacologic interventions used to treat acute attacks of primary headache (whether or not available or approved in the United States) • Non-pharmacologic interventions Æ Hydration Æ Physical therapy Æ Procedures (e.g., occipital nerve blocks, sphenopalantine ganglion blocks, trigger point injections) Æ Noninvasive neuromodulation devices (e.g., transcutaneous VerDate Sep<11>2014 16:57 Nov 21, 2019 Jkt 250001 electrical nerve stimulation, transcranial magnetic stimulation, transcutaneous vagal stimulation, remote electrical neurostimulation) Æ Behavioral therapy (e.g., cognitive behavioral therapy, diet therapy, sleep therapy, exercise therapy, support group therapy) Æ Supplements (e.g., magnesium, cannabidiol) Æ Complementary therapies (e.g., biofeedback, acupuncture, mindfulness-based stress reduction) Æ Other non-pharmacologic interventions used to treat acute attacks of primary headache Comparators: • Pharmacologic interventions Æ Other class Æ Other drug within class Æ Same drug(s), different route, treatment duration, initiation time, or other aspect Æ As comparator to nonpharmacologic intervention • Nonpharmacologic interventions Æ Other nonpharmacologic intervention class Æ Other nonpharmacologic intervention, within class Æ As comparator to pharmacologic intervention • No pharmacologic or nonpharmacologic interventions Æ Placebo Æ No intervention Outcomes (* denotes important outcomes that will be used when developing Strength of Evidence tables): • Acute headache attack* Æ Severity of acute headache attack Æ Resolution of acute headache attack Æ Duration of acute headache attack • Headache-related symptoms (e.g., nausea/vomiting, photosensitivity)* Æ Severity of headache-related symptoms Æ Resolution of headache-related symptoms Æ Duration of headache-related symptoms Æ Most bothersome symptom • Emergency department visits, clinic visits, or hospitalizations* • Quality of life* • Functional outcomes Æ Impact on family life Æ Employment/school attendance Æ Time spent managing disease • Resource use • Acceptability of intervention by patients • Patient satisfaction with intervention • Number of prescribed medications • Adverse events Æ Maternal D Serious maternal adverse events* • ‘‘Serious’’ adverse events (including PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 D D • • • • • • • • • those that are composite outcomes), as defined by study authors • Cardiovascular outcomes, such as stroke, myocardial infarction D Non-serious maternal adverse events • Nonobstetrical (e.g., maternal weight gain, tachycardia, hypertension, gastrointestinal) • Preterm labor, cesarean section • Reduced breast milk production • Symptoms related to withdrawal of medication D Discontinuation of intervention (or of study participation) due to maternal adverse events* Æ Fetal/infant D Serious fetal/infant adverse events* • ‘‘Serious’’ adverse events (including those that are composite outcomes), as defined by study authors • Death—spontaneous abortion, stillbirth, infant death • Preterm birth • Low birth weight for gestational age • Congenital anomalies or other newborn abnormalities • Perinatal complications, e.g., low APGAR score, respiratory distress, neonatal intensive care unit time • Neurodevelopmental—social, emotional, or cognitive delay or disability Non-serious fetal/infant adverse events • Breastfeeding—delayed initiation, cessation, reduced frequency, reduced volume of breast milk • Poor infant attachment/bonding • Symptoms related to withdrawal of medication Discontinuation of intervention (or of study participation) due to fetal/ infant adverse events * Potential Modifiers: Phase Æ Preconception Æ First trimester Æ Second trimester Æ Third trimester Æ Postpartum Æ Breastfeeding Type of primary headache Æ Migraine Æ Tension headache Æ Cluster headache Æ Other TACs Timing: Any Setting: Any Design: Randomized controlled trials Nonrandomized comparative studies, including pre-post studies Single group studies N-of-1 studies Case-control studies E:\FR\FM\22NON1.SGM 22NON1 Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices • Case reports or series of case reports • Cross-sectional studies/surveys Æ Prospective or retrospective (all applicable study types) • For harms, we will start by searching for existing systematic reviews of interventions used during pregnancy, postpartum, or breastfeeding, regardless of their indication (i.e., for any disease/condition, not only primary headaches). We will not enforce a date restriction when screening for eligible systematic reviews, but when multiple eligible systematic reviews exist for a certain drug/class of drugs, we will use the most recent or most complete one. Æ We will subsequently search for, and include, large primary studies of interventions not adequately covered by the existing systematic reviews of harms. The specific eligibility criteria (particularly pertaining to study design, minimum sample size, and publication date) will be determined based on available EPC resources, the number of interventions without adequate existing systematic reviews, and the volume of potentially eligible studies. Æ For harms, we will also search the U.S. Food and Drug Administration, other international equivalent agencies, and pharmacopoeia. FOR FURTHER INFORMATION CONTACT: Dated: November 19, 2019. Virginia Mackay-Smith, Associate Director. Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR); (Formerly Known as the Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)); Notice of Charter Renewal [FR Doc. 2019–25414 Filed 11–21–19; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of charter renewal. This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2021. khammond on DSKJM1Z7X2PROD with NOTICES Jkt 250001 BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention This gives notice under (specific statutes and regulations citations and) the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR); (formerly known as the Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2021. FOR FURTHER INFORMATION CONTACT: Kimberly Lochner, ScD, Designated Federal Officer, BSC, CPR, Centers for Disease Control and Prevention, Department of Health and Human Services, 1600 Clifton Road NE, SUMMARY: AGENCY: 16:57 Nov 21, 2019 [FR Doc. 2019–25352 Filed 11–21–19; 8:45 am] Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of charter renewal. Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC); Notice of Charter Renewal VerDate Sep<11>2014 Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. AGENCY: Centers for Disease Control and Prevention SUMMARY: Gwendolyn H. Cattledge, Ph.D., M.S.E.H., Deputy Associate Director for Science, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Department of Health and Human Services, 4770 Buford Highway NE, Mailstop F–63, Atlanta, Georgia 30341, telephone (770) 488–1430l; email address GCattledge@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 64527 Mailstop H21–6, Atlanta, Georgia 30329–4027, telephone (404) 718–3420; Email address KDL4@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2019–25354 Filed 11–21–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID); (Formerly Known as the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)); Notice of Charter Renewal Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of charter renewal. AGENCY: This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID); (formerly known as the Board of Scientific Counselors, Office of Infectious Diseases, (BSC, OID)), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through October 31, 2021. FOR FURTHER INFORMATION CONTACT: Sarah Wiley, MPH, Designated Federal Officer, BSC, DDID, Centers for Disease Control and Prevention, Department of Health and Human Services, 1600 Clifton Road NE, Mailstop H24–12, Atlanta, Georgia 30329–4027, telephone (404) 639–2100; email address SWiley@ cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for SUMMARY: E:\FR\FM\22NON1.SGM 22NON1

