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Federal Register / Vol. 84, No. 175 / Tuesday, September 10, 2019 / Notices 47521

FR 56469, September 18, 2015, or access causes in whom childbearing is III. Petitions the information at: https://www.gpo.gov/ complete. Subsequent to this approval, Anyone with knowledge that any of fdsys/pkg/FR-2015-09-18/pdf/2015- the USPTO received a patent term the dates as published are incorrect may 23389.pdf. restoration application for AEGEA submit either electronic or written Docket: For access to the docket to VAPOR SYSTEM (U.S. Patent No. comments and, under 21 CFR 60.24, ask read background documents or the 8,574,226) from Tsunami MedTech, for a redetermination (see DATES). electronic and written/paper comments LLC, and the USPTO requested FDA’s Furthermore, as specified in § 60.30 (21 received, go to https:// assistance in determining this patent’s CFR 60.30), any interested person may www.regulations.gov and insert the eligibility for patent term restoration. In petition FDA for a determination docket number, found in brackets in the a letter dated April 4, 2018, FDA regarding whether the applicant for heading of this document, into the advised the USPTO that this medical extension acted with due diligence ‘‘Search’’ box and follow the prompts device had undergone a regulatory during the regulatory review period. To and/or go to the Dockets Management review period and that the approval of meet its burden, the petition must Staff, 5630 Fishers Lane, Rm. 1061, AEGEA VAPOR SYSTEM represented comply with all the requirements of Rockville, MD 20852. the first permitted commercial § 60.30, including but not limited to: FOR FURTHER INFORMATION CONTACT: marketing or use of the product. Must be timely (see DATES), must be Beverly Friedman, Office of Regulatory Thereafter, the USPTO requested that filed in accordance with § 10.20, must Policy, Food and Drug Administration, FDA determine the product’s regulatory contain sufficient facts to merit an FDA 10903 New Hampshire Ave., Bldg. 51, review period. investigation, and must certify that a Rm. 6250, Silver Spring, MD 20993, II. Determination of Regulatory Review true and complete copy of the petition 301–796–3600. Period has been served upon the patent SUPPLEMENTARY INFORMATION: applicant. (See H. Rept. 857, part 1, 98th FDA has determined that the Cong., 2d sess., pp. 41–42, 1984.) I. Background applicable regulatory review period for Petitions should be in the format The Drug Price Competition and AEGEA VAPOR SYSTEM is 1,381 days. specified in 21 CFR 10.30. Patent Term Restoration Act of 1984 Of this time, 1,148 days occurred during Submit petitions electronically to (Pub. L. 98–417) and the Generic the testing phase of the regulatory https://www.regulations.gov at Docket Animal Drug and Patent Term review period, while 233 days occurred No. FDA–2013–S–0610. Submit written Restoration Act (Pub. L. 100–670) during the approval phase. These petitions (two copies are required) to the generally provide that a patent may be periods of time were derived from the Dockets Management Staff (HFA–305), extended for a period of up to 5 years following dates: Food and Drug Administration, 5630 so long as the patented item (human 1. The date an exemption for this Fishers Lane, Rm. 1061, Rockville, MD drug product, animal drug product, device, under section 520(g) of the 20852. Federal Food, Drug, and Cosmetic Act medical device, food additive, or color Dated: September 4, 2019. additive) was subject to regulatory (FD&C Act) (21 U.S.C. 360j(g)), became Lowell J. Schiller, review by FDA before the item was effective: September 4, 2013. FDA has marketed. Under these acts, a product’s verified the applicant’s claim that the Principal Associate Commissioner for Policy. regulatory review period forms the basis date the investigational device [FR Doc. 2019–19496 Filed 9–9–19; 8:45 am] for determining the amount of extension exemption (IDE) for human tests to BILLING CODE 4164–01–P an applicant may receive. begin, as required under section 520(g) A regulatory review period consists of of the FD&C Act, became effective two periods of time: A testing phase and September 4, 2013. DEPARTMENT OF HEALTH AND an approval phase. For medical devices, 2. The date an application was HUMAN SERVICES initially submitted with respect to the the testing phase begins with a clinical Food and Drug Administration investigation of the device and runs device under section 515 of the FD&C until the approval phase begins. The Act (21 U.S.C. 360e): October 25, 2016. [Docket No. FDA–2019–N–3968] approval phase starts with the initial The applicant claims December 17, submission