80 FR 66543 - Using Technologies and Innovative Methods To Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 209 (October 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 209 (October 29, 2015)
| Page Range | 66543-66545 | |
| FR Document | 2015-27581 |
[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)] [Notices] [Pages 66543-66545] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27581] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3579] Using Technologies and Innovative Methods To Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit input from a broad group of stakeholders on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations. Specifically, FDA seeks information to understand individual and industry experiences with the use of such technologies to more efficiently conduct clinical research. FDA also seeks stakeholder perspectives on possible barriers to implementing these technologies and methods to conduct clinical investigations. DATES: Submit electronic or written comments by December 28, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-N-3579 for ``Using Technologies and Innovative Methods to Conduct FDA-Regulated Clinical Investigations of Investigational Drugs.'' Please identify the specific question or issue that the comment addresses. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. [[Page 66544]] 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Nicole Silva, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3341, Silver Spring, MD 20993-0002, 301- 796-3419; Aaliyah K. Eaves, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002, 301-796-2948; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background Clinical investigations that ensure the protection of the rights, safety, and welfare of trial participants and that yield reliable data are critical to FDA's mission to ensure that medical products are safe and effective. The clinical trial enterprise continues to evolve and become more complex, and the scientific and infrastructure challenges of conducting clinical investigations affect the cost and timeliness of medical product development. Challenges in recruiting and retaining sufficient numbers of trial participants to conduct an adequately powered investigation in a reasonable amount of time may contribute to the cost and complexity. Creative uses of technology in conducting clinical investigations have emerged over the previous decade and include advances that have the potential to improve recruitment, participation, and retention of trial participants. New technology and communication infrastructure allow for collection of data and communication wherever the trial participant is located, including at his or her health care provider's location, creating opportunities to overcome geographical and logistical barriers that otherwise might prevent a potential trial participant from participating in a clinical investigation, as well as facilitating the integration of research with clinical care. In addition to potential convenience for the trial participant, these tools and technologies may present sponsors with the opportunity to capture data more frequently and efficiently than would be feasible if data collection were only conducted when the trial participant visited the study site. This may enhance the sponsor's ability to understand the safety and effectiveness of drugs, biologics, and medical devices; increase additional meaningful data gathering; minimize missing data; and maximize trial participation and retention. Some of these technologies and methods may be used regardless of the trial participant's location and may include, for example, mobile health technology, telemedicine, and remote sensors. Use of these technologies and methods allows for more flexibility for the sponsor and clinical investigator in the oversight of clinical investigation conduct, data collection, and monitoring of trial participants and clinical sites. Other elements that may be incorporated into clinical investigations to improve trial participant recruitment include online/ Web-based eligibility screening, informed consent, and communication between investigators and participants. II. Purpose of the Docket FDA is soliciting public input from a broad group of stakeholders regarding technologies and innovative methods for using technology to more efficiently conduct clinical research. FDA is interested in identifying new opportunities to study medical products, as well as receiving comments on barriers, challenges, and relevant considerations that may affect a medical product clinical investigation that uses these technologies and methods. III. Issues for Comment In addition to the general information requests in section II of this document, FDA is interested in obtaining information and public comment on the following specific issues: 1. What technologies, communication infrastructure, or innovative methods are being used to conduct clinical investigations? FDA is aware of several groups conducting and interested in conducting clinical investigations using mobile technology and remote methods for data collection. FDA requests feedback on experiences with implementing such methods or models (for example, lessons learned), as well as information supporting the use of any suggested technologies, methods, or models, including any characteristics that would make the technology more or less desirable for use in clinical trials. 2. What are ways FDA could encourage adoption of these technologies and innovative methods in the conduct of clinical investigations? 3. Identify any clinical, cultural, business, regulatory, or other barriers perceived by stakeholders that serve as a disincentive to the use of technology to facilitate the conduct of clinical investigations. a. What challenges do stakeholders anticipate in adoption of these technologies or methods? Are there challenges in complying with regulatory requirements surrounding the conduct of clinical investigations that use such technologies or methods? b. What are the perceived barriers or challenges to obtaining and documenting informed consent or obtaining institutional review board review, approval, and oversight for clinical investigations utilizing these technologies or methods? 