[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36820-36821]
[FR Doc No: 2015-15644]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1887]

Source Data Capture From Electronic Health Records: Using
Standardized Clinical Research Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Center for Drug Evaluation and Research (CDER) is
interested in supporting demonstration projects to test the capability
and evaluate performance of using an end-to-end Electronic Health
Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture
approach, using established data and implementation standards in a
regulated clinical research environment. A demonstration project should
ideally test the use of a standards-based technology solution to enable
the collection of related healthcare and clinical research information
within a single system and workflow. Stakeholders may include regulated
industry, EHR and EDC vendors, academic medical centers, and other
interested parties.

DATES: Submit either electric or written requests for participation in
the demonstration project by August 10, 2015.

ADDRESSES: Submit written requests for single copies of the documents
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301-
796-5333<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The information systems, as well as the underlying data models,
that define both clinical care and clinical research are widely
disparate. This was not an issue for the conduct of clinical research
prior to use of EHRs or EDC because data were captured on paper case
report forms. However, much has changed in the past decade for clinical
research where EDC systems are now ubiquitous for the capture of
clinical trials data. Similarly, EHRs have had widespread adoption and
are rapidly becoming a standard part of clinical care.
    In 2013, FDA published a final guidance on ``Electronic Source Data
in Clinical Investigations'' which encourages use of electronic source
data in the conduct of clinical trials intended for inclusion in
investigational and new drug applications. The electronic capture of
data from EHRs and healthcare devices, such as electrocardiogram
management systems, digital imaging and mobile health devices, as well
as electronic Patient Reported Outcomes Instruments has the potential
to improve the reliability, quality, traceability, provenance and
integrity of data from electronic source to regulatory submission.
    Demonstration projects should assess and report value and
challenges of the EHR-to-EDC single-point capture of source data in a
clinical research environment. Streamlining clinical research at the
source may open up opportunities to improve clinical trial design and
execution, speed the cycle of clinical research and get medicines to
market faster.
    Specifically, the use of a standards-based technology solution in
clinical trials has the potential to:
     Eliminate duplication of data by capturing and
transmitting electronic source data;
     auto-populate the electronic study forms from EHRs;
     reduce transcription errors and improve the quality of
data;
     encourage entering source data at the point of care;
     facilitate remote monitoring of data to reduce the number
of onsite visits by regulated biopharmaceutical industry;
     improve site monitoring to minimize the need for cross-
reference data in multiple sources;
     make it easier for investigators to conduct clinical
research;
     facilitate the inspection and reconstruction of clinical
investigations by FDA; and

     improve the standards-based technology solution to
encourage widespread adoption.

II. Questions to Stakeholders

    1. What other potential benefits to stakeholders can be achieved
through the use of a standards-based technology solution focusing on
EHR and EDC integration?
    2. What are the challenges to the implementation of a standards-
based technology solution focusing on EHR and EDC integration?
    3. What are the gaps between the data collected in a healthcare
setting by EHRs vs. clinical research data required for regulated drug
development?
    4. Are there any perceived regulatory obstacles to the
implementation of a standards-based technology solution focusing on EHR
and EDC integration? (Examples include: Source data verification,
remote monitoring, 21 CFR part 11, patient privacy, access control and
confidentiality safeguards.) If yes, what approach(es) would you
recommend to overcome these obstacles?
    5. Are there any obstacles to the implementation of a standards-
based technology solution focusing on EHR and EDC integration?
    6. What standards-based solutions may exist?

III. Requests for Response

    Comments, proposed approaches, interest to participate, and
responses to the questions are to be identified with the docket number
found in brackets in the heading of this document. Interested parties
should include the following information in the request: Contact name,
contact phone number, email address, name of the stakeholder, and
address. Once requests for participation are received, FDA will contact
interested stakeholders to discuss demonstration projects. The elapsed
time duration of any project is expected to be approximately 12 months
but may be extended as needed.

    Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15644 Filed 6-25-15; 8:45 am]
BILLING CODE 4164-01-P


P-20-0098 Sanitized Support Documents Index:
 P-20-0098 Sanitized Determination Document (linked)
 P-20-0098 Sanitized CHEM Report (attached)
 P-20-0098 Sanitized ECO Report (attached)
 P-20-0098 Sanitized ENG Report (attached)
 P-20-0098 Sanitized EXP Report (attached)
 P-20-0098 Sanitized Fate Report (attached)
 P-20-0098 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


Summary of Ag Handler Exposure Monitoring in the State of Washington and
Reported Pesticide-related Illnesses in California

The trend is clearly down in terms of significantly depressed
cholinesterase enzyme levels among ag handlers with regard to the use of
azinphos methyl in the State of Washington per their 2005 report.

