Request for Information on the Office of Disease Prevention Strategic Plan for Fiscal Years (FY) 2019-2023, 58005-58006 [2017-26453]
Download as PDF
Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–5767 for ‘‘Abbreviated New
Drug Applications for Certain Highly
Purified Synthetic Peptide Drug
Products That Refer to Listed Drugs of
Recombinant Deoxyribonucleic Acid
Origin; Draft Guidance for Industry;
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
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
VerDate Sep<11>2014
20:38 Dec 07, 2017
Jkt 244001
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.
Gail
Schmerfeld, Office of Generic Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1672, Silver Spring,
MD 20993–0002, 301–796–9291,
Gail.Schmerfeld@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of October 3, 2017,
FDA published a notice of availability
with a 60-day comment period to
request comments on the draft guidance
for industry entitled ‘‘ANDAs for
Certain Highly Purified Synthetic
Peptide Drug Products That Refer to
Listed Drugs of rDNA Origin.’’
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 submission of ANDAs for certain
highly purified synthetic peptide drug
products that refer to listed drugs of
rDNA origin. 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 draft guidance is
not subject to Executive Order 12866.
Based on public interest in the draft
guidance, FDA is extending the
comment period for the notice of
availability for 60 days, until February
4, 2018. The Agency believes that a 60day extension allows adequate time for
interested persons to submit comments
without significantly delaying guidance
on these important issues.
SUPPLEMENTARY INFORMATION:
Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26436 Filed 12–7–17; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
58005
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information on the Office
of Disease Prevention Strategic Plan
for Fiscal Years (FY) 2019–2023
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This Request for Information
(RFI) is intended to gather broad public
input on the FY 2019–2023 Strategic
Plan for the Office of Disease Prevention
(ODP) in the Division of Program
Coordination, Planning, and Strategic
Initiatives (DPCPSI), National Institutes
of Health (NIH). The ODP invites input
from prevention researchers in
academia and industry, health care
professionals, patient advocates and
advocacy organizations, scientific or
professional organizations, federal
agencies, and other interested members
of the public. Organizations are strongly
encouraged to submit a single response
that reflects the views of their
organization and membership as a
whole.
SUMMARY:
The ODP’s Request for
Information is open for public comment
for a period of 45 days. Comments must
be received by January 22, 2018 to
ensure consideration.
ADDRESSES: Comments must be
submitted electronically using the webbased form available at https://
prevention.nih.gov/strategic-plan/
request-for-information.
FOR FURTHER INFORMATION CONTACT:
Please direct all inquiries to Wilma
Peterman Cross, M.S.; Deputy Director,
Office of Disease Prevention, National
Institutes of Health; Phone: 301–827–
5561; email: prevention@mail.nih.gov.
SUPPLEMENTARY INFORMATION: To ensure
consideration, responses must be
submitted electronically using the webbased form available at https://
prevention.nih.gov/strategic-plan/
request-for-information. The web form
will provide confirmation of response
submission, but respondents will not
receive individualized feedback. All
respondents are encouraged to sign up
for the ODP email list at https://
prevention.nih.gov/subscribe to receive
information related to Office activities,
including updates on the development
and release of the final strategic plan.
The mission of the Office of Disease
Prevention (ODP) is to improve the
public health by increasing the scope,
quality, dissemination, and impact of
prevention research supported by the
DATES:
E:\FR\FM\08DEN1.SGM
08DEN1
sradovich on DSK3GMQ082PROD with NOTICES
58006
Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
NIH. The ODP fulfills this mission by
providing leadership for the
development, coordination, and
implementation of prevention research
in collaboration with NIH Institutes,
Centers, and Offices and other partners.
The first ODP strategic plan was
released in February 2014 and charted
new directions and, at the same time,
built upon and expanded existing
programs. The Office has made
considerable progress on the priorities
identified in the initial plan, and the
ODP remains committed to playing an
integral role in advancing trans-NIH
prevention-related activities. Input
received from this Request for
Information will inform the
development of the final FY 2019–2023
Strategic Plan, which will outline
activities coordinated by the ODP to
assess, facilitate, and stimulate research
in disease prevention, and disseminate
the results of this research to improve
public health.
The ODP is seeking input on the
following strategic priorities:
• Strategic Priority I: Systematically
monitor NIH investments in prevention
research and the progress and results of
that research.
