82 FR 58005 - Request for Information on the Office of Disease Prevention Strategic Plan for Fiscal Years (FY) 2019-2023
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 235 (December 8, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 235 (December 8, 2017)
| Page Range | 58005-58006 | |
| FR Document | 2017-26453 |
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)] [Notices] [Pages 58005-58006] From the Federal Register Online [www.thefederalregister.org] [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 http://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
![Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices 58005
comments, that information will be except in accordance with 21 CFR 10.20 DEPARTMENT OF HEALTH AND
posted on https://www.regulations.gov. and other applicable disclosure law. For HUMAN SERVICES
• If you want to submit a comment more information about FDA’s posting
with confidential information that you of comments to public dockets, see 80 National Institutes of Health
do not wish to be made available to the FR 56469, September 18, 2015, or access
public, submit the comment as a the information at: https://www.gpo.gov/ Request for Information on the Office
written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015- of Disease Prevention Strategic Plan
manner detailed (see ‘‘Written/Paper 23389.pdf. for Fiscal Years (FY) 2019–2023
Submissions’’ and ‘‘Instructions’’). AGENCY: National Institutes of Health,
Docket: For access to the docket to
Written/Paper Submissions read background documents or the HHS.
Submit written/paper submissions as electronic and written/paper comments ACTION: Notice.
follows: received, go to https://
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the SUMMARY: This Request for Information
written/paper submissions): Dockets docket number, found in brackets in the (RFI) is intended to gather broad public
Management Staff (HFA–305), Food and heading of this document, into the input on the FY 2019–2023 Strategic
Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts Plan for the Office of Disease Prevention
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management (ODP) in the Division of Program
• For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061, Coordination, Planning, and Strategic
submitted to the Dockets Management Rockville, MD 20852. Initiatives (DPCPSI), National Institutes
Staff, FDA will post your comment, as of Health (NIH). The ODP invites input
well as any attachments, except for FOR FURTHER INFORMATION CONTACT: Gail from prevention researchers in
information submitted, marked and Schmerfeld, Office of Generic Drugs, academia and industry, health care
identified, as confidential, if submitted Center for Drug Evaluation and professionals, patient advocates and
as detailed in ‘‘Instructions.’’ Research, Food and Drug advocacy organizations, scientific or
Instructions: All submissions received Administration, 10903 New Hampshire professional organizations, federal
must include the Docket No. FDA– Ave., Bldg. 75, Rm. 1672, Silver Spring, agencies, and other interested members
2017–D–5767 for ‘‘Abbreviated New MD 20993–0002, 301–796–9291, of the public. Organizations are strongly
Drug Applications for Certain Highly Gail.Schmerfeld@fda.hhs.gov. encouraged to submit a single response
Purified Synthetic Peptide Drug SUPPLEMENTARY INFORMATION: In the that reflects the views of their
Products That Refer to Listed Drugs of Federal Register of October 3, 2017, organization and membership as a
Recombinant Deoxyribonucleic Acid FDA published a notice of availability whole.
Origin; Draft Guidance for Industry; with a 60-day comment period to DATES: The ODP’s Request for
Availability.’’ Received comments will request comments on the draft guidance Information is open for public comment
be placed in the docket and, except for for industry entitled ‘‘ANDAs for for a period of 45 days. Comments must
those submitted as ‘‘Confidential Certain Highly Purified Synthetic be received by January 22, 2018 to
Submissions,’’ publicly viewable at Peptide Drug Products That Refer to ensure consideration.
https://www.regulations.gov or at the Listed Drugs of rDNA Origin.’’ ADDRESSES: Comments must be
Dockets Management Staff between 9
This draft guidance is being issued submitted electronically using the web-
a.m. and 4 p.m., Monday through
consistent with FDA’s good guidance based form available at https://
Friday.
• Confidential Submissions—To practices regulation (21 CFR 10.115). prevention.nih.gov/strategic-plan/
submit a comment with confidential The draft guidance, when finalized, will request-for-information.
information that you do not wish to be represent the current thinking of FDA FOR FURTHER INFORMATION CONTACT:
made publicly available, submit your on the submission of ANDAs for certain Please direct all inquiries to Wilma
comments only as a written/paper highly purified synthetic peptide drug Peterman Cross, M.S.; Deputy Director,
submission. You should submit two products that refer to listed drugs of Office of Disease Prevention, National
copies total. One copy will include the rDNA origin. It does not establish any Institutes of Health; Phone: 301–827–
information you claim to be confidential rights for any person and is not binding 5561; email: prevention@mail.nih.gov.
with a heading or cover note that states on FDA or the public. You can use an SUPPLEMENTARY INFORMATION: To ensure
‘‘THIS DOCUMENT CONTAINS alternative approach if it satisfies the consideration, responses must be
CONFIDENTIAL INFORMATION.’’ The requirements of the applicable statutes submitted electronically using the web-
Agency will review this copy, including and regulations. This draft guidance is based form available at https://
the claimed confidential information, in not subject to Executive Order 12866. prevention.nih.gov/strategic-plan/
its consideration of comments. The Based on public interest in the draft request-for-information. The web form
second copy, which will have the guidance, FDA is extending the will provide confirmation of response
claimed confidential information comment period for the notice of submission, but respondents will not
redacted/blacked out, will be available availability for 60 days, until February receive individualized feedback. All
for public viewing and posted on 4, 2018. The Agency believes that a 60- respondents are encouraged to sign up
https://www.regulations.gov. Submit day extension allows adequate time for for the ODP email list at http://
both copies to the Dockets Management interested persons to submit comments prevention.nih.gov/subscribe to receive
Staff. If you do not wish your name and without significantly delaying guidance information related to Office activities,
sradovich on DSK3GMQ082PROD with NOTICES
contact information to be made publicly on these important issues. including updates on the development
available, you can provide this Dated: December 4, 2017. and release of the final strategic plan.
information on the cover sheet and not The mission of the Office of Disease
Leslie Kux,
in the body of your comments and you Prevention (ODP) is to improve the
must identify this information as Associate Commissioner for Policy. public health by increasing the scope,
‘‘confidential.’’ Any information marked [FR Doc. 2017–26436 Filed 12–7–17; 8:45 am] quality, dissemination, and impact of
as ‘‘confidential’’ will not be disclosed BILLING CODE 4164–01–P prevention research supported by the
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![58006 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
NIH. The ODP fulfills this mission by preventing or ameliorating high-risk DEPARTMENT OF HEALTH AND
providing leadership for the behaviors and exposures, the occurrence HUMAN SERVICES
development, coordination, and of a disease, disorder, or injury, or the
implementation of prevention research progression of detectable but National Institutes of Health
in collaboration with NIH Institutes, asymptomatic disease. Prevention
Centers, and Offices and other partners. research also includes research studies Submission for OMB Review; 30-Day
The first ODP strategic plan was to develop and evaluate disease Comment Request; A Generic
released in February 2014 and charted prevention, health promotion Submission for Formative Research,
new directions and, at the same time, recommendations, and public health Pre-testing, Stakeholder Measures and
built upon and expanded existing programs. The ODP definition of Advocate Forms at NCI (National
programs. The Office has made prevention includes the following Cancer Institute)
considerable progress on the priorities categories of research: AGENCY: National Institutes of Health,
identified in the initial plan, and the • Identification of modifiable risk and HHS.
ODP remains committed to playing an protective factors for diseases/disorders/ ACTION: Notice.
integral role in advancing trans-NIH injuries
prevention-related activities. Input • Studies on assessment of risk, SUMMARY: In compliance with the
received from this Request for including genetic susceptibility Paperwork Reduction Act of 1995, the
Information will inform the • Development of methods for National Institutes of Health (NIH) has
development of the final FY 2019–2023 screening and identification of markers submitted to the Office of Management
Strategic Plan, which will outline for those at risk for onset or progression and Budget (OMB) a request for review
activities coordinated by the ODP to of asymptomatic diseases/disorders, or and approval of the information
assess, facilitate, and stimulate research those at risk for adverse, high-risk collection listed below.
in disease prevention, and disseminate behaviors/injuries DATES: Comments regarding this
the results of this research to improve • Development and evaluation of information collection are best assured
public health. interventions to promote health for of having their full effect if received
The ODP is seeking input on the groups of individuals without within 30-days of the date of this
following strategic priorities: recognized signs or symptoms of the publication.
• Strategic Priority I: Systematically target condition
monitor NIH investments in prevention ADDRESSES: Written comments and/or
• Translation of proven effective
research and the progress and results of suggestions regarding the item(s)
prevention interventions into practice
that research. contained in this notice, especially
• Strategic Priority II: Identify • Effectiveness studies that examine
regarding the estimated public burden
prevention research areas for investment factors related to the organization,
and associated response time, should be
or expanded effort by the NIH. management, financing, and adoption of
directed to the: Office of Management
• Strategic Priority III: Promote the prevention services and practices
and Budget, Office of Regulatory Affairs,
use of the best available methods in • Methodological and statistical OIRA_submission@omb.eop.gov or by
prevention research and support the procedures for assessing risk and fax to 202–395–6974, Attention: Desk
development of better methods. measuring the effects of preventive Officer for NIH.
• Strategic Priority IV: Promote interventions.
FOR FURTHER INFORMATION CONTACT: To
collaborative prevention research Responses to this RFI are voluntary
and may be submitted anonymously. request more information on the
projects and facilitate coordination of proposed project or to obtain a copy of
such projects across the NIH and with Please do not include any personally
identifiable or other information that the data collection plans and
other public and private entities. instruments, contact: Amy Williams,
• Strategic Priority V: Advance the you do not wish to make public.
Director of the Office of Advocacy
understanding of prevention research, Proprietary, classified, confidential, or
sensitive information should not be Relations (OAR), NCI, NIH, 31 Center
increase the availability of prevention Drive, Bldg. 31, Room 10A28, MSC
research resources and programs, and included in responses. Comments
submitted will be compiled for 2580, Bethesda, MD 20892, call non-
enhance ODP’s stakeholder engagement. toll-free number 240–781–3406, or
The ODP is also seeking input on the discussion and incorporated into the
strategic plan as appropriate. Any email your request, including your
following questions:
• What new strategic priorities personal identifiers (personal names, address, to amy.williams@nih.gov.
should the ODP consider adding to its email addresses, etc.) will be removed SUPPLEMENTARY INFORMATION: This
plan? when responses are compiled. proposed information collection was
• What opportunities or challenges in This RFI is for informational and previously published in the Federal
disease prevention research and planning purposes only and is not a Register on October 2, 2017, page 45870
methods could the ODP help to address? solicitation for applications or an (82 FR 45870) and allowed 60 days for
• Who should the ODP partner with obligation on the part of the United public comment. No public comments
to address pressing needs in disease States (U.S.) Government to provide were received. The National Cancer
prevention research and methods? support for any ideas identified in Institute (NCI), National Institutes of
• What areas transcend disease response to it. Please note that the U.S. Health, may not conduct or sponsor,
prevention research that the ODP Government will not pay for the and the respondent is not required to
respond to, an information collection
sradovich on DSK3GMQ082PROD with NOTICES
should consider as it develops its new preparation of any information
plan? submitted or for use of that information. that has been extended, revised, or
The definition of prevention research implemented on or after October 1,
used by the ODP to guide its work and Dated: December 1, 2017. 1995, unless it displays a currently valid
decision-making encompasses research Lawrence A. Tabak, OMB control number.
designed to yield results directly Deputy Director, National Institutes of Health. In compliance with Section
applicable to identifying and assessing [FR Doc. 2017–26453 Filed 12–7–17; 8:45 am] 3507(a)(1)(D) of the Paperwork
risk, developing interventions for BILLING CODE 4140–01–P Reduction Act of 1995, the National
VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\08DEN1.SGM 08DEN1](https://thefederalregister.org/doc/82_FR_58240/page/2.svg)
Document Created: 2017-12-08 01:43:40
Document Modified: 2017-12-08 01:43:40
| 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 | 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. | |
| 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] | |
| FR Citation | 82 FR 58005 |
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