of an application to market 2015, as the date the premarket approval International Drug Scheduling; the device and continues until application (PMA) for AEGEA VAPOR Convention on Psychotropic permission to market the device is SYSTEM (PMA P160047) was initially Substances; Single Convention on granted. Although only a portion of a submitted. However, FDA records Drugs; APINACA; AB– regulatory review period may count indicate that PMA P160047 was FUBINACA; 5F–AMB; 5F–MDMB–PICA; toward the actual amount of extension submitted as a complete application on 4–F–MDMB–BINACA; 4–CMC; N- that the Director of USPTO may award October 25, 2016. ethylhexedrone; alpha-PHP; DOC; (half the testing phase must be 3. The date the application was Crotonyl ; Valeryl Fentanyl; subtracted as well as any time that may approved: June 14, 2017. FDA has Flualprazolam; Etizolam; and 8 have occurred before the patent was verified the applicant’s claim that PMA Additional Preparations Listed in issued), FDA’s determination of the P160047 was approved on June 14, Schedule III of the 1961 Single length of a regulatory review period for 2017. Convention on Narcotic Drugs; a medical device will include all of the This determination of the regulatory Request for Comments testing phase and approval phase as review period establishes the maximum AGENCY: Food and Drug Administration, specified in 35 U.S.C. 156(g)(3)(B). potential length of a patent extension. HHS. FDA has approved for marketing the However, the USPTO applies several ACTION: Notice; request for comments. medical device AEGEA VAPOR statutory limitations in its calculations SYSTEM. AEGEA VAPOR SYSTEM is of the actual period for patent extension. SUMMARY: The Food and Drug indicated for ablation of the endometrial In its application for patent extension, Administration (FDA) is requesting lining of the uterus in premenopausal this applicant seeks 931 days of patent interested persons to submit comments women with menorrhagia due to benign term extension. concerning abuse potential, actual

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abuse, medical usefulness, trafficking, Management Staff (HFA–305), Food and must identify this information as and impact of scheduling changes on Drug Administration, 5630 Fishers ‘‘confidential.’’ Any information marked availability for medical use of 21 drug Lane, Rm. 1061, Rockville, MD 20852. as ‘‘confidential’’ will not be disclosed substances. These comments will be • For written/paper comments except in accordance with 21 CFR 10.20 considered in preparing a response from submitted to the Dockets Management and other applicable disclosure law. For the United States to the World Health Staff, FDA will post your comment, as more information about FDA’s posting Organization (WHO) regarding the abuse well as any attachments, except for of comments to public dockets, see 80 liability and diversion of these drugs. information submitted, marked and FR 56469, September 18, 2015, or access WHO will use this information to identified, as confidential, if submitted the information at: https://www.gpo.gov/ consider whether to recommend that as detailed in ‘‘Instructions.’’ fdsys/pkg/FR-2015-09-18/pdf/2015- certain international restrictions be Instructions: All submissions received 23389.pdf. placed on these drugs. This notice must include the Docket No. FDA– Docket: For access to the docket to requesting comments is required by the 2019–N–3968 for ‘‘International Drug read background documents or the Scheduling; Convention on Controlled Substances Act (the CSA). electronic and written/paper comments Psychotropic Substances; Single DATES: Submit either electronic or received, go to https:// Convention on Narcotic Drugs; written comments by October 4, 2019. www.regulations.gov and insert the APINACA (AKB–48); AB–FUBINACA; ADDRESSES: You may submit comments docket number, found in brackets in the 5F–AMB (5F–AMB–PINACA, 5F– as follows. Please note that late, heading of this document, into the MMB–PINACA); 5F–MDMB–PICA (5F– untimely filed comments will not be ‘‘Search’’ box and follow the prompts MDMB–2201); 4–F–MDMB–BINACA considered. Electronic comments must and/or go to the Dockets Management (4F–ADB); 4–CMC (4- be submitted on or before (October 4, Staff, 5630 Fishers Lane, Rm. 1061, chloromethcathinone; clefedrone); N- 2019. The https://www.regulations.gov Rockville, MD 20852. electronic filing system will accept ethylhexedrone (NEH, hexen, ethyl- FOR FURTHER INFORMATION CONTACT: comments until 11:59 p.m. Eastern Time hex); alpha-PHP (PV–7, a- James R. Hunter, Center for Drug at the end of October 4, 2019. Comments pyrrolidinohexanophenone); DOC (2,5- Evaluation