Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections, 47525-47526 [2019-19527]
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Federal Register / Vol. 84, No. 175 / Tuesday, September 10, 2019 / Notices
Acetyldihydrocodeine is an opiate
derivative of low to moderate potency
used as a cough suppressant and
analgesic in various other countries.
Acetyldihydrocodeine is not approved
for medical use in the United States and
is controlled under Schedule I of the
CSA.
Codeine is an opioid drug closely
related to morphine. Codeine can cause
opioid tolerance, dependence,
addiction, poisoning, and respiratory
depression in high doses. It is an active
ingredient in several approved narcotic
analgesic and antitussive medicines in
the United States. Codeine is approved
for marketing in the United States and
available as a single-ingredient product,
or in combination with one or more
nonnarcotic ingredients in recognized
therapeutic amounts. Codeine is
controlled in Schedule II of the CSA.
Some codeine combination products are
controlled in Schedule III and some in
Schedule V, depending on the
concentration or amount of codeine
present in the approved product.
Dihydrocodeine is a semisynthetic
narcotic related to codeine.
Dihydrocodeine is an active ingredient
in prescription-only oral tablet
combination products approved for
marketing in the United States for the
treatment of moderate to moderately
severe pain. Dihydrocodeine is
controlled in Schedule II of the CSA.
Some dihydrocodeine-containing
combination products are controlled in
Schedule III and some in Schedule V,
depending on the concentration or
amount of dihydrocodeine present in
the approved product.
Ethylmorphine is a derivative of
morphine with analgesic and antitussive
effects. It is not approved for medical
use in the United States but is approved
for use in various other countries
around the world. Ethylmorphine is
controlled in Schedule II of the CSA.
Some ethylmorphine containing
combination products are controlled in
Schedule III and some in Schedule V,
depending on the concentration or
amount of ethylmorphine present in the
approved product.
Nicocodine (nicocodeine) and
nicodicodine (nicodicodeine) are esters
of codeine and dihydrocodeine,
respectively. They are opioids with
analgesic and cough suppressant effects.
They are not approved for medical use
in the United States. Nicocodeine is
controlled in Schedule I of the CSA. As
an ester of dihydrocodeine,
nicodicodeine is controlled in Schedule
II of the CSA.
Pholcodine is an opiate with cough
suppressant effects but little to no
analgesic effects. It is an active
VerDate Sep<11>2014
16:56 Sep 09, 2019
Jkt 247001
ingredient in cough lozenges in some
countries but is not an ingredient in any
products approved for medical use in
the United States. Pholcodine is
controlled in Schedule I of the CSA.
IV. Opportunity To Submit Domestic
Information
As required by paragraph (d)(2)(A) of
the CSA, FDA, on behalf of HHS, invites
interested persons to submit comments
regarding the 21 drug substances. Any
comments received will be considered
by HHS when it prepares a scientific
and medical evaluation for drug
substances that is responsive to the
WHO Questionnaire for these drug
substances. HHS will forward such
evaluation of these drug substances to
WHO, for WHO’s consideration in
deciding whether to recommend
international control/decontrol of any of
these drug substances. Such control
could limit, among other things, the
manufacture and distribution (import/
export) of these drug substances and
could impose certain recordkeeping
requirements on them.
Although FDA is, through this notice,
requesting comments from interested
persons, which will be considered by
HHS when it prepares an evaluation of
these drug substances, HHS will not
now make any recommendations to
WHO regarding whether any of these
drugs should be subjected to
international controls. Instead, HHS will
defer such consideration until WHO has
made official recommendations to the
Commission on Narcotic Drugs, which
are expected to be made in late 2019.
Any HHS position regarding
international control of these drug
substances will be preceded by another
Federal Register notice soliciting public
comments, as required by paragraph
(d)(2)(B) of the CSA.
Dated: September 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19492 Filed 9–9–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Membership on the Secretary’s
Advisory Committee on Human
Research Protections
Office of the Assistant
Secretary for Health, Office for Human
Research Protections, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
PO 00000
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47525
The Office for Human
Research Protections (OHRP), a program
office in the Office of the Assistant
Secretary for Health, Department of
Health and Human Services (HHS), is
seeking nominations of qualified
candidates to be considered for
appointment as members of the
Secretary’s Advisory Committee on
Human Research Protections (SACHRP).
SACHRP provides advice and
recommendations to the Secretary, HHS
(Secretary), through the Assistant
Secretary for Health, on matters
pertaining to the continuance and
improvement of functions within the
authority of HHS directed toward
protections for human subjects in
research. SACHRP was established by
the Secretary on October 1, 2002. OHRP
is seeking nominations of qualified
candidates to fill three positions on the
Committee membership that will be
vacated during the 2020 and 2021
calendar years.
DATES: Nominations for membership on
the Committee must be received no later
than 45 days from the date of this
publication.
ADDRESSES: Nominations may be
emailed to SACHRP@hhs.gov.
Nominations may also be mailed or
delivered Julia Gorey, Executive
Director, SACHRP, Office for Human
Research Protections, Department of
Health and Human Services, 1101
Wootton Parkway, Suite 200, Rockville,
MD 20852. Nominations will not be
accepted by facsimile.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, Executive Director, SACHRP,
Office for Human Research Protections,
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852, telephone: 240–
453–8141. A copy of the Committee
charter and list of the current members
can be obtained by contacting Ms.
Gorey, accessing the SACHRP website at
www.hhs.gov/ohrp/sachrp, or
requesting via email at sachrp@hhs.gov.
SUPPLEMENTARY INFORMATION: The
Committee provides advice on matters
pertaining to the continuance and
improvement of functions within the
authority of HHS directed toward
protections for human subjects in
research. Specifically, the Committee
provides advice relating to the
responsible conduct of research
involving human subjects with
particular emphasis on special
populations such as neonates and
children, prisoners, the decisionally
impaired, pregnant women, embryos
and fetuses, individuals and
populations in international studies,
investigator conflicts of interest and
populations in which there are
SUMMARY:
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khammond on DSKBBV9HB2PROD with NOTICES
47526
Federal Register / Vol. 84, No. 175 / Tuesday, September 10, 2019 / Notices
individually identifiable samples, data
or information.
In addition, the Committee is
responsible for reviewing selected
ongoing work and planned activities of
the OHRP and other offices/agencies
within HHS responsible for human
subjects protection. These evaluations
may include, but are not limited to, a
review of assurance systems, the
application of minimal research risk
standards, the granting of waivers,
education programs sponsored by
OHRP, and the ongoing monitoring and
oversight of institutional review boards
and the institutions that sponsor
research.
Nominations: The OHRP is requesting
nominations to fill three positions for
voting members of SACHRP.
Nominations of potential candidates for
consideration are being sought from a
wide array of fields, including, but not
limited to: Public health and medicine,
behavioral and social sciences, health
administration, and biomedical ethics.
To qualify for consideration of
appointment to the Committee, an
individual must possess demonstrated
experience and expertise in any of the
several disciplines and fields pertinent
to human subjects protection and/or
clinical research.
The individuals selected for
appointment to the Committee can be
invited to serve a term of up to four
years. Committee members receive a
stipend and reimbursement for per diem
and any travel expenses incurred for
attending Committee meetings and/or
conducting other business in the
interest of the Committee. Interested
applicants may self-nominate.
Nominations should be typewritten.
The following information should be
included in the package of material
submitted for each individual being
nominated for consideration: (1) A letter
of nomination that clearly states the
name and affiliation of the nominee, the
basis for the nomination (i.e., specific
attributes which qualify the nominee for
service in this capacity), and a statement
that the nominee is willing to serve as
a member of the Committee; (2) the
nominator’s name, address, daytime
telephone number, and the home and/
or work address, telephone number, and
email address of the individual being
nominated; and (3) a current copy of the
nominee’s curriculum vitae. Federal
employees should not be nominated for
consideration of appointment to this
Committee.
