81 FR 90855 - Use of Electronic Informed Consent-Questions and Answers; Guidance for Institutional Review Boards, Investigators, and Sponsors; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 241 (December 15, 2016)

Page Range		90855-90857
FR Document		2016-30146

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS), are announcing the availability of a guidance entitled ``Use of Electronic Informed Consent--Questions and Answers.'' The guidance is intended for institutional review boards (IRBs), investigators, and sponsors engaged in or responsible for oversight of human subject research under HHS and/or FDA regulations. The guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. This guidance finalizes the draft guidance entitled ``Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers'' issued in March 2015.

Federal Register, Volume 81 Issue 241 (Thursday, December 15, 2016)

[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Pages 90855-90857]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-30146]

[[Page 90855]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0390]

Use of Electronic Informed Consent--Questions and Answers;
Guidance for Institutional Review Boards, Investigators, and Sponsors;
Availability

AGENCY: Food and Drug Administration and Office for Human Research
Protections, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) and the Office for
Human Research Protections (OHRP), Department of Health and Human
Services (HHS), are announcing the availability of a guidance entitled
``Use of Electronic Informed Consent--Questions and Answers.'' The
guidance is intended for institutional review boards (IRBs),
investigators, and sponsors engaged in or responsible for oversight of
human subject research under HHS and/or FDA regulations. The guidance
provides recommendations on the use of electronic systems and processes
that may employ multiple electronic media to obtain informed consent
for both HHS-regulated human subject research and FDA-regulated
clinical investigations of medical products, including human drug and
biological products, medical devices, and combinations thereof. This
guidance finalizes the draft guidance entitled ``Use of Electronic
Informed Consent in Clinical Investigations--Questions and Answers''
issued in March 2015.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

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-D-0390 for ``Use of Electronic Informed Consent--Questions and
Answers; Guidance for Institutional Review Boards, Investigators, and
Sponsors; Availability.'' 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.
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.
See section III of the SUPPLEMENTARY INFORMATION section for
submitting written requests for single copies of this guidance and for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Cheryl Grandinetti, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3348, Silver Spring, MD 20993-0002, 301-
796-2500; Nicole Wolanski, Office of Good Clinical Practice, Office of
Special Medical Programs, Office of Medical Products and Tobacco, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5108,
Silver Spring, MD 20993, 301 796-6570; 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; Irfan Khan, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
3459, Silver Spring, MD 20993, 1-800-638-2041 or 301-796-7100; or Irene
Stith-Coleman, Office for Human Research Protections, 1101 Wootton
Pkwy., suite 200, Rockville, MD 20852, 240-453-6900.

SUPPLEMENTARY INFORMATION:

I. Background

FDA and OHRP are announcing the availability of a guidance entitled
``Use of Electronic Informed Consent--Questions and Answers.'' The
guidance is intended for IRBs, investigators, and sponsors responsible
for oversight of human subject research under HHS and/or FDA
regulations. The guidance provides recommendations on the use of
electronic systems and processes that

[[Page 90856]]

