81 FR 32335 - Notice of Request for Information by the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 99 (May 23, 2016)

Page Range		32335-32336
FR Document		2016-12043

The Presidential Advisory Council on Combating Antibiotic- Resistant Bacteria (Advisory Council) requests information from the general public and stakeholders related to efforts and strategies to combat antibiotic-resistance. In the process of developing their report, Initial Assessments of the National Action Plan for Combating Antibiotic-Resistant Bacteria, the Advisory Council followed the framework of the National Action Plan for Combating Antibiotic Resistant Bacteria (Action Plan) to hear about a wide range of ongoing and planned activities by the federal government, including some stakeholders/sectors relevant to this overall effort. This Request for Information (RFI) offers the opportunity for interested individuals, organizations, associations, industries, and others, to provide their feedback. Responses to the questions must be received by 11:59 p.m. on June 22, 2016 to be considered. The questions are also available through an online form on the Advisory Council Web page at www.hhs.gov/ ash/carb. Individuals who wish to send in their responses via email should send an email to [email protected], indicating the question number(s) for which they are responding.

Federal Register, Volume 81 Issue 99 (Monday, May 23, 2016)

[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Notices]
[Pages 32335-32336]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12043]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Notice of Request for Information by the Presidential Advisory 
Council on Combating Antibiotic-Resistant Bacteria

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Presidential Advisory Council on Combating Antibiotic-
Resistant Bacteria (Advisory Council) requests information from the 
general public and stakeholders related to efforts and strategies to 
combat antibiotic-resistance. In the process of developing their 
report, Initial Assessments of the National Action Plan for Combating 
Antibiotic-Resistant Bacteria, the Advisory Council followed the 
framework of the National Action Plan for Combating Antibiotic 
Resistant Bacteria (Action Plan) to hear about a wide range of ongoing 
and planned activities by the federal government, including some 
stakeholders/sectors relevant to this overall effort. This Request for 
Information (RFI) offers the opportunity for interested individuals, 
organizations, associations, industries, and others, to provide their 
feedback. Responses to the questions must be received by 11:59 p.m. on 
June 22, 2016 to be considered. The questions are also available 
through an online form on the Advisory Council Web page at www.hhs.gov/ash/carb. Individuals who wish to send in their responses via email 
should send an email to [email protected], indicating the question number(s) 
for which they are responding.

DATES: Comments must be received by 11:59 p.m. on June 22, 2016 to be 
considered.

ADDRESSES: Individuals are encouraged to submit their responses through 
one of the following methods. Utilization of the online form available 
on www.hhs.gov/ash/carb is the preferred method of submission. Should 
you choose to send in your responses via email, please be sure to 
include the question number(s) in the subject line. Do not include in 
your response information of a confidential nature, such as sensitive 
personal information or proprietary information. Responses to this 
notice are not offers and cannot be accepted by the federal government 
to form a binding contract or issue a grant. Please be aware that your 
comments will not affirmatively be posted publicly, however they may be 
made available to the public, in part or in full, subject to applicable 
laws and regulations.
     Online Form: www.hhs.gov/ash/carb. Online submissions will 
receive an automatic confirmation acknowledging receipt of your 
response, but will not receive individualized feedback on any 
suggestions.
     Email: [email protected]. Please indicate the question 
number(s) in the subject line of your email. Email submissions will 
receive an electronic confirmation acknowledging receipt of your 
response, but will not receive individualized feedback on any 
suggestions.

