80 FR 27972 - Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 94 (May 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 94 (May 15, 2015)
| Page Range | 27972-27973 | |
| FR Document | 2015-11685 |
[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)] [Notices] [Pages 27972-27973] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11685] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-1484] Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators.'' The purpose of this guidance is to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at FDA. Although not an exhaustive step-by-step instruction manual, this guidance highlights certain elements of this process to facilitate a sponsor-investigator's successful submission of an IND. This guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations. Details of the informational content of an IND as well as information needed to complete required forms also are provided throughout this guidance. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 14, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach, and Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301- 796-0700; or 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. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators.'' The purpose of this guidance is to assist investigators in preparing and submitting complete INDs to CDER and CBER at FDA. Sponsor-investigators seeking to do clinical research often do not have the regulatory knowledge or the resources to hire experts to help them with the IND submission process. Although not an exhaustive step-by-step instruction manual, this guidance highlights certain elements of this process to facilitate a sponsor-investigator's successful submission of an IND. This guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations. The guidance does not include discussions of all of the requirements that apply to the IND submission and review process or to conducting clinical research. This guidance is directed primarily at those sponsor-investigators who are seeking to evaluate a drug that is either currently approved or is being investigated under an existing IND for a different indication. This guidance is not intended for sponsor-investigators who are developing a drug for commercial purposes (i.e., seeking market approval or licensure). This guidance does not apply to clinical trials that do not need to be conducted under an IND (i.e., that qualify for an IND exemption). The guidance also is not intended to address expanded access INDs or biologic devices. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on INDs prepared and submitted by sponsor-investigators. It does not establish any rights for any person and is not binding on 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 that 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 312 have been approved under OMB control number 0910-0014. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and [[Page 27973]] will be posted to the docket at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov. Dated: May 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-11685 Filed 5-14-15; 8:45 am] BILLING CODE 4164-01-P
![27972 Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Notices
The SA will notify the RO at least 60 the IND review process and general submission process. Although not an
days prior to the end of the responsibilities of sponsor-investigators exhaustive step-by-step instruction
rehabilitation hospital’s/unit’s cost related to clinical investigations. Details manual, this guidance highlights certain
reporting period of the IRF’s compliance of the informational content of an IND elements of this process to facilitate a
or non-compliance with the payment as well as information needed to sponsor-investigator’s successful
requirements. The information collected complete required forms also are submission of an IND. This guidance
on these forms, along with other provided throughout this guidance. also discusses the IND review process
information submitted by the IRF is DATES: Although you can comment on and general responsibilities of sponsor-
necessary for determining exclusion any guidance at any time (see 21 CFR investigators related to clinical
from the IPPS. Hospitals and units that 10.115(g)(5)), to ensure that the Agency investigations. The guidance does not
have already been excluded need not considers your comment on this draft include discussions of all of the
reapply for exclusion. These facilities guidance before it begins work on the requirements that apply to the IND
will automatically be reevaluated yearly final version of the guidance, submit submission and review process or to
to determine whether they continue to either electronic or written comments conducting clinical research.
meet the exclusion criteria. on the draft guidance by July 14, 2015. This guidance is directed primarily at
Form Number: CMS–437A and CMS– those sponsor-investigators who are
ADDRESSES: Submit written requests for
437B (OMB Control Number: 0938– seeking to evaluate a drug that is either
single copies of the draft guidance to the
0986); Frequency: Yearly; Affected currently approved or is being
Division of Drug Information, Center for
Public: Private Sector (Business or other investigated under an existing IND for a
Drug Evaluation and Research, Food
for-profits); Number of Respondents: different indication. This guidance is
and Drug Administration, 10001 New
478; Total Annual Responses: 478; Total not intended for sponsor-investigators
Hampshire Ave., Hillandale Building,
Annual Hours: 120. (For policy who are developing a drug for
4th Floor, Silver Spring, MD 20993–
questions regarding this collection commercial purposes (i.e., seeking
0002; or the Office of Communication,
contact James Cowher at 410–786– market approval or licensure). This
Outreach, and Development (HFM–40),
1948). guidance does not apply to clinical
Center for Biologics Evaluation and
Dated: May 12, 2015. Research, Food and Drug trials that do not need to be conducted
William N. Parham, III Administration, 10903 New Hampshire under an IND (i.e., that qualify for an
Director, Paperwork Reduction Staff, Office Ave., Bldg. 71, Rm. 3128, Silver Spring, IND exemption). The guidance also is
of Strategic Operations and Regulatory MD 20993–0002. Send one self- not intended to address expanded
Affairs. addressed adhesive label to assist that access INDs or biologic devices.