• Strategic Priority II: Identify
prevention research areas for investment
or expanded effort by the NIH.
• Strategic Priority III: Promote the
use of the best available methods in
prevention research and support the
development of better methods.
• Strategic Priority IV: Promote
collaborative prevention research
projects and facilitate coordination of
such projects across the NIH and with
other public and private entities.
• Strategic Priority V: Advance the
understanding of prevention research,
increase the availability of prevention
research resources and programs, and
enhance ODP’s stakeholder engagement.
The ODP is also seeking input on the
following questions:
• What new strategic priorities
should the ODP consider adding to its
plan?
• What opportunities or challenges in
disease prevention research and
methods could the ODP help to address?
• Who should the ODP partner with
to address pressing needs in disease
prevention research and methods?
• What areas transcend disease
prevention research that the ODP
should consider as it develops its new
plan?
The definition of prevention research
used by the ODP to guide its work and
decision-making encompasses research
designed to yield results directly
applicable to identifying and assessing
risk, developing interventions for
VerDate Sep<11>2014
20:38 Dec 07, 2017
Jkt 244001
preventing or ameliorating high-risk
behaviors and exposures, the occurrence
of a disease, disorder, or injury, or the
progression of detectable but
asymptomatic disease. Prevention
research also includes research studies
to develop and evaluate disease
prevention, health promotion
recommendations, and public health
programs. The ODP definition of
prevention includes the following
categories of research:
• Identification of modifiable risk and
protective factors for diseases/disorders/
injuries
• Studies on assessment of risk,
including genetic susceptibility
• Development of methods for
screening and identification of markers
for those at risk for onset or progression
of asymptomatic diseases/disorders, or
those at risk for adverse, high-risk
behaviors/injuries
• Development and evaluation of
interventions to promote health for
groups of individuals without
recognized signs or symptoms of the
target condition
• Translation of proven effective
prevention interventions into practice
• Effectiveness studies that examine
factors related to the organization,
management, financing, and adoption of
prevention services and practices
• Methodological and statistical
procedures for assessing risk and
measuring the effects of preventive
interventions.
Responses to this RFI are voluntary
and may be submitted anonymously.
Please do not include any personally
identifiable or other information that
you do not wish to make public.
Proprietary, classified, confidential, or
sensitive information should not be
included in responses. Comments
submitted will be compiled for
discussion and incorporated into the
strategic plan as appropriate. Any
personal identifiers (personal names,
email addresses, etc.) will be removed
when responses are compiled.
This RFI is for informational and
planning purposes only and is not a
solicitation for applications or an
obligation on the part of the United
States (U.S.) Government to provide
support for any ideas identified in
response to it. Please note that the U.S.
Government will not pay for the
preparation of any information
submitted or for use of that information.
Dated: December 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017–26453 Filed 12–7–17; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; A Generic
Submission for Formative Research,
Pre-testing, Stakeholder Measures and
Advocate Forms at NCI (National
Cancer Institute)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Amy Williams,
Director of the Office of Advocacy
Relations (OAR), NCI, NIH, 31 Center
Drive, Bldg. 31, Room 10A28, MSC
2580, Bethesda, MD 20892, call nontoll-free number 240–781–3406, or
email your request, including your
address, to amy.williams@nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on October 2, 2017, page 45870
(82 FR 45870) and allowed 60 days for
public comment. No public comments
were received. The National Cancer
Institute (NCI), National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
ADDRESSES:
E:\FR\FM\08DEN1.SGM
08DEN1
Agencies
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 58005-58006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26453]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Information on the Office of Disease Prevention
Strategic Plan for Fiscal Years (FY) 2019-2023
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This Request for Information (RFI) is intended to gather broad
public input on the FY 2019-2023 Strategic Plan for the Office of
Disease Prevention (ODP) in the Division of Program Coordination,
Planning, and Strategic Initiatives (DPCPSI), National Institutes of
Health (NIH). The ODP invites input from prevention researchers in
academia and industry, health care professionals, patient advocates and
advocacy organizations, scientific or professional organizations,
federal agencies, and other interested members of the public.
Organizations are strongly encouraged to submit a single response that
reflects the views of their organization and membership as a whole.
DATES: The ODP's Request for Information is open for public comment for
a period of 45 days. Comments must be received by January 22, 2018 to
ensure consideration.
ADDRESSES: Comments must be submitted electronically using the web-
based form available at https://prevention.nih.gov/strategic-plan/request-for-information.