SUPPLEMENTARY INFORMATION: Under Executive Order 13676, dated September 
18, 2014, authority was given to the Secretary of Health and Human 
Services (HHS) to establish the Advisory Council, in consultation with 
the Secretaries of Defense and Agriculture. Activities of the Advisory 
Council are governed by the provisions of Public Law 92-463, as amended 
(5 U.S.C. App.), which sets forth standards for the formation and use 
of federal advisory committees.
    The Advisory Council will provide advice, information, and 
recommendations to the Secretary of HHS regarding programs and policies 
intended to support and evaluate the implementation of Executive Order 
13676, including the National Strategy for Combating Antibiotic-
Resistant

[[Page 32336]]

Bacteria and the Action Plan. The Advisory Council shall function 
solely for advisory purposes.
    In carrying out its mission, the Advisory Council will provide 
advice, information, and recommendations to the Secretary regarding 
programs and policies intended to preserve the effectiveness of 
antibiotics by optimizing their use; advance research to develop 
improved methods for combating antibiotic resistance and conducting 
antibiotic stewardship; strengthen surveillance of antibiotic-resistant 
bacterial infections; prevent the transmission of antibiotic-resistant 
bacterial infections; advance the development of rapid point-of-care 
and agricultural diagnostics; further research on new treatments for 
bacterial infections; develop alternatives to antibiotics for 
agricultural purposes; maximize the dissemination of up-to-date 
information on the appropriate and proper use of antibiotics to the 
general public and human and animal healthcare providers; and improve 
international coordination of efforts to combat antibiotic resistance. 
In response to their mission, the Advisory Council recently released 
their first report, Initial Assessments of the National Action Plan for 
Combating Antibiotic-Resistant Bacteria, at their second public meeting 
held on March 30-31, 2016, in Washington, DC.
    Background: In the process of developing their report, the Advisory 
Council followed the framework of the Action Plan to hear about a wide 
range of ongoing and planned activities by the federal government, 
including some stakeholders/sectors relevant to this overall effort. 
Acknowledging that there are others who the Advisory Council would like 
to hear from, they are seeking that information through this RFI. The 
purpose of the questions posed in this RFI is to gain additional 
information from the public on the subject matter in several areas 
addressed in the Action Plan. The responses gathered from the RFI will 
be reviewed by the members of the Advisory Council and will be taken 
into consideration as they move forward with their activities. The 
responses provided are for the Advisory Council's informational 
purposes only. Response to this RFI is voluntary. Responders are free 
to address any or all of the questions below.
    Request for Information: To solicit additional information from the 
public, including individuals, organizations, associations, and 
industries involved in combating antibiotic-resistance, the Advisory 
Council seeks responses on the following requests for information:
    1. Describe how organizations are influencing curricula regarding 
primary prevention (antibiotic stewardship, infection prevention, and 
control). Please include information about certification examinations, 
requirements, and continuing education, if relevant.
    2. Describe how healthcare organizations can best: (a) Educate and 
provide feedback to providers in clinics/facilities about infectious 
diseases diagnostic testing, optimal antibiotic prescribing, and 
infection prevention; where relevant, please include information about 
what incentives and disincentives these organizations have in place 
with the goal of improving antibiotic prescribing (e.g., using clinical 
decision support) and prevent spread of resistant infections; and, (b) 
encourage and/or incentivize providers to report antibiotic use and 
resistance data for all patient populations.
    3. Please provide examples of successful behavior change models 
that can be applied to preventive strategies, such as infection control 
and antibiotic stewardship.
    4. Please provide information on the best ways to collect data on 
antibiotic use [and resistance] in animal agriculture through public-
private collaborations. Your response can include information on the 
types of data to be collected, including the method of collection, and 
the metrics for reporting the data. If helpful, please cite sample 
models as examples to depict your answer.
    5. Please provide information on the different resources that exist 
to promote the understanding of how antibiotics are being used in 
humans and animals in different parts of the world. Your response can 
include information on the types of support to connect with such 
resources, as appropriate (examples include public-private 
partnerships, strategic resourcing, or other means).
    More information can be found at www.hhs.gov/ash/carb.

    Dated: May 18, 2016.
Bruce Gellin,
Designated Federal Officer, Presidential Advisory Council on Combating 
Antibiotic-Resistant Bacteria, Deputy Assistant Secretary for Health.
[FR Doc. 2016-12043 Filed 5-20-16; 8:45 am]
 BILLING CODE 4150-44-P

Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices 32335

NHANES, including questions about In 2017–2018, we also plan to birth certificate linkage that had been
food security and nutrition program conduct a Dietary Supplement Imaging included in previous NHANES will be
participation, dietary supplement use, pilot study, as well as implement multi- dropped from NHANES 2017–2018.
and weight history/self-image/related mode screening and electronic consent There is no cost to respondents other
behavior. procedures in NHANES. The consent for than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per re- Total burden
Type of respondent Form name responses per
respondents sponse (in hours
respondent hours)

Individuals in households NHANES Questionnaire ...................................... 14,410 1 2.5 36,025
Individuals in households Blood Pressure Methodology Study Phase 1 ..... 1,404 1 30/60 702
Individuals in households Blood Pressure Methodology Study Phase 2 ..... 2,000 1 30/60 1,000
Individuals in households Ambulatory Blood Pressure Pilot Study .............. 1,200 1 25 30,000
Individuals in households Oral HPV rinse Follow-up Study 6 months (esti- 2,880 1 10/60 480
mated 80% of original sample of 3600).
Individuals in households Oral HPV rinse Follow-up Study 12 Months (es- 2,520 1 10/60 420
timated 70% of original sample).
Individuals in households Oral HPV rinse Follow-up Study 18 months (es- 2,160 1 10/60 360
timated 60% of original sample).
Individuals in households Oral HPV rinse Follow-up Study 24 Months (es- 1,800 1 10/60 300
timated 50% of original sample).
Individuals in households Flexible Consumer Behavior Survey Phone Fol- 5,000 1 20/60 1,667
low-Up.
Individuals in households Special Studies .................................................... 3,500 1 3 10,500

Total ........................ .............................................................................. ........................ ........................ ........................ 81,454

Leroy A. Richardson, including some stakeholders/sectors publicly, however they may be made
Chief, Information Collection Review Office, relevant to this overall effort. This available to the public, in part or in full,
Office of Scientific Integrity, Office of the Request for Information (RFI) offers the subject to applicable laws and
Associate Director for Science, Office of the opportunity for interested individuals, regulations.
Director, Centers for Disease Control and organizations, associations, industries, • Online Form: www.hhs.gov/ash/
Prevention. and others, to provide their feedback. carb. Online submissions will receive
[FR Doc. 2016–12009 Filed 5–20–16; 8:45 am] Responses to the questions must be an automatic confirmation
BILLING CODE 4163–18–P received by 11:59 p.m. on June 22, 2016 acknowledging receipt of your response,
to be considered. The questions are also but will not receive individualized
available through an online form on the feedback on any suggestions.
DEPARTMENT OF HEALTH AND Advisory Council Web page at • Email: CARB@hhs.gov. Please
HUMAN SERVICES www.hhs.gov/ash/carb. Individuals who indicate the question number(s) in the
wish to send in their responses via subject line of your email. Email
Notice of Request for Information by submissions will receive an electronic
the Presidential Advisory Council on email should send an email to CARB@
hhs.gov, indicating the question confirmation acknowledging receipt of
Combating Antibiotic-Resistant your response, but will not receive
Bacteria number(s) for which they are
responding. individualized feedback on any
AGENCY: Office of the Assistant suggestions.
DATES: Comments must be received by
Secretary for Health, Office of the 11:59 p.m. on June 22, 2016 to be SUPPLEMENTARY INFORMATION: Under
Secretary, Department of Health and considered. Executive Order 13676, dated
Human Services. September 18, 2014, authority was given
ACTION: Notice. ADDRESSES: Individuals are encouraged to the Secretary of Health and Human
to submit their responses through one of Services (HHS) to establish the Advisory
SUMMARY: The Presidential Advisory the following methods. Utilization of Council, in consultation with the
Council on Combating Antibiotic- the online form available on Secretaries of Defense and Agriculture.
Resistant Bacteria (Advisory Council) www.hhs.gov/ash/carb is the preferred Activities of the Advisory Council are
requests information from the general method of submission. Should you governed by the provisions of Public
public and stakeholders related to choose to send in your responses via Law 92–463, as amended (5 U.S.C.
efforts and strategies to combat email, please be sure to include the App.), which sets forth standards for the
antibiotic-resistance. In the process of question number(s) in the subject line. formation and use of federal advisory
developing their report, Initial Do not include in your response committees.
Assessments of the National Action information of a confidential nature, The Advisory Council will provide
sradovich on DSK3TPTVN1PROD with NOTICES

