83 FR 32881 - Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery-Influences of Sex and Gender; Public Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 136 (July 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 136 (July 16, 2018)
| Page Range | 32881-32882 | |
| FR Document | 2018-15096 |
[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)] [Notices] [Pages 32881-32882] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15096] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0001] Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery--Influences of Sex and Gender; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration's (FDA or Agency) Office of Women's Health, Center for Drug Evaluation and Research, and Center for Tobacco Products are announcing the following conference entitled ``Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery--Influences of Sex and Gender.'' The purpose of the conference is to discuss the biological (sex) and sociological (gender) influences on misuse, abuse, and cessation of opioids and tobacco. Researchers, educators, and clinicians may benefit from attending this multidisciplinary review and update on opioid and tobacco. DATES: The two-day conference will be held on September 27, 2018 (8:30 a.m.-4:00 p.m.) and September 28, 2018 (8:30 a.m.-4:00 p.m.). See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The conference will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503-A), Silver Spring, MD 20993. Entrance for the conference participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Gwendolyn Jones, Food and Drug Administration, Bldg. 32, Rm. 2333, 10903 New Hampshire Ave., Silver Spring, MD 20993, OWH_OandNConf@fda.hhs.gov, 301-796-9940. SUPPLEMENTARY INFORMATION: I. Background FDA is responsible for protecting the public health by assuring the safety and efficacy of FDA-regulated products. This conference will provide the Agency with further insight into the devastating public health crises caused by pervasive opioid and tobacco use. Drug overdose deaths and opioid-involved deaths continue to increase in the United States. Many of the drug overdose deaths (more than 6 out of 10) involve an opioid. Since 1999, the number of overdose deaths involving opioids (including prescription opioids and heroin) quadrupled. Drug overdose deaths and opioid-involved deaths continue to increase in the United States. Of the 63,632 drug overdose deaths in 2016, 66.4 percent (42,249) involved opioids, with increases across age groups, racial/ ethnic groups, urbanization levels, and multiple states. Combustible cigarettes have been identified as the dominant cause of tobacco- related disease and are responsible for more than 20 million premature deaths since the first Surgeon General's report in 1964. Together, opioid and tobacco use are the leading causes of preventable disease and death in the United States, and women are increasingly affected. Sex and gender differences may influence susceptibility to substance abuse, which could have implications for optimal prevention and treatment. Gender influencers also impact public health from a familial and environmental perspective. Researchers, educators, and clinicians must be able to recognize and consider both sex and gender differences to identify and treat women most at risk. II. Topics for Discussion at the Conference The conference will include presentations and panel discussions by experts in the field of opioid and tobacco research, professional education, and clinical care on the biological (sex) and sociological (gender) influences on misuse, abuse, and cessation of opioids and tobacco. Each panel discussion will have a Q&A session to respond to questions from in-person attendees. III. Participating in the Conference Registration: To register for the Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery--Influences of Sex and Gender, please visit the following website: https://www.eventbrite.com/e/scientific-conference-opioid-and-nicotine-use-dependence-and-recovery-influences-of-sex-and-gender-tickets-47087275308. Registration is free and in-person seating is limited. The conference will also be available for viewing via webcast. Persons interested in attending or viewing this conference must register online by September 24, 2018, 5:00 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please email Gwendolyn Jones at OWH_OandNConf@fda.hhs.gov (See FOR FURTHER INFORMATION CONTACT) no later than September 24, 2018. Streaming Webcast of the public meeting: This public meeting will also be webcast and can only be viewed if registered. To register, please go to [[Page 32882]] https://www.eventbrite.com/e/scientific-conference-opioid-and-nicotine-use-dependence-and-recovery-influences-of-sex-and-gender-tickets-47087275308. Registrants will receive confirmation and information about accessing the webcast when they have been accepted. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Dated: July 10, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-15096 Filed 7-13-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32881
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section; activity responses per burden per Total hours
respondents responses
respondent response
111.75(a)(1)(ii); Determining whether specifications are
met .................................................................................... 1 1 1 8 8
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Since OMB’s last approval of the INFORMATION section for registration date differences may influence susceptibility
information collection, we have and information. to substance abuse, which could have
received no petitions. We therefore ADDRESSES: The conference will be held implications for optimal prevention and
retain the currently approved estimated at FDA’s White Oak Campus, 10903 treatment. Gender influencers also
burden which assumes no more than New Hampshire Ave., Bldg. 31 impact public health from a familial and
one petition will be submitted annually. Conference Center, the Great Room (Rm. environmental perspective. Researchers,
We further assume it would take 1503–A), Silver Spring, MD 20993. educators, and clinicians must be able
respondents 8 hours to prepare the Entrance for the conference participants to recognize and consider both sex and
factual and legal information necessary (non-FDA employees) is through gender differences to identify and treat
to support a petition for exemption and Building 1 where routine security check women most at risk.
