80 FR 8325 - Society of Clinical Research Associates-Food and Drug Administration; “Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practice”
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 31 (February 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 31 (February 17, 2015)
| Page Range | 8325-8326 | |
| FR Document | 2015-03118 |
[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)] [Notices] [Pages 8325-8326] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03118] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Society of Clinical Research Associates--Food and Drug Administration; ``Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practice'' AGENCY: Food and Drug Administration, HHS. ACTION: Notice of Public Workshop. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the following conference: Educational Conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The public workshop FDA's clinical trial requirements is designed to aid the Clinical Research Professional's understanding of the mission, responsibilities and authority of the FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among the FDA and clinical trial staff, investigators and institutional review boards (IRB). 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 [[Page 8326]] clinical investigators, of IRB, and of research sponsors. Date and Time: The conference will be held on March 11 and 12, (Wednesday and Thursday) 2015, from 8:00 a.m. to 5 p.m. Location: The conference will be held at the Holiday Inn Golden Gateway Hotel, 1500 Van Ness Ave., San Francisco, CA 91409, 415-441- 4000. Attendees are responsible for their own accommodations. Please mention SOCRA to receive the hotel room rate of $159.00 plus applicable taxes (available until February 13, 2015, or until the SOCRA room block is filled). Contact Person: 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. 800-762-7292 or 215-822- 8644, FAX: 215-822-8633, email: [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). 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--$450.00, Federal Government nonmember--$525.00, FDA Employee--(free) Fee Waived. If you need special accommodations due to a disability, please contact SOCRA (see Contact Person) 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 Credits for SOCRA continuing education (CE) and Nurse continuing nurse education (CNE), SOCRA designates this live activity for a maximum of 13.3 American Medical Association Physician's Recognition Award Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation. Continuing medical education (CME) for Physicians: SOCRA is accredited by the Accreditation Council for Continuing Medical Education to provide CME 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 Contact Person for address). To register via the Internet, go to http://www.socra.org/html/FDA_Conference.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 Contact Person). SUPPLEMENTARY INFORMATION: 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 informed consent, clinical investigation requirements, institutional review board inspections, electronic record requirements, and investigator initiated research 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 Programs; (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 the 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; (16) Question and Answer Session/Panel Discussion. 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 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. Dated: February 10, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-03118 Filed 2-13-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 8325
of automated collection techniques or I. Background III. Comments
other forms of information technology. Interested persons may submit either
Consideration will be given to FDA is announcing the availability of
a guidance for industry entitled electronic comments regarding this
comments and suggestions submitted document to http://www.regulations.gov
within 60 days of this publication. ‘‘Complicated Urinary Tract Infections:
Developing Drugs for Treatment.’’ The or written comments to the Division of
Robert Sargis, purpose of this guidance is to assist Dockets Management (see ADDRESSES). It
Reports Clearance Officer. sponsors in the development of drugs is only necessary to send one set of
[FR Doc. 2015–03144 Filed 2–13–15; 8:45 am] for the treatment of cUTIs. comments. Identify comments with the
BILLING CODE 4184–01–P
docket number found in brackets in the
This guidance includes heading of this document. Received
recommendations for an efficacy comments may be seen in the Division
DEPARTMENT OF HEALTH AND endpoint and noninferiority trial design. of Dockets Management between 9 a.m.
HUMAN SERVICES The efficacy endpoint, based on and 4 p.m., Monday through Friday, and
resolution of clinical symptoms and will be posted to the docket at http://
Food and Drug Administration eradication of bacteria from the urinary www.regulations.gov.
tract, was derived from previously
[Docket No. FDA–2012–D–0148] IV. Electronic Access
conducted clinical trials for the
Complicated Urinary Tract Infections: treatment of cUTI. The guidance Persons with access to the Internet
Developing Drugs for Treatment; provides a scientific justification for a may obtain the document at either
Guidance for Industry; Availability noninferiority margin based on http://www.fda.gov/Drugs/Guidance
historical observational data compared ComplianceRegulatoryInformation/
AGENCY: Food and Drug Administration, to the results of previously conducted Guidances/default.htm or http://
HHS. clinical trials. After careful www.regulations.gov.
ACTION: Notice. consideration of comments received in Dated: February 10, 2015.
response to the revised draft guidance Leslie Kux,
SUMMARY: The Food and Drug
issued on February 24, 2012, important
Administration (FDA) is announcing the Associate Commissioner for Policy.
clarifications about trial populations
availability of a guidance for industry [FR Doc. 2015–03100 Filed 2–13–15; 8:45 am]
and endpoints for cUTI were included
entitled ‘‘Complicated Urinary Tract BILLING CODE 4164–01–P
in this guidance. In addition, this
Infections: Developing Drugs for
guidance reflects recent developments
Treatment.’’ The purpose of this
in scientific information that pertain to
guidance is to assist sponsors in the DEPARTMENT OF HEALTH AND
drugs being developed for the treatment
clinical development of drugs for the HUMAN SERVICES
of cUTI.
treatment of complicated urinary tract
infections (cUTIs). This guidance Issuance of this guidance fulfills a Food and Drug Administration
finalizes the revised draft guidance of portion of the requirements of title VIII, [Docket No. FDA–2015–N–0001]
the same name issued on February 24, section 804, of the Food and Drug
2012. Administration Safety and Innovation Society of Clinical Research
DATES: Submit either electronic or Act (Pub. L. 112–144), which requires Associates—Food and Drug
written comments on Agency guidances FDA to review and, as appropriate, Administration; ‘‘Food and Drug
at any time. revise not fewer than three guidance Administration Clinical Trial
documents per year for the conduct of Requirements, Regulations,
ADDRESSES: Submit written requests for
clinical trials with respect to Compliance and Good Clinical
single copies of this guidance to the
antibacterial and antifungal drugs. Practice’’
Division of Drug Information, Center for
Drug Evaluation and Research, Food This guidance is being issued
AGENCY: Food and Drug Administration,
and Drug Administration, 10001 New consistent with FDA’s good guidance
HHS.
Hampshire Ave., Hillandale Bldg., 4th practices regulation (21 CFR 10.115).
The guidance represents the Agency’s ACTION: Notice of Public Workshop.
Floor, Silver Spring, MD 20993. Send
one self-addressed adhesive label to current thinking on this topic. It does SUMMARY: The Food and Drug
assist that office in processing your not create or confer any rights for or on Administration (FDA) is announcing the
requests. See the SUPPLEMENTARY any person and does not operate to bind following conference: Educational
INFORMATION section for electronic FDA or the public. An alternative Conference co-sponsored with the
access to the guidance document. approach may be used if such approach Society of Clinical Research Associates
Submit electronic comments on the satisfies the requirements of the (SOCRA). The public workshop FDA’s
guidance to http://www.regulations.gov. applicable statutes and regulations. clinical trial requirements is designed to
Submit written comments to the aid the Clinical Research Professional’s
II. The Paperwork Reduction Act of
Division of Dockets Management (HFA– understanding of the mission,
1995
305), Food and Drug Administration, responsibilities and authority of the
5630 Fishers Lane, Rm. 1061, Rockville, This guidance refers to previously FDA and to facilitate interaction with
MD 20852. approved collections of information that FDA representatives. The program will
FOR FURTHER INFORMATION CONTACT: are subject to review by the Office of focus on the relationships among the
tkelley on DSK3SPTVN1PROD with NOTICES
Joseph G. Toerner, Center for Drug Management and Budget (OMB) under FDA and clinical trial staff, investigators
Evaluation and Research, Food and the Paperwork Reduction Act of 1995 and institutional review boards (IRB).
Drug Administration, 10903 New (44 U.S.C. 3501–3520). The collections Individual FDA representatives will
Hampshire Ave., Bldg. 22, Rm. 6244, of information in 21 CFR parts 312 and discuss the informed consent process
Silver Spring, MD 20993–0002, 301– 314 have been approved under OMB and informed consent documents;
796–1300. control numbers 0910–0014 and 0910– regulations relating to drugs, devices
SUPPLEMENTARY INFORMATION: 0001, respectively. and biologics, as well as inspections of
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![8326 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices
clinical investigators, of IRB, and of physicians. CNE for Nurses: Society of closely with stakeholders and
research sponsors. Clinical Research Associates is maximizing the availability and clarity
Date and Time: The conference will accredited as a provider of continuing of information to stakeholders and the
be held on March 11 and 12, nursing education by the American public. The workshop also is consistent
(Wednesday and Thursday) 2015, from Nurses Credentialing Center’s with the Small Business Regulatory
8:00 a.m. to 5 p.m. Commission on Accreditation. Enforcement Fairness Act of 1996 (Pub.
Location: The conference will be held Registration Instructions: To register, L. 104–121), as outreach activities by
at the Holiday Inn Golden Gateway please submit a registration form with Government Agencies to small
Hotel, 1500 Van Ness Ave., San your name, affiliation, mailing address, businesses.
Francisco, CA 91409, 415–441–4000. telephone, FAX number, and email,
Attendees are responsible for their Dated: February 10, 2015.
along with a check or money order Leslie Kux,
own accommodations. Please mention payable to ‘‘SOCRA’’. Mail to:
SOCRA to receive the hotel room rate of Associate Commissioner for Policy.
SOCRA(see Contact Person for address).
$159.00 plus applicable taxes (available To register via the Internet, go to http:// [FR Doc. 2015–03118 Filed 2–13–15; 8:45 am]
until February 13, 2015, or until the www.socra.org/html/ BILLING CODE 4164–01–P
SOCRA room block is filled). FDA_Conference.htm. Payment by
Contact Person: Jane Kreis, Food and major credit card is accepted (Visa/
Drug, Administration, 1301 Clay St., MasterCard/AMEX only). For more
DEPARTMENT OF HEALTH AND
Suite 1180N, Oakland, CA 94612, 510– HUMAN SERVICES
information on the meeting registration,
287–2708, FAX: 510–287–2739 or
or for questions on the workshop, Food and Drug Administration
Society of Clinical Research Associates
contact SOCRA (see Contact Person).