Plan for Combating Antibiotic-Resistant such as sensitive personal information advice, information, and
Bacteria, the Advisory Council followed or proprietary information. Responses to recommendations to the Secretary of
the framework of the National Action this notice are not offers and cannot be HHS regarding programs and policies
Plan for Combating Antibiotic Resistant accepted by the federal government to intended to support and evaluate the
Bacteria (Action Plan) to hear about a form a binding contract or issue a grant. implementation of Executive Order
wide range of ongoing and planned Please be aware that your comments 13676, including the National Strategy
activities by the federal government, will not affirmatively be posted for Combating Antibiotic-Resistant

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32336 Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices

Bacteria and the Action Plan. The 1. Describe how organizations are DEPARTMENT OF HEALTH AND
Advisory Council shall function solely influencing curricula regarding primary HUMAN SERVICES
for advisory purposes. prevention (antibiotic stewardship,
In carrying out its mission, the infection prevention, and control). National Institutes of Health
Advisory Council will provide advice, Please include information about
information, and recommendations to Center for Scientific Review; Notice of
certification examinations,
the Secretary regarding programs and Closed Meetings
requirements, and continuing
policies intended to preserve the education, if relevant. Pursuant to section 10(d) of the
effectiveness of antibiotics by Federal Advisory Committee Act, as
optimizing their use; advance research 2. Describe how healthcare
amended (5 U.S.C. App.), notice is
to develop improved methods for organizations can best: (a) Educate and
hereby given of the following meetings.
combating antibiotic resistance and provide feedback to providers in clinics/ The meetings will be closed to the
conducting antibiotic stewardship; facilities about infectious diseases public in accordance with the
strengthen surveillance of antibiotic- diagnostic testing, optimal antibiotic provisions set forth in sections
resistant bacterial infections; prevent prescribing, and infection prevention; 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
the transmission of antibiotic-resistant where relevant, please include as amended. The grant applications and
bacterial infections; advance the information about what incentives and the discussions could disclose
development of rapid point-of-care and disincentives these organizations have confidential trade secrets or commercial
agricultural diagnostics; further research in place with the goal of improving property such as patentable material,
on new treatments for bacterial antibiotic prescribing (e.g., using and personal information concerning
infections; develop alternatives to clinical decision support) and prevent individuals associated with the grant
antibiotics for agricultural purposes; spread of resistant infections; and, (b) applications, the disclosure of which
maximize the dissemination of up-to- encourage and/or incentivize providers would constitute a clearly unwarranted
date information on the appropriate and invasion of personal privacy.
to report antibiotic use and resistance
proper use of antibiotics to the general
data for all patient populations. Name of Committee: Molecular, Cellular
public and human and animal
3. Please provide examples of and Developmental Neuroscience Integrated
healthcare providers; and improve
Review Group; Neurotransporters, Receptors,
international coordination of efforts to successful behavior change models that
and Calcium Signaling Study Section.
combat antibiotic resistance. In response can be applied to preventive strategies, Date: June 16–17, 2016.
to their mission, the Advisory Council such as infection control and antibiotic Time: 8:00 a.m. to 3:00 p.m.
recently released their first report, stewardship. Agenda: To review and evaluate grant
Initial Assessments of the National applications.
