82 FR 44625 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 184 (September 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 184 (September 25, 2017)
| Page Range | 44625-44626 | |
| FR Document | 2017-20375 |
[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)] [Notices] [Pages 44625-44626] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20375] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4952] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; and inspections of clinical investigators, IRBs, and research sponsors. DATES: The public workshop will be held on November 15 and 16, 2017, from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at the Wyndham Lake Buena Vista Resort, 1850 Hotel Plaza Blvd., Lake Buena Vista, FL 32830, 407- 828-4444. FOR FURTHER INFORMATION CONTACT: Kim Prenter, Food and Drug Administration, 15100 NW. 67th Ave., Suite 400, Miami Lakes, FL 33014, 305-816-1474, Fax: 305-816-1536; or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 800-762-7292, Fax 215-822-8633, email: [email protected], Web site: https://www.socra.org. SUPPLEMENTARY INFORMATION: I. Background The public workshop helps fulfill the Department of Health and Human Services' and FDA's important mission to protect the public health. The public workshop will provide those engaged in FDA-regulated (human) clinical trials with information on a number of topics concerning FDA requirements related to clinical investigations, informed consent, and inspections of clinical investigators and IRBs. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The public workshop helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach activities by Government agencies to small businesses. II. Topics for Discussion Topics for discussion include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse Event Reporting-- Science, Regulation, Error and Safety; (3) Part 11 Compliance-- Electronic Signatures; (4) Informed Consent Regulations; (5) IRB Regulations and FDA Inspections; (6) Keeping Informed and Working Together; (7) FDA Conduct of Clinical Investigator Inspections; (8) Meetings with FDA: Why, When, and How; (9) Investigator Initiated Research; (10) Medical Device Aspects of Clinical Research; (11) Working with FDA's Center for Biologics Evaluation and Research; and (12) The Inspection Is Over--What Happens Next? Possible FDA Compliance Actions. III. Participating in the Public Workshop Registration: Attendees are responsible for their own accommodations. Please mention SOCRA to receive the hotel room rate of $129 plus applicable taxes (available until October 16, 2017, or until the SOCRA room block is filled). For additional registration and meeting information, visit https://www.socra.org/ or https://www.socra.org/conferences-and-education/live-conferences/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference/register/. Registrations fees are as follows: $575 for SOCRA members, $650 for non-members (includes membership), $450 for Federal Government members, $525 for Federal Government non-members, and fee waived for FDA Employees. The registration fee covers expenses including refreshments, lunch, materials, and speaker expenses. Registration for the conference is open through November 14, 2017. If you need special accommodations due to a disability, please contact Kim Prenter (see FOR FURTHER INFORMATION CONTACT) at least 10 days in advance. Other Issues for Consideration: Extended periods of question and answer and discussion have been included in the program schedule. This program offers 13.3 hours of Continuing Medical Education (CME) and Continuing Nursing Education (CNE) credit. CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for Nurses: The Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. ANCC/PSNA Provider Reference Number: 205-3-A-09. [[Page 44626]] Dated: September 19, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20375 Filed 9-22-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 44625
available for inspection at the offices of institutional review boards (IRBs). Regulations and FDA Inspections; (6)
the Board of Governors. Interested Individual FDA representatives will Keeping Informed and Working
persons may express their views in discuss the informed consent process Together; (7) FDA Conduct of Clinical
writing on the standards enumerated in and informed consent documents; Investigator Inspections; (8) Meetings
the BHC Act (12 U.S.C. 1842(c)). If the regulations relating to drugs, devices, with FDA: Why, When, and How; (9)
proposal also involves the acquisition of and biologics; and inspections of Investigator Initiated Research; (10)
a nonbanking company, the review also clinical investigators, IRBs, and research Medical Device Aspects of Clinical
includes whether the acquisition of the sponsors. Research; (11) Working with FDA’s
nonbanking company complies with the DATES: The public workshop will be Center for Biologics Evaluation and
standards in section 4 of the BHC Act held on November 15 and 16, 2017, Research; and (12) The Inspection Is
(12 U.S.C. 1843). Unless otherwise from 8 a.m. to 5 p.m. See the Over—What Happens Next? Possible
noted, nonbanking activities will be SUPPLEMENTARY INFORMATION section for FDA Compliance Actions.
conducted throughout the United States. registration date and information.
Unless otherwise noted, comments ADDRESSES: The public workshop will
III. Participating in the Public
regarding each of these applications be held at the Wyndham Lake Buena Workshop
must be received at the Reserve Bank Vista Resort, 1850 Hotel Plaza Blvd.,
indicated or the offices of the Board of Registration: Attendees are
Lake Buena Vista, FL 32830, 407–828– responsible for their own
Governors not later than October 20, 4444.