Only one ag handler had significantly depressed cholinesterase enzyme
levels in the State of Washington in 2005 and two in 2004 per EPA’s
document titled , “Proposed Decisions for the Remaining Uses of
Azinphos Methyl, June 9, 2006.”   In 2005, 611 workers were tested and
580 were tested in 2004.

Per the 2005 State of Washington report for all workers of pesticides,
“…the likelihood of a worker experiencing  > 20% depression in both
tests  [red blood cell and serum cholinesterase], was very low (0.8% of
total workers with a periodic test).”

“…hours of handling is not a strong predictor of the degree of ChE
depression for individuals.”

“The greatest proportion of ChE depression exceeding the benchmark of
20% from baseline occurred primarily during dormant season spraying of
tree fruits.”  However, the azinphos methyl label forbids its
application during the dormant season.

For all pesticides, the State of Washington found numerous violations
involving the lack of an appropriate respirator cartridge or change out
of schedule and not wearing appropriate chemical resistant headgear when
required by the pesticide label.

In 2004 and 2005, “50% of employers  investigated are using a [another
named OP pesticide, not AZM] product that does not include a label
requirement for respiratory protection.”

Per a summary report by the California Department of Pesticide
Regulations, there were no illnesses reported by California physicians
associated with the use of azinphos methyl in from 1999 to 2002 and none
in 2004. There was one possible illness in 2003.


[Federal Register Volume 88, Number 59 (Tuesday, March 28, 2023)]
[Notices]
[Pages 18371-18373]
[FR Doc No: 2023-06373]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2023-0045]

Increasing Public Access to the Results of USDOT-Funded
Transportation Research

Issue Date: March 23, 2023.
AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Notice; request for information.

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SUMMARY: The United States Department of Transportation (DOT) invites
public comment on issues or topics the DOT should consider as it
updates the DOT Public Access Plan in response to new White House
Office of Science and Technology Policy (OSTP) guidance.

DATES: Comments are requested by May 10, 2023. See the SUPPLEMENTARY
INFORMATION section on ``Public Participation,'' below, for more
information about written comments.

ADDRESSES: Written Comments: Comments should refer to the docket number
above and be submitted by one of the following methods:
     Federal Rulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Email: [email protected] Include the docket number in
the subject line of the message.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001. Include docket number on the
outside of the envelope.
     Hand Delivery: 1200 New Jersey Avenue SE, West Building
Ground Floor, Room W12-140, Washington, DC, between 9 a.m. and 5 p.m.
ET, Monday through Friday, except Federal Holidays. Include docket
number on outside or first page of your submission.
    Instructions: All submission received must include the agency name
and the docket number. All comments received in the Federal Rulemaking
Portal will be posted without change, including any personal
information provided.
    For detailed instructions on submitting comments and additional
information on the rulemaking process, see the Public Participation
heading of the SUPPLEMENTARY INFORMATION section of this document. Note
that all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Privacy Act: Except as provided below, all comments received into
the docket will be made public in their entirety. The comments will be
searchable by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You should not include information in
your comment that you do not want to be made public. You may review
DOT's complete Privacy Act Statement in the Federal Register published
on April 11, 2000 (65 FR 19477-78) or at https://www.transportation.gov/privacy.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or to the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: Mx. Leighton L Christiansen, Data
Curator, National Transportation Library, Bureau of Transportation
Statistics, Office of the Assistant Secretary for Research and
Technology, by email at [email protected] or by phone at (202) 578-
0185.

SUPPLEMENTARY INFORMATION:

Purpose

    DOT seeks public input on the Increasing Public Access to the
Results of USDOT Funded Transportation Research (DOT Public Access
Plan).