4. FDA is interested in obtaining information on potential trial participant acceptance, privacy, and human subject protection issues that may occur as a result of the use of technologies and innovative methods for the conduct of clinical investigations. In particular, FDA is [[Page 66545]] interested in assessing potential trial participants' interest, tolerance, concerns, and willingness to participate in clinical investigations that involve nontraditional settings or utilize new technologies. FDA is also interested in identifying the factors that affect trial participant awareness, acceptance, enrollment, and retention for these investigations. a. Are there specific patient groups or therapeutic areas that could particularly benefit from these types of technologies or methods? b. What new opportunities for the conduct of clinical investigations are created through the use of continuous or intermittent remote monitoring and data collection? c. What are some of the anticipated risks to trial participants that may occur as a result of the use of these technologies or off-site methods in clinical investigations? d. What are some of the anticipated benefits to trial participants that may occur as a result of the use of these technologies or off-site methods in clinical investigations? e. Are there perceived challenges to participation in clinical investigations utilizing these types of technologies or methods because of concerns regarding inadvertent disclosure of trial participants' information or breach of privacy? Are there concerns relating to the integrity of data collection or encryption or the secure transmission of information? f. Are there unique considerations for ensuring integrity of the source data, for example, authenticity and reliability? g. How should validation of participant-operated mobile devices be addressed? h. What are the challenges presented when data are collected using the Bring Your Own Device (BYOD) model? BYOD in clinical investigations refers to the practice of trial participants using their own devices, such as smartphones or tablets, for data collection. For example, participants in a clinical investigation may use their own computer devices to access and respond to study-related questionnaires. What are the perceived barriers to pooling data collected from different devices provided by individual trial participants, as well as pooling data from the BYOD model with data collected at the investigational site or on paper forms? How should situations such as mid-study user device switches be handled? i. What are the challenges or special considerations with recruiting and/or retaining potential trial participants with low levels of computer literacy or individuals who may have limited or no access to mobile technologies, computer devices, or the Internet? How can these challenges or special considerations best be addressed? Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27581 Filed 10-28-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices 66543
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of dis-
Number of Total annual Average burden
21 CFR Section closures per Total hours
respondents disclosures per disclosure
respondent
54.4(b)—Clinical Investigators .......................................... 7,106 1 7,106 0.17 1,208
(10 minutes) .....
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 23, 2015. OMB control number 0910–0802. The instructions for submitting comments.
Leslie Kux, approval expires on September 30, Comments submitted electronically,
Associate Commissioner for Policy. 2018. A copy of the supporting including attachments, to http://
[FR Doc. 2015–27559 Filed 10–28–15; 8:45 am] statement for this information collection www.regulations.gov will be posted to
BILLING CODE 4164–01–P is available on the Internet at http:// the docket unchanged. Because your
www.reginfo.gov/public/do/PRAMain. comment will be made public, you are
Dated: October 23, 2015. solely responsible for ensuring that your
DEPARTMENT OF HEALTH AND Leslie Kux, comment does not include any
HUMAN SERVICES confidential information that you or a
Associate Commissioner for Policy.
third party may not wish to be posted,
Food and Drug Administration [FR Doc. 2015–27558 Filed 10–28–15; 8:45 am]
such as medical information, your or
BILLING CODE 4164–01–P
[Docket No. FDA–2013–D–0286] anyone else’s Social Security number, or
confidential business information, such
Agency Information Collection as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND
Activities; Announcement of Office of that if you include your name, contact
HUMAN SERVICES
Management and Budget Approval; information, or other information that
Guidance for Industry on Formal Food and Drug Administration identifies you in the body of your
Meetings Between the Food and Drug comments, that information will be
Administration and Biosimilar [Docket No. FDA–2015–N–3579] posted on http://www.regulations.gov.
Biological Product Sponsors or • If you want to submit a comment
Using Technologies and Innovative
Applicants with confidential information that you
Methods To Conduct Food and Drug
do not wish to be made available to the
AGENCY: Food and Drug Administration, Administration-Regulated Clinical
public, submit the comment as a
HHS. Investigations of Investigational
written/paper submission and in the
ACTION: Notice. Drugs; Establishment of a Public
manner detailed (see ‘‘Written/Paper
Docket
SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
Administration (FDA) is announcing AGENCY: Food and Drug Administration, Written/Paper Submissions
that a collection of information entitled HHS.
