81 FR 7802 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 30 (February 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 30 (February 16, 2016)
| Page Range | 7802-7803 | |
| FR Document | 2016-02965 |
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)] [Notices] [Pages 7802-7803] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02965] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``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, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA, 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; as well as inspections of clinical investigators, of IRBs, and of research sponsors. DATES: The public workshop will be held on March 9 and 10, 2016, from 8 a.m. to 5 p.m. ADDRESSES: The public workshop will be held at the Holiday Inn San Diego Bayside, 4875 North Harbor Dr., San Diego, CA 92106, 619-224- 3621. FOR FURTHER INFORMATION CONTACT: Jane Kreis, Food and Drug Administration, 1301 Clay St., Suite 1180N, Oakland, CA 94612, 510-287- 2708, FAX: 510-287-2739, or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, telephone: 800-762-7292 or 215-822-8644, FAX: 215-822-8633, [email protected], Web site: www.socra.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 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 workshop will provide those engaged in FDA-regulated (human) clinical trials with information on a number of topics concerning FDA requirements related to informed consent, clinical investigation requirements, IRB inspections, electronic record requirements, and investigator initiated research. 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 workshop helps to achieve objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393), which include 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 at the Public Workshop Topics for discussion include the following: (1) The Role of the FDA District Office Relative to the Bioresearch Monitoring Program (BIMO); (2) Modernizing FDA's Clinical Trials/BIMO; (3) What FDA Expects in a Pharmaceutical Clinical Trial; (4) Medical Device Aspects of Clinical Research; (5) Adverse Event Reporting--Science, Regulation, Error, and Safety; (6) Working With FDA's Center for Biologics Evaluation and Research; (7) Ethical Issues in Subject Enrollment; (8) Keeping Informed and Working Together; (9) FDA Conduct of Clinical Investigator Inspections; (10) Investigator Initiated Research; (11) Meetings With FDA--Why, When, and How; (12) Part 11 Compliance-- Electronic Signatures; (13) IRB Regulations and FDA Inspections; (14) Informed Consent Regulations; (15) The Inspection is Over--What Happens Next? Possible FDA Compliance Actions; and (16) Question and Answer Session/Panel Discussion. Registration: The registration fee will cover actual expenses including refreshments, lunch, materials, and speaker expenses. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. The cost of the registration is as follows: SOCRA member--$575, SOCRA nonmember (includes membership)--$650, Federal Government member--$450, Federal [[Page 7803]] Government nonmember--$525, and FDA Employee--(free) Fee Waived. Attendees are responsible for their own accommodations. Please mention SOCRA to receive the hotel room rate of $142 plus applicable taxes (available until the SOCRA room block is filled). If you need special accommodations due to a disability, please contact SOCRA (see FOR FURTHER INFORMATION CONTACT) at least 21 days in advance. Extended periods of question and answer and discussion have been included in the program schedule. SOCRA designates this education activity for a maximum of 13.3 Continuing Education (CE) Credits for SOCRA CE and Nurse CNE; SOCRA designates this live activity for a maximum of 13.3 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation. CME for Physicians: SOCRA is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, telephone, fax number, and email, along with a check or money order payable to ``SOCRA.'' Mail to: SOCRA (see FOR FURTHER INFORMATION CONTACT). To register via the Internet, go to http://www.socra.org/html/FDAConference.htm. Payment by major credit card is accepted (Visa/ MasterCard/AMEX only). For more information on the meeting registration, or for questions on the workshop, contact SOCRA (see FOR FURTHER INFORMATION CONTACT). Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-02965 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
![7802 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)
Health Departments ...................................... Adult HIV Case Report ................................. 59 1,061 20/60
Health Departments ...................................... Pediatric HIV Case Report ........................... 59 5 20/60
Health Departments ...................................... Case Report Evaluations ............................. 59 107 20/60
Health Departments ...................................... Case Report Updates ................................... 59 1,576 2/60
Health Departments ...................................... Laboratory Updates ...................................... 59 6,303 1/60
Health Departments ...................................... HIV Incidence Surveillance (HIS) ................. 25 2,288 10/60
Health Departments ...................................... Molecular HIV Surveillance (MHS) .............. 53 829 5/60
Health Departments ...................................... Perinatal HIV Exposure Reporting (PHER) 35 114 30/60
Health Departments ...................................... Annual Reporting: Standards Evaluation 59 1 8
Report (SER).