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[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64523-64527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Management of Primary 
Headache During Pregnancy

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

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

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Management of 
Primary Headache during Pregnancy, which is currently being conducted 
by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before 30 days after date of 
publication.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence Management of Primary 
Headache during Pregnancy. AHRQ is conducting this systematic review 
pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 
299a(a).
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies

[[Page 64524]]

conducted). We are looking for studies that report on Management of 
Primary Headache during Pregnancy, including those that describe 
adverse events. The entire research protocol is available online at: 
https://effectivehealthcare.ahrq.gov/products/headaches-pregnancy/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Management of Primary Headache during 
Pregnancy helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: Study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on indications not 
included in the review cannot be used by the EPC Program. This is a 
voluntary request for information, and all costs for complying with 
this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

Key Questions (KQ)

    KQ 1: What are the (comparative) benefits and harms of 
interventions to prevent attacks of primary headache in women who are 
pregnant (or attempting to become pregnant), postpartum, or 
breastfeeding?
    KQ 1a. Do the (comparative) benefits and harms vary by phase (i.e., 
preconception, first trimester of pregnancy, second trimester of 
pregnancy, third trimester of pregnancy, postpartum, breastfeeding)?
    KQ 1b. Do the (comparative) benefits and harms vary by type of 
primary headache (i.e., migraine, tension headache, cluster headache, 
and other trigeminal autonomic cephalgias)?
    KQ 2: What are the (comparative) benefits and harms of 
interventions to treat acute attacks of primary headache in women who 
are pregnant (or attempting to become pregnant), postpartum, or 
breastfeeding?
    KQ 2a. Do the (comparative) benefits and harms vary by phase (i.e., 
preconception, first trimester of pregnancy, second trimester of 
pregnancy, third trimester of pregnancy, postpartum, breastfeeding)?
    KQ 2b. Do the (comparative) benefits and harms vary by type of 
primary headache (i.e., migraine, tension headache, cluster headache, 
and other trigeminal autonomic cephalgias)?