to prepare the petition, for a total of 8 procedures will be performed. For II. Topics for Discussion at the
burden hours annually. These figures parking and security information, please Conference
are based on our experience with the refer to https://www.fda.gov/AboutFDA/
information collection. WorkingatFDA/BuildingsandFacilities/ The conference will include
Dated: July 10, 2018. WhiteOakCampusInformation/ presentations and panel discussions by
ucm241740.htm. experts in the field of opioid and
Leslie Kux,
tobacco research, professional
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: education, and clinical care on the
[FR Doc. 2018–15088 Filed 7–13–18; 8:45 am] Gwendolyn Jones, Food and Drug biological (sex) and sociological
BILLING CODE 4164–01–P Administration, Bldg. 32, Rm. 2333, (gender) influences on misuse, abuse,
10903 New Hampshire Ave., Silver and cessation of opioids and tobacco.
Spring, MD 20993, OWH_OandNConf@ Each panel discussion will have a Q&A
DEPARTMENT OF HEALTH AND fda.hhs.gov, 301–796–9940. session to respond to questions from in-
HUMAN SERVICES SUPPLEMENTARY INFORMATION: person attendees.
Food and Drug Administration I. Background III. Participating in the Conference
FDA is responsible for protecting the Registration: To register for the
[Docket No. FDA–2018–N–0001]
public health by assuring the safety and Scientific Conference: Opioid and
Scientific Conference: Opioid and efficacy of FDA-regulated products. This Nicotine Use, Dependence, and
Nicotine Use, Dependence, and conference will provide the Agency Recovery—Influences of Sex and
Recovery—Influences of Sex and with further insight into the devastating Gender, please visit the following
Gender; Public Meeting public health crises caused by pervasive website: https://www.eventbrite.com/e/
opioid and tobacco use. Drug overdose scientific-conference-opioid-and-
AGENCY: Food and Drug Administration, deaths and opioid-involved deaths nicotine-use-dependence-and-recovery-
HHS. continue to increase in the United influences-of-sex-and-gender-tickets-
ACTION: Notice of public meeting. States. Many of the drug overdose 47087275308.
deaths (more than 6 out of 10) involve Registration is free and in-person
SUMMARY: The Food and Drug an opioid. Since 1999, the number of seating is limited. The conference will
Administration’s (FDA or Agency) overdose deaths involving opioids also be available for viewing via
Office of Women’s Health, Center for (including prescription opioids and webcast. Persons interested in attending
Drug Evaluation and Research, and heroin) quadrupled. Drug overdose or viewing this conference must register
Center for Tobacco Products are deaths and opioid-involved deaths online by September 24, 2018, 5:00 p.m.