may employ multiple electronic media to obtain informed consent for
both HHS-regulated human subject research and FDA-regulated clinical
investigations of medical products, including human drug and biological
products, medical devices, and combinations thereof. In particular, the
guidance provides recommendations on procedures that may be followed
when using an electronic informed consent (eIC) to help: (1) Ensure
protection of the rights, safety, and welfare of human subjects; (2)
facilitate the subject's comprehension of the information presented
during the eIC process; (3) ensure that appropriate documentation of
consent is obtained when electronic systems and processes that may
employ multiple electronic media are used to obtain informed consent;
and (4) ensure the quality and integrity of eIC data included in FDA
applications and made available to FDA during inspections.
In the Federal Register of March 9, 2015 (80 FR 12496), FDA
announced the availability of a draft guidance entitled ``Use of
Electronic Informed Consent in Clinical Investigations--Questions and
Answers.'' FDA received a number of comments on the draft guidance. In
response to these comments, this guidance provides further
clarification on: (1) How to present information in the eIC to the
subject; (2) how and where to conduct the eIC process; (3) how and when
questions from subjects should be answered; (4) steps that may be taken
to facilitate the subject's understanding; (5) how to convey additional
information to the subject during the course of the research; (6) how
to use electronic signatures to document eIC; (7) how to verify the
identity of the subjects who will be electronically signing the
informed consent; (8) how to use electronic informed consent for
pediatric studies; (9) how to provide copies of the eIC to the subject;
(10) steps that may be taken to ensure privacy, security, and
confidentiality of the eIC information; (11) how to obtain Health
Insurance Portability and Accountability Act authorizations for
research electronically; (12) what eIC materials the investigator
should submit to the IRB; (13) what the IRB's responsibilities are in
the eIC process; (14) the eIC documentation required for FDA submission
with applications; (15) steps to ensure that eIC materials are archived
appropriately for FDA-regulated clinical investigations; and (16) what
eIC materials or documents FDA will require during an inspection.
In addition, in the Federal Register of March 9, 2015 (80 FR
12497), OHRP asked for public comment on whether OHRP should adopt the
positions and recommendations proposed in the draft guidance for
research regulated under the HHS protection of human subjects
regulations, 45 CFR part 46, and whether OHRP and FDA should issue a
joint guidance on this topic. In response to these comments, the final
guidance was developed in collaboration with FDA and OHRP and is issued
as a joint final guidance.
To enhance human subject protection and reduce regulatory burden,
OHRP and FDA have been actively working to harmonize the Agencies'
regulatory requirements and guidance for human subject research. This
guidance was developed as a part of these efforts. OHRP and FDA believe
that it will be helpful to the regulated community to issue a joint
guidance, which will clearly demonstrate the Agencies' collaborative
approach to the topic of electronic informed consent.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA and OHRP on the use of electronic informed
consent. It does not establish any rights for any person and is not
binding on OHRP, FDA, or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21
CFR part 11 related to electronic records and electronic signatures
have been approved under OMB control number 0910-0303; the collections
of information in 21 CFR parts 50 and 56 related to protection of human
subjects and to IRBs have been approved under OMB control number 0910-
0755; the collections of information in 21 CFR 56.115 related to IRB
recordkeeping requirements, which include requirements for records
related to informed consent, have been approved under OMB control
number 0910-0130; the collections of information in 21 CFR part 312
have been approved under OMB control number 0910-0014; and the
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078. The collections of information related to
the protection of human subjects under 45 CFR part 46 and to IRB
recordkeeping under 45 CFR 46.115 have been approved under OMB control
number 0990-0260.

III. Addresses for Written Requests

Submit written requests for single copies of this guidance and for
electronic access to the guidance document to one of the following
Centers.

----------------------------------------------------------------------------------------------------------------
Center Address Telephone Other information
----------------------------------------------------------------------------------------------------------------
Division of Drug Information, 10001 New Hampshire Ave., ..................... .........................
Center for Drug Evaluation and Hillandale Building, 4th
Research, Food and Drug Floor, Silver Spring, MD
Administration. 20993-0002.
Office of Good Clinical Practice, 10903 New Hampshire Ave., ..................... .........................
Office of Special Medical Bldg. 32, rm. 5103,
Programs, Office of Medical Silver Spring, MD 20993-
Products and Tobacco, Food and 0002.
Drug Administration.
Office for Human Research 1101 Wootton Pkwy., suite ..................... .........................
Protections. 200, Rockville, MD 20852.
Center for Biologics Evaluation 10903 New Hampshire Ave., 240-7911-402......... .........................
and Research, Food and Drug Bldg. 71, rm. 7301,
Administration. Silver Spring, MD 20993-
0002.
Center for Devices and 10903 New Hampshire Ave., 1-800-638-2041 or 301- Send one self-addressed
Radiological Health, Food and Bldg. 66, rm. 4621, 796-7100. adhesive label to assist
Drug Administration. Silver Spring, MD 20993. that office in
processing your
requests.
----------------------------------------------------------------------------------------------------------------

[[Page 90857]]

IV. Electronic Access

Persons with access to the Internet may obtain the guidance at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm, http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm, http://www.hhs.gov/ohrp/newsroom/rfc/index.html, or http://www.regulations.gov.

