Assistant Secretary for Administration; Delegation of Authority, 50457-50458 [2019-20840]
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Federal Register / Vol. 84, No. 186 / Wednesday, September 25, 2019 / Notices
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
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 Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed 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for electronic access to the draft
guidance document.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:
Cindy Burnsteel, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0817,
email: cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft GFI #263 entitled
‘‘Recommendations for Sponsors of
Medically Important Antimicrobial
Drugs Approved for Use in Animals to
Voluntarily Bring Under Veterinary
Oversight All Products That Continue to
be Available Over-the-Counter.’’ This
draft guidance, when finalized, will
provide information to sponsors of
certain new animal drug products who
are interested in changing the approved
marketing status of these products from
OTC to Rx consistent with FDA’s
recommendation that the use of such
drugs in animals be limited to uses that
include veterinary oversight in order to
mitigate development of antimicrobial
resistance and thereby preserve the
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effectiveness of these drugs for use as
therapies to treat infections in humans
and animals. The draft guidance, when
finalized, also will recommend
timeframes for stakeholders wishing to
comply voluntarily with this guidance.
In 2016, in response to
recommendations made by FDA as part
of a strategy to address antimicrobial
resistance associated with the use of
antimicrobial drugs in animal
agriculture, sponsors of all medically
important antimicrobial drugs approved
for use in or on the feed or drinking
water of food-producing animals
worked with FDA to voluntarily
withdraw approval of indications that
were not considered necessary for
assuring animal health (production
indications), and voluntarily change all
remaining approved uses of such new
animal drugs from OTC to either
Veterinary Feed Directive or Rx
marketing status, as applicable.1
Although all medically important
antimicrobials used in feed or water for
food-producing animals are currently
under veterinary oversight, some other
dosage form products (e.g., injectable,
tablet, intramammary infusion)
intended for use in food-producing and
non-food-producing animals remain
available OTC. This draft guidance,
when finalized, will provide sponsors
with specific recommendations on how
to facilitate voluntary changes to the
approved conditions of use of these
drugs to prescription marketing status.
The voluntary process outlined in this
draft guidance will help to ensure new
animal drugs containing antimicrobials
of human medical importance are
administered only under veterinary
oversight and only for therapeutic uses.
II. Significance of Guidance
This level 1 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 veterinary oversight
of medically important antimicrobial
drugs administered to animals. 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
1 See GFI #213, ‘‘New Animal Drugs and New
Animal Drug Combination Products Administered
in or on Medicated Feed or Drinking Water of FoodProducing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use
Conditions with GFI #209’’ (https://www.fda.gov/
regulatory-information/search-fda-guidancedocuments/cvm-gfi-213-new-animal-drugs-andnew-animal-drug-combination-productsadministered-or-medicated-feed)
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draft guidance is not subject to
Executive Order 12866.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in section 512(n)(1) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360b(n)(1)) have been
approved under OMB control number
0910–0669. The collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
IV. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: September 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–20688 Filed 9–23–19; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Assistant Secretary for Administration;
Delegation of Authority
Notice is hereby given that I have
delegated to the Assistant Secretary for
Preparedness and Response (ASPR); the
Director, Centers for Disease Control
and Prevention (CDC); the
Administrator, Health Resources and
Services Administration (HRSA); the
Director, National Institutes for Health
(NIH); the Director, Office of Global
Affairs (OGA); and the Administrator,
Substance Abuse and Mental Health
Services Administration (SAMHSA) the
authority vested in the Secretary by
section 212(l) of the Department of
Defense and Labor, Health and Human
Services, and Education Appropriations
Act, 2019 and Continuing
Appropriations Act, 2019 (FY 19 HHS
Appropriations Act) Public Law 115–
245, division B, title II, (September 28,
2018), or substantially similar
authorities vested in me in the future by
Congress, in order to carry out
international health activities, including
HIV/AIDS and other infectious disease,
chronic and environmental disease, and
other health activities abroad. Section
212(l) of the FY19 HHS Appropriations
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Federal Register / Vol. 84, No. 186 / Wednesday, September 25, 2019 / Notices
Act permits the Secretary of HHS to
exercise authority equivalent to that
available to the Secretary of State under
22 U.S.C. 2669(c) to award personal
services contracts for work performed in
foreign countries.
