Federal Register / Vol. 84, No. 175 / Tuesday, September 10, 2019 / Notices 47525

Acetyldihydrocodeine is an opiate 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 analgesic 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 morphine. 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 (nicocodeine) 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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individually identifiable samples, data function. Every effort is made to ensure Date: October 16, 2019. or information. that individuals from a broad Time: 8:00 a.m. to 5:00 p.m. In addition, the Committee is representation of geographic areas, Agenda: To review and evaluate grant responsible for reviewing selected applications. women and men, ethnic and minority Place: Hyatt Regency Bethesda, 7400 ongoing work and planned activities of groups, and the disabled are given Wisconsin Avenue, Bethesda, MD 20814. the OHRP and other offices/agencies consideration for membership on HHS Contact Person: Robert Stephen Coyne, within HHS responsible for human Federal advisory committees. Ph.D., Scientific Review Officer, National subjects protection. These evaluations Appointment to this Committee shall be Cancer Institute, NIH, Division of Extramural may include, but are not limited to, a made without discrimination on the Activities, Special Review Branch, 9609 review of assurance systems, the basis of age, race, ethnicity, gender, Medical Center Drive, Room 7W236, application of minimal research risk sexual orientation, disability, and Rockville, MD 20850, 240–276–5120, [email protected]. standards, the granting of waivers, cultural, religious, or socioeconomic education programs sponsored by status. Name of Committee: National Cancer OHRP, and the ongoing monitoring and Institute Special Emphasis Panel; SEP–1: Individuals who are selected to be Small Grants Program for Cancer Research oversight of institutional review boards considered for appointment will be (Omnibus R03). and the institutions that sponsor required to provide detailed information Date: October 30, 2019. research. regarding their financial holdings, Time: 12:00 p.m. to 5:00 p.m. Nominations: The OHRP is requesting consultancies, and research grants or Agenda: To review and evaluate grant nominations to fill three positions for contracts. Disclosure of this information applications. voting members of SACHRP. is necessary in order to determine if the Place: National Cancer Institute Shady Nominations of potential candidates for Grove, 9609 Medical Center Drive, 7W242, selected candidate is involved in any Rockville, MD 20850 (Telephone Conference consideration are being sought from a activity that may pose a potential wide array of fields, including, but not Call). conflict with the official duties to be Contact Person: Zhiqiang Zou, Ph.D., limited to: Public health and medicine, performed as a member of SACHRP. Scientific Review Officer, Special Review behavioral and social sciences, health Branch, Division of Extramural Activities, Authority: 42 U.S.C. 217a, Section 222 of administration, and biomedical ethics. National Cancer Institute, NIH, 9609 Medical the Public Health Service Act, as amended. To qualify for consideration of Center Drive, 7W242, Bethesda, MD 20892, The Committee is governed by the provisions 240–276–6372, [email protected]. appointment to the Committee, an of Public Law 92–463, as amended (5 U.S.C. individual must possess demonstrated Appendix 2), which sets forth standards for Name of Committee: National Cancer experience and expertise in any of the the formation and use of advisory Institute Special Emphasis Panel; Research several disciplines and fields pertinent committees. Projects in Cancer Systems Biology. to human subjects protection and/or Date: October 31, 2019. Dated: August 23, 2019. clinical research. Time: 12:00 p.m. to 4:00 p.m. The individuals selected for Julia Gorey, Agenda: To review and evaluate grant Executive Director, Secretary’s Advisory applications. appointment to the Committee can be Place: National Cancer Institute Shady invited to serve a term of up to four Committee on Human Research Protections, Office for Human Research Protections. Grove, 9609 Medical Center Drive, Room years. Committee members receive a 7W238, Rockville, MD 20850 (Telephone [FR Doc. 2019–19527 Filed 9–9–19; 8:45 am] stipend and reimbursement for per diem Conference Call). and any travel expenses incurred for BILLING CODE 4150–36–P Contact Person: Byeong-Chel Lee, Ph.D., attending Committee meetings and/or Scientific Review Officer, Resources and conducting other business in the Training Review Branch, Division of interest of the Committee. Interested DEPARTMENT OF HEALTH AND Extramural Activities, National Cancer applicants may self-nominate. HUMAN SERVICES Institute, NIH, 9609 Medical Center Drive, Nominations should be typewritten. Room 7W238, Rockville, MD 20850, 240– National Institutes of Health 276–7755, [email protected]. The following information should be included in the package of material Name of Committee: National Cancer National Cancer Institute; Notice of Institute Special Emphasis Panel; PQ: Cancer submitted for each individual being Closed Meetings with Underlying HIV Infection. nominated for consideration: (1) A letter Date: November 13, 2019. of nomination that clearly states the Pursuant to section 10(d) of the Time: 12:00 p.m. to 5:00 p.m. name and affiliation of the nominee, the Federal Advisory Committee Act, as Agenda: To review and evaluate grant basis for the nomination (i.e., specific amended, notice is hereby given of the applications. attributes which qualify the nominee for following meetings. Place: National Cancer Institute Shady service in this capacity), and a statement The meetings will be closed to the Grove, 9609 Medical Center Drive, 7W242, that the nominee is willing to serve as public in accordance with the Rockville, MD 20850 (Telephone Conference provisions set forth in sections Call). a member of the Committee; (2) the Contact Person: Zhiqiang Zou, Ph.D., nominator’s name, address, daytime 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Scientific Review Officer, Special Review telephone number, and the home and/ as amended. The grant applications and Branch, Division of Extramural Activities, or work address, telephone number, and the discussions could disclose National Cancer Institute, NIH, 9609 Medical email address of the individual being confidential trade secrets or commercial Center Drive, 7W242, Bethesda, MD 20892, nominated; and (3) a current copy of the property such as patentable material, 240–276–6372, [email protected]. nominee’s curriculum vitae. Federal and personal information concerning Name of Committee: National Cancer employees should not be nominated for individuals associated with the grant Institute Initial Review Group; Subcommittee consideration of appointment to this applications, the disclosure of which A—Cancer Centers. Committee. would constitute a clearly unwarranted Date: November 21, 2019. Time: 8:00 a.m. to 2:00 p.m. The Department makes every effort to invasion of personal privacy. Agenda: To review and evaluate grant ensure that the membership of HHS Name of Committee: National Cancer applications. Federal advisory committees is fairly Institute Special Emphasis Panel; SEP–4: Place: Bethesda North Marriott Hotel & balanced in terms of points of view Small Grants Program for Cancer Research Conference Center, 5701 Marinelli Road, represented and the committee’s (Omnibus R03). Bethesda, MD 20852.

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