2017. accommodations. Please mention
FOR FURTHER INFORMATION CONTACT: Kim SOCRA to receive the hotel room rate of
A. Federal Reserve Bank of Prenter, Food and Drug Administration,
Minneapolis (Brendan S. Murrin, $129 plus applicable taxes (available
15100 NW. 67th Ave., Suite 400, Miami until October 16, 2017, or until the
Assistant Vice President) 90 Hennepin Lakes, FL 33014, 305–816–1474, Fax:
Avenue, Minneapolis, Minnesota SOCRA room block is filled). For
305–816–1536; or Society of Clinical additional registration and meeting
55480–0291: Research Associates (SOCRA), 530 West
1. Full Service Insurance Agency, Inc., information, visit https://
Butler Ave., Suite 109, Chalfont, PA
Buxton, North Dakota; to acquire 100 www.socra.org/ or https://
18914, 800–762–7292, Fax 215–822–
percent of the voting shares of First and www.socra.org/conferences-and-
8633, email: SoCRAmail@aol.com, Web
Farmers Bank Holding Company and education/live-conferences/fda-clinical-
site: https://www.socra.org.
thereby indirectly acquire shares of The trial-requirements-regulations-
SUPPLEMENTARY INFORMATION:
First and Farmers Bank, both of compliance-and-gcp-conference/
Portland, North Dakota. I. Background register/.
Board of Governors of the Federal Reserve The public workshop helps fulfill the Registrations fees are as follows: $575
System, September 20, 2017. Department of Health and Human for SOCRA members, $650 for non-
Yao-Chin Chao, Services’ and FDA’s important mission members (includes membership), $450
Assistant Secretary of the Board. to protect the public health. The public for Federal Government members, $525
[FR Doc. 2017–20424 Filed 9–22–17; 8:45 am] workshop will provide those engaged in for Federal Government non-members,
BILLING CODE P FDA-regulated (human) clinical trials and fee waived for FDA Employees.
with information on a number of topics
The registration fee covers expenses
concerning FDA requirements related to
including refreshments, lunch,
DEPARTMENT OF HEALTH AND clinical investigations, informed
materials, and speaker expenses.
HUMAN SERVICES consent, and inspections of clinical
Registration for the conference is open
investigators and IRBs.
FDA has made education of the drug through November 14, 2017.
Food and Drug Administration
and device manufacturing community a If you need special accommodations
[Docket No. FDA–2017–N–4952]
high priority to help ensure the quality due to a disability, please contact Kim
Food and Drug Administration Clinical of FDA-regulated drugs and devices. Prenter (see FOR FURTHER INFORMATION
Trial Requirements, Regulations, The public workshop helps to achieve CONTACT) at least 10 days in advance.
Compliance, and Good Clinical objectives set forth in section 406 of the Other Issues for Consideration:
Practice; Public Workshop Food and Drug Administration Extended periods of question and
Modernization Act of 1997 (21 U.S.C. answer and discussion have been
AGENCY: Food and Drug Administration, 393), which includes working closely
included in the program schedule. This
HHS. with stakeholders and maximizing the
program offers 13.3 hours of Continuing
ACTION: Notice of public workshop. availability and clarity of information to
Medical Education (CME) and
stakeholders and the public. The
SUMMARY: The Food and Drug Continuing Nursing Education (CNE)
workshop also is consistent with the
Administration (FDA) is announcing an Small Business Regulatory Enforcement credit. CME for Physicians: The Society
educational conference co-sponsored Fairness Act of 1996 (Pub. L. 104–121), of Clinical Research Associates is
with the Society of Clinical Research as outreach activities by Government accredited by the Accreditation Council
Associates (SOCRA). The public agencies to small businesses. for Continuing Medical Education to
provide continuing medical education
asabaliauskas on DSKBBXCHB2PROD with NOTICES
workshop on FDA’s clinical trial
requirements is designed to aid the II. Topics for Discussion for physicians. CNE for Nurses: The
clinical research professional’s Topics for discussion include the Society of Clinical Research Associates
understanding of the mission and following: (1) What FDA Expects in a is accredited as a provider of continuing
authority of FDA and to facilitate Pharmaceutical Clinical Trial; (2) nursing education by the American
interaction with FDA representatives. Adverse Event Reporting—Science, Nurses Credentialing Center’s
The program will focus on the Regulation, Error and Safety; (3) Part 11 Commission on Accreditation. ANCC/
relationships among FDA and clinical Compliance—Electronic Signatures; (4) PSNA Provider Reference Number: 205–
trial staff, investigators, and Informed Consent Regulations; (5) IRB 3–A–09.
