Source: https://www.federalregister.gov/documents/2014/11/05/2014-26304/agency-information-collection-activities-proposed-collection-comment-request-investigational-new
Timestamp: 2019-10-23 12:32:25
Document Index: 360481290

Matched Legal Cases: ['art 312', 'art 312', 'art 312', 'art 312', '§\u2009312', 'art 312', '§\u2009312', '§\u2009312', '§\u2009312', '§\u200950', '§\u2009312', '§\u2009312', '§\u2009312', '§\u200950', '§\u2009312', '§\u2009312', '§\u2009312', '§\u2009312', '§\u2009314', '§\u200950', '§\u2009312', '§\u2009312']

Federal Register :: Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications
65663-65669 (7 pages)
https://www.federalregister.gov/d/2014-26304 https://www.federalregister.gov/d/2014-26304
FDA PRA Staff, Office of Operations, Food Start Printed Page 65664and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
FDA is requesting OMB approval for the reporting and recordkeeping requirements contained in FDA regulations entitled “Investigational New Drug Application” in 21 CFR part 312 (part 312). Part 312 implements provisions of section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) (the FD&C Act) to issue regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted.
The IND information collection requirements provide the means by which FDA can monitor the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products, including the following: (1) Monitor the safety of ongoing clinical investigations; (2) determine whether the clinical testing of a drug should be authorized; (3) ensure production of reliable data on the metabolism and pharmacological action of the drug in humans; (4) obtain timely information on adverse reactions to the drug; (5) obtain information on side effects associated with increasing doses; (6) obtain information on the drug's effectiveness; (7) ensure the design of well-controlled, scientifically valid studies; (8) obtain other information pertinent to determining whether clinical testing should be continued, and information related to the protection of human subjects. Without the information provided by industry as required under the IND regulations, FDA cannot authorize or monitor the clinical investigations which must be conducted prior to authorizing the sale and general use of new drugs. These reports enable FDA to monitor a study's progress, to assure subject safety, to assure that a study will be conducted ethically, and to increase the likelihood that the sponsor will conduct studies that will be useful in determining whether the drug should be marketed and available for use in medical practice.
Form FDA-1571—“Investigational New Drug Application.” A person who intends to conduct a clinical investigation submits this form to FDA. It includes the following information: (1) A cover sheet containing background information on the sponsor and investigator; (2) a table of contents; (3) an introductory statement and general investigational plan; (4) an investigator's brochure describing the drug substance; (5) a protocol for each planned study; (6) chemistry, manufacturing, and control information for each investigation; (7) pharmacology and toxicology information for each investigation; and (8) previous human experience with the investigational drug.
21 CFR 312.2(e)—Requests for FDA advice on the applicability of part 312 to a planned clinical investigation.
21 CFR 312.6—Labeling of an investigational new drug. Estimates for the information collection in this requirement are included under § 312.23(a)(7)(iv)(d).
21 CFR 312.8—Charging for investigational drugs under an IND.
21 CFR 312.10—Applications for waiver of requirements under part 312. As indicated in § 312.10(a), estimates for the information collection in this requirement are included under §§ 312.23 and 312.31. In addition, other waiver requests under § 312.10 are estimated in table 1.
21 CFR 312.20(c)—Applications for investigations involving an exception from informed consent under § 50.24 (21 CFR 50.24). Estimates for the Start Printed Page 65665information collection in this requirement are included under § 312.23.
21 CFR 312.23—IND (content and format).
.23(a)(1)—Cover sheet FDA-1571.
.23(a)(2)—Table of Contents.
.23(a)(3)—Investigational plan for each planned study.
.23(a)(5)—Investigator's brochure.
.23(a)(6)—Protocols—Phase 1, 2, and 3.
.23(a)(7)—Chemistry, manufacturing, and control information.
.23(a)(7)(iv)(a),(b),(c)—A description of the drug substance, a list of all components, and any placebo used.
.23(a)(7)(iv)(d)—Labeling: Copies of labels and labeling to be provided each investigator.
.23(a)(7)(iv)(e)—Environmental impact analysis regarding drug manufacturing and use.
.23(a)(8)—Pharmacological and toxicology information.
.23(a)(9)—Previous human experience with the investigational drug.
.23(a)(10)—Additional information.
.23(a)(11)—Relevant information.
.23(f)—Identification of exception from informed consent.
21 CFR 312.30—Protocol amendments.
.30(a)—New protocol
.30(b)—Changes in protocol
.30(c)—New investigator.
.30(d)—Content and format.
.30(e)—Frequency.
21 CFR 312.31—Information amendments.
.31(b)—Content and format.
—Chemistry, toxicology, or technical information.
21 CFR 312.32—Safety reports.
.32(c)(1)—Written reports to FDA and to investigators.
.32(c)(2)—Telephone reports to FDA for fatal or life-threatening experience.
.32(c)(3)—Format or frequency.
.32(d)—Followup submissions.
21 CFR 312.33—Annual reports.
.33(a)—Individual study information.
.33(b)—Summary information.
(b)(1)—Adverse experiences.
(b)(2)—Safety report summary.
(b)(3)—List of fatalities and causes of death.
(b)(4)—List of discontinuing subjects.
(b)(5)—Drug action.
(b)(6)—Preclinical studies and findings.
(b)(7)—Significant changes.
.33(c)—Next year general investigational plan.
.33(d)—Brochure revision.
.33(e)—Phase I protocol modifications.
.33(f)—Foreign marketing developments.
21 CFR 312.38(b) and (c)—Notification of withdrawal of an IND.
21 CFR 312.41—Comment and advice on an IND. Estimates for the information collection in this requirement are included under § 312.23.
21 CFR 312.42—Sponsor requests that a clinical hold be removed, and submits a complete response to the issues identified in the clinical hold order.
21 CFR 312.44(c) and (d)—Opportunity for sponsor response to FDA when IND is terminated.
21 CFR 312.45(a) and (b)—Sponsor request for, or response to, an inactive status determination of an IND.
21 CFR 312.47—Meetings, including “End-of-Phase 2” meetings and “Pre-NDA” meetings.
21 CFR 312.48—Dispute resolution. Estimates for the information collection in this requirement are included under § 312.47.
21 CFR 312.53(c)—Investigator information. Investigator report (Form FDA-1572) and narrative; Investigator's background information; Phase 1 outline of planned investigation and Phase 2 outline of study protocol.
21 CFR 312.54(a) and (b)—Sponsor submissions concerning investigations involving an exception from informed consent under § 50.24.
21 CFR 312.55(b)—Sponsor reports to investigators on new observations, especially adverse reactions and safe use. Only “new observations” are estimated under this section; investigator brochures are included under § 312.23.
21 CFR 312.56(b), (c), and (d)—Sponsor monitoring of all clinical investigations, investigators, and drug safety; notification to FDA and others.
21 CFR 312.58(a)—Sponsor's submission of records to FDA on request.
21 CFR 312.64—Investigator reports to the sponsor.
.64(a)—Progress reports.
.64(b)—Safety reports
.64(c)—Final reports.
.64(d)—Financial disclosure reports.
21 CFR 312.66—Investigator reports to institutional review board (IRB). Estimates for the information collection in this requirement are included under § 312.53.
21 CFR 312.70—Investigator disqualification; opportunity to respond to FDA.
21 CFR 312.83—Sponsor submission of treatment protocol. Estimates for this requirement are included under § 312.320.
21 CFR 312.85—Sponsors conducting phase 4 studies. Estimates for the information collection in this requirement are included under § 312.23, and under §§ 314.50, 314.70, and 314.81 in OMB control number 0910-0001.
21 CFR 312.110(b)—Requests to export an investigational drug.
21 CFR 312.120—Submissions related to foreign clinical studies not conducted under an IND.
21 CFR 312.130—Requests for disclosable information in an IND and from investigations involving an exception from informed consent under § 50.24.
21 CFR 312.310(b); 312.305(b)—Submissions related to expanded access and treatment of an individual patient.
21 CFR 312.310(d)—Submissions related to emergency use of an investigational new drug.
21 CFR 312.315(c); 312.305(b)—Submissions related to expanded access and treatment of an intermediate-size patient population.
21 CFR 312.320—Submissions related to a treatment IND or treatment protocol.
21 CFR 312.52(a)—Transfer of obligations to a contract research organization.
21 CFR 312.57—Sponsor recordkeeping on the investigational drug.
21 CFR 312.59—Sponsor recordkeeping of disposition of unused supply of drugs. Estimates for the information collection in this requirement are included under § 312.57.
21 CFR 312.62(a)—Investigator recordkeeping of disposition of drugs.
21 CFR 312.62(b)—Investigator recordkeeping of case histories of individuals.
21 CFR 312.120(d)—Recordkeeping requirements for submissions related to foreign clinical studies not conducted under an IND. Estimates for the information collection in this requirement are included under § 312.57.
21 CFR 312.160(a)(3)—Records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests.
21 CFR 312.160(c)—Shipper records of alternative disposition of unused drugs.
FDA estimates the burden of this collection of information as follows:Start Printed Page 65666
312.31(b), Information amendments 4,537 3.39 15,377 100 1,537,700
312.56(b), (c), and (d), Sponsor notifications to FDA and others resulting from: (1) The sponsor's monitoring of all clinical investigations and determining that an investigator is not in compliance with the investigation agreements; (2) the sponsor's review and evaluation of the evidence relating to the safety and effectiveness of the investigational drug; and (3) the sponsor's determination that the investigational drug presents an unreasonable and significant risk to subjects. (Includes third party disclosure) 3,584 6.52 23,355 80 1,868,400
Table 2—Estimated Annual Recordkeeping Burden for Human Drugs1
312.160(a)(3), Records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests 547 1.40 782 0.50 (30 minutes) 391
312.160(c) Shipper records of alternative disposition of unused drugs 547 1.40 782 0.50 (30 minutes) 391
Table 3—Estimated Annual Reporting Burden for Biologics1
Table 4—Estimated Annual Recordkeeping Burden for Biologics1
312.160(a)(3), Records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests 111 1.40 155 0.50 (30 minutes) 78
312.160(c), Shipper records of alternative disposition of unused drugs 111 1.40 155 0.50 (30 minutes) 78
[FR Doc. 2014-26304 Filed 11-4-14; 8:45 am]