Background

    On February 22, 2013, the White House Office of Science and
Technology Policy (OSTP) released a memorandum entitled ``Increasing
Access to the Results of Federally Funded Scientific Research''
<<https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf>>, which called for all Executive
Departments with greater than $100 million in yearly research and
development expenditures to prepare a plan for improving the Public's
access to the results of Federally funded research. On December 16,
2015, the DOT published its ``Plan to Increase Public Access to the
Results of Federally-Funded Scientific Research, Version 1.1'' <<
https://doi.org/10.21949/1503646>> in response. The 2015 Public Access
Plan codified and extended DOT's longstanding commitment to and
practice of sharing DOT-supported research results. Further, the 2015
plan included making the digital datasets underlying the research
results accessible by the public.
    On August 25, 2022, the White House Office of Science and
Technology Policy (OSTP) released a memorandum entitled ``Ensuring
Free, Immediate, and Equitable Access to Federally Funded Research''
<<https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf>> which establishes new guidance for improving
public access to scholarly publications and data resulting from
Federally supported research. This second OSTP memorandum calls on all
Federal Departments and Agencies to prepare new or updated Public
Access plans to ensure the Public's immediate access to the results of
Federally funded research, which will further advance research
transparency and advance U.S. economic competitiveness by raising
awareness of new research discoveries and innovations.
    In response, DOT will draft a version 2 of its Public Access Plan.
The updated plan will:

     Affirm and enhances DOT's commitment to the Public's
access to DOT-funded Scientific Research results, including digitally
formatted scientific data;
     Affirm DOT's support for the reproducibility of Scientific
Research results;
     Build on DOT's commitment to the Public's access to DOT-
funded Scientific Research results by adding Source Code and Software,
among the categories of accessible Research Outputs;
     Ensure the free and immediate availability, reliable
preservation, and continuous access to DOT-funded research results,
without embargo; and
     Enhance the usefulness of Scientific Research results to
promote further innovation, increase American economic competitiveness,
and advance the safety, reliability, sustainability, and equity of the
national transportation system.

Specific Questions

    DOT seeks information regarding the DOT Public Access Plan from all
interested stakeholders, including, but not limited to: members of the
public; principal investigators; research institutions; libraries;
scholarly publishers; scientific societies; transportation agencies;
transportation-focused groups, organizations, and associations; data
scientists; data repositories; and others.
    DOT is providing the following questions to prompt feedback and
comments. DOT encourages public comment on any or all of these
questions, and also seeks any other information commenters believe is
relevant.
    The questions to which DOT is interested in receiving responses
are:
    1. How best to improve access to textual research outputs. A high
percentage of DOT funded research results are delivered via technical
reports, research briefs, manuals, technology transfer documents, and
other grey literature, designed for immediate sharing and rapid
implementation. The current DOT Public Access Plans allows researchers
to distribute these outputs through the website or repository of their
choice, and requires a copy be submitted to the DOT National
Transportation Library digital repository for long-term preservation
and public access. DOT seeks information on how to improve and
streamline this submission process to improve timeliness; and, to avoid
reinforcing inequities to access and submission, while not creating new
ones.
    2. How best to improve accessibility of textual research outputs.
DOT research grants and contracts require researchers to submit textual
research outputs that are accessible to members of the public who use
computer screen readers and other assistive technologies to access
information, as consistent with Section 508 of the Rehabilitation Act
of 1973 and the 2018 ITC Refresh, 36 CFR 1194. DOT seeks information on
how to improve equity of access to research results.
    3. How best to improve access to scholarly publications from DOT
funded research. Section 3.a) of the 2022 OSTP memo calls on agencies
to ``update or develop new public access plans for ensuring, as
appropriate and consistent with applicable law, that all peer-reviewed
scholarly publications authored or co-authored by individuals or
institutions resulting from federally funded research are made freely
available and publicly accessible by default in agency-designated
repositories without any embargo or delay after publication.'' DOT
seeks information on: i. How peer-reviewed scholarly publications
should be made publicly accessible; ii. How to maximize equitable reach
of public access to peer-reviewed scholarly publications, including by
providing free online access to peer-reviewed scholarly publications in
formats that allow for machine-readability and enabling broad
accessibility through assistive devices; and, iii. The circumstances or
prerequisites needed to make the publications freely and publicly
available by default, including any use and re-use rights, and which
restrictions, including attribution, may apply.
    4. How best to improve access to datasets. The 2015 DOT Public
Access Plan required all data underlying research conclusions be made
publicly accessible, while protecting sensitive personal, business, and
security information. Further, the Plan required research proposals
include a data management plan (DMP) that, among other things, detailed
where datasets would be preserved. However, DOT allowed researchers a
choice of where to preserve the data: in an institutional or third-
party domain-specific or generalist repository; with DOT; or, to self-
distribute data when requested by the public. Further the 2015 DOT plan
allowed researchers to include reasonable preservation costs in their
research proposal. Going forward, the updated plan will continue to
mandate research data must be shared while protecting sensitive
information. However, in order meet the requirements of the 2022 OSTP
memo and to better ensure long-term preservation of data of interest to
DOT, the broader research community, and the public, researchers must
preserve data in an institutional or third-party repository or with
DOT, but self-distribution will no longer be allowed. DOT will continue
to encourage researchers to plan for, and budget for, long-term data
preservation as part of the research proposal process. DOT seeks
information on how to best facilitate, support, and fund long-term data
preservation and sharing.
    5. How to implement evolving ethical frameworks to DOT-funded
research. A percentage of transportation research involves the direct
study of human subjects as they interact with the transportation
infrastructure and operations. Transportation researchers have a long
history of protecting human subjects under academic Institutional
Review Board (IRB) and similar ethical guidelines. With the increase in
volume of digital data collected about people and populations during
research execution, some collectively in identified public settings and
some oriented to observation of individuals requiring their knowledge
and consent, the global movement towards open science and data sharing
has developed new ethical frameworks. One example of these is the
``CARE Principles for Indigenous Data Governance'' << https://www.gida-global.org/care>>, created to allow Indigenous People to assert greater
control over the use of Indigenous data and knowledge. DOT seeks
information on how to ensure DOT supported research is engaged with and
implements these evolving ethical frameworks.
    6. How to best improve access to other types of research outputs.
The 2015 DOT Public Access Plan focused on making text-based research
outputs and digital datasets accessible to the public. But
transportation research is not confined to only these two types of
outputs. More and more research outputs include software, code,
simulations, visualizations, and others yet to come. With the need to
update our Public Access Plan, DOT is interested in having supported
researchers share all research outputs with the public, where
practicable and within legal parameters. DOT seeks information on the
projected types of research outputs, the level of effort and expense in
sharing them, as well as ethical and legal concerns with sharing other
types of research outputs.
    7. How to implement persistent identifiers (PIDs) for people;
research documents and outputs; and, research