Health Departments ...................................... Annual Reporting: Annual Performance Re- 59 1 42
port (APR).
Leroy A. Richardson, DATES: The public workshop will be public. The workshop also is consistent
Chief, Information Collection Review Office, held on March 9 and 10, 2016, from 8 with the Small Business Regulatory
Office of Scientific Integrity, Office of the a.m. to 5 p.m. Enforcement Fairness Act of 1996 (Pub.
Associate Director for Science, Office of the ADDRESSES: The public workshop will L. 104–121), as outreach activities by
Director, Centers for Disease Control and be held at the Holiday Inn San Diego Government Agencies to small
Prevention.
Bayside, 4875 North Harbor Dr., San businesses.
[FR Doc. 2016–03046 Filed 2–12–16; 8:45 am]
Diego, CA 92106, 619–224–3621.
BILLING CODE 4163–18–P II. Topics for Discussion at the Public
FOR FURTHER INFORMATION CONTACT: Jane
Workshop
Kreis, Food and Drug Administration,
1301 Clay St., Suite 1180N, Oakland, Topics for discussion include the
DEPARTMENT OF HEALTH AND
CA 94612, 510–287–2708, FAX: 510– following: (1) The Role of the FDA
HUMAN SERVICES
287–2739, or Society of Clinical District Office Relative to the
Food and Drug Administration Research Associates (SOCRA), 530 West Bioresearch Monitoring Program
Butler Ave., Suite 109, Chalfont, PA (BIMO); (2) Modernizing FDA’s Clinical
18914, telephone: 800–762–7292 or Trials/BIMO; (3) What FDA Expects in
[Docket No. FDA–2016–N–0001]
215–822–8644, FAX: 215–822–8633, a Pharmaceutical Clinical Trial; (4)
Food and Drug Administration Clinical Office@socra.org, Web site: Medical Device Aspects of Clinical
Trial Requirements, Regulations, www.socra.org. (FDA has verified the Research; (5) Adverse Event Reporting—
Compliance, and Good Clinical Web site addresses throughout this Science, Regulation, Error, and Safety;
Practices; Public Workshop document, but we are not responsible (6) Working With FDA’s Center for
for any subsequent changes to the Web Biologics Evaluation and Research; (7)
AGENCY: Food and Drug Administration, sites after this document publishes in Ethical Issues in Subject Enrollment; (8)
HHS. the Federal Register.) Keeping Informed and Working
SUPPLEMENTARY INFORMATION: Together; (9) FDA Conduct of Clinical
ACTION: Notice of public workshop.
I. Background Investigator Inspections; (10)
SUMMARY: The Food and Drug The public workshop helps fulfill the Investigator Initiated Research; (11)
Administration (FDA) is announcing the Department of Health and Human Meetings With FDA—Why, When, and
following public workshop entitled Services’ and FDA’s important mission How; (12) Part 11 Compliance—
‘‘Educational Conference Co-Sponsored to protect the public health. The Electronic Signatures; (13) IRB
With the Society of Clinical Research workshop will provide those engaged in Regulations and FDA Inspections; (14)
Associates (SOCRA).’’ The public FDA-regulated (human) clinical trials Informed Consent Regulations; (15) The
workshop on FDA’s clinical trial with information on a number of topics Inspection is Over—What Happens
requirements is designed to aid the concerning FDA requirements related to Next? Possible FDA Compliance
Clinical Research Professional’s informed consent, clinical investigation Actions; and (16) Question and Answer
understanding of the mission, requirements, IRB inspections, Session/Panel Discussion.