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![44626 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices
Dated: September 19, 2017. • Federal eRulemaking Portal: M–0180, FDA–2017–M–0181, FDA–
Anna K. Abram, https://www.regulations.gov. Follow the 2017–M–0229, FDA–2017–M–0560,
Deputy Commissioner for Policy, Planning, instructions for submitting comments. FDA–2017–M–0831, FDA–2017–M–
Legislation, and Analysis. Comments submitted electronically, 0661, FDA–2017–M–0971, FDA–2017–
[FR Doc. 2017–20375 Filed 9–22–17; 8:45 am] including attachments, to https:// M–2652, FDA–2017–M–1121, FDA–
BILLING CODE 4164–01–P www.regulations.gov will be posted to 2017–M–1122, FDA–2017–M–1228,
the docket unchanged. Because your FDA–2017–M–1845, FDA–2017–M–
comment will be made public, you are 1227, FDA–2017–M–1713, FDA–2017–
DEPARTMENT OF HEALTH AND solely responsible for ensuring that your M–1714, FDA–2017–M–1950, FDA–
HUMAN SERVICES comment does not include any 2017–M–2594, FDA–2017–M–2766,
confidential information that you or a FDA–2017–M–2767, FDA–2017–M–
Food and Drug Administration third party may not wish to be posted, 2768, FDA–2017–M–3103, FDA–2017–
[Docket Nos. FDA–2015–M–4474, FDA– such as medical information, your or M–3200, FDA–2017–M–3430, FDA–
2016–M–1915, FDA–2016–M–1837, FDA– anyone else’s Social Security number, or 2017–M–3579, FDA–2017–M–3580,
2016–M–1916, FDA–2016–M–1914, FDA– confidential business information, such FDA–2017–M–3778, FDA–2017–M–
2016–M–1917, FDA–2016–M–2182, FDA– as a manufacturing process. Please note 3839, FDA–2017–M–3928, FDA–2017–
2016–M–2183, FDA–2016–M–2184, FDA– that if you include your name, contact M–3982, FDA–2017–M–3990, and FDA–
2016–M–2185, FDA–2016–M–2332, FDA– information, or other information that 2017–M–3983 for ‘‘Medical Devices;
2016–M–2334, FDA–2016–M–2333, FDA– identifies you in the body of your Availability of Safety and Effectiveness
2016–M–2485, FDA–2016–M–2498, FDA– comments, that information will be Summaries for Premarket Approval
2016–M–2499, FDA–2016–M–2500, FDA– posted on https://www.regulations.gov. Applications.’’ Received comments will
2016–M–2649, FDA–2016–M–2650, FDA– • If you want to submit a comment be placed in the docket and, except for
2016–M–2651, FDA–2016–M–2735, FDA–
with confidential information that you those submitted as ‘‘Confidential
2016–M–2974, FDA–2016–M–2971, FDA–
2016–M–1972, FDA–2016–M–2973, FDA– do not wish to be made available to the Submissions,’’ publicly viewable at
2016–M–2975, FDA–2016–M–3430, FDA– public, submit the comment as a https://www.regulations.gov or at the
2016–M–3431, FDA–2016–M–3913, FDA– written/paper submission and in the Dockets Management Staff between 9
2016–M–3653, FDA–2016–M–3914, FDA– manner detailed (see ‘‘Written/Paper a.m. and 4 p.m., Monday through
2016–M–3915, FDA–2016–M–4046, FDA– Submissions’’ and ‘‘Instructions’’). Friday.