[FR Doc. 2015–11798 Filed 5–14–15; 8:45 am] office in processing your requests. See This draft guidance is being issued
BILLING CODE 4120–01–P the SUPPLEMENTARY INFORMATION section consistent with FDA’s good guidance
for electronic access to the draft practices regulation (21 CFR 10.115).
guidance document. The draft guidance, when finalized, will
DEPARTMENT OF HEALTH AND Submit electronic comments on the represent the current thinking of FDA
HUMAN SERVICES draft guidance to http:// on INDs prepared and submitted by
www.regulations.gov. Submit written sponsor-investigators. It does not
Food and Drug Administration comments to the Division of Dockets establish any rights for any person and
[Docket No. FDA–2015–D–1484] Management (HFA–305), Food and Drug is not binding on FDA or the public.
Administration, 5630 Fishers Lane, Rm. You can use an alternative approach if
Investigational New Drug Applications 1061, Rockville, MD 20852. it satisfies the requirements of the
Prepared and Submitted by Sponsor- FOR FURTHER INFORMATION CONTACT: applicable statutes and regulations.
Investigators; Draft Guidance for Amalia Himaya, Center for Drug
Industry; Availability II. The Paperwork Reduction Act of
Evaluation and Research, Food and 1995
AGENCY: Food and Drug Administration, Drug Administration, 10903 New
HHS. Hampshire Ave., Bldg. 22, Rm. 6439, This guidance refers to previously
ACTION: Notice. Silver Spring, MD 20993–0002, 301– approved collections of information that
796–0700; or Stephen Ripley, Center for are subject to review by the Office of
SUMMARY: The Food and Drug Biologics Evaluation and Research, Management and Budget (OMB) under
Administration (FDA or Agency) is Food and Drug Administration, 10903 the Paperwork Reduction Act of 1995
announcing the availability of a draft New Hampshire Ave., Bldg. 71, Rm. (44 U.S.C. 3501–3520). The collections
guidance for industry entitled 7301, Silver Spring, MD 20993–0002, of information in 21 CFR part 312 have
‘‘Investigational New Drug Applications 240–402–7911. been approved under OMB control
Prepared and Submitted by Sponsor- SUPPLEMENTARY INFORMATION: number 0910–0014.
Investigators.’’ The purpose of this
I. Background III. Comments
guidance is to assist sponsor-
investigators in preparing and FDA is announcing the availability of Interested persons may submit either
submitting complete investigational a draft guidance for industry entitled electronic comments regarding this
new drug applications (INDs) to the ‘‘Investigational New Drug Applications document to http://www.regulations.gov
Center for Drug Evaluation and Research Prepared and Submitted by Sponsor- or written comments to the Division of
mstockstill on DSK4VPTVN1PROD with NOTICES
(CDER) and the Center for Biologics Investigators.’’ The purpose of this Dockets Management (see ADDRESSES). It
Evaluation and Research (CBER) at FDA. guidance is to assist investigators in is only necessary to send one set of
Although not an exhaustive step-by-step preparing and submitting complete comments. Identify comments with the
instruction manual, this guidance INDs to CDER and CBER at FDA. docket number found in brackets in the
highlights certain elements of this Sponsor-investigators seeking to do heading of this document. Received
process to facilitate a sponsor- clinical research often do not have the comments may be seen in the Division
investigator’s successful submission of regulatory knowledge or the resources to of Dockets Management between 9 a.m.
an IND. This guidance also discusses hire experts to help them with the IND and 4 p.m., Monday through Friday, and
VerDate Sep<11>2014 18:20 May 14, 2015 Jkt 235001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\15MYN1.SGM 15MYN1](https://thefederalregister.org/doc/80_FR_28066/page/1.svg)
![Federal Register / Vol. 80, No. 94 / Friday, May 15, 2015 / Notices 27973
will be posted to the docket at http:// For more information on the the long natural history associated with
www.regulations.gov. workshop, please visit FDA’s Medical this disease, imprecision in accurately
Devices News & Events—Workshops & diagnosing and targeting the tumor
IV. Electronic Access
Conferences calendar at http:// regions, and the lack of validated
Persons with access to the Internet www.fda.gov/MedicalDevices/ biomarkers or surrogate endpoints to
may obtain the document at http:// NewsEvents/WorkshopsConferences/ establish clinical benefit in a reasonable
www.fda.gov/Drugs/Guidance default.htm. (Select this workshop from period of time.
ComplianceRegulatoryInformation/ the posted events list.) No commercial The purposes of this public workshop
Guidances/default.htm, http:// or promotional material will be are to: (1) Foster collaboration and
www.fda.gov/BiologicsBloodVaccines/ permitted to be presented or distributed receive input from experts within the
GuidanceComplianceRegulatory at the workshop. scientific community; (2) obtain input
Information/default.htm, or http:// Transcripts: Please be advised that as from various stakeholders including
www.regulations.gov. soon as a transcript is available, it will patients, investigators and industry
Dated: May 11, 2015. be accessible at http:// regarding the development of minimally
Leslie Kux, www.regulations.gov. It may be viewed invasive devices to ablate prostatic
Associate Commissioner for Policy. at the Division of Dockets Management tissue; (3) foster clinical research; (4)
[FR Doc. 2015–11685 Filed 5–14–15; 8:45 am] between 9 a.m. and 4 p.m. A transcript discuss strategies to accelerate
BILLING CODE 4164–01–P
will also be available in either hardcopy anticancer device development; and (5)
or on CD–ROM, after submission of a provide transparency via a public forum
Freedom of Information request. Written regarding the regulatory challenges of
DEPARTMENT OF HEALTH AND requests are to be sent to the Division developing products for management of
HUMAN SERVICES of Freedom of Information (ELEM– patients with localized prostate cancer.