responsibilities, and authority of FDA electronic record requirements, and Registration: The registration fee will
and to facilitate interaction with FDA investigator initiated research. cover actual expenses including
representatives. The program will focus FDA has made education of the drug refreshments, lunch, materials, and
on the relationships among FDA, and device manufacturing community a speaker expenses. Seats are limited;
clinical trial staff, investigators, and high priority to help ensure the quality please submit your registration as soon
mstockstill on DSK4VPTVN1PROD with NOTICES
institutional review boards (IRBs). of FDA-regulated drugs and devices. as possible. Workshop space will be
Individual FDA representatives will The workshop helps to achieve filled in order of receipt of registration.
discuss the informed consent process objectives set forth in section 406 of the Those accepted into the workshop will
and informed consent documents; FDA Modernization Act of 1997 (21 receive confirmation. The cost of the
regulations relating to drugs, devices, U.S.C. 393), which include working registration is as follows: SOCRA
and biologics; as well as inspections of closely with stakeholders and member—$575, SOCRA nonmember
clinical investigators, of IRBs, and of maximizing the availability and clarity (includes membership)—$650, Federal
research sponsors. of information to stakeholders and the Government member—$450, Federal
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![Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7803
Government nonmember—$525, and DEPARTMENT OF HEALTH AND ADDRESSES: All statements of interest
FDA Employee—(free) Fee Waived. HUMAN SERVICES from consumer organizations interested
Attendees are responsible for their in participating in the selection process
own accommodations. Please mention Food and Drug Administration and consumer representative
SOCRA to receive the hotel room rate of [Docket No. FDA–2016–N–0001] nominations should be submitted
$142 plus applicable taxes (available electronically to kimberly.hamilton@
until the SOCRA room block is filled). Request for Nominations for fda.hhs.gov, by mail to Advisory
If you need special accommodations Individuals and Consumer Committee Oversight and Management
due to a disability, please contact Organizations for Advisory Staff, 10903 New Hampshire Ave., Bldg.
SOCRA (see FOR FURTHER INFORMATION Committees 32, Rm. 5103, Silver Spring, MD 20993–
CONTACT) at least 21 days in advance. 0002, or by FAX: 301–847–8640.
Extended periods of question and AGENCY: Food and Drug Administration,
Consumer Representative
answer and discussion have been HHS.
nominations should be submitted
included in the program schedule. ACTION: Notice. electronically by logging into the FDA
SOCRA designates this education Advisory Committee Membership
activity for a maximum of 13.3 SUMMARY: The Food and Drug
Administration (FDA) is requesting that Nomination Portal: https://
Continuing Education (CE) Credits for www.accessdata.fda.gov/scripts/
SOCRA CE and Nurse CNE; SOCRA any consumer organizations interested
in participating in the selection of FACTRSPortal/FACTRS/index.cfm, by
designates this live activity for a mail to Advisory Committee Oversight
maximum of 13.3 AMA PRA Category 1 voting and/or nonvoting consumer
representatives to serve on its advisory and Management Staff, 10903 New
Credit(s)TM. Physicians should claim Hampshire Ave., Bldg. 32, Rm. 5103,
committees or panels notify FDA in
only the credit commensurate with the Silver Spring, MD 20993–0002, or by
writing. FDA is also requesting
extent of their participation. CME for FAX: 301–847–8640. Additional
nominations for voting and/or
Physicians: SOCRA is accredited by the information about becoming a member
nonvoting consumer representatives to
Accreditation Council for Continuing on an FDA advisory committee can also
serve on advisory committees and/or
Medical Education to provide be obtained by visiting FDA’s Web site
panels for which vacancies currently
continuing medical education for at http://www.fda.gov/
exist or are expected to occur in the near
physicians. CNE for Nurses: Society of AdvisoryCommittees/default.htm.
future. Nominees recommended to serve
Clinical Research Associates is
as a voting or nonvoting consumer FOR FURTHER INFORMATION CONTACT: For
accredited as a provider of continuing
representative may be self-nominated or questions relating to participation in the
nursing education by the American
may be nominated by a consumer selection process: Kimberly Hamilton,
Nurses Credentialing Center’s
organization. Advisory Committee Oversight and
Commission on Accreditation.