The authority delegated herein
includes the authority to determine the
necessity of negotiating, executing, and
performing such contracts without
regard to statutory provisions as relate
to the negotiation, making, and
performance of contracts and
performance of work in the United
States. This authority is immediately
revoked in the event that any
subsequent fiscal year HHS
appropriations act does not contain the
provision currently in section 212(1) or
substantially similar authority.
The Director, CDC may redelegate this
authority to the Chief Operating Officer,
CDC for a period of one (1) year from
the effective date of this delegation to
respond to the current Ebola outbreak.
This authority may not be further
redelegated except as noted above.
The delegatees shall consult with the
Secretary of State and relevant Chief of
Mission to ensure that this authority is
exercised in a manner consistent with
section 207 of the Foreign Service Act
of 1980 and other applicable statutes
administered by the Department of
State.
This delegation became effective upon
date of signature. In addition, I hereby
affirm and ratify any actions taken by
the delegatees or their subordinates
which involved the exercise of the
authorities delegated herein, or
substantially similar authorities vested
in me by prior annual HHS
appropriations acts, prior to the
effective date of the delegation.
Dated: September 19, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2019–20840 Filed 9–24–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on HIV/AIDS
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
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AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Service is hereby giving notice that the
SUMMARY:
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Presidential Advisory Council on HIV/
AIDS (PACHA or the Council) will be
holding the 65th full Council meeting in
Miami, Florida. Miami-Dade County is
one of the counties indicated in Ending
the HIV Epidemic: A Plan for America.
Agenda items will include an update on
HIV and the Latinx Community, Ending
the HIV Epidemic in Florida and Puerto
Rico, addressing the unique needs in
Florida and Puerto Rico, a federal panel
to discuss federal efforts and
mechanisms to ensure continued
community engagement, and a
presentation on performance indicators
for tracking the Initiative. The meeting
will be open to the public; a public
comment session will be held during
the meeting. Pre-registration is
encouraged for members of the public
who wish to attend the meeting and
who wish to participate in the public
comment session. Individuals who wish
to attend the meeting and/or send in
their public comment via email should
send an email to Caroline Talev, MPA,
at Caroline.Talev@hhs.gov. PreRegistration must be complete by
Tuesday, October 15, 2019.
DATES: The Council meeting is
scheduled to convene on Monday,
October 21, 2019 from approximately
1:30 p.m. to 5:30 p.m. ET and Tuesday,
October 22, 2019 from approximately
9:00 a.m. to 5:00 p.m. ET (times are
tentative and subject to change). The
meeting agenda will be posted on the
PACHA web page at https://
www.hiv.gov/federal-response/pacha/
about-pacha. Public attendance is
limited to available space.
ADDRESSES: Miami Marriott Biscayne
Bay, 1633 N Bayshore Drive, Miami,
Florida 33132.
FOR FURTHER INFORMATION CONTACT: Ms.
Caroline Talev, MPA, Public Health
Analyst, Presidential Advisory Council
on HIV/AIDS, 330 C Street SW, Room
L106B, Washington, DC 20024; (202)
795–7622 or Caroline.Talev@hhs.gov.
Additional information can be obtained
by accessing the Council’s page on the
HIV.gov site at www.hiv.gov/pacha.
SUPPLEMENTARY INFORMATION: PACHA
was established by Executive Order
12963, dated June 14, 1995, as amended
by Executive Order 13009, dated June
14, 1996 and is currently operating
under the authority given in Executive
Order 13811, dated September 29, 2017.
The Council was established to provide
advice, information, and
recommendations to the Secretary
regarding programs and policies
intended to promote effective
prevention and care of HIV infection
and AIDS. The functions of the Council
are solely advisory in nature.