announcing the following conference continue to increase in the United Eastern Time. Early registration is
entitled ‘‘Scientific Conference: Opioid States. Of the 63,632 drug overdose recommended because seating is
and Nicotine Use, Dependence, and deaths in 2016, 66.4 percent (42,249) limited; therefore, FDA may limit the
Recovery—Influences of Sex and involved opioids, with increases across number of participants from each
Gender.’’ The purpose of the conference age groups, racial/ethnic groups, organization. Registrants will receive
is to discuss the biological (sex) and urbanization levels, and multiple states. confirmation when they have been
sociological (gender) influences on Combustible cigarettes have been accepted. If you need special
misuse, abuse, and cessation of opioids identified as the dominant cause of accommodations due to a disability,
and tobacco. Researchers, educators, tobacco-related disease and are please email Gwendolyn Jones at OWH_
sradovich on DSK3GMQ082PROD with NOTICES
and clinicians may benefit from responsible for more than 20 million OandNConf@fda.hhs.gov (See FOR
attending this multidisciplinary review premature deaths since the first Surgeon FURTHER INFORMATION CONTACT) no later
and update on opioid and tobacco. General’s report in 1964. Together, than September 24, 2018.
DATES: The two-day conference will be opioid and tobacco use are the leading Streaming Webcast of the public
held on September 27, 2018 (8:30 a.m.– causes of preventable disease and death meeting: This public meeting will also
4:00 p.m.) and September 28, 2018 (8:30 in the United States, and women are be webcast and can only be viewed if
a.m.–4:00 p.m.). See the SUPPLEMENTARY increasingly affected. Sex and gender registered. To register, please go to
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![32882 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
https://www.eventbrite.com/e/scientific- FOR FURTHER INFORMATION CONTACT: One of the guidance document’s
conference-opioid-and-nicotine-use- Domini Bean, Office of Operations, conditions is that the compounded
dependence-and-recovery-influences-of- Food and Drug Administration, Three radiopharmaceutical is not essentially a
sex-and-gender-tickets-47087275308. White Flint North, 10A–12M, 11601 copy of an approved
Registrants will receive confirmation Landsdown St., North Bethesda, MD radiopharmaceutical. If a compounder
and information about accessing the 20852, 301–796–5733, PRAStaff@ intends to rely on a determination from
webcast when they have been accepted. fda.hhs.gov. a prescriber that there is a change
FDA has verified the website addresses SUPPLEMENTARY INFORMATION: In between the compounded
in this document, as of the date this compliance with 44 U.S.C. 3507, FDA radiopharmaceutical and the
document publishes in the Federal has submitted the following proposed comparable approved
Register, but websites are subject to collection of information to OMB for radiopharmaceutical that produces a
change over time. review and clearance. clinical difference for an identified
Dated: July 10, 2018.
individual patient, either the
Guidance for Industry on Compounding prescribing practitioner or the
Leslie Kux, and Repackaging of compounder documents the
Associate Commissioner for Policy. Radiopharmaceuticals by State- determination on the prescription or
[FR Doc. 2018–15096 Filed 7–13–18; 8:45 am] Licensed Nuclear Pharmacies, Federal order in writing. This documentation
BILLING CODE 4164–01–P Facilities, and Certain Other Entities reflects a conversation with the
OMB Control Number—NEW prescribing practitioner, and the
compounder maintains records of the
DEPARTMENT OF HEALTH AND This information collection supports prescription or order documenting this
HUMAN SERVICES the Agency guidance document entitled determination.
‘‘Guidance for Industry on In the Federal Register of December
Food and Drug Administration Compounding and Repackaging of 29, 2016 (81 FR 96011), FDA published
Radiopharmaceuticals by State-Licensed a notice of availability for the draft
[Docket No. FDA–2016–D–4318] Nuclear Pharmacies, Federal Facilities, guidance, including a 60-day notice
and Certain Other Entities.’’ soliciting public comment on the
Agency Information Collection Under current law, information collection
Activities; Submission for Office of radiopharmaceuticals that are recommendations. Several comments
Management and Budget Review; compounded by entities that are not were received and are discussed below;
Comment Request; Guidance for registered with FDA as outsourcing however, none of the comments
Industry on Compounding and facilities, and radiopharmaceuticals that suggested we revise the burden estimate
Repackaging of Radiopharmaceuticals are repackaged, are subject to all from our 60-day notice.
by State-Licensed Nuclear Pharmacies, applicable provisions of the Federal (Comment 1) One commenter said
Federal Facilities, and Certain Other Food, Drug, and Cosmetic Act (FD&C documentation of a minor deviation
Entities Act) related to drug production. Because from an approved radiopharmaceutical
Congress explicitly excluded should remain at the facility that
AGENCY: Food and Drug Administration, radiopharmaceuticals from section 503A
HHS. performed the minor deviation.
of the FD&C Act (21 U.S.C. 353a) (see (Response 1) The documentation
ACTION: Notice. section 503A(d)(2)), compounded condition (i.e., documentation of a
radiopharmaceuticals are not eligible for prescriber’s determination that there is
SUMMARY: The Food and Drug
the exemptions under section 503A a change that produces a clinical
Administration (FDA) is announcing
from section 505 of the FD&C Act (21 difference between the compounded
that a proposed collection of
U.S.C. 355) (concerning new drug radiopharmaceutical and the
information has been submitted to the
approval requirements), section comparable FDA-approved
Office of Management and Budget
502(f)(1) of the FD&C Act (21 U.S.C. radiopharmaceutical for an identified
(OMB) for review and clearance under
352(f)(1)) (concerning labeling with individual patient) does not apply to
the Paperwork Reduction Act of 1995.
adequate directions for use), and section compounding that consists only of
DATES: Fax written comments on the 501(a)(2)(B) of the FD&C Act (21 U.S.C. minor deviations as defined in the
collection of information by August 15, 351(a)(2)(B)) (concerning current good guidance document (i.e., a change from
2018. manufacturing practice requirements). the approved labeling in radioactivity,
ADDRESSES: To ensure that comments on In addition, the FD&C Act does not volume, or the step-by-step procedures
the information collection are received, provide an exemption for repackaged made when compounding the
OMB recommends that written radiopharmaceuticals. radiopharmaceutical from an FDA-
comments be faxed to the Office of FDA developed this guidance approved drug product in a patient-
Information and Regulatory Affairs, document to describe the conditions ready dose). The documentation
OMB, Attn: FDA Desk Officer, Fax: 202– under which the Agency generally does condition applies to compounding a
395–7285, or emailed to oira_ not intend to take action for violations radiopharmaceutical that involves
submission@omb.eop.gov. All of sections 505, 502(f)(1), and manipulation other than minor
comments should be identified with the 501(a)(2)(B) of the FD&C Act when a deviations.
OMB control number 0910–NEW and State-licensed nuclear pharmacy, (Comment 2) One commenter
title ‘‘Guidance for Industry on Federal facility, or other facility that is
sradovich on DSK3GMQ082PROD with NOTICES
supports the requirement for notating
Compounding and Repackaging of not an outsourcing facility and that clinical differences, particularly for
Radiopharmaceuticals by State-Licensed holds a radioactive materials license for documenting both the change to the
Nuclear Pharmacies, Federal Facilities, medical use issued by the Nuclear radiopharmaceutical and the reason that
and Certain Other Entities.’’ Also Regulatory Commission or by an the change is important for the patient.
include the FDA docket number found Agreement State compounds or (Response 2) FDA concurs with this
in brackets in the heading of this repackages radiopharmaceuticals for commenter’s views about the
document. human use. importance of the documentation.
VerDate Sep<11>2014 17:31 Jul 13, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\16JYN1.SGM 16JYN1](https://thefederalregister.org/doc/83_FR_33017/page/2.svg)
Document Created: 2018-07-14 00:54:29
Document Modified: 2018-07-14 00:54:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meeting. | |
| Dates | The two-day conference will be held on September 27, 2018 (8:30 a.m.-4:00 p.m.) and September 28, 2018 (8:30 a.m.-4:00 p.m.). See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Gwendolyn Jones, Food and Drug Administration, Bldg. 32, Rm. 2333, 10903 New Hampshire Ave., Silver Spring, MD 20993, [email protected], 301-796-9940. | |
| FR Citation | 83 FR 32881 |
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