and Research, Controlled received by mail/hand delivery/courier dimethoxy-4-chloroamfetamine); (for written/paper submissions) will be Crotonyl Fentanyl; Valeryl Fentanyl; Substance Staff, Food and Drug considered timely if they are Flualprazolam; Etizolam; Preparations Administration, 10903 New Hampshire postmarked or the delivery service listed in Schedule III of the 1961 Single Ave., Bldg. 51, Rm. 5150, Silver Spring, acceptance receipt is on or before that Convention on Narcotic Drugs as MD 20993–0002, 301–796–3156, email: date. follows: , [email protected]. ; ; SUPPLEMENTARY INFORMATION: Electronic Submissions ; Nicocodine; Submit electronic comments in the ; ; : I. Background Request for Comments.’’ Received following way: The United States is a party to the • comments, those filed in a timely Federal eRulemaking Portal: 1971 Convention on Psychotropic manner (see ADDRESSES), will be placed https://www.regulations.gov. Follow the Substances (Psychotropic Convention). in the docket and, except for those instructions for submitting comments. Article 2 of the Psychotropic submitted as ‘‘Confidential Comments submitted electronically, Convention provides that if a party to including attachments, to https:// Submissions,’’ publicly viewable at https://www.regulations.gov or at the the convention or WHO has information www.regulations.gov will be posted to about a substance, which in its opinion the docket unchanged. Because your Dockets Management Staff between 9 a.m. and 4 p.m., Monday through may require international control or comment will be made public, you are change in such control, it shall so notify solely responsible for ensuring that your Friday. • the Secretary-General of the United comment does not include any Confidential Submissions—To submit a comment with confidential Nations (the U.N. Secretary-General) confidential information that you or a and provide the U.N. Secretary-General third party may not wish to be posted, information that you do not wish to be with information in support of its such as medical information, your or made publicly available, submit your opinion. anyone else’s Social Security number, or comments only as a written/paper confidential business information, such submission. You should submit two Paragraph (d)(2)(A) of the CSA (21 as a manufacturing process. Please note copies total. One copy will include the U.S.C. 811) (Title II of the that if you include your name, contact information you claim to be confidential Comprehensive Drug Abuse Prevention information, or other information that with a heading or cover note that states and Control Act of 1970) provides that identifies you in the body of your ‘‘THIS DOCUMENT CONTAINS when WHO notifies the United States comments, that information will be CONFIDENTIAL INFORMATION.’’ The under Article 2 of the Psychotropic posted on https://www.regulations.gov. Agency will review this copy, including Convention that it has information that • If you want to submit a comment the claimed confidential information, in may justify adding a drug or other with confidential information that you its consideration of comments. The substances to one of the schedules of the do not wish to be made available to the second copy, which will have the Psychotropic Convention, transferring a public, submit the comment as a claimed confidential information drug or substance from one schedule to written/paper submission and in the redacted/blacked out, will be available another, or deleting it from the manner detailed (see ‘‘Written/Paper for public viewing and posted on schedules, the Secretary of State must Submissions’’ and ‘‘Instructions’’). https://www.regulations.gov. Submit transmit the notice to the Secretary of both copies to the Dockets Management Health and Human Services (Secretary Written/Paper Submissions Staff. If you do not wish your name and of HHS). The Secretary of HHS must Submit written/paper submissions as contact information to be made publicly then publish the notice in the Federal follows: available, you can provide this Register and provide opportunity for • Mail/Hand delivery/Courier (for information on the cover sheet and not interested persons to submit comments written/paper submissions): Dockets in the body of your comments and you that will be considered by HHS in its