Contextual Question

    What is the available evidence concerning levels in maternal serum/
blood, fetal/infant serum/blood, breast milk, amniotic fluid, meconium, 
cord blood, or child urine of drugs used to prevent or treat attacks of 
primary headache in women who are pregnant (or attempting to become 
pregnant), postpartum, or breastfeeding?

Study Eligibility Criteria

    We had discussions with a Technical Expert Panel (TEP) during which 
we reviewed the specific eligibility criteria. As part of the 
discussions, we asked the TEP to provide guidance on prioritizing 
outcomes and selecting among harms/adverse events of interest.

KQ 1 (Prevention of Primary Headache)

    Population(s):

 Women who are pregnant (or attempting to become pregnant/in 
the preconception phase), postpartum (defined as up to 12 months post-
delivery), or breastfeeding (for any length of time) with history of 
primary headache
    [cir] Migraine, tension headache, cluster headache or other 
trigeminal autonomic cephalgia (TACs)
    [cir] Women attempting to become pregnant include those actively 
planning pregnancy, by any method, who may wish to use only treatments 
found to be safe and effective during pregnancy.

 Exclude: Women with history of secondary headache of any 
origin
    Interventions:

 Pharmacologic interventions
    [cir] Tricyclic antidepressants (e.g., amitriptyline, 
nortriptyline, imipramine)
    [cir] Beta blockers (e.g., metoprolol, propranolol, nadolol, 
atenolol, timolol, nebivolol)
    [cir] Calcium channel blockers (e.g., verapamil, nimodipine, 
nifedipine, nicardipine)
    [cir] Other antihypertensive medications (e.g., lisinopril, 
candesartan, clonidine)
    [cir] Antiepileptic drugs (e.g., divalproex sodium, sodium 
valproate, valproic acid, topiramate, gabapentin, carbamazepine, 
lamotrigine)
    [cir] Serotonin and norepinephrine reuptake inhibitors (SSNRIs) 
(e.g., venlafaxine, duloxetine)
    [cir] Benzodiazepines (e.g., clonazepam)
    [cir] N-methyl-D-aspartate (NMDA) receptor antagonists (e.g., 
memantine)
    [cir] Calcitonin gene-related peptide (CGRP) inhibitors (e.g., 
erenumab, fremanezumab, galcanezumab)
    [cir] Antihistamines (e.g., cyproheptadine)
    [cir] Antimanic agents (e.g., lithium)
    [cir] Tetracyclic antidepressants (e.g., mirtazapine)
    [cir] Corticosteroids (e.g., methylprednisolone, triamcinolone 
acetonide, combinations of local anesthetics and corticosteroids)
    [cir] Other pharmacologic interventions used to prevent primary 
headache (whether or not available or approved in the United States)
 Non-pharmacologic interventions
    [cir] Supplements (e.g., riboflavin, magnesium, coenzyme Q10, 
melatonin, feverfew, butterbur, frankincense)
    [cir] Nerve blocks (e.g., occipital nerve blocks, sphenopalantine 
ganglion blocks, trigger point injections)
    [cir] Chemodenervation (e.g., onabotulinum toxin A, abobotulinum 
toxin A)
    [cir] Physical therapy
    [cir] Hydration
    [cir] Noninvasive neuromodulation devices (e.g., transcutaneous

[[Page 64525]]

electrical nerve stimulation, transcranial magnetic stimulation, 
transcutaneous vagal stimulation, remote electrical neurostimulation)
    [cir] Behavioral therapy (e.g., cognitive behavioral therapy, diet 
therapy, sleep therapy, exercise therapy, support group therapy)
    [cir] Complementary therapies (e.g., biofeedback, acupuncture, 
mindfulness-based stress reduction)
    [cir] Other non-pharmacologic interventions used to prevent primary 
headache

    Comparators:

 Pharmacologic interventions
    [cir] Other class
    [cir] Other drug within class
    [cir] Same drug(s), different route, treatment duration, initiation 
time, or other aspect
    [cir] As comparator to nonpharmacologic intervention
 Nonpharmacologic interventions
    [cir] Other nonpharmacologic intervention class
    [cir] Other nonpharmacologic intervention, within class
    [cir] As comparator to pharmacologic intervention
 No pharmacologic or nonpharmacologic interventions
    [cir] Placebo
    [cir] No intervention

    Outcomes: (* denotes important outcomes that will be used when 
developing Strength of Evidence tables)

 Acute headache attacks*
    [cir] Occurrence of acute headache attacks
    [cir] Frequency of acute headache attacks
    [cir] Severity of acute headache attacks
    [cir] Duration of acute headache attacks
 Headache-related symptoms (e.g., nausea/vomiting, 
photosensitivity, dizziness)*
    [cir] Occurrence of headache-related symptoms
    [cir] Frequency of headache-related symptoms
    [cir] Severity of headache-related symptoms
    [cir] Duration of headache-related symptoms
    [cir] Most bothersome symptom
 Emergency department visits, clinic visits, or 
hospitalizations*
 Quality of life*
 Functional outcomes
    [cir] Impact on family life
    [cir] Employment/school attendance
    [cir] Time spent managing disease
 Resource use
 Acceptability of intervention by patients
 Patient satisfaction with intervention
 Number of prescribed medications
 Number of days with acute medication use
 Adverse events
    [cir] Maternal
    [ssquf] Serious maternal adverse events*
     ``Serious'' adverse events (including those that are 
composite outcomes), as defined by study authors
     Cardiovascular outcomes, such as stroke, myocardial 
infarction
    [ssquf] Non-serious maternal adverse events
     Nonobstetrical (e.g., maternal weight gain, tachycardia, 
hypertension, gastrointestinal)
     Preterm labor, cesarean section
     Reduced breast milk production
     Symptoms related to withdrawal of medication
    [ssquf] Discontinuation of intervention (or of study participation) 
due to maternal adverse events*
    [cir] Fetal/infant
    [ssquf] Serious fetal/infant adverse events*
     ``Serious'' adverse events (including those that are 
composite outcomes), as defined by study authors
     Death--spontaneous abortion, stillbirth, infant death
     Preterm birth
     Low birth weight for gestational age
     Congenital anomalies or other newborn abnormalities
     Perinatal complications, e.g., low APGAR score, 
respiratory distress, neonatal intensive care unit time
     Neurodevelopmental--social, emotional, or cognitive delay 
or disability
    [ssquf] Non-serious fetal/infant adverse events
     Breastfeeding--delayed initiation, cessation, reduced 
frequency, reduced volume of breast milk
     Poor infant attachment/bonding
     Symptoms related to withdrawal of medication
    [ssquf] Discontinuation of intervention (or of study participation) 
due to fetal/infant adverse events*

    Potential Modifiers:

 Phase
    [cir] Preconception
    [cir] First trimester
    [cir] Second trimester
    [cir] Third trimester
    [cir] Postpartum
    [cir] Breastfeeding
 Type of primary headache
    [cir] Migraine
    [cir] Tension headache
    [cir] Cluster headache
    [cir] Other TACs

    Timing:

 Any

    Setting:

 Any

    Design:

 Randomized controlled trials
 Nonrandomized comparative studies, including pre-post studies
 Single group studies
 N-of-1 studies
 Case-control studies
 Case reports or series of case reports
 Cross-sectional studies/surveys
    [cir] Prospective or retrospective (all applicable study types)
 For harms, we will start by searching for existing systematic 
reviews of interventions used during pregnancy, postpartum, or 
breastfeeding, regardless of their indication (i.e., for any disease/
condition, not only primary headaches). We will not enforce a date 
restriction when screening for eligible systematic reviews, but when 
multiple eligible systematic reviews exist for a certain drug/class of 
drugs, we will use the most recent or most complete one.
    [cir] We will subsequently search for, and include, large primary 
studies of interventions not adequately covered by the existing 
systematic reviews of harms. The specific eligibility criteria 
(particularly pertaining to study design, minimum sample size, and 
publication date) will be determined based on available EPC resources, 
the number of interventions without adequate existing systematic 
reviews, and the volume of potentially eligible studies.
    [cir] For harms, we will also search the U.S. Food and Drug 
Administration, other international equivalent agencies, and 
pharmacopoeia.

KQ 2 (Treatment of Primary Headache)

    Population(s):

 Women who are pregnant (or attempting to become pregnant/in 
the preconception phase), postpartum (defined as up to 12 months post-
delivery), or breastfeeding (for any length of time) with acute attacks 
of primary headache
    [cir] Migraine, tension headache, cluster headache, or other 
trigeminal autonomic cephalgia (TACs)
    [cir] Women attempting to become pregnant include those actively 
planning pregnancy, by any method, who may wish to use only treatments 
found to be safe and effective during pregnancy.
 Exclude: Women with attacks of secondary headache of any 
origin

    Interventions:

 Pharmacologic interventions
    [cir] Analgesics/antipyretics (e.g., acetaminophen)

[[Page 64526]]

    [cir] Nonsteroidal antiinflammatory drugs (NSAIDs) (e.g., 
ibuprofen, naproxen, aspirin, celecoxib, ketorolac, indomethacin, 
ketoprofen, diclofenac, mefenamic acid)
    [cir] Other over-the-counter analgesics (e.g., combination aspirin, 
acetaminophen, and caffeine; combination acetaminophen, isometheptene, 
and dichloralphenazone)
    [cir] Antiemetics: dopamine receptor antagonists (e.g., 
metoclopramide, promethazine, prochlorperazine, droperidol, 
chlorpromazine)
    [cir] Antiemetics: 5HT3 antagonists (e.g., ondansetron)
    [cir] Antihistamines (e.g., meclizine, diphenhydramine, 
dimenhydrinate, promethazine)
    [cir] Central nervous system stimulants (e.g., caffeine)
    [cir] Muscle relaxants (e.g., baclofen, tizanidine, metaxalone, 
carisoprodol)
    [cir] Corticosteroids (e.g., prednisolone, prednisolone, 
methylprednisolone, dexamethasone, betamethasone)
    [cir] Triptans/Serotonin receptor agonists (e.g., sumatriptan, 
frovatriptan, naratriptan, rizatriptan, almotriptan, eletriptan, 
zolmitriptan, combination sumatriptan and naproxen)
    [cir] Opioid containing analgesics (e.g., codeine, hydrocodone, 
oxycodone, morphine, meperidine, tramadol, butorphanol, nalbuphine)
    [cir] Butalbital-containing analgesics (e.g., butalbital; 
combination butalbital and acetaminophen; combination butalbital, 
aspirin, and caffeine)
    [cir] Ergot products (e.g., dihydroergotamine, ergotamine, 
combination ergotamine and caffeine)
    [cir] Sympathomimetic amines (e.g., isometheptene)
    [cir] Topical anesthetics (e.g., lidocaine)
    [cir] Antipsychotics (e.g., chlorpromazine, olanzapine)
    [cir] Somatostatin analogs (e.g., octreotide)
    [cir] Intravenous magnesium
    [cir] Other pharmacologic interventions used to treat acute attacks 
of primary headache (whether or not available or approved in the United 
States)
 Non-pharmacologic interventions
    [cir] Hydration
    [cir] Physical therapy
    [cir] Procedures (e.g., occipital nerve blocks, sphenopalantine 
ganglion blocks, trigger point injections)
    [cir] Noninvasive neuromodulation devices (e.g., transcutaneous 
electrical nerve stimulation, transcranial magnetic stimulation, 
transcutaneous vagal stimulation, remote electrical neurostimulation)
    [cir] Behavioral therapy (e.g., cognitive behavioral therapy, diet 
therapy, sleep therapy, exercise therapy, support group therapy)
    [cir] Supplements (e.g., magnesium, cannabidiol)
    [cir] Complementary therapies (e.g., biofeedback, acupuncture, 
mindfulness-based stress reduction)
    [cir] Other non-pharmacologic interventions used to treat acute 
attacks of primary headache

    Comparators:

 Pharmacologic interventions
    [cir] Other class
    [cir] Other drug within class
    [cir] Same drug(s), different route, treatment duration, initiation 
time, or other aspect
    [cir] As comparator to nonpharmacologic intervention
 Nonpharmacologic interventions
    [cir] Other nonpharmacologic intervention class
    [cir] Other nonpharmacologic intervention, within class
    [cir] As comparator to pharmacologic intervention
 No pharmacologic or nonpharmacologic interventions
    [cir] Placebo
    [cir] No intervention
    Outcomes (* denotes important outcomes that will be used when 
developing Strength of Evidence tables):

 Acute headache attack*
    [cir] Severity of acute headache attack
    [cir] Resolution of acute headache attack
    [cir] Duration of acute headache attack
 Headache-related symptoms (e.g., nausea/vomiting, 
photosensitivity)*
    [cir] Severity of headache-related symptoms
    [cir] Resolution of headache-related symptoms
    [cir] Duration of headache-related symptoms
    [cir] Most bothersome symptom
 Emergency department visits, clinic visits, or 
hospitalizations*
 Quality of life*
 Functional outcomes
    [cir] Impact on family life
    [cir] Employment/school attendance
    [cir] Time spent managing disease
 Resource use
 Acceptability of intervention by patients
 Patient satisfaction with intervention
 Number of prescribed medications
 Adverse events
    [cir] Maternal
    [ssquf] Serious maternal adverse events*
     ``Serious'' adverse events (including those that are 
composite outcomes), as defined by study authors
     Cardiovascular outcomes, such as stroke, myocardial 
infarction
    [ssquf] Non-serious maternal adverse events
     Nonobstetrical (e.g., maternal weight gain, tachycardia, 
hypertension, gastrointestinal)
     Preterm labor, cesarean section
     Reduced breast milk production
     Symptoms related to withdrawal of medication
    [ssquf] Discontinuation of intervention (or of study participation) 
due to maternal adverse events*
    [cir] Fetal/infant
    [ssquf] Serious fetal/infant adverse events*
     ``Serious'' adverse events (including those that are 
composite outcomes), as defined by study authors
     Death--spontaneous abortion, stillbirth, infant death
     Preterm birth
     Low birth weight for gestational age
     Congenital anomalies or other newborn abnormalities
     Perinatal complications, e.g., low APGAR score, 
respiratory distress, neonatal intensive care unit time
     Neurodevelopmental--social, emotional, or cognitive delay 
or disability
[ssquf] Non-serious fetal/infant adverse events
     Breastfeeding--delayed initiation, cessation, reduced 
frequency, reduced volume of breast milk
     Poor infant attachment/bonding
     Symptoms related to withdrawal of medication
[ssquf] Discontinuation of intervention (or of study participation) due 
to fetal/infant adverse events *

    Potential Modifiers:

 Phase
    [cir] Preconception
    [cir] First trimester
    [cir] Second trimester
    [cir] Third trimester
    [cir] Postpartum
    [cir] Breastfeeding
 Type of primary headache
    [cir] Migraine
    [cir] Tension headache
    [cir] Cluster headache
    [cir] Other TACs

    Timing:

 Any

    Setting:

 Any

    Design:

 Randomized controlled trials
 Nonrandomized comparative studies, including pre-post studies
 Single group studies
 N-of-1 studies
 Case-control studies

[[Page 64527]]

 Case reports or series of case reports
 Cross-sectional studies/surveys
    [cir] Prospective or retrospective (all applicable study types)
 For harms, we will start by searching for existing systematic 
reviews of interventions used during pregnancy, postpartum, or 
breastfeeding, regardless of their indication (i.e., for any disease/
condition, not only primary headaches). We will not enforce a date 
restriction when screening for eligible systematic reviews, but when 
multiple eligible systematic reviews exist for a certain drug/class of 
drugs, we will use the most recent or most complete one.
    [cir] We will subsequently search for, and include, large primary 
studies of interventions not adequately covered by the existing 
systematic reviews of harms. The specific eligibility criteria 
(particularly pertaining to study design, minimum sample size, and 
publication date) will be determined based on available EPC resources, 
the number of interventions without adequate existing systematic 
reviews, and the volume of potentially eligible studies.
    [cir] For harms, we will also search the U.S. Food and Drug 
Administration, other international equivalent agencies, and 
pharmacopoeia.

    Dated: November 19, 2019.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2019-25414 Filed 11-21-19; 8:45 am]
BILLING CODE 4160-90-P