FOR FURTHER INFORMATION CONTACT: Please direct all inquiries to Wilma
Peterman Cross, M.S.; Deputy Director, Office of Disease Prevention,
National Institutes of Health; Phone: 301-827-5561; email:
[email protected].
SUPPLEMENTARY INFORMATION: To ensure consideration, responses must be
submitted electronically using the web-based form available at https://prevention.nih.gov/strategic-plan/request-for-information. The web form
will provide confirmation of response submission, but respondents will
not receive individualized feedback. All respondents are encouraged to
sign up for the ODP email list at https://prevention.nih.gov/subscribe
to receive information related to Office activities, including updates
on the development and release of the final strategic plan.
The mission of the Office of Disease Prevention (ODP) is to improve
the public health by increasing the scope, quality, dissemination, and
impact of prevention research supported by the
[[Page 58006]]
NIH. The ODP fulfills this mission by providing leadership for the
development, coordination, and implementation of prevention research in
collaboration with NIH Institutes, Centers, and Offices and other
partners. The first ODP strategic plan was released in February 2014
and charted new directions and, at the same time, built upon and
expanded existing programs. The Office has made considerable progress
on the priorities identified in the initial plan, and the ODP remains
committed to playing an integral role in advancing trans-NIH
prevention-related activities. Input received from this Request for
Information will inform the development of the final FY 2019-2023
Strategic Plan, which will outline activities coordinated by the ODP to
assess, facilitate, and stimulate research in disease prevention, and
disseminate the results of this research to improve public health.
The ODP is seeking input on the following strategic priorities:
Strategic Priority I: Systematically monitor NIH
investments in prevention research and the progress and results of that
research.
Strategic Priority II: Identify prevention research areas
for investment or expanded effort by the NIH.
Strategic Priority III: Promote the use of the best
available methods in prevention research and support the development of
better methods.
Strategic Priority IV: Promote collaborative prevention
research projects and facilitate coordination of such projects across
the NIH and with other public and private entities.
Strategic Priority V: Advance the understanding of
prevention research, increase the availability of prevention research
resources and programs, and enhance ODP's stakeholder engagement.
The ODP is also seeking input on the following questions:
What new strategic priorities should the ODP consider
adding to its plan?
What opportunities or challenges in disease prevention
research and methods could the ODP help to address?
Who should the ODP partner with to address pressing needs
in disease prevention research and methods?
What areas transcend disease prevention research that the
ODP should consider as it develops its new plan?
The definition of prevention research used by the ODP to guide its
work and decision-making encompasses research designed to yield results
directly applicable to identifying and assessing risk, developing
interventions for preventing or ameliorating high-risk behaviors and
exposures, the occurrence of a disease, disorder, or injury, or the
progression of detectable but asymptomatic disease. Prevention research
also includes research studies to develop and evaluate disease
prevention, health promotion recommendations, and public health
programs. The ODP definition of prevention includes the following
categories of research:
Identification of modifiable risk and protective factors
for diseases/disorders/injuries
Studies on assessment of risk, including genetic
susceptibility
Development of methods for screening and identification of
markers for those at risk for onset or progression of asymptomatic
diseases/disorders, or those at risk for adverse, high-risk behaviors/
injuries
Development and evaluation of interventions to promote
health for groups of individuals without recognized signs or symptoms
of the target condition
Translation of proven effective prevention interventions
into practice
Effectiveness studies that examine factors related to the
organization, management, financing, and adoption of prevention
services and practices
Methodological and statistical procedures for assessing
risk and measuring the effects of preventive interventions.
Responses to this RFI are voluntary and may be submitted
anonymously. Please do not include any personally identifiable or other
information that you do not wish to make public. Proprietary,
classified, confidential, or sensitive information should not be
included in responses. Comments submitted will be compiled for
discussion and incorporated into the strategic plan as appropriate. Any
personal identifiers (personal names, email addresses, etc.) will be
removed when responses are compiled.
This RFI is for informational and planning purposes only and is not
a solicitation for applications or an obligation on the part of the
United States (U.S.) Government to provide support for any ideas
identified in response to it. Please note that the U.S. Government will
not pay for the preparation of any information submitted or for use of
that information.
Dated: December 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017-26453 Filed 12-7-17; 8:45 am]
BILLING CODE 4140-01-P