The Department makes every effort to
ensure that the membership of HHS
Federal advisory committees is fairly
balanced in terms of points of view
represented and the committee’s
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function. Every effort is made to ensure
that individuals from a broad
representation of geographic areas,
women and men, ethnic and minority
groups, and the disabled are given
consideration for membership on HHS
Federal advisory committees.
Appointment to this Committee shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and
cultural, religious, or socioeconomic
status.
Individuals who are selected to be
considered for appointment will be
required to provide detailed information
regarding their financial holdings,
consultancies, and research grants or
contracts. Disclosure of this information
is necessary in order to determine if the
selected candidate is involved in any
activity that may pose a potential
conflict with the official duties to be
performed as a member of SACHRP.
Authority: 42 U.S.C. 217a, Section 222 of
the Public Health Service Act, as amended.
The Committee is governed by the provisions
of Public Law 92–463, as amended (5 U.S.C.
Appendix 2), which sets forth standards for
the formation and use of advisory
committees.
Dated: August 23, 2019.
Julia Gorey,
Executive Director, Secretary’s Advisory
Committee on Human Research Protections,
Office for Human Research Protections.
[FR Doc. 2019–19527 Filed 9–9–19; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–4:
Small Grants Program for Cancer Research
(Omnibus R03).
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Date: October 16, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Robert Stephen Coyne,
Ph.D., Scientific Review Officer, National
Cancer Institute, NIH, Division of Extramural
Activities, Special Review Branch, 9609
Medical Center Drive, Room 7W236,
Rockville, MD 20850, 240–276–5120,
coyners@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–1:
Small Grants Program for Cancer Research
(Omnibus R03).
Date: October 30, 2019.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, 7W242,
Rockville, MD 20850 (Telephone Conference
Call).
Contact Person: Zhiqiang Zou, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, 7W242, Bethesda, MD 20892,
240–276–6372, zouzhiq@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Research
Projects in Cancer Systems Biology.
Date: October 31, 2019.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W238, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Byeong-Chel Lee, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W238, Rockville, MD 20850, 240–
276–7755, byeong-chel.lee@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; PQ: Cancer
with Underlying HIV Infection.
Date: November 13, 2019.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, 7W242,
Rockville, MD 20850 (Telephone Conference
Call).
Contact Person: Zhiqiang Zou, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, 7W242, Bethesda, MD 20892,
240–276–6372, zouzhiq@mail.nih.gov.
Name of Committee: National Cancer
Institute Initial Review Group; Subcommittee
A—Cancer Centers.
Date: November 21, 2019.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 84, Number 175 (Tuesday, September 10, 2019)]
[Notices]
[Pages 47525-47526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19527]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Nominations for Membership on the Secretary's
Advisory Committee on Human Research Protections
AGENCY: Office of the Assistant Secretary for Health, Office for Human
Research Protections, Office of the Secretary, Department of Health and
Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Office for Human Research Protections (OHRP), a program
office in the Office of the Assistant Secretary for Health, Department
of Health and Human Services (HHS), is seeking nominations of qualified
candidates to be considered for appointment as members of the
Secretary's Advisory Committee on Human Research Protections (SACHRP).
SACHRP provides advice and recommendations to the Secretary, HHS
(Secretary), through the Assistant Secretary for Health, on matters
pertaining to the continuance and improvement of functions within the
authority of HHS directed toward protections for human subjects in
research. SACHRP was established by the Secretary on October 1, 2002.
OHRP is seeking nominations of qualified candidates to fill three
positions on the Committee membership that will be vacated during the
2020 and 2021 calendar years.
DATES: Nominations for membership on the Committee must be received no
later than 45 days from the date of this publication.
ADDRESSES: Nominations may be emailed to [email protected]. Nominations
may also be mailed or delivered Julia Gorey, Executive Director,
SACHRP, Office for Human Research Protections, Department of Health and
Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
Nominations will not be accepted by facsimile.