ACTION: Notice; establishment of docket; Submit written/paper submissions as
‘‘Guidance for Industry on Formal
request for comments. follows:
Meetings Between the Food and Drug
• Mail/Hand delivery/Courier (for
Administration and Biosimilar
SUMMARY: The Food and Drug written/paper submissions): Division of
Biological Product Sponsors or
Administration (FDA or Agency) is Dockets Management (HFA–305), Food
Applicant’’ has been approved by the
announcing the establishment of a and Drug Administration, 5630 Fishers
Office of Management and Budget
public docket to solicit input from a Lane, rm. 1061, Rockville, MD 20852.
(OMB) under the Paperwork Reduction
broad group of stakeholders on the • For written/paper comments
Act of 1995.
scope and direction of the use of submitted to the Division of Dockets
FOR FURTHER INFORMATION CONTACT: FDA technologies and innovative methods in Management, FDA will post your
PRA Staff, Office of Operations, Food the conduct of clinical investigations. comment, as well as any attachments,
and Drug Administration, 8455 Specifically, FDA seeks information to except for information submitted,
Colesville Rd., COLE–14526, Silver understand individual and industry marked and identified, as confidential,
Spring, MD 20993–0002, PRAStaff@ experiences with the use of such if submitted as detailed in
fda.hhs.gov. technologies to more efficiently conduct ‘‘Instructions.’’
SUPPLEMENTARY INFORMATION: On June clinical research. FDA also seeks Instructions: All submissions received
25, 2015, the Agency submitted a stakeholder perspectives on possible must include the Docket No. FDA–
proposed collection of information barriers to implementing these 2015–N–3579 for ‘‘Using Technologies
entitled ‘‘Guidance for Industry on technologies and methods to conduct and Innovative Methods to Conduct
Formal Meetings Between the Food and clinical investigations. FDA-Regulated Clinical Investigations
Drug Administration and Biosimilar DATES: Submit electronic or written of Investigational Drugs.’’ Please
Biological Product Sponsors or identify the specific question or issue
asabaliauskas on DSK5VPTVN1PROD with NOTICES
comments by December 28, 2015.
Applicant’’ to OMB for review and ADDRESSES: You may submit comments that the comment addresses. Received
clearance under 44 U.S.C. 3507. An as follows: comments will be placed in the docket
Agency may not conduct or sponsor, and, except for those submitted as
and a person is not required to respond Electronic Submissions ‘‘Confidential Submissions,’’ publicly
to, a collection of information unless it Submit electronic comments in the viewable at http://www.regulations.gov
displays a currently valid OMB control following way: or at the Division of Dockets
number. OMB has now approved the • Federal eRulemaking Portal: http:// Management between 9 a.m. and 4 p.m.,
information collection and has assigned www.regulations.gov. Follow the Monday through Friday.
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![Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices 66545
interested in assessing potential trial individuals who may have limited or no Dated: October 23, 2015.
participants’ interest, tolerance, access to mobile technologies, computer Leslie Kux,
concerns, and willingness to participate devices, or the Internet? How can these Associate Commissioner for Policy.
in clinical investigations that involve challenges or special considerations best [FR Doc. 2015–27557 Filed 10–28–15; 8:45 am]
nontraditional settings or utilize new be addressed? BILLING CODE 4164–01–P
technologies. FDA is also interested in Dated: October 26, 2015.
identifying the factors that affect trial
Leslie Kux,
participant awareness, acceptance, DEPARTMENT OF HEALTH AND
Associate Commissioner for Policy.
enrollment, and retention for these HUMAN SERVICES
investigations. [FR Doc. 2015–27581 Filed 10–28–15; 8:45 am]
a. Are there specific patient groups or BILLING CODE 4164–01–P Health Resources and Services
therapeutic areas that could particularly Administration
benefit from these types of technologies
or methods? DEPARTMENT OF HEALTH AND Statement of Organization, Functions
b. What new opportunities for the HUMAN SERVICES and Delegations of Authority
conduct of clinical investigations are
Food and Drug Administration This notice amends Part R of the
created through the use of continuous or
Statement of Organization, Functions
intermittent remote monitoring and data
[Docket No. FDA–2014–D–2138] and Delegations of Authority of the
collection?
c. What are some of the anticipated Department of Health and Human
risks to trial participants that may occur Agency Information Collection Services (HHS), Health Resources and
as a result of the use of these Activities; Announcement of Office of Services Administration (HRSA) (60 FR
technologies or off-site methods in Management and Budget Approval; 56605, as amended November 6, 1995;
clinical investigations? Guidance for Industry on Adverse as last amended at 80 FR 44358 dated
d. What are some of the anticipated Event Reporting for Outsourcing July 27, 2015).