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The Council consists of not more than
25 members. Council members are
selected from prominent community
leaders with particular expertise in, or
knowledge of, matters concerning HIV
and AIDS, public health, global health,
philanthropy, marketing or business, as
well as other national leaders held in
high esteem from other sectors of
society. Council members are appointed
by the Secretary or designee, in
consultation with the White House. The
agenda for will be posted on HIV.gov at
https://www.hiv.gov/federal-response/
pacha/about-pacha.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify Caroline
Talev at Caroline.Talev@hhs.gov. Due to
space constraints, pre-registration for
public attendance is advisable and can
be accomplished by contacting Caroline
Talev at Caroline.Talev@hhs.gov by
close of business Tuesday, October 15,
2019. Members of the public will have
the opportunity to provide comments
during the meeting. Comments will be
limited to no more than three minutes
per speaker. Any individual who wishes
to participate in the public comment
session must register with Caroline
Talev at Caroline.Talev@hhs.gov by
close of business Tuesday, October 15,
2019; registration for public comment
will not be accepted by telephone.
Individuals are encouraged to provide a
written statement of any public
comment(s) for accurate minute taking
purposes. Any members of the public
who wish to have printed material
distributed to PACHA members at the
meeting are asked to submit, at a
minimum, 1 copy of the material(s) to
Caroline Talev, no later than close of
business on Tuesday, October 15, 2019.
Dated: September 16, 2019.
B. Kaye Hayes,
Principal Deputy Director, Office of Infectious
Disease and HIV/AIDS Policy, Executive
Director, Presidential Advisory Council on
HIV/AIDS, Office of the Assistant Secretary
for Health, Department of Health and Human
Services.
[FR Doc. 2019–20783 Filed 9–24–19; 8:45 am]
BILLING CODE 4150–43–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
AGENCY:
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[Federal Register Volume 84, Number 186 (Wednesday, September 25, 2019)]
[Notices]
[Pages 50457-50458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20840]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Assistant Secretary for Administration; Delegation of Authority
Notice is hereby given that I have delegated to the Assistant
Secretary for Preparedness and Response (ASPR); the Director, Centers
for Disease Control and Prevention (CDC); the Administrator, Health
Resources and Services Administration (HRSA); the Director, National
Institutes for Health (NIH); the Director, Office of Global Affairs
(OGA); and the Administrator, Substance Abuse and Mental Health
Services Administration (SAMHSA) the authority vested in the Secretary
by section 212(l) of the Department of Defense and Labor, Health and
Human Services, and Education Appropriations Act, 2019 and Continuing
Appropriations Act, 2019 (FY 19 HHS Appropriations Act) Public Law 115-
245, division B, title II, (September 28, 2018), or substantially
similar authorities vested in me in the future by Congress, in order to
carry out international health activities, including HIV/AIDS and other
infectious disease, chronic and environmental disease, and other health
activities abroad. Section 212(l) of the FY19 HHS Appropriations
[[Page 50458]]
Act permits the Secretary of HHS to exercise authority equivalent to
that available to the Secretary of State under 22 U.S.C. 2669(c) to
award personal services contracts for work performed in foreign
countries.
The authority delegated herein includes the authority to determine
the necessity of negotiating, executing, and performing such contracts
without regard to statutory provisions as relate to the negotiation,
making, and performance of contracts and performance of work in the
United States. This authority is immediately revoked in the event that
any subsequent fiscal year HHS appropriations act does not contain the
provision currently in section 212(1) or substantially similar
authority.
The Director, CDC may redelegate this authority to the Chief
Operating Officer, CDC for a period of one (1) year from the effective
date of this delegation to respond to the current Ebola outbreak. This
authority may not be further redelegated except as noted above.
The delegatees shall consult with the Secretary of State and
relevant Chief of Mission to ensure that this authority is exercised in
a manner consistent with section 207 of the Foreign Service Act of 1980
and other applicable statutes administered by the Department of State.
This delegation became effective upon date of signature. In
addition, I hereby affirm and ratify any actions taken by the
delegatees or their subordinates which involved the exercise of the
authorities delegated herein, or substantially similar authorities
vested in me by prior annual HHS appropriations acts, prior to the
effective date of the delegation.
Dated: September 19, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-20840 Filed 9-24-19; 8:45 am]
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