FOR FURTHER INFORMATION CONTACT: Julia Gorey, Executive Director,
SACHRP, Office for Human Research Protections, 1101 Wootton Parkway,
Suite 200, Rockville, MD 20852, telephone: 240-453-8141. A copy of the
Committee charter and list of the current members can be obtained by
contacting Ms. Gorey, accessing the SACHRP website at www.hhs.gov/ohrp/sachrp, or requesting via email at [email protected]
SUPPLEMENTARY INFORMATION: The Committee provides advice on matters
pertaining to the continuance and improvement of functions within the
authority of HHS directed toward protections for human subjects in
research. Specifically, the Committee provides advice relating to the
responsible conduct of research involving human subjects with
particular emphasis on special populations such as neonates and
children, prisoners, the decisionally impaired, pregnant women, embryos
and fetuses, individuals and populations in international studies,
investigator conflicts of interest and populations in which there are
[[Page 47526]]
individually identifiable samples, data or information.
In addition, the Committee is responsible for reviewing selected
ongoing work and planned activities of the OHRP and other offices/
agencies within HHS responsible for human subjects protection. These
evaluations may include, but are not limited to, a review of assurance
systems, the application of minimal research risk standards, the
granting of waivers, education programs sponsored by OHRP, and the
ongoing monitoring and oversight of institutional review boards and the
institutions that sponsor research.
Nominations: The OHRP is requesting nominations to fill three
positions for voting members of SACHRP. Nominations of potential
candidates for consideration are being sought from a wide array of
fields, including, but not limited to: Public health and medicine,
behavioral and social sciences, health administration, and biomedical
ethics. To qualify for consideration of appointment to the Committee,
an individual must possess demonstrated experience and expertise in any
of the several disciplines and fields pertinent to human subjects
protection and/or clinical research.
The individuals selected for appointment to the Committee can be
invited to serve a term of up to four years. Committee members receive
a stipend and reimbursement for per diem and any travel expenses
incurred for attending Committee meetings and/or conducting other
business in the interest of the Committee. Interested applicants may
self-nominate.
Nominations should be typewritten. The following information should
be included in the package of material submitted for each individual
being nominated for consideration: (1) A letter of nomination that
clearly states the name and affiliation of the nominee, the basis for
the nomination (i.e., specific attributes which qualify the nominee for
service in this capacity), and a statement that the nominee is willing
to serve as a member of the Committee; (2) the nominator's name,
address, daytime telephone number, and the home and/or work address,
telephone number, and email address of the individual being nominated;
and (3) a current copy of the nominee's curriculum vitae. Federal
employees should not be nominated for consideration of appointment to
this Committee.
The Department makes every effort to ensure that the membership of
HHS Federal advisory committees is fairly balanced in terms of points
of view represented and the committee's function. Every effort is made
to ensure that individuals from a broad representation of geographic
areas, women and men, ethnic and minority groups, and the disabled are
given consideration for membership on HHS Federal advisory committees.
Appointment to this Committee shall be made without discrimination on
the basis of age, race, ethnicity, gender, sexual orientation,
disability, and cultural, religious, or socioeconomic status.
Individuals who are selected to be considered for appointment will
be required to provide detailed information regarding their financial
holdings, consultancies, and research grants or contracts. Disclosure
of this information is necessary in order to determine if the selected
candidate is involved in any activity that may pose a potential
conflict with the official duties to be performed as a member of
SACHRP.
Authority: 42 U.S.C. 217a, Section 222 of the Public Health
Service Act, as amended. The Committee is governed by the provisions
of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets
forth standards for the formation and use of advisory committees.
Dated: August 23, 2019.
Julia Gorey,
Executive Director, Secretary's Advisory Committee on Human Research
Protections, Office for Human Research Protections.
[FR Doc. 2019-19527 Filed 9-9-19; 8:45 am]
BILLING CODE 4150-36-P