2016–M–4344, FDA–2016–M–4458, FDA– • Confidential Submissions—To
2016–M–4459, FDA–2016–M–4483, FDA– Written/Paper Submissions
submit a comment with confidential
2016–M–4657, FDA–2016–M–4530, FDA– Submit written/paper submissions as information that you do not wish to be
2016–M–4653, FDA–2017–M–0180, FDA– follows: made publicly available, submit your
2017–M–0181, FDA–2017–M–0229, FDA– • Mail/Hand delivery/Courier (for comments only as a written/paper
2017–M–0560, FDA–2017–M–0831, FDA– written/paper submissions): Dockets
2017–M–0661, FDA–2017–M–0971, FDA– submission. You should submit two
Management Staff (HFA–305), Food and copies total. One copy will include the
2017–M–2652, FDA–2017–M–1121, FDA–
2017–M–1122, FDA–2017–M–1228, FDA–
Drug Administration, 5630 Fishers information you claim to be confidential
2017–M–1845, FDA–2017–M–1227, FDA– Lane, Rm. 1061, Rockville, MD 20852. with a heading or cover note that states
2017–M–1713, FDA–2017–M–1714, FDA– • For written/paper comments ‘‘THIS DOCUMENT CONTAINS
2017–M–1950, FDA–2017–M–2594, FDA– submitted to the Dockets Management CONFIDENTIAL INFORMATION.’’ The
2017–M–2766, FDA–2017–M–2767, FDA– Staff, FDA will post your comment, as Agency will review this copy, including
2017–M–2768, FDA–2017–M–3103, FDA– well as any attachments, except for the claimed confidential information, in
2017–M–3200, FDA–2017–M–3430, FDA– information submitted, marked and its consideration of comments. The
2017–M–3579, FDA–2017–M–3580, FDA– identified, as confidential, if submitted second copy, which will have the
2017–M–3778, FDA–2017–M–3839, FDA– as detailed in ‘‘Instructions.’’
2017–M–3928, FDA–2017–M–3982, FDA– claimed confidential information
Instructions: All submissions received redacted/blacked out, will be available
2017–M–3990, and FDA–2017–M–3983]
must include the Docket Nos. FDA– for public viewing and posted on
Medical Devices; Availability of Safety 2015–M–4474, FDA–2016–M–1915, https://www.regulations.gov. Submit
and Effectiveness Summaries for FDA–2016–M–1837, FDA–2016–M– both copies to the Dockets Management
Premarket Approval Applications 1916, FDA–2016–M–1914, FDA–2016– Staff. If you do not wish your name and
M–1917, FDA–2016–M–2182, FDA– contact information to be made publicly
AGENCY: Food and Drug Administration, 2016–M–2183, FDA–2016–M–2184, available, you can provide this
HHS. FDA–2016–M–2185, FDA–2016–M– information on the cover sheet and not
ACTION: Notice. 2332, FDA–2016–M–2334, FDA–2016– in the body of your comments and you
M–2333, FDA–2016–M–2485, FDA– must identify this information as
SUMMARY: The Food and Drug 2016–M–2498, FDA–2016–M–2499, ‘‘confidential.’’ Any information marked
Administration (FDA) is publishing a FDA–2016–M–2500, FDA–2016–M– as ‘‘confidential’’ will not be disclosed
list of premarket approval applications 2649, FDA–2016–M–2650, FDA–2016– except in accordance with 21 CFR 10.20
(PMAs) that have been approved. This M–2651, FDA–2016–M–2735, FDA– and other applicable disclosure law. For
list is intended to inform the public of 2016–M–2974, FDA–2016–M–2971, more information about FDA’s posting
the availability of safety and FDA–2016–M–1972, FDA–2016–M– of comments to public dockets, see 80
effectiveness summaries of approved
asabaliauskas on DSKBBXCHB2PROD with NOTICES
2973, FDA–2016–M–2975, FDA–2016– FR 56469, September 18, 2015, or access
PMAs through the Internet and the M–3430, FDA–2016–M–3431, FDA– the information at: https://www.gpo.gov/
Agency’s Dockets Management Staff. 2016–M–3913, FDA–2016–M–3653, fdsys/pkg/FR-2015-09-18/pdf/2015-
ADDRESSES: You may submit comments FDA–2016–M–3914, FDA–2016–M– 23389.pdf.
as follows: 3915, FDA–2016–M–4046, FDA–2016– Docket: For access to the docket to
M–4344, FDA–2016–M–4458, FDA– read background documents or the
Electronic Submissions 2016–M–4459, FDA–2016–M–4483, electronic and written/paper comments
Submit electronic comments in the FDA–2016–M–4657, FDA–2016–M– received, go to https://
following way: 4530, FDA–2016–M–4653, FDA–2017– www.regulations.gov and insert the
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Document Created: 2018-10-24 14:43:04
Document Modified: 2018-10-24 14:43:04
| 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 public workshop. | |
| Dates | The public workshop will be held on November 15 and 16, 2017, from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Kim Prenter, Food and Drug Administration, 15100 NW. 67th Ave., Suite 400, Miami Lakes, FL 33014, 305-816-1474, Fax: 305-816-1536; or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 800-762-7292, Fax 215-822-8633, email: [email protected], Web site: https://www.socra.org. | |
| FR Citation | 82 FR 44625 |
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