benefits to trial participants that may Facilities This notice reflects organizational
occur as a result of the use of these changes in the Health Resources and
AGENCY: Food and Drug Administration, Services Administration (HRSA), Office
technologies or off-site methods in
HHS. of Planning, Analysis, and Evaluation
clinical investigations?
e. Are there perceived challenges to ACTION: Notice. (RA5). Specifically, this notice: (1)
participation in clinical investigations Establishes the Office of Strategic
utilizing these types of technologies or SUMMARY: The Food and Drug Initiatives (RA59) within the Office of
methods because of concerns regarding Administration (FDA) is announcing Planning, Analysis, and Evaluation.
inadvertent disclosure of trial that a collection of information entitled Chapter RA5—Office of Planning,
participants’ information or breach of ‘‘Guidance for Industry on Adverse Analysis, and Evaluation
privacy? Are there concerns relating to Event Reporting for Outsourcing
the integrity of data collection or Facilities Under Section 503B of the Section RA5—00, Mission
encryption or the secure transmission of Federal Food, Drug and Cosmetic Act’’ The Office of Planning, Analysis, and
information? has been approved by the Office of Evaluation (RA5) provide HRSA-wide
f. Are there unique considerations for Management and Budget (OMB) under leadership on cross-agency initiatives
ensuring integrity of the source data, for the Paperwork Reduction Act of 1995. and Departmental priorities.
example, authenticity and reliability? FOR FURTHER INFORMATION CONTACT: FDA
g. How should validation of Section RA5–10, Organization
PRA Staff, Office of Operations, Food
participant-operated mobile devices be and Drug Administration, 8455 Delete the organization for the Office
addressed? Colesville Rd., COLE–14526, Silver of Planning, Analysis, and Evaluation in
h. What are the challenges presented Spring, MD 20993–0002, PRAStaff@ its entirety and replace with the
when data are collected using the Bring fda.hhs.gov. following:
Your Own Device (BYOD) model? The Office of Planning, Analysis, and
BYOD in clinical investigations refers to SUPPLEMENTARY INFORMATION: On August Evaluation (RA5) is headed by the
the practice of trial participants using 4, 2015, the Agency submitted a Director, who reports directly to the
their own devices, such as smartphones proposed collection of information Administrator, Health Resources and
or tablets, for data collection. For entitled ‘‘Guidance for Industry on Services Administration. The Office of
example, participants in a clinical Adverse Event Reporting for Planning, Analysis, and Evaluation
investigation may use their own Outsourcing Facilities Under Section includes the following components:
computer devices to access and respond 503B of the Federal Food, Drug, and (1) Office of the Director (RA5);
to study-related questionnaires. What Cosmetic Act’’ to OMB for review and (2) Office of Policy Analysis (RA53);
are the perceived barriers to pooling clearance under 44 U.S.C. 3507. An (3) Office of Research and Evaluation
data collected from different devices Agency may not conduct or sponsor, (RA56);
provided by individual trial and a person is not required to respond (4) Office of External Engagement
participants, as well as pooling data to, a collection of information unless it (RA57);
from the BYOD model with data displays a currently valid OMB control
asabaliauskas on DSK5VPTVN1PROD with NOTICES
(5) Office of Performance and Quality
collected at the investigational site or on number. OMB has now approved the Measurement (RA58); and
paper forms? How should situations information collection and has assigned (6) Office of Strategic Initiatives
such as mid-study user device switches OMB control number 0910–0800. The (RA59).
be handled? approval expires on September 30,
i. What are the challenges or special 2018. A copy of the supporting Section RA5–20, Functions
considerations with recruiting and/or statement for this information collection This notice reflects organizational
retaining potential trial participants is available on the Internet at http:// changes in the Health Resources and
with low levels of computer literacy or www.reginfo.gov/public/do/PRAMain. Services Administration (HRSA), Office
VerDate Sep<11>2014 23:37 Oct 28, 2015 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\29OCN1.SGM 29OCN1](https://thefederalregister.org/doc/80_FR_66752/page/3.svg)
Document Created: 2015-12-14 15:21:35
Document Modified: 2015-12-14 15:21:35
| 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; establishment of docket; request for comments. | |
| Dates | Submit electronic or written comments by December 28, 2015. | |
| Contact | Nicole Silva, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3341, Silver Spring, MD 20993-0002, 301- 796-3419; Aaliyah K. Eaves, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002, 301-796-2948; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 80 FR 66543 |
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