Meeting of the President's Council on Fitness, Sports, and Nutrition, 16187-16188 [2016-06810]
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Federal Register / Vol. 81, No. 58 / Friday, March 25, 2016 / Notices
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Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Gail
Schmerfeld, Office of Generic Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–9291, email: gail.schmerfeld@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘General Principles for Evaluating the
Abuse Deterrence of Generic Solid Oral
Opioid Drug Products.’’ Prescription
opioid analgesics are an important
component of modern pain
management. However, abuse and
misuse of these drug products have
created a serious and growing public
health problem. One important step
toward the goal of creating safer opioid
analgesics has been the development of
opioid drug products that are
formulated to deter abuse. FDA
considers the development of these
products a high public health priority.
It is important that generic versions of
opioids that reference listed drugs
whose labeling describes abusedeterrent properties are available to help
ensure availability of analgesics for
patients who need them.
For FDA to approve an abbreviated
new drug application (ANDA), the
Agency must find, among other things,
that the generic drug product has the
same active ingredient(s), dosage form,
route of administration, strength, and,
with limited exceptions, labeling as the
reference listed drug (RLD); is
bioequivalent to its RLD; that the
methods used in, or the facilities and
controls used for, the manufacture,
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processing, and packing of the drug are
adequate to assure and preserve its
identity, strength, quality, and purity;
and that the inactive ingredients and
composition of the generic drug are not
unsafe for use under the conditions
prescribed, recommended, or suggested
in the labeling (see, e.g., the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) 505(j)(2)(A) and (j)(4) (21
U.S.C. 355(j)(2)(A) and (j)(4))). FDA
classifies as ‘‘therapeutically
equivalent’’ those products that meet
the following general criteria: (1) They
are approved as safe and effective; (2)
they are pharmaceutical equivalents in
that they: (a) Contain identical amounts
of the same active ingredient in the
same dosage form and route of
administration, and (b) meet
compendial or other applicable
standards of strength, quality, purity,
and identity; (3) they are bioequivalent;
(4) they are adequately labeled; and (5)
they are manufactured in compliance
with current good manufacturing
practices regulations. (See preface of
Approved Drug Products with
Therapeutic Equivalence Evaluations
(commonly referred to as the Orange
Book).) FDA believes that a product
classified as therapeutically equivalent
can be substituted with the full
expectation that the substituted product
will produce the same clinical effect
and safety profile as the reference
product.
Accordingly, if the RLD’s labeling
describes abuse-deterrent properties, the
ANDA applicant should evaluate its
product to show that it is no less abusedeterrent than the RLD with respect to
all potential routes of abuse. Marketing
a generic opioid drug product that is
less abuse-deterrent than the RLD could
lead opioid abusers to preferentially
seek out and abuse generics.
This draft guidance describes FDA’s
current thinking about the studies that
should be conducted by a potential
ANDA applicant and submitted to FDA
in an ANDA to demonstrate that a
generic solid oral opioid drug product is
no less abuse-deterrent than its RLD
with respect to all potential routes of
abuse.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the principles for evaluating the
abuse-deterrence of generic solid oral
opioid drug products. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
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FDA intends to hold a public meeting
following the close of the comment
period to discuss further the evaluation
of the abuse deterrence of generic opioid
drug products and related issues, as
appropriate. Further details will follow
in a notice of public meeting published
in the Federal Register.
II. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: March 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–06766 Filed 3–24–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the President’s Council on
Fitness, Sports, and Nutrition
President’s Council on Fitness,
Sports, and Nutrition, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice of meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services (HHS) is hereby giving notice
that the President’s Council on Fitness,
Sports, and Nutrition (PCFSN) will hold
its annual meeting. The meeting will be
open to the public.
DATES: The meeting will be held on May
16, 2016, from 9:00 a.m. to 12:00 p.m.
ADDRESSES: Hubert H. Humphrey
Building, 200 Independence Avenue
SW., Great Hall, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Ms.
Shellie Pfohl, Executive Director, Office
of the President’s Council on Fitness,
Sports, and Nutrition, Tower Building,
1101 Wootton Parkway, Suite 560,
Rockville, MD 20852, (240) 276–9567.
Information about PCFSN, including
details about the upcoming meeting, can
be obtained at www.fitness.gov.