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preparation of the scientific and medical The 42nd ECDD will convene to review meeting. Focal points will be given further evaluations of the drug or substance. psychoactive substances (attached) regarding instructions and direct access to online their potential to cause dependence, abuse questionnaires. The questionnaires will be II. WHO Notification and harm to health, and their potential analysed by the Secretariat and prepared as The Secretary of HHS received the therapeutic applications. WHO will make a report that will be shared with the following notice from WHO (non- recommendations to the UN Secretary- Committee for review. General on the need for and level of relevant text removed): Focal points are also encouraged to provide international control of these substances. any additional relevant information Ref.: C.L.30.2019 Member States are invited to collaborate in (unpublished or published) on substances to this process through designated national The World Health Organization (WHO) be reviewed at the 42nd ECDD to: presents its compliments to Member States focal points, as in the past and in line with [email protected] by 20 September and Associate Members and in reference to the publication ‘‘Guidance on the WHO C.L.14.2019 has the pleasure of informing review of psychoactive substances for 2019. that the 42nd Expert Committee on Drug international control’’ (EB126/2010/REC1, The World Health Organization takes this Dependence (ECDD) will meet in Geneva Annex 6, Para 21).1 opportunity to renew to Member States and from 21 to 25 October 2019. The Expert For this purpose, a questionnaire was Associate Members the assurance of its Committee on Drug Dependence meetings are designed to gather country information on highest consideration. of a closed nature, however a public the legitimate use, harmful use, status of GENEVA, 29 July 2019 information session on 21 October will be national control and potential impact of 1http://apps.who.int/gb/ebwha/pdf_files/ open to Member States. international control for each substance EB126-REC1/B126_REC1-en.pdf#page=95. Further information, including a full under evaluation. agenda of the meeting, will be available on National focal points designated by 42nd Expert Committee on Drug Dependence the ECDD website: https://www.who.int/ Member States following C.L.14.2019 will be (ECDD) 21 to 25 October 2019, WHO medicines/access/controlled-substances/ approached to complete the questionnaire on headquarters, Geneva, Switzerland ecdd/ecdd/en/. substances under review at the 42nd ECDD Substances Under Review

CRITICAL REVIEW

Synthetic cannabinoids ...... 1. APINACA (AKB–48). 2. AB–FUBINACA. 3. 5F–AMB (5F–AMB–PINACA, 5F–MMB–PINACA). 4. 5F–MDMB–PICA (5F–MDMB–2201). 5. 4-F-MDMB-BINACA (4F-ADB). Synthetic stimulants ...... 6. 4–CMC (4-chloromethcathinone; clefedrone). 7. N-ethylhexedrone (NEH, Hexen, Ethyl-Hex). 8. Alpha–PHP (PV-7, a-pyrrolidinohexanophenone). 9. DOC (2,5-Dimethoxy-4-chloroamfetamine). Fentanyl Analogues ...... 10. Crotonyl fentanyl. 11. Valeryl fentanyl. Benzodiazepines ...... 12. Flualprazolam. 13. Etizolam.

PRE-REVIEW

Preparations listed in Schedule III of the 1961 Single Convention on Preparations of: Narcotic Drugs. Æ Acetyldihydrocodeine. Æ Codeine. Æ Dihydrocodeine. Æ Ethylmorphine. Æ Nicocodine. Æ Nicodicodine. Æ Norcodeine. Æ Pholcodine. when compounded with one or more other ingredients and containing not more than 100 milligrams of the drug per dosage unit and with a concentration of not more than 2.5 percent in undivided preparation.

FDA has verified the website cannabinoid with a high affinity for the withdrawal, as well as numerous reports addresses contained in the WHO notice, CB1 receptor. This substance of emergency room admissions resulting as of the date this document publishes functionally (biologically) mimics the from their abuse. There are no in the Federal Register, but websites are effects of delta-9- commercial or approved medical uses subject to change over time. Access to (THC), a Schedule I substance, and the for APINACA. On May 16, 2013, view the WHO questionnaire can be main psychoactive constituent in the APINACA was temporarily controlled as found at https://www.who.int/ (marijuana) plant. Synthetic a Schedule I substance under the CSA. medicines/access/controlled- cannabinoids have been marketed under On May 11, 2016, APINACA was substances/ecdd_41_meeting/en/. the guise of ‘‘herbal incense,’’ and permanently placed in Schedule I under the CSA. III. Substances Under WHO Review promoted by drug traffickers as legal alternatives to marijuana. Chronic abuse AB–FUBINACA (chemical name: N- APINACA (AKB–48) (chemical name: of synthetic cannabinoids has been (1-amino-3-methyl-1-oxobutan-2-yl)-1- N-(1-adamantyl)-1-pentyl-1H-indazole- linked to adverse health effects (4-fluorobenzyl)-1H-indazole-3- 3-carboxamide) is a synthetic including signs of addiction and carboxamide) is a synthetic cannabinoid