1029), Food and Drug Administration, II. Topics for Discussion at the Public
Food and Drug Administration 12420 Parklawn Dr., Element Bldg., Workshop
[Docket No. FDA–2015–N–0001] Rockville, MD 20857. A link to the
transcripts will also be available on the The following topics will be
Food and Drug Administration- Internet at http://www.fda.gov/ discussed at this workshop:
MedicalDevices/NewsEvents/ • Regulatory issues in partial gland
American Urological Association-
WorkshopsConferences/default.htm ablation for prostate cancer;
Society of Urologic Oncology
(select this workshop from the posted • overview of technology and
Workshop on Partial Gland Ablation
events list), approximately 45 days after consensus reports;
for Prostate Cancer; Public Workshop • the use of imaging and biopsy for
the workshop.
AGENCY: Food and Drug Administration, patient selection and treatment
FOR FURTHER INFORMATION CONTACT: John targeting; and
HHS.
Baxley, Center for Devices and • the design of clinical trials to
ACTION: Notice of public workshop. Radiological Health, Food and Drug measure cancer-specific and patient-
SUMMARY: The Food and Drug Administration, 10903 New Hampshire centered outcomes.
Administration (FDA) is announcing the Ave., Bldg. 66, Rm. G210, Silver Spring, The workshop will consist of formal
following public workshop entitled MD 20993, 301–796–6549, email: presentations examining these
‘‘AUA–FDA–SUO Workshop on Partial john.baxley@fda.hhs.gov. regulatory, scientific and clinical topics,
Gland Ablation for Prostate Cancer.’’ SUPPLEMENTARY INFORMATION: followed by panel discussion. During
The topics to be discussed are the panel discussion, there will also be the
technologies and imaging used in partial I. Background
opportunity for public participation and
gland ablation, and the design of FDA’s Center for Devices and input.
clinical trials to measure the most Radiological Health, the AUA, and the Dated: May 12, 2015.
appropriate endpoints for partial gland Society of Urologic Oncology (SUO) are
Leslie Kux,
ablation for prostate cancer. The cosponsoring this workshop. The
purpose is to provide a forum to discuss Associate Commissioner for Policy.
workshop will be part of the American
Urological Association (AUA) annual the development of products that ablate [FR Doc. 2015–11897 Filed 5–13–15; 11:15 am]
meeting in New Orleans, LA. prostatic tissue, particularly products BILLING CODE 4164–01–P
DATES: The public workshop will be that target ablation to regions of known
held on Sunday, May 17, 2015, from 1 cancer while intentionally sparing the
remainder of the prostate from DEPARTMENT OF HEALTH AND
p.m. to 6 p.m.
treatment. HUMAN SERVICES
ADDRESSES: The workshop will be held
at the New Orleans Ernest N. Morial The majority of cases of prostate
Food and Drug Administration
Convention Center, 900 Convention cancer diagnosed in the United States
Center Blvd., New Orleans, LA 70130. represent low risk, organ-confined [Docket No. FDA–2015–D–1211]
Registration: Persons interested in disease, which may be overtreated if
attending this workshop must register conventional treatment methods (i.e., Revised Recommendations for
online for the AUA annual meeting. The radical prostatectomy and whole gland Reducing the Risk of Human
facilities are limited and, therefore, radiation therapy) are employed. Over Immunodeficiency Virus Transmission
by Blood and Blood Products; Draft
mstockstill on DSK4VPTVN1PROD with NOTICES
attendance may be limited. To register the past decade, partial gland ablation
for the workshop, please visit the AUA therapies have emerged as treatment Guidance for Industry; Availability
Web site, http://www.aua2015.org/ alternatives that can spare patients from AGENCY: Food and Drug Administration,
register/. many of the undesired side effects HHS.
If you need special accommodations associated with standard, radical ACTION: Notice.
due to a disability, please contact Ms. treatment. However, multiple challenges
Susan Monahan, 301–796–5661, email: currently impede the adoption of partial SUMMARY: The Food and Drug
susan.monahan@fda.hhs.gov. gland ablation technologies, including Administration (FDA or Agency) is
VerDate Sep<11>2014 18:20 May 14, 2015 Jkt 235001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\15MYN1.SGM 15MYN1](https://thefederalregister.org/doc/80_FR_28066/page/2.svg)
Document Created: 2018-02-21 10:27:34
Document Modified: 2018-02-21 10:27:34
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 14, 2015. | |
| Contact | Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301- 796-0700; or 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. | |
| FR Citation | 80 FR 27972 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR