Solicitation of Written Comments To Inform Development of a National Youth Sports Strategy, 7391-7392 [2019-03788]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Sara
Rothman, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5197, Silver Spring,
MD 20993, 301–796–3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Evaluation of Bulk Drug Substances
Nominated for Use in Compounding
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ Section
503B (21 U.S.C. 353b), added to the
FD&C Act by the Drug Quality and
Security Act in 2013, describes the
conditions that must be satisfied for
human drug products compounded by
an outsourcing facility to be exempt
from the following three sections of the
FD&C Act: section 505 (21 U.S.C. 355)
(concerning the approval of drugs under
new drug applications or abbreviated
new drug applications); section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate
directions for use); and section 582 (21
U.S.C. 360eee-1) (concerning drug
supply chain security requirements).
One of the conditions that must be met
for a drug product compounded by an
VerDate Sep<11>2014
17:33 Mar 01, 2019
Jkt 247001
outsourcing facility to qualify for these
exemptions is that the outsourcing
facility does not compound drug
products using a bulk drug substance
unless either: (1) It appears on a list
established by the Secretary of Health
and Human Services identifying bulk
drug substances for which there is a
clinical need (see section
503B(a)(2)(A)(i) of the FD&C Act) (503B
Bulks List) or (2) the drug compounded
from such bulk drug substances appears
on the drug shortage list in effect under
section 506E of the FD&C Act (21 U.S.C.
356e) at the time of compounding,
distribution, and dispensing (see section
503B(a)(2)(A)(ii) of the FD&C Act).
This guidance addresses FDA policies
for developing the 503B Bulks List,
including the Agency’s interpretation of
the phrase ‘‘bulk drug substances for
which there is a clinical need,’’ as it is
used in section 503B of the FD&C Act.
The guidance also addresses the factors
and processes by which the Agency
intends to evaluate and list bulk drug
substances.
In the Federal Register of March 26,
2018 (83 FR 12952), FDA issued a notice
announcing the availability of the draft
version of this guidance. The comment
period ended on May 25, 2018. FDA
received approximately 60 comments on
the draft guidance. In response to
received comments or on its own
initiative, FDA made certain changes to
the guidance. For example, FDA has
further explained how Congress’
limitation on bulk drug substances that
can be used in compounding under
section 503B helps to preserve the
integrity of the new drug approval
process and identified the process to
request that FDA add or remove a bulk
drug substance from the 503B Bulks List
after the Agency has made a final
determination with respect to that
substance in the Federal Register.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the current
thinking of FDA on ‘‘Evaluation of Bulk
Drug Substances Nominated for Use in
Compounding Under Section 503B of
the Federal Food, Drug, and Cosmetic
Act.’’ 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. This guidance is not subject
to Executive Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
7391
RegulatoryInformation/Guidances/
default.htm, or https://
www.regulations.gov.
Dated: February 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–03807 Filed 3–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Written Comments To
Inform Development of a National
Youth Sports Strategy
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) solicits written
comments from the public on specific
topics and questions that will inform
the development of the National Youth
Sports Strategy.
DATES: Written comments will be
accepted through 11:59 p.m. E.T. on
April 1, 2019.
ADDRESSES: Written public comments
will be accepted via email. Instructions
for submitting comments are available
on the internet at https://fitness.gov.
FOR FURTHER INFORMATION CONTACT:
Katrina L. Piercy, Ph.D., R.D., Office of
Disease Prevention and Health
Promotion (ODPHP), Office of the
Assistant Secretary for Health (OASH),
HHS; 1101 Wootton Parkway, Suite LL–
100; Rockville, MD 20852; Telephone:
(240) 453–8280. Email: odphpinfo@
hhs.gov.
SUMMARY:
Executive
Order 13824 directs the development of
a National Strategy on Youth Sports and
outlines the key pillars that the strategy
will address. The Office of Disease
Prevention and Health Promotion and
the President’s Council on Sports,
Fitness & Nutrition are leading the
development of this strategy.
SUPPLEMENTARY INFORMATION:
Key Pillars of Youth Sports Strategy
1. Increase awareness of the benefits
of participation in sports and regular
physical activity, as well as the
importance of good nutrition;
2. Promote private and public sector
strategies to increase participation in
sports, encourage regular physical
activity, and improve nutrition;
3. Develop metrics that gauge youth
sports participation and physical
activity to inform efforts that will
E:\FR\FM\04MRN1.SGM
04MRN1
7392
Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
improve participation in sports and
regular physical activity among young
Americans; and
4. Establish a national and local
strategy to recruit volunteers who will
encourage and support youth
participation in sports and regular
physical activity, through coaching,
mentoring, teaching, or administering
athletic and nutritional programs.