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that is a potent full agonist at CB1 Synthetic cannabinoids have been currently accepted medical use in receptors. This substance functionally marketed under the guise of ‘‘herbal treatment in the United States. On July (biologically) mimics the effects of the incense,’’ and promoted by drug 18, 2019, N-Ethylhexedrone and alpha- structurally unrelated THC, a Schedule traffickers as legal alternatives to PHP were temporarily controlled as a I substance, and the main psychoactive marijuana. 5F–MDMB–PICA has been Schedule I substance under the CSA. chemical constituent in marijuana. associated with law enforcement DOC (chemical names: 2,5- Synthetic cannabinoids have been seizures and overdoses requiring Dimethoxy-4-chloroamfetamine; 2,5- marketed under the guise of ‘‘herbal emergency medical intervention. On dimethoxy-4-chloroamphetamine; 1-(4- incense,’’ and promoted by drug April 16, 2019, 5F–MDMB–PICA was chloro-2,5-dimethoxyphenyl)propan-2- traffickers as legal alternatives to temporarily controlled as a Schedule I amine) is a hallucinogenic substance marijuana. AB–FUBINACA use has been substance under the CSA. with psychedelic effects. Law associated with serious adverse events 4F–MDMB–BINACA (4F–ADB) enforcement has encountered DOC in including death in the United States. (chemical name: Methyl 2-(1-(4- tablet, capsule, powder, liquid, and There are no commercial or approved fluorobutyl)-1H-indazole-3- blotter paper forms. Its use has been medical uses for AB–FUBINACA. On carboxamido)-3,3-dimethylbutanoate) is associated with at least one death. DOC February 10, 2014, AB–FUBINACA was a synthetic cannabinoid that is a potent has no currently accepted medical use temporarily controlled as a Schedule I full agonist at CB1 receptors. This in treatment in the United States. DOC substance under the CSA. On September substance functionally (biologically) is not controlled under the CSA but is 6, 2016, AB–FUBINACA was mimics the effects of THC, a Schedule a Schedule I controlled substance in the permanently placed as a Schedule I I substance, and the main psychoactive state of Florida. controlled substance under the CSA. constituent in marijuana. 4F–MDMB– Crotonyl fentanyl (chemical name: N- 5F–AMB (5F–AMB–PINACA, 5F– BINACA has been encountered in (1-phenethylpiperidin-4-yl)-N- MMB–PINACA) (chemical name: numerous synthetic cannabinoid phenylbut-2-enamide) and valeryl Methyl 2-(1-(5-fluoropentyl)-1H- products that are smoked for their fentanyl (chemical name: N-(1- indazole-3-carboxamido)-3- psychoactive effects. Multiple law phenethylpiperidin-4-yl)-N- methylbutanoate) is a synthetic enforcement encounters of 4F–MDMB– phenylpentanamide) are synthetic cannabinoid that is a potent full agonist BINACA have been reported involving that have a pharmacological at CB1 receptors. This substance overdose deaths, illicit use, and seizures profile similar to other Schedule I and functionally (biologically) mimics the of drug evidence between December II controlled substances such as effects of THC, a Schedule I substance, 2018 and February 2019. There are no cyclopropyl fentanyl, fentanyl, and and the main psychoactive constituent commercial or approved medical uses other related mu- agonist in marijuana. Synthetic cannabinoids for 4F–MDMB–BINACA. 4F–MDMB– substances. They are clandestinely have been marketed under the guise of BINACA is a positional isomer of 5F– produced and associated with adverse ‘‘herbal incense,’’ and promoted by drug AMB (chemical name: Methyl 2-(1-(5- events typically associated with opioid traffickers as legal alternatives to fluoropentyl)-1H-indazole-3- marijuana. The use of synthetic carboxamido)-3-methylbutanoate), as use such as respiratory depression, cannabinoids, including, 5F–AMB has defined by 21 CFR 1300.01, and has anxiety, constipation, tiredness, been associated with nausea and been a Schedule I controlled substance hallucinations, and withdrawal. vomiting, shortness of breath or under the CSA since April 10, 2017. Crotonyl fentanyl and valeryl fentanyl depressed breathing, hypertension, 4–CMC (4-chloromethcathinone; have been encountered by law tachycardia, chest pain, muscle clefedrone, clephedrone) (chemical enforcement and/or reported in the twitching, acute renal failure, anxiety, name: 1-(4-chlorophenyl)-2- scientific literature by public health agitation, psychosis, suicidal ideation, (methylamino)propan-1-one) is a officials as being illicitly distributed and and/or cognitive impairment. There are synthetic cathinone. 4–CMC produces abused. Crotonyl fentanyl and valeryl no commercial or approved medical central nervous system stimulant effects fentanyl have no commercial or uses for 5F–AMB. On April 10, 2017, and is abused for its psychoactive currently accepted medical uses in the 5F–AMB was temporarily controlled as properties. 4–CMC abuse has been United States. On February 1, 2018, a Schedule I substance under the CSA. associated with adverse health effects. valeryl fentanyl was temporarily placed This temporary rule was extended 4–CMC has no currently accepted into Schedule I of the CSA. The effective April 10, 2019. On April 8, medical use in treatment in the United chemical structure of crotonyl fentanyl 2019, a Drug Enforcement States. 4–CMC is not controlled under defines it as a fentanyl-related Administration Notice of Proposed the CSA, but it is considered a Schedule substance, as defined in 21 CFR Rulemaking proposed permanently I controlled substance by a number of 1308.11(h)(30); therefore, crotonyl placing 5F–AMB into Schedule I of the states in the United States. fentanyl was temporarily controlled as a CSA. N-Ethylhexedrone (chemical name: 2- Schedule I controlled substance under 5F–MDMB–PICA (5F–MDMB–2201) (ethylamino)-1-phenylhexan-1-one; the CSA as of February 6, 2018. (chemical name: Methyl 2-(1-(5- NEH, hexen, Ethyl-Hex) and alpha-PHP Flualprazolam and etizolam belong to fluoropentyl)-1H-indazole-3- (chemical name: 1-phenyl-2-(pyrrolidin- a class of substances known as carboxamido)-3,3-dimethylbutanoate) is 1-yl)hexan-1-one; PV–7, a- benzodiazepines. Benzodiazepines a synthetic cannabinoid that has been pyrrolidinohexanophenone) are produce central nervous system sold online and used to mimic the synthetic cathinones. N-Ethylhexedrone depression and are commonly used to biological effects of THC, the main and alpha-PHP produce central nervous treat insomnia, anxiety, and seizure psychoactive constituent in marijuana. system stimulant effects and are abused disorders. Etizolam is currently Research and clinical reports have for their psychoactive properties. N- prescribed in some countries; however, demonstrated that synthetic Ethylhexedrone and alpha-PHP have neither drug substance is approved for cannabinoids are applied onto plant been associated with adverse health medical use in the United States. material so that the material may be effects leading to emergency department Currently, flualprazolam and etizolam smoked as users attempt to obtain a admissions, and deaths. N- are not controlled under the CSA, but euphoric and psychoactive ‘‘high.’’ Ethylhexedrone and alpha-PHP have no are controlled in a number of States.

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Acetyldihydrocodeine is an ingredient in cough lozenges in some SUMMARY: The Office for Human derivative of low to moderate potency countries but is not an ingredient in any Research Protections (OHRP), a program used as a cough suppressant and products approved for medical use in office in the Office of the Assistant in various other countries. the United States. Pholcodine is Secretary for Health, Department of Acetyldihydrocodeine is not approved controlled in Schedule I of the CSA. Health and Human Services (HHS), is for medical use in the United States and seeking nominations of qualified IV. Opportunity To Submit Domestic is controlled under Schedule I of the candidates to be considered for CSA. Information appointment as members of the Codeine is an opioid drug closely As required by paragraph (d)(2)(A) of Secretary’s Advisory Committee on related to . Codeine can cause the CSA, FDA, on behalf of HHS, invites Human Research Protections (SACHRP). opioid tolerance, dependence, interested persons to submit comments SACHRP provides advice and addiction, poisoning, and respiratory regarding the 21 drug substances. Any recommendations to the Secretary, HHS depression in high doses. It is an active comments received will be considered (Secretary), through the Assistant ingredient in several approved narcotic by HHS when it prepares a scientific Secretary for Health, on matters analgesic and antitussive medicines in and medical evaluation for drug pertaining to the continuance and the United States. Codeine is approved substances that is responsive to the improvement of functions within the for marketing in the United States and WHO Questionnaire for these drug authority of HHS directed toward available as a single-ingredient product, substances. HHS will forward such protections for human subjects in or in combination with one or more evaluation of these drug substances to research. SACHRP was established by nonnarcotic ingredients in recognized WHO, for WHO’s consideration in the Secretary on October 1, 2002. OHRP therapeutic amounts. Codeine is deciding whether to recommend is seeking nominations of qualified controlled in Schedule II of the CSA. international control/decontrol of any of candidates to fill three positions on the Some codeine combination products are these drug substances. Such control Committee membership that will be controlled in Schedule III and some in could limit, among other things, the vacated during the 2020 and 2021 Schedule V, depending on the manufacture and distribution (import/ calendar years. concentration or amount of codeine export) of these drug substances and DATES: Nominations for membership on present in the approved product. could impose certain recordkeeping the Committee must be received no later Dihydrocodeine is a semisynthetic requirements on them. than 45 days from the date of this narcotic related to codeine. Although FDA is, through this notice, publication. Dihydrocodeine is an active ingredient requesting comments from interested in prescription-only oral tablet ADDRESSES: Nominations may be persons, which will be considered by emailed to [email protected]. combination products approved for HHS when it prepares an evaluation of marketing in the United States for the Nominations may also be mailed or these drug substances, HHS will not delivered Julia Gorey, Executive treatment of moderate to moderately now make any recommendations to severe pain. Dihydrocodeine is Director, SACHRP, Office for Human WHO regarding whether any of these Research Protections, Department of controlled in Schedule II of the CSA. drugs should be subjected to Some dihydrocodeine-containing Health and Human Services, 1101 international controls. Instead, HHS will Wootton Parkway, Suite 200, Rockville, combination products are controlled in defer such consideration until WHO has Schedule III and some in Schedule V, MD 20852. Nominations will not be made official recommendations to the accepted by facsimile. depending on the concentration or Commission on Narcotic Drugs, which FOR FURTHER INFORMATION CONTACT: Julia amount of dihydrocodeine present in are expected to be made in late 2019. Gorey, Executive Director, SACHRP, the approved product. Any HHS position regarding Office for Human Research Protections, Ethylmorphine is a derivative of international control of these drug morphine with analgesic and antitussive 1101 Wootton Parkway, Suite 200, substances will be preceded by another Rockville, MD 20852, telephone: 240– effects. It is not approved for medical Federal Register notice soliciting public use in the United States but is approved 453–8141. A copy of the Committee comments, as required by paragraph charter and list of the current members for use in various other countries (d)(2)(B) of the CSA. around the world. Ethylmorphine is can be obtained by contacting Ms. controlled in Schedule II of the CSA. Dated: September 4, 2019. Gorey, accessing the SACHRP website at Some ethylmorphine containing Lowell J. Schiller, www.hhs.gov/ohrp/sachrp, or combination products are controlled in Principal Associate Commissioner for Policy. requesting via email at [email protected]. Schedule III and some in Schedule V, [FR Doc. 2019–19492 Filed 9–9–19; 8:45 am] SUPPLEMENTARY INFORMATION: The depending on the concentration or BILLING CODE 4164–01–P Committee provides advice on matters amount of ethylmorphine present in the pertaining to the continuance and approved product. improvement of functions within the Nicocodine () and DEPARTMENT OF HEALTH AND authority of HHS directed toward nicodicodine (nicodicodeine) are esters HUMAN SERVICES protections for human subjects in of codeine and dihydrocodeine, research. Specifically, the Committee respectively. They are opioids with Solicitation of Nominations for provides advice relating to the analgesic and cough suppressant effects. Membership on the Secretary’s responsible conduct of research They are not approved for medical use Advisory Committee on Human involving human subjects with in the United States. Nicocodeine is Research Protections particular emphasis on special controlled in Schedule I of the CSA. As AGENCY: Office of the Assistant populations such as neonates and an ester of dihydrocodeine, Secretary for Health, Office for Human children, prisoners, the decisionally nicodicodeine is controlled in Schedule Research Protections, Office of the impaired, pregnant women, embryos II of the CSA. Secretary, Department of Health and and fetuses, individuals and Pholcodine is an opiate with cough Human Services. populations in international studies, suppressant effects but little to no investigator conflicts of interest and ACTION: Notice. analgesic effects. It is an active populations in which there are

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