SUPPLEMENTARY INFORMATION: The
primary functions of the PCFSN include
(1) advising the President, through the
Secretary, concerning progress made in
carrying out the provisions of Executive
Order 13545 and recommending to the
President, through the Secretary, actions
to accelerate progress; (2) advising the
Secretary on ways to promote regular
physical activity, fitness, sports
SUMMARY:
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Federal Register / Vol. 81, No. 58 / Friday, March 25, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
participation, and good nutrition.
Recommendations may address, but are
not necessarily limited to, public
awareness campaigns; federal, state, and
local physical activity; fitness, sports
participation, and nutrition initiatives;
and partnership opportunities between
public- and private-sector health
promotion entities; (3) functioning as a
liaison to relevant state, local, and
private entities in order to advise the
Secretary regarding opportunities to
extend and improve physical activity,
fitness, sports, and nutrition programs
and services at the local, state, and
national levels; and (4) monitoring the
need to enhance programs and
educational and promotional materials
sponsored, overseen, or disseminated by
the Council, and shall advise the
Secretary, as necessary, concerning such
need. In performing its functions, the
Council shall take into account the
Federal Dietary Guidelines for
Americans and the Physical Activity
Guidelines for Americans.
The PCFSN will hold, at a minimum,
one meeting per fiscal year. The meeting
will be held to (1) assess ongoing
Council activities; and, (2) discuss and
plan future projects and programs. The
agenda for the planned meeting is being
developed and will be posted at
www.fitness.gov when it has been
finalized.
The meeting that is scheduled to be
held on May 16, 2016, is open to the
public. Every effort will be made to
provide reasonable accommodations for
persons with disabilities and/or special
needs who wish to attend the meeting.
Persons with disabilities and/or special
needs should call (240) 276–9567 no
later than close of business on May 2,
2016, to request accommodations.
Members of the public who wish to
attend the meeting are asked to preregister by sending an email to
rsvp.fitness@hhs.gov or by calling (240)
276–9567. Registration for public
attendance must be completed before
close of business on May 9, 2016.
Dated: March 11, 2016.
Tasha Bradley,
Director of Communications, Office of the
President’s Council on Fitness, Sports, and
Nutrition, U.S. Department of Health and
Human Services.
[FR Doc. 2016–06810 Filed 3–24–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Minority Health
Office of Minority Health,
Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the Advisory Committee on
Minority Health (ACMH) will hold a
meeting conducted as a telephone
conference call. This call will be open
to the public. Preregistration is required
for both public participation and
comment. Any individual who wishes
to participate in the call should email
OMH-ACMH@hhs.gov by April 12,
2016. Instructions regarding
participating in the call and how to
provide verbal public comments will be
given at the time of preregistration.
Information about the meeting is
available from the designated contact
and will be posted on the Web site for
the Office of Minority Health (OMH),
www.minorityhealth.hhs.gov.
Information about ACMH activities can
be found on the OMH Web site under
the heading About OMH.
DATES: The conference call will be held
on April 14, 2016, 11:00 a.m.–1:00 p.m.
ET
ADDRESSES: Instructions regarding
participating in the call will be given at
the time of preregistration.
FOR FURTHER INFORMATION CONTACT: Dr.
Minh Wendt, Designated Federal
Officer, ACMH, Tower Building, 1101
Wootton Parkway, Suite 600, Rockville,
Maryland 20852. Phone: 240–453–8222;
fax: 240–453–8223; email OMH-ACMH@
hhs.gov.
SUPPLEMENTARY INFORMATION: In
accordance with Public Law 105–392,
the ACMH was established to provide
advice to the Deputy Assistant Secretary
for Minority Health on improving the
health of each racial and ethnic
minority group and on the development
of goals and specific program activities
of the OMH.
Topics to be discussed during this
conference call include planning for
upcoming in-person meetings and
finalizing the charge and the formation
of the data workgroup.
This call will be limited to 125
participants. The OMH will make every
effort to accommodate persons with
special needs. Individuals who have
special needs for which special
SUMMARY:
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accommodations may be required
should contact Professional and
Scientific Associates at (703) 234–1700
and reference this meeting. Requests for
special accommodations should be
made at least ten (10) business days
prior to the meeting.