entities. The 2015 DOT Public Access Plan called for persistent
identification of research outputs and researchers. The 2022 OSTP memo,
section 4.b) requires all federally funded researchers to have a
personal persistent identifier as defined in NSPM-33 Implementation
Guidance << https://www.whitehouse.gov/wp-content/uploads/2022/01/010422-NSPM-33-Implementation-Guidance.pdf>> section 2. Further, the
OSTP memo section 4.c) requires persistent identification of research
and development awards, such as research grants and contracts. Finally,
DOT is interested in being able to uniquely and persistently identify
research entities, to enable analysis of outputs and research
relationships. DOT seeks suggestions on improving the use of persistent
identifiers and their metadata, including adoption use cases from
institutions.
    8. How to improve research project lifecycle management. The 2015
DOT Public Access Plan commits DOT to sharing research project
information through a publicly accessible database. DOT seeks
suggestions on improving our research project management tools and
practices, and welcomes institutional use case examples.

Public Participation

How do I prepare and submit comments?

    Your comments must be written in English. To ensure that your
comments are filed correctly in the docket, please include the docket
number of this document in your comments.
    Please submit one copy (two copies if submitting by mail or hand
delivery) of your comments, including the attachments, to the docket
following the instructions given above under ADDRESSES. Please note, if
you are submitting comments electronically as a PDF (Adobe) file, we
ask that the documents submitted be scanned using an Optical Character
Recognition (OCR) process, and without password protection, thus
allowing the agency to open, search, and copy certain portions of your
submissions.

How do I submit confidential business information?

    Any submissions containing Confidential Information must be
delivered to OST in the following manner:
     Submitted in a sealed envelope marked ``confidential
treatment requested'';
     Document(s) or information that the submitter would like
withheld should be marked ``PROPIN''; accompanied by an index listing
the document(s) or information that the submitter would like the
Departments to withhold. The index should include information such as
numbers used to identify the relevant document(s) or information,
document title and description, and relevant page numbers and/or
section numbers within a document; and
     Submitted with a statement explaining the submitter's
grounds for objecting to disclosure of the information to the public.
    DOT will treat such marked submissions as confidential under the
FOIA and will not include them in the public docket. DOT also requests
that submitters of Confidential Information include a non-confidential
version (either redacted or summarized) of those confidential
submissions in the public docket. In the event that the submitter
cannot provide a non-confidential version of its submission, DOT
requests that the submitter post a notice in the docket stating that it
has provided DOT with Confidential Information. Should a submitter fail
to docket either a non-confidential version of its submission or to
post a notice that Confidential Information has been provided, we will
note the receipt of the submission on the docket, with the submitter's
organization or name (to the degree permitted by law) and the date of
submission.