Written Public Comments: Written
comments to inform the development of
the strategy are encouraged from the
public and will be accepted via email
until 11:59 p.m. E.T. April 1, 2019.
Instructions for submitting comments
are available at https://fitness.gov. HHS
requests that commenters respond to the
questions posed on https://fitness.gov. A
subsequent public comment period will
open this summer to provide comments
on the draft strategy report.
Dated: February 19, 2019.
Donald Wright,
Deputy Assistant Secretary for Health Disease
Prevention and Health Promotion.
[FR Doc. 2019–03788 Filed 3–1–19; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Information Technology
Advisory Committee 2019 Schedule
Office of the National
Coordinator for Health Information
Technology (ONC), HHS.
ACTION: 2019 public meeting dates of the
Health Information Technology
Advisory Committee.
AGENCY:
The Health Information
Technology Advisory Committee
(HITAC) was established in accordance
with section 4003(e) of the 21st Century
Cures Act and the Federal Advisory
Committee Act. The HITAC, among
other things, identifies priorities for
standards adoption and makes
recommendations to the National
Coordinator for Health Information
Technology (National Coordinator). The
HITAC will hold public meetings
throughout 2019. See list of public
meetings below.
FOR FURTHER INFORMATION CONTACT:
Lauren Richie, Designated Federal
Officer, at Lauren.Richie@hhs.gov, or
(202) 205–7674.
SUPPLEMENTARY INFORMATION: Section
4003(e) of the 21st Century Cures Act
(Pub. L. 114–255) establishes the Health
Information Technology Advisory
Committee (referred to as the ‘‘HITAC’’).
The HITAC will be governed by the
provisions of the Federal Advisory
SUMMARY:
VerDate Sep<11>2014
17:33 Mar 01, 2019
Jkt 247001
• May 13, 2019 from approximately
9:30 a .m. to 2:30 p.m./Eastern Time
(virtual meeting)
• June 19, 2019 from approximately
9:30 a.m. to 2:30 p.m./Eastern Time
(virtual meeting)
Composition
• September 17, 2019 from
approximately 9:30 a.m. to 2:30 p.m./
The HITAC is comprised of at least 25
Eastern Time at the Key Bridge
members, of which:
Marriott Hotel, 1401 Lee Highway,
• No fewer than 2 members are
Arlington, Virginia 22209
advocates for patients or consumers of
• October 16, 2019 from approximately
health information technology;
9:30 a.m. to 2:30 p.m./Eastern Time
• 3 members are appointed by the
(virtual meeting)
HHS Secretary
• November 13, 2019 from
Æ 1 of whom shall be appointed to
approximately 9:30 a.m. to 2:30 p.m./
represent the Department of Health
Eastern Time (virtual meeting)
and Human Services and
All meetings are open to the public.
Æ 1 of whom shall be a public health
Additional meetings may be scheduled
official;
• 2 members are appointed by the
as needed. For web conference
majority leader of the Senate;
instructions and the most up-to-date
• 2 members are appointed by the
information, please visit the HITAC
minority leader of the Senate;
calendar on the ONC website, https://
• 2 members are appointed by the
www.healthit.gov/FACAS/calendar.
Contact Person for Meetings: Lauren
Speaker of the House of Representatives;
• 2 members are appointed by the
Richie, lauren.richie@hhs.gov . A notice
in the Federal Register about last
minority leader of the House of
minute modifications that impact a
Representatives; and
• Other members are appointed by
previously announced advisory
the Comptroller General of the United
committee meeting cannot always be
published quickly enough to provide
States.
Members will serve for one-, two-, or
timely notice. Please email Lauren
three-year terms. All members may be
Richie for the most current information
reappointed for subsequent three-year
about meetings.