Members of the public will have an
opportunity to provide comments at the
meeting. Public comments will be
limited to two minutes per speaker
during the time allotted. Individuals
who would like to submit written
statements should email, mail, or fax
their comments to the designated
contact at least seven (7) business days
prior to the meeting.
Any members of the public who wish
to have electronic or printed material
distributed to ACMH members should
email OMH-ACMH@hhs.gov or mail
their materials to the Designated Federal
Officer, ACMH, Tower Building, 1101
Wootton Parkway, Suite 600, Rockville,
Maryland 20852, prior to close of
business on April 8, 2016.
Dated: March 2, 2016.
Minh Wendt,
Designated Federal Officer, Office of Minority
Health, U.S. Department of Health and
Human Services.
[FR Doc. 2016–06809 Filed 3–24–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
HHS gives notice concerning
the final effect of the HHS decision to
designate a class of employees from the
Battelle Laboratories-King Avenue in
Columbus, Ohio, as an addition to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
NIOSH, 1090 Tusculum Avenue, MS C–
46, Cincinnati, OH 45226–1938,
Telephone 877–222–7570. Information
requests can also be submitted by email
to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
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[Federal Register Volume 81, Number 58 (Friday, March 25, 2016)]
[Notices]
[Pages 16187-16188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06810]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the President's Council on Fitness, Sports, and
Nutrition
AGENCY: President's Council on Fitness, Sports, and Nutrition, Office
of the Assistant Secretary for Health, Office of the Secretary,
Department of Health and Human Services.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S.
Department of Health and Human Services (HHS) is hereby giving notice
that the President's Council on Fitness, Sports, and Nutrition (PCFSN)
will hold its annual meeting. The meeting will be open to the public.
DATES: The meeting will be held on May 16, 2016, from 9:00 a.m. to
12:00 p.m.
ADDRESSES: Hubert H. Humphrey Building, 200 Independence Avenue SW.,
Great Hall, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Ms. Shellie Pfohl, Executive Director,
Office of the President's Council on Fitness, Sports, and Nutrition,
Tower Building, 1101 Wootton Parkway, Suite 560, Rockville, MD 20852,
(240) 276-9567. Information about PCFSN, including details about the
upcoming meeting, can be obtained at www.fitness.gov.
SUPPLEMENTARY INFORMATION: The primary functions of the PCFSN include
(1) advising the President, through the Secretary, concerning progress
made in carrying out the provisions of Executive Order 13545 and
recommending to the President, through the Secretary, actions to
accelerate progress; (2) advising the Secretary on ways to promote
regular physical activity, fitness, sports
[[Page 16188]]
participation, and good nutrition. Recommendations may address, but are
not necessarily limited to, public awareness campaigns; federal, state,
and local physical activity; fitness, sports participation, and
nutrition initiatives; and partnership opportunities between public-
and private-sector health promotion entities; (3) functioning as a
liaison to relevant state, local, and private entities in order to
advise the Secretary regarding opportunities to extend and improve
physical activity, fitness, sports, and nutrition programs and services
at the local, state, and national levels; and (4) monitoring the need
to enhance programs and educational and promotional materials
sponsored, overseen, or disseminated by the Council, and shall advise
the Secretary, as necessary, concerning such need. In performing its
functions, the Council shall take into account the Federal Dietary
Guidelines for Americans and the Physical Activity Guidelines for
Americans.
The PCFSN will hold, at a minimum, one meeting per fiscal year. The
meeting will be held to (1) assess ongoing Council activities; and, (2)
discuss and plan future projects and programs. The agenda for the
planned meeting is being developed and will be posted at
www.fitness.gov when it has been finalized.
The meeting that is scheduled to be held on May 16, 2016, is open
to the public. Every effort will be made to provide reasonable
accommodations for persons with disabilities and/or special needs who
wish to attend the meeting. Persons with disabilities and/or special
needs should call (240) 276-9567 no later than close of business on May
2, 2016, to request accommodations. Members of the public who wish to
attend the meeting are asked to pre-register by sending an email to
rsvp.fitness@hhs.gov or by calling (240) 276-9567. Registration for
public attendance must be completed before close of business on May 9,
2016.
Dated: March 11, 2016.
Tasha Bradley,
Director of Communications, Office of the President's Council on
Fitness, Sports, and Nutrition, U.S. Department of Health and Human
Services.
[FR Doc. 2016-06810 Filed 3-24-16; 8:45 am]
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