(SOCRA), 530 West Butler Ave., Suite [Docket No. FDA–2015–N–0001]
109, Chalfont, PA 18914. 800–762–7292 SUPPLEMENTARY INFORMATION: The
or 215–822–8644, FAX: 215–822–8633, public workshop helps fulfill the
Orthopaedic and Rehabilitation Panel
email: Office@socra.org Web site: Department of Health and Human
of the Medical Devices Advisory
www.socra.org. (FDA has verified the Services’ and FDA’s important mission
Committee; Notice of Meeting
Web site addresses throughout this to protect the public health. The
document, but we are not responsible workshop will provide those engaged in AGENCY: Food and Drug Administration,
for any subsequent changes to the Web FDA-regulated (human) clinical trials HHS.
sites after this document publishes in with information on a number of topics ACTION: Notice.
the Federal Register). concerning FDA requirements related
Registration: The registration fee will informed consent, clinical investigation This notice announces a forthcoming
cover actual expenses including requirements, institutional review board meeting of a public advisory committee
refreshments, lunch, materials and inspections, electronic record of the Food and Drug Administration
speaker expenses. Seats are limited; requirements, and investigator initiated (FDA). The meeting will be open to the
please submit your registration as soon research Topics for discussion include public.
as possible. Workshop space will be the following: (1) The Role of the FDA Name of Committee: Orthopaedic and
filled in order of receipt of registration. District Office Relative to the Rehabilitation Panel of the Medical
Those accepted into the workshop will Bioresearch Monitoring Program Devices Advisory Committee.
receive confirmation. The cost of the (BIMO); (2) Modernizing FDA’s Clinical General Function of the Committee:
registration is as follows: SOCRA Trials/BIMO Programs; (3) What FDA To provide advice and
member—$575, SOCRA nonmember Expects in a Pharmaceutical Clinical recommendations to the Agency on
(includes membership)—$650, Federal Trial: (4) Medical Device Aspects of FDA’s regulatory issues.
Government member—$450.00, Federal Clinical Research; (5) Adverse Event Date and Time: The meeting will be
Government nonmember—$525.00, Reporting—Science, Regulation, Error held on February 20, 2015, from 8 a.m.
FDA Employee—(free) Fee Waived. and Safety; (6) Working with FDA’s to 6 p.m.
If you need special accommodations Center for Biologics Evaluation and Location: Hilton/Washington DC
due to a disability, please contact Research; (7) Ethical Issues in Subject North, 620 Perry Pkwy., Gaithersburg,
SOCRA (see Contact Person) at least 21 Enrollment; (8) Keeping Informed and MD 20877. The hotel’s telephone
days in advance. Working Together; (9) FDA Conduct of number is 301–977–8900. Answers to
Extended periods of question and Clinical Investigator Inspections; (10) commonly asked questions including
answer and discussion have been Investigator Initiated Research; (11) information regarding special
included in the program schedule. Meetings with the FDA—Why, When accommodations due to a disability,
SOCRA designates this education and How; (12) Part 11 Compliance— visitor parking, and transportation may
activity for a maximum of 13.3 Electronic Signatures; (13) IRB be accessed at: http://www.fda.gov/
Continuing Education Credits for Regulations and FDA Inspections; (14) AdvisoryCommittees/AboutAdvisory
SOCRA continuing education (CE) and Informed Consent Regulations; (15) The Committees/ucm408555.htm.
Nurse continuing nurse education Inspection is Over—What Happens Contact Person: Sara Anderson, Food
(CNE), SOCRA designates this live Next? Possible FDA Compliance and Drug Administration, 10903 New
activity for a maximum of 13.3 Actions; (16) Question and Answer Hampshire Ave., Bldg. 66, Rm.1643,
American Medical Association Session/Panel Discussion. Silver Spring, MD 20993–0002,
Physician’s Recognition Award Category FDA has made education of the drug sara.anderson@fda.hhs.gov, 301–796–
tkelley on DSK3SPTVN1PROD with NOTICES
1 Credit(s)TM. Physicians should claim and device manufacturing community a 7047, or FDA Advisory Committee
only the credit commensurate with the high priority to help ensure the quality Information Line, 1–800–741–8138
extent of their participation. Continuing of FDA-regulated drugs and devices. (301–443–0572 in the Washington, DC
medical education (CME) for The workshop helps to achieve area). A notice in the Federal Register
Physicians: SOCRA is accredited by the objectives set forth in section 406 of the about last minute modifications that
Accreditation Council for Continuing FDA Modernization Act of 1997 (21 impact a previously announced
Medical Education to provide CME for U.S.C. 393) which includes working advisory committee meeting cannot
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Document Created: 2015-12-18 13:20:05
Document Modified: 2015-12-18 13:20:05
| 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. | |
| FR Citation | 80 FR 8325 |
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