Agenda: As outlined in the 21st
terms. Each member is limited to two
three-year terms, not to exceed six years Century Cures Act, the HITAC will
of service. After establishment, members develop and submit recommendations
shall be appointed for a three-year term. to the National Coordinator on the
Members serve without pay, but will be topics of interoperability, privacy and
security, and patient access. In addition,
provided per-diem and travel costs for
the committee will also address any
committee services.
administrative matters and hear
Recommendations
periodic reports from ONC. ONC
intends to make background material
The HITAC recommendations to the
available to the public no later than 24
National Coordinator are publicly
hours prior to the meeting start time. If
available at https://www.healthit.gov/
ONC is unable to post the background
topic/federal-advisory-committees/
recommendations-national-coordinator- material on its website prior to the
meeting, the material will be made
health-it.
publicly available at the location of the
Public Meetings
advisory committee meeting, and the
The schedule of meetings to be held
background material will be posted on
in 2019 is as follows:
ONC’s website after the meeting, at
• February 20, 2019 from approximately https://www.healthit.gov/hitac.
Procedure: Interested persons may
9:30 a.m.. to 2:30 p.m./Eastern Time
present data, information, or views,
(virtual meeting)
orally or in writing, on issues pending
• March 19–20, 2019 from
approximately 9:30 a.m. to 2:30 p.m./ before the committee. Written
submissions may be made to the contact
Eastern Time each day at the Omni
person prior to the meeting date. An
Shoreham Hotel, 2500 Calvert Street
oral public comment period will be
NW, Washington, DC 20008
scheduled at each meeting. Time
• April 10, 2019 from approximately
9:30 a.m. to 2:30 p.m./Eastern Time at allotted for each presentation will be
limited to three minutes. If the number
the Omni Shoreham Hotel, 2500
of speakers requesting to comment is
Calvert Street NW, Washington, DC
greater than can be reasonably
20008
accommodated during the scheduled
• April 25, 2019 from approximately
public comment period, ONC will take
9:30 a .m. to 2:30 p.m./Eastern Time
written comments after the meeting.
(virtual meeting)
Committee Act (FACA) (Pub. L. 92–
463), as amended, (5 U.S.C. App.),
which sets forth standards for the
formation and use of federal advisory
committees.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7391-7392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03788]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Written Comments To Inform Development of a
National Youth Sports Strategy
AGENCY: Office of Disease Prevention and Health Promotion, Office of
the Assistant Secretary for Health, Office of the Secretary, Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) solicits
written comments from the public on specific topics and questions that
will inform the development of the National Youth Sports Strategy.
DATES: Written comments will be accepted through 11:59 p.m. E.T. on
April 1, 2019.
ADDRESSES: Written public comments will be accepted via email.
Instructions for submitting comments are available on the internet at
https://fitness.gov.
FOR FURTHER INFORMATION CONTACT: Katrina L. Piercy, Ph.D., R.D., Office
of Disease Prevention and Health Promotion (ODPHP), Office of the
Assistant Secretary for Health (OASH), HHS; 1101 Wootton Parkway, Suite
LL-100; Rockville, MD 20852; Telephone: (240) 453-8280. Email:
odphpinfo@hhs.gov.
SUPPLEMENTARY INFORMATION: Executive Order 13824 directs the
development of a National Strategy on Youth Sports and outlines the key
pillars that the strategy will address. The Office of Disease
Prevention and Health Promotion and the President's Council on Sports,
Fitness & Nutrition are leading the development of this strategy.
Key Pillars of Youth Sports Strategy
1. Increase awareness of the benefits of participation in sports
and regular physical activity, as well as the importance of good
nutrition;
2. Promote private and public sector strategies to increase
participation in sports, encourage regular physical activity, and
improve nutrition;
3. Develop metrics that gauge youth sports participation and
physical activity to inform efforts that will
[[Page 7392]]
improve participation in sports and regular physical activity among
young Americans; and
4. Establish a national and local strategy to recruit volunteers
who will encourage and support youth participation in sports and
regular physical activity, through coaching, mentoring, teaching, or
administering athletic and nutritional programs.
Written Public Comments: Written comments to inform the development
of the strategy are encouraged from the public and will be accepted via
email until 11:59 p.m. E.T. April 1, 2019. Instructions for submitting
comments are available at https://fitness.gov. HHS requests that
commenters respond to the questions posed on https://fitness.gov. A
subsequent public comment period will open this summer to provide
comments on the draft strategy report.
Dated: February 19, 2019.
Donald Wright,
Deputy Assistant Secretary for Health Disease Prevention and Health
Promotion.
[FR Doc. 2019-03788 Filed 3-1-19; 8:45 am]
BILLING CODE 4150-32-P
