81 FR 63767 - Clinical Investigator Training Course
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 180 (September 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 180 (September 16, 2016)
| Page Range | 63767-63768 | |
| FR Document | 2016-22348 |
[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)] [Notices] [Pages 63767-63768] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22348] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1214] Clinical Investigator Training Course AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), is announcing a 3-day training course for clinical investigators on the scientific, ethical, and regulatory aspects of clinical trials for medical products. This training course is intended to provide clinical investigators, such as clinicians, nurses, pharmacists, and other health care providers involved in conducting clinical trials, with expertise in the design, conduct, and analysis of clinical trials; to improve the quality of clinical trials; and to enhance the safety of trial participants. Senior FDA staff, along with other experts, will present on issues critical for successful conduct of clinical research. DATES: The training course will be held on November 7, 2016, from 8:20 a.m. to 5:30 p.m. (registration begins at 7:30 a.m.); on November 8, 2016, from 8:30 a.m. to 4:45 p.m.; and on November 9, 2016, from 8:30 a.m. to 3:30 p.m. ADDRESSES: The course will be held at the Silver Spring Civic Building at Veterans Plaza, One Veterans Place, Silver Spring, MD 20910. GPS device address: 8525 Fenton St., Silver Spring, MD 20910. For additional information, please refer to http://www.silverspringdowntown.com/go/silver-spring-civic-building-and-veterans-plaza. (FDA has verified the Web address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) FOR FURTHER INFORMATION CONTACT: Nicole Silva, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6323, Silver Spring, MD 20993, 301-796-3419, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Clinical trial investigators play a critical role in the development of medical products. They bear the responsibility for ensuring the safe and ethical treatment of study subjects and for acquiring adequate and reliable data to support regulatory decisions. This course is intended to train clinical investigators in all elements of clinical trials, including the preclinical and clinical information needed to support the investigational use of medical products; the statistical design of trials; and scientific, regulatory, and ethical considerations related to conduct of clinical trials. The course lecturers will include a diverse representation of senior FDA staff and other experts, enabling communication on issues critical for successful conduct of clinical research. II. Description of the Training Course A. Purpose The training course is designed to provide clinical investigators with an overview of the following information:The essential toxicological, pharmacological, and manufacturing data to support investigational use in humans; Fundamental issues in the design and conduct of clinical trials; Statistical and analytic considerations in the interpretation of trial data; Appropriate safety evaluation during studies; and The ethical considerations and regulatory requirements for clinical trials. In addition, the course aims to: Foster a cadre of clinical investigators with knowledge, experience, and commitment to investigational medicine; Promote communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in experimental medicine; Improve the quality of clinical trial data; and Enhance protection of subjects in clinical trials. B. Agenda The course will be conducted over 3 days and will be presented mainly by senior FDA staff with other lecturers presenting on selected topics. The agenda is available at http://www.fda.gov/Training/ClinicalInvestigatorTrainingCourse/default.htm. C. Target Audience The course is targeted toward clinicians, nurses, pharmacists and other health care professionals responsible for, or involved in, the conduct and/or design of clinical trials. Registration: There is no registration fee to attend this in-person training [[Page 63768]] course; however, seats are limited and registration will be on a first- come, first-served basis. To register, you need to complete the registration online by October 28, 2016, at http://www.fda.gov/Training/ClinicalInvestigatorTrainingCourse/default.htm. Upon completion of registration, you will receive an email that confirms your registration. There will be no onsite registration or remote access for this training. Accommodations: Attendees are responsible for their own hotel accommodations. If you need special accommodations due to a disability, please contact Nicole Silva (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. Persons attending the course are advised that FDA is not responsible for providing access to electrical outlets. Dated: September 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22348 Filed 9-15-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices 63767
clinical considerations for these DEPARTMENT OF HEALTH AND ethical treatment of study subjects and
products. HUMAN SERVICES for acquiring adequate and reliable data
In the Federal Register of October 14, to support regulatory decisions. This
Food and Drug Administration course is intended to train clinical
2015 (80 FR 61822), FDA announced the
availability of the draft guidance of the [Docket No. FDA–2013–N–1214] investigators in all elements of clinical
trials, including the preclinical and
same title dated October 2015. FDA
Clinical Investigator Training Course clinical information needed to support
received one comment on the draft
the investigational use of medical
guidance and that comment was AGENCY: Food and Drug Administration, products; the statistical design of trials;
considered as the guidance was HHS. and scientific, regulatory, and ethical
finalized. Minor editorial changes were ACTION: Notice. considerations related to conduct of
made in response to the comment to clinical trials. The course lecturers will
improve clarity. The guidance SUMMARY: The Food and Drug include a diverse representation of
announced in this notice finalizes the Administration (FDA), in collaboration senior FDA staff and other experts,
draft guidance dated October 2015 and with the University of Maryland Center enabling communication on issues
supplements the guidance entitled of Excellence in Regulatory Science and critical for successful conduct of clinical
‘‘Guidance for FDA Reviewers and Innovation (M–CERSI), is announcing a research.
Sponsors: Content and Review of 3-day training course for clinical
investigators on the scientific, ethical, II. Description of the Training Course
Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene and regulatory aspects of clinical trials A. Purpose
Therapy Investigational New Drug for medical products. This training
course is intended to provide clinical The training course is designed to
Applications (INDs),’’ dated April 2008. provide clinical investigators with an
investigators, such as clinicians, nurses,
This guidance is being issued pharmacists, and other health care overview of the following information:
consistent with FDA’s good guidance providers involved in conducting • The essential toxicological,
practices regulation (21 CFR 10.115). clinical trials, with expertise in the pharmacological, and manufacturing
The guidance represents the current design, conduct, and analysis of clinical data to support investigational use in
thinking of FDA on recommendations trials; to improve the quality of clinical humans;
for MVGTs. It does not establish any trials; and to enhance the safety of trial • Fundamental issues in the design
rights for any person and is not binding participants. Senior FDA staff, along and conduct of clinical trials;
• Statistical and analytic
on FDA or the public. You can use an with other experts, will present on
considerations in the interpretation of
alternative approach if it satisfies the issues critical for successful conduct of
trial data;
requirements of the applicable statutes clinical research. • Appropriate safety evaluation
and regulations. DATES: The training course will be held during studies; and
II. Paperwork Reduction Act of 1995
on November 7, 2016, from 8:20 a.m. to • The ethical considerations and
5:30 p.m. (registration begins at 7:30 regulatory requirements for clinical
This guidance refers to previously a.m.); on November 8, 2016, from 8:30 trials.
approved collections of information a.m. to 4:45 p.m.; and on November 9, In addition, the course aims to:
found in FDA regulations. These 2016, from 8:30 a.m. to 3:30 p.m. • Foster a cadre of clinical
collections of information are subject to ADDRESSES: The course will be held at investigators with knowledge,
review by the Office of Management and the Silver Spring Civic Building at experience, and commitment to
Veterans Plaza, One Veterans Place, investigational medicine;
Budget (OMB) under the Paperwork
Silver Spring, MD 20910. GPS device • Promote communication between
Reduction Act of 1995 (44 U.S.C. 3501– clinical investigators and FDA;
3520). The collections of information in address: 8525 Fenton St., Silver Spring,
MD 20910. For additional information, • Enhance investigators’
21 CFR parts 211 and 610 have been understanding of FDA’s role in
please refer to http://
approved under OMB control number experimental medicine;
www.silverspringdowntown.com/go/
0910–0139 and in 21 CFR part 312
silver-spring-civic-building-and- • Improve the quality of clinical trial
under OMB control number 0910–0014. veterans-plaza. (FDA has verified the data; and
Web address, but FDA is not responsible • Enhance protection of subjects in
III. Electronic Access
for subsequent changes to the Web site clinical trials.
Persons with access to the Internet after this document publishes in the B. Agenda
may obtain the guidance at either http:// Federal Register.)
The course will be conducted over 3
www.fda.gov/BiologicsBloodVaccines/ FOR FURTHER INFORMATION CONTACT: days and will be presented mainly by
GuidanceCompliance Nicole Silva, Office of Medical Policy, senior FDA staff with other lecturers
RegulatoryInformation/Guidances/ Center for Drug Evaluation and presenting on selected topics. The
default.htm or http:// Research, Food and Drug agenda is available at http://www.fda.
www.regulations.gov. Administration, 10903 New Hampshire gov/Training/ClinicalInvestigator
Dated: September 12, 2016. Ave., Bldg. 51, Rm. 6323, Silver Spring, TrainingCourse/default.htm.
MD 20993, 301–796–3419,
Leslie Kux, C. Target Audience
Nicole.Silva@fda.hhs.gov.
mstockstill on DSK3G9T082PROD with NOTICES
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION: The course is targeted toward
[FR Doc. 2016–22353 Filed 9–15–16; 8:45 am] clinicians, nurses, pharmacists and
BILLING CODE 4164–01–P I. Background other health care professionals
Clinical trial investigators play a responsible for, or involved in, the
critical role in the development of conduct and/or design of clinical trials.
medical products. They bear the Registration: There is no registration
responsibility for ensuring the safe and fee to attend this in-person training
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![63768 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices
course; however, seats are limited and Electronic Submissions information you claim to be confidential
registration will be on a first-come, first- Submit electronic comments in the with a heading or cover note that states
served basis. To register, you need to following way: ‘‘THIS DOCUMENT CONTAINS
complete the registration online by • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
October 28, 2016, at http://www.fda.gov/ www.regulations.gov. Follow the Agency will review this copy, including
Training/ClinicalInvestigatorTraining instructions for submitting comments. the claimed confidential information, in
Course/default.htm. Upon completion Comments submitted electronically, its consideration of comments. The
of registration, you will receive an email including attachments, to http:// second copy, which will have the
that confirms your registration. There www.regulations.gov will be posted to claimed confidential information
will be no onsite registration or remote the docket unchanged. Because your redacted/blacked out, will be available
access for this training. comment will be made public, you are for public viewing and posted on http://
Accommodations: Attendees are solely responsible for ensuring that your www.regulations.gov. Submit both
responsible for their own hotel comment does not include any copies to the Division of Dockets
accommodations. If you need special confidential information that you or a Management. If you do not wish your
accommodations due to a disability, third party may not wish to be posted, name and contact information to be
please contact Nicole Silva (see FOR such as medical information, your or made publicly available, you can
FURTHER INFORMATION CONTACT) at least 7 anyone else’s Social Security number, or provide this information on the cover
days in advance. Persons attending the confidential business information, such sheet and not in the body of your
course are advised that FDA is not as a manufacturing process. Please note comments and you must identify this
responsible for providing access to that if you include your name, contact information as ‘‘confidential.’’ Any
electrical outlets. information, or other information that information marked as ‘‘confidential’’
identifies you in the body of your will not be disclosed except in
Dated: September 8, 2016.
comments, that information will be accordance with 21 CFR 10.20 and other
Leslie Kux, applicable disclosure law. For more
Associate Commissioner for Policy.
posted on http://www.regulations.gov.
• If you want to submit a comment information about FDA’s posting of
[FR Doc. 2016–22348 Filed 9–15–16; 8:45 am]
with confidential information that you comments to public dockets, see 80 FR
BILLING CODE 4164–01–P
do not wish to be made available to the 56469, September 18, 2015, or access
public, submit the comment as a the information at: http://www.fda.gov/
written/paper submission and in the regulatoryinformation/dockets/
DEPARTMENT OF HEALTH AND default.htm.
manner detailed (see ‘‘Written/Paper
HUMAN SERVICES Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’).
read background documents or the
Food and Drug Administration Written/Paper Submissions electronic and written/paper comments
Submit written/paper submissions as received, go to http://
[Docket No. FDA–2016–D–1853] follows: www.regulations.gov and insert the
• Mail/Hand delivery/Courier (for docket number, found in brackets in the
Agency Information Collection heading of this document, into the
Activities; Proposed Collection; written/paper submissions): Division of
Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
Comment Request; Unique Device and/or go to the Division of Dockets
Identification System and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
• For written/paper comments 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration,
submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: FDA
HHS.
Management, FDA will post your PRA Staff, Office of Operations, Food
ACTION: Notice. comment, as well as any attachments, and Drug Administration, Three White
except for information submitted, Flint North 10A–12M, 11601
SUMMARY: The Food and Drug marked and identified, as confidential, Landsdown St., North Bethesda, MD
Administration (FDA) is announcing an if submitted as detailed in 20852, PRAStaff@fda.hhs.gov.
opportunity for public comment on the ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the
proposed collection of certain Instructions: All submissions received PRA (44 U.S.C. 3501–3520), Federal
information by the Agency. Under the must include the Docket No. FDA– Agencies must obtain approval from the
Paperwork Reduction Act of 1995 (the 2016–D–1853 for ‘‘Agency Information Office of Management and Budget
PRA), Federal Agencies are required to Collection Activities; Proposed (OMB) for each collection of
publish notice in the Federal Register Collection; Comment Request; Unique information they conduct or sponsor.
concerning each proposed collection of Device Identification System.’’ Received ‘‘Collection of information’’ is defined
information, including each proposed comments will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR
extension of an existing collection of and, except for those submitted as 1320.3(c) and includes Agency requests
information, and to allow 60 days for ‘‘Confidential Submissions,’’ publicly or requirements that members of the
public comment in response to the viewable at http://www.regulations.gov public submit reports, keep records, or
notice. This notice solicits comments on or at the Division of Dockets provide information to a third party.
information collection associated with Management between 9 a.m. and 4 p.m., Section 3506(c)(2)(A) of the PRA (44
the Unique Device Identification Monday through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
mstockstill on DSK3G9T082PROD with NOTICES
System. • Confidential Submissions—To Agencies to provide a 60-day notice in
submit a comment with confidential the Federal Register concerning each
DATES: Submit either electronic or
information that you do not wish to be proposed collection of information,
written comments on the collection of
made publicly available, submit your including each proposed extension of an
information by November 15, 2016.
comments only as a written/paper existing collection of information,
ADDRESSES: You may submit comments submission. You should submit two before submitting the collection to OMB
as follows: copies total. One copy will include the for approval. To comply with this
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Document Created: 2016-09-16 00:26:06
Document Modified: 2016-09-16 00:26:06
| 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 training course will be held on November 7, 2016, from 8:20 a.m. to 5:30 p.m. (registration begins at 7:30 a.m.); on November 8, 2016, from 8:30 a.m. to 4:45 p.m.; and on November 9, 2016, from 8:30 a.m. to 3:30 p.m. | |
| Contact | Nicole Silva, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6323, Silver Spring, MD 20993, 301-796-3419, [email protected] | |
| FR Citation | 81 FR 63767 |
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