Will the Agency consider late comments?

    OST will consider all comments received before the close of
business on the comment closing date indicated above under DATES. To
the extent possible, the agency will also consider comments received
after that date.

How can I read the comments submitted by other people?

    You may read the comments received at the address given above under
written comments. The hours of the docket are indicated above in the
same location. You may also see the comments on the internet,
identified by the docket number at the heading of this notice, at
http://www.regulations.gov.

    Issued in Washington, DC, on March 23, 2023, under authority
delegated at 49 CFR 1.25a.
Robert C. Hampshire,
Deputy Assistant Secretary for Research and Technology.
[FR Doc. 2023-06373 Filed 3-27-23; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: August 29, 2008 (Volume 73, Number 169)]
[Notices]
[Page 50963]
[DOCID:fr29au08-72]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8709-8]

Clean Air Act Advisory Committee (CAAAC): Notice of Meeting

AGENCY: Environmental Protection Agency.

ACTION: Notice of meeting.

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SUMMARY: The Environmental Protection Agency (EPA) established the
Clean Air Act Advisory Committee (CAAAC) on November 19, 1990, to
provide independent advice and counsel to EPA on policy issues
associated with implementation of the Clean Air Act of 1990. The
Committee advises on economic, environmental, technical scientific, and
enforcement policy issues.

DATES AND ADDRESSES: Open meeting notice; pursuant to 5 U.S.C. App. 2
section 10(a)(2), notice is hereby given that the Clean Air Act
Advisory Committee will hold its next open meeting on Thursday,
September 18, 2008. The meeting is open to the public to attend and
will begin at approximately 8:30 a.m. to 4 p.m. at the DoubleTree Hotel
at 300 Army Navy Drive, in Arlington, Virginia. The Subcommittee
meetings will be held on September 17, 2008 and will begin at
approximately 8:30 a.m. to 4:30 p.m. at the same location as the full
Committee. Seating will be available on a first come, first served
basis. The agenda for the CAAAC full committee meeting on September 18,
2008, will be posted on the Clean Air Act Advisory Committee Web site
at http://www.epa.gov/oar/caaac/.
    Inspection of Committee Documents: The Committee agenda and any
documents prepared for the meeting will be publicly available at the
meeting. Thereafter, these documents, together with CAAAC meeting
minutes, will be available by contacting the Office of Air and
Radiation Docket and requesting information under docket OAR-2004-0075.
The Docket office can be reached by telephoning<PHONE_NUMBER>; Fax 202-
566-9744.

FOR FURTHER INFORMATION CONTACT: Concerning the CAAAC, please contact
Pat Childers, Office of Air and Radiation, U.S. EPA<PHONE_NUMBER>, Fax
(202) 564-1352 or by mail at U.S. EPA, Office of Air and Radiation
(Mail code 6102 A), 1200 Pennsylvania Avenue, NW., Washington, DC
20004. For information on the Subcommittees, please contact the
following individuals: (1) Permits/NSR/Toxics Integration--Liz Naess,
(919) 541-1892; (2) Economic Incentives and Regulatory Innovations--
Pat Childers,<PHONE_NUMBER>; and (3) Mobile Source Technical Review--
John Guy,<PHONE_NUMBER>. Additional Information on these meetings,
CAAAC, and its Subcommittees can be found on the CAAAC Web site: http:/
/www.epa.gov/oar/caaac/.
    For information on access or services for individuals with
disabilities, please contact Mr. Pat Childers at<PHONE_NUMBER> or
<EMAIL_ADDRESS>To request accommodation of a disability, please
contact Mr. Childers, preferably at least 10 days prior to the meeting,
to give EPA as much time as possible to process your request.

    Dated: August 25, 2008.
Pat Childers,
Designated Federal Official, Clean Air Act Advisory Committee, Office
of Air and Radiation.
[FR Doc. E8-20124 Filed 8-28-08; 8:45 am]

BILLING CODE 6560-50-P