4. Please provide information on the Place: Westin Crystal City, 1800 Jefferson
Action Plan for Combating Antibiotic- best ways to collect data on antibiotic
Resistant Bacteria, at their second Davis Highway, Arlington, VA 22202.
use [and resistance] in animal Contact Person: Peter B. Guthrie, Ph.D.,
public meeting held on March 30–31,
agriculture through public-private Scientific Review Officer, Center for
2016, in Washington, DC. Scientific Review, National Institutes of
Background: In the process of collaborations. Your response can
include information on the types of data Health, 6701 Rockledge Drive, Room 4182,
developing their report, the Advisory MSC 7850, Bethesda, MD 20892, (301) 435–
Council followed the framework of the to be collected, including the method of 1239, guthriep@csr.nih.gov.
Action Plan to hear about a wide range collection, and the metrics for reporting Name of Committee: Endocrinology,
of ongoing and planned activities by the the data. If helpful, please cite sample Metabolism, Nutrition and Reproductive
federal government, including some models as examples to depict your Sciences Integrated Review Group; Molecular
stakeholders/sectors relevant to this answer. and Cellular Endocrinology Study Section.
overall effort. Acknowledging that there Date: June 16–17, 2016.
5. Please provide information on the Time: 8:00 a.m. to 5:00 p.m.
are others who the Advisory Council different resources that exist to promote Agenda: To review and evaluate grant
would like to hear from, they are the understanding of how antibiotics are applications.
seeking that information through this being used in humans and animals in Place: The Westgate Hotel, 1055 2nd Ave.,
RFI. The purpose of the questions posed San Diego, CA 92101.
different parts of the world. Your
in this RFI is to gain additional Contact Person: John Bleasdale, Ph.D.,
information from the public on the response can include information on the Scientific Review Officer, Center for
subject matter in several areas addressed types of support to connect with such Scientific Review, National Institutes of
in the Action Plan. The responses resources, as appropriate (examples Health, 6701 Rockledge Drive, Room 6170,
gathered from the RFI will be reviewed include public-private partnerships, MSC 7892, Bethesda, MD 20892, 301–435–
strategic resourcing, or other means). 4514, bleasdaleje@csr.nih.gov.
by the members of the Advisory Council
and will be taken into consideration as Name of Committee: Bioengineering
More information can be found at Sciences & Technologies Integrated Review
they move forward with their activities. www.hhs.gov/ash/carb. Group; Gene and Drug Delivery Systems
The responses provided are for the Study Section.
Dated: May 18, 2016.
Advisory Council’s informational Date: June 22–23, 2016.
purposes only. Response to this RFI is Bruce Gellin,
Time: 8:00 a.m. to 6:00 p.m.
voluntary. Responders are free to Designated Federal Officer, Presidential Agenda: To review and evaluate grant
address any or all of the questions Advisory Council on Combating Antibiotic- applications.
below. Resistant Bacteria, Deputy Assistant Secretary Place: Doubletree Hotel Bethesda
sradovich on DSK3TPTVN1PROD with NOTICES

Request for Information: To solicit for Health. (Formerly Holiday Inn Select), 8120
additional information from the public, [FR Doc. 2016–12043 Filed 5–20–16; 8:45 am] Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Amy L. Rubinstein, Ph.D.,
including individuals, organizations, BILLING CODE 4150–44–P
Scientific Review Officer, Center for
associations, and industries involved in Scientific Review, National Institutes of
combating antibiotic-resistance, the Health, 6701 Rockledge Drive, Room 5152,
Advisory Council seeks responses on MSC 7844, Bethesda, MD 20892, 301–408–
the following requests for information: 9754, rubinsteinal@csr.nih.gov.

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Document Created: 2018-02-07 15:07:09
Document Modified: 2018-02-07 15:07:09

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.
Dates		Comments must be received by 11:59 p.m. on June 22, 2016 to be considered.
FR Citation		81 FR 32335