FDA seeks to include the views of Management Staff (ACOMS), Food and
Registration Instructions: To register,
women and men, members of all racial Drug Administration, 10903 New
please submit a registration form with
and ethnic groups, and individuals with Hampshire Ave., Bldg. 32., Rm. 5117,
your name, affiliation, mailing address,
and without disabilities on its advisory Silver Spring, MD 20993–0002, 301–
telephone, fax number, and email, along
committees and, therefore, encourages 796–8224, email: kimberly.hamilton@
with a check or money order payable to
nominations of appropriately qualified fda.hhs.gov.
‘‘SOCRA.’’ Mail to: SOCRA (see FOR
candidates from these groups. For questions relating to specific
FURTHER INFORMATION CONTACT). To
register via the Internet, go to http:// DATES: Any consumer organization advisory committees or panels, contact
www.socra.org/html/ interested in participating in the the appropriate Contact Person listed in
FDAConference.htm. Payment by major selection of an appropriate voting or table 1 in the SUPPLEMENTARY
credit card is accepted (Visa/ nonvoting member to represent INFORMATION section.
MasterCard/AMEX only). For more consumer interests on an FDA advisory
committee or panel may send a letter or SUPPLEMENTARY INFORMATION:
information on the meeting registration,
or for questions on the workshop, email stating that interest to FDA (see I. Background
contact SOCRA (see FOR FURTHER ADDRESSES) by March 17, 2016, for
INFORMATION CONTACT). vacancies listed in this notice. FDA is requesting that any consumer
Concurrently, nomination materials for organizations interested in participating
Dated: February 9, 2016. prospective candidates should be sent to in the selection of voting and/or
Leslie Kux, FDA (see ADDRESSES) by March 17, nonvoting consumer representatives to
Associate Commissioner for Policy. 2016. Nominations will be accepted for serve on its advisory committees or
[FR Doc. 2016–02965 Filed 2–12–16; 8:45 am] current vacancies and for those that will panels notify FDA in writing (see table
BILLING CODE 4164–01–P or may occur through March 31, 2016. 1 for Contact Person).
TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person Committee/panel
Janie Kim, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Cellular, Tissue and Gene Thera-
mstockstill on DSK4VPTVN1PROD with NOTICES
Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993–0002, Phone: 301–796–9016, Email: pies.
Janie.Kim@fda.hhs.gov.
Philip Bautista, Center for Drugs Evaluation and Research, Food and Drug Administration, 10903 New Drug Safety and Risk Management
Hampshire Ave., Bldg. 31, Rm. 2410, Silver Spring, MD 20993–0002, Phone: 301–796–9006, Email: Advisory Committee.
Philip.Bautista@fda.hhs.gov.
Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Immunology Devices Panel.
Hampshire Ave., Bldg. 66, Rm. 1552, Silver Spring, MD 20993–0002, Phone: 301–796–5290, Email:
Natasha.Facey@fda.hhs.gov.
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Document Created: 2016-02-13 03:13:41
Document Modified: 2016-02-13 03:13:41
| 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 March 9 and 10, 2016, from 8 a.m. to 5 p.m. | |
| Contact | Jane Kreis, Food and Drug Administration, 1301 Clay St., Suite 1180N, Oakland, CA 94612, 510-287- 2708, FAX: 510-287-2739, or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, telephone: 800-762-7292 or 215-822-8644, FAX: 215-822-8633, [email protected], Web site: www.socra.org. (FDA has verified the Web | |
| FR Citation | 81 FR 7802 |
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