Leslie Kux,
Assistant Commissioner for Policy, Food and Drug Administration.
Karen B. DeSalvo,
Acting Assistant Secretary for Health, Department of Health and Human
Services.
[FR Doc. 2016-30146 Filed 12-14-16; 8:45 am]
BILLING CODE 4164-01-P

90856 Federal Register / Vol. 81, No. 241 / Thursday, December 15, 2016 / Notices

may employ multiple electronic media the subject; (10) steps that may be taken not establish any rights for any person
to obtain informed consent for both to ensure privacy, security, and and is not binding on OHRP, FDA, or
HHS-regulated human subject research confidentiality of the eIC information; the public. You can use an alternative
and FDA-regulated clinical (11) how to obtain Health Insurance approach if it satisfies the requirements
investigations of medical products, Portability and Accountability Act of the applicable statutes and
including human drug and biological authorizations for research regulations.
products, medical devices, and electronically; (12) what eIC materials
the investigator should submit to the II. The Paperwork Reduction Act of
combinations thereof. In particular, the
IRB; (13) what the IRB’s responsibilities 1995
guidance provides recommendations on
procedures that may be followed when are in the eIC process; (14) the eIC This guidance refers to previously
using an electronic informed consent documentation required for FDA approved collections of information.
(eIC) to help: (1) Ensure protection of submission with applications; (15) steps These collections of information are
the rights, safety, and welfare of human to ensure that eIC materials are archived subject to review by the Office of
subjects; (2) facilitate the subject’s appropriately for FDA-regulated clinical Management and Budget (OMB) under
comprehension of the information investigations; and (16) what eIC the Paperwork Reduction Act of 1995
presented during the eIC process; (3) materials or documents FDA will (44 U.S.C. 3501–3520). The collections
ensure that appropriate documentation require during an inspection. of information in 21 CFR part 11 related
of consent is obtained when electronic In addition, in the Federal Register of to electronic records and electronic
systems and processes that may employ March 9, 2015 (80 FR 12497), OHRP signatures have been approved under
multiple electronic media are used to asked for public comment on whether OMB control number 0910–0303; the
obtain informed consent; and (4) ensure OHRP should adopt the positions and collections of information in 21 CFR
the quality and integrity of eIC data recommendations proposed in the draft
parts 50 and 56 related to protection of
included in FDA applications and made guidance for research regulated under
human subjects and to IRBs have been
available to FDA during inspections. the HHS protection of human subjects
approved under OMB control number
regulations, 45 CFR part 46, and
In the Federal Register of March 9, 0910–0755; the collections of
whether OHRP and FDA should issue a
2015 (80 FR 12496), FDA announced the information in 21 CFR 56.115 related to
joint guidance on this topic. In response
availability of a draft guidance entitled IRB recordkeeping requirements, which
to these comments, the final guidance
‘‘Use of Electronic Informed Consent in include requirements for records related
was developed in collaboration with
Clinical Investigations—Questions and to informed consent, have been
FDA and OHRP and is issued as a joint
Answers.’’ FDA received a number of approved under OMB control number
final guidance.
comments on the draft guidance. In To enhance human subject protection 0910–0130; the collections of
response to these comments, this and reduce regulatory burden, OHRP information in 21 CFR part 312 have
guidance provides further clarification and FDA have been actively working to been approved under OMB control
on: (1) How to present information in harmonize the Agencies’ regulatory number 0910–0014; and the collections
the eIC to the subject; (2) how and requirements and guidance for human of information in 21 CFR part 812 have
where to conduct the eIC process; (3) subject research. This guidance was been approved under OMB control
how and when questions from subjects developed as a part of these efforts. number 0910–0078. The collections of
should be answered; (4) steps that may OHRP and FDA believe that it will be information related to the protection of
be taken to facilitate the subject’s helpful to the regulated community to human subjects under 45 CFR part 46
understanding; (5) how to convey issue a joint guidance, which will and to IRB recordkeeping under 45 CFR
additional information to the subject clearly demonstrate the Agencies’ 46.115 have been approved under OMB
during the course of the research; (6) collaborative approach to the topic of control number 0990–0260.
how to use electronic signatures to electronic informed consent. III. Addresses for Written Requests
document eIC; (7) how to verify the This guidance is being issued
identity of the subjects who will be consistent with FDA’s good guidance Submit written requests for single
electronically signing the informed practices regulation (21 CFR 10.115). copies of this guidance and for
consent; (8) how to use electronic The guidance represents the current electronic access to the guidance
informed consent for pediatric studies; thinking of FDA and OHRP on the use document to one of the following
(9) how to provide copies of the eIC to of electronic informed consent. It does Centers.

Center Address Telephone Other information

Division of Drug Information, Center for 10001 New Hampshire Ave., ....................................
Drug Evaluation and Research, Food Hillandale Building, 4th Floor, Silver
and Drug Administration. Spring, MD 20993–0002.
Office of Good Clinical Practice, Office 10903 New Hampshire Ave., Bldg. ....................................
of Special Medical Programs, Office 32, rm. 5103, Silver Spring, MD
of Medical Products and Tobacco, 20993–0002.
Food and Drug Administration.
Office for Human Research Protections 1101 Wootton Pkwy., suite 200, ....................................
Rockville, MD 20852.
Center for Biologics Evaluation and 10903 New Hampshire Ave., Bldg. 240–7911–402 ...........
rmajette on DSK2TPTVN1PROD with NOTICES

Research, Food and Drug Adminis- 71, rm. 7301, Silver Spring, MD
tration. 20993–0002.
Center for Devices and Radiological 10903 New Hampshire Ave., Bldg. 1–800–638–2041 or Send one self-addressed adhesive
Health, Food and Drug Administra- 66, rm. 4621, Silver Spring, MD 301–796–7100. label to assist that office in proc-
tion. 20993. essing your requests.

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Federal Register / Vol. 81, No. 241 / Thursday, December 15, 2016 / Notices 90857

IV. Electronic Access ACTION: Notice. review certain premarket notifications
Persons with access to the Internet (510(k)s). Participation in this third-
SUMMARY: The Food and Drug party review program by accredited
may obtain the guidance at http:// Administration (FDA) is announcing
www.fda.gov/Drugs/Guidance persons is entirely voluntary. A third
that a proposed collection of
ComplianceRegulatoryInformation/ information has been submitted to the party wishing to participate will submit
Guidances/default.htm, http:// Office of Management and Budget a request for accreditation to FDA.
www.fda.gov/BiologicsBloodVaccines/ (OMB) for review and clearance under Accredited third-party reviewers have
GuidanceComplianceRegulatory the Paperwork Reduction Act of 1995. the ability to review a manufacturer’s
Information/Guidances/default.htm, 510(k) submission for selected devices.
DATES: Fax written comments on the
http://www.fda.gov/MedicalDevices/ After reviewing a submission, the
collection of information by January 17,
DeviceRegulationandGuidance/ reviewer will forward a copy of the
2017.
GuidanceDocuments/default.htm, 510(k) submission, along with the
http://www.fda.gov/ScienceResearch/ ADDRESSES: To ensure that comments on
the information collection are received, reviewer’s documented review and
SpecialTopics/RunningClinicalTrials/ recommendation, to FDA. Third-party
GuidancesInformationSheetsandNotices OMB recommends that written
comments be faxed to the Office of reviewers should maintain records of
/ucm219433.htm, http://www.fda.gov/ their 510(k) reviews and a copy of the
ScienceResearch/SpecialTopics/ Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: 510(k) for a reasonable period of time,
RunningClinicalTrials/Proposed
202–395–7285, or emailed to oira_ usually a period of 3 years.
RegulationsandDraftGuidances/
default.htm, http://www.hhs.gov/ohrp/ submission@omb.eop.gov. All This information collection will allow
newsroom/rfc/index.html, or http:// comments should be identified with the FDA to continue to implement the
www.regulations.gov. OMB control number 0910–0375. Also accredited person review program
include the FDA docket number found established by FDAMA and improve the
Leslie Kux, in brackets in the heading of this efficiency of 510(k) review for low- to
Assistant Commissioner for Policy, Food and document.
Drug Administration. moderate-risk devices. Respondents to
FOR FURTHER INFORMATION CONTACT: FDA this information collection are
Karen B. DeSalvo,
PRA Staff, Office of Operations, Food businesses or other for-profit
Acting Assistant Secretary for Health,
and Drug Administration, Three White organizations.
Department of Health and Human Services.
Flint North, 10A63, 11601 Landsdown
[FR Doc. 2016–30146 Filed 12–14–16; 8:45 am] FDA receives an average of one
St., North Bethesda, MD 20852,
BILLING CODE 4164–01–P application for accreditation for third-
PRAStaff@fda.hhs.gov.
party review per year. According to
SUPPLEMENTARY INFORMATION: In
FDA’s data, the number of 510(k)s
DEPARTMENT OF HEALTH AND compliance with 44 U.S.C. 3507, FDA
submitted for third-party review is
HUMAN SERVICES has submitted the following proposed
collection of information to OMB for approximately 260 annually, which is
review and clearance. 26 annual reviews per each of the 10
Food and Drug Administration
accredited reviewers. Third-party
[Docket No. FDA–2013–N–0795] Medical Devices; Third-Party Review reviewers are required to keep records
Under the Food and Drug of their review of each submission.
Agency Information Collection Administration Modernization Act—
Activities; Submission for Office of OMB Control Number 0910–0375— In the Federal Register of July 8, 2016
Management and Budget Review; Extension (81 FR 44627), FDA published a 60-day
Comment Request; Medical Devices; notice requesting public comment on
Section 210 of the Food and Drug the proposed collection of information.
Third-Party Review Under the Food
Administration Modernization Act
and Drug Administration FDA estimates the burden of this
(FDAMA) established section 523 of the
Modernization Act collection of information as follows:
Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, (21 U.S.C. 360m), directing FDA to
HHS. accredit persons in the private sector to

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Requests for accreditation ................................................... 1 1 1 24 24
510(k) reviews conducted by accredited third parties ......... 10 26 260 40 10,400

Total .............................................................................. ........................ ........................ ........................ ........................ 10,424
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
rmajette on DSK2TPTVN1PROD with NOTICES

Number of Average
Number of Total annual
Activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

510(k) reviews ...................................................................... 10 26 260 10 2,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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Document Created: 2016-12-15 01:10:59
Document Modified: 2016-12-15 01:10:59

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 of availability.
Dates		Submit either electronic or written comments on Agency guidances at any time.
Contact		Cheryl Grandinetti, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3348, Silver Spring, MD 20993-0002, 301- 796-2500; Nicole Wolanski, Office of Good Clinical Practice, Office of Special Medical Programs, Office of Medical Products and Tobacco, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5108, Silver Spring, MD 20993, 301 796-6570; 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; Irfan Khan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3459, Silver Spring, MD 20993, 1-800-638-2041 or 301-796-7100; or Irene Stith-Coleman, Office for Human Research Protections, 1101 Wootton Pkwy., suite 200, Rockville, MD 20852, 240-453-6900.
FR Citation		81 FR 90855

81 FR 90855 - Use of Electronic Informed Consent-Questions and Answers; Guidance for Institutional Review Boards, Investigators, and Sponsors; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 241 (December 15, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration