Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications, 65663-65669 [2014-26304]

Download as PDF Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices OMHA facilitator to discuss potential settlement of claims with authorized settlement officials. Additional information on these two pilots can be found on OMHA’s Web site, http:// www.hhs.gov/omha. In addition to these initiatives, OMHA continues to pursue new case processing efficiencies and an electronic case adjudication processing environment (ECAPE) to bring further efficiencies to the appeals process. II. Request for Information OMHA is seeking input from the public on the current initiatives being undertaken at the Administrative Law Judge level, as well as suggestions for additional initiatives which could be undertaken at OMHA to address the Medicare claim and entitlement appeals workload and backlog at the Administrative Law Judge level. Input is sought on the following topics and questions: • Are there suggestions related to the current initiatives for addressing the increased workload and/or backlog of appeals at the Administrative Law Judge level that comply with current statutory authorities and requirements? • Are there other suggestions for addressing the increased workload and/ or backlog of appeals at the Administrative Law Judge level that comply with current statutory authorities and requirements? • Are there any current regulations that apply to the Administrative Law Judge level of the Medicare claim and entitlement appeals process that could be revised to streamline the adjudication process while ensuring that parties to the appeals, as defined at 42 CFR 405.902 and 405.906, are afforded opportunities to participate in the process and are kept apprised of appeals related to claims submitted by them or on their behalf? mstockstill on DSK4VPTVN1PROD with NOTICES (Catalog of Federal Domestic Assistance Program No. 93.770, Medicare—Prescription Drug Coverage; Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: October 30, 2014. Nancy J. Griswold, Chief Administrative Law Judge, Office of Medicare Hearings and Appeals. [FR Doc. 2014–26214 Filed 11–4–14; 8:45 am] BILLING CODE 4150–46–P VerDate Sep<11>2014 17:42 Nov 04, 2014 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [CFDA Number: 93.647] Announcement of the Award of a Single-Source Program Expansion Supplement Grant to Child Trends, Inc., in Bethesda, MD Office of Planning, Research and Evaluation, ACF, HHS. ACTION: Announcement of the award of a single-source expansion supplement grant to Child Trends, Inc., in Bethesda, MD, to support activities that promote the economic and social well-being of individuals, families, and communities. AGENCY: The Administration for Children and Families (ACF), Office of Planning, Research and Evaluation (OPRE) announces the award of a singlesource expansion supplement award in the amount of $120,000 to Child Trends, Inc., in Bethesda, MD, to support activities that will provide researchbased information to improve understanding of how to promote the economic and social well-being of underserved and under-represented populations. DATES: September 30, 2014 through September 29, 2015. FOR FURTHER INFORMATION CONTACT: Ann Rivera, Social Science Research Analyst, Office of Planning, Research & Evaluation, Administration for Children and Families, 370 L’Enfant Promenade SW., Washington, DC 20447; Telephone: (202) 401–5506; Email: ann.rivera@ acf.hhs.gov. SUPPLEMENTARY INFORMATION: Under this grant program, Child Trends, Inc., a non-profit, nonpartisan research center, has established the National Research Center on Hispanic Children and Families, which brings together an interdisciplinary team of academic and organizational partners to provide leadership in culturally competent research that can inform policies concerning low-income Hispanic families and to foster significant scholarship regarding the needs and experiences of the Hispanic populations throughout the nation. This ACFsponsored research center develops research products and research-based resources that aim to build research capacity in the field and to improve understanding of Hispanic populations in order to inform policy development and programmatic responses. The award of a single-source expansion supplement to this research SUMMARY: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 65663 center will support activities to develop research-based resources to inform ACF program offices, current and future ACF grantees, and potential ACF grant applicants about the characteristics and needs of underserved and underrepresented populations. Statutory Authority: Section 1110 of the Social Security Act (42 U.S.C. 1310). Melody Wayland, Senior Grants Policy Specialist, Office of Administration, Office of Financial Services/ Division of Grants Policy. [FR Doc. 2014–26226 Filed 11–4–14; 8:45 am] BILLING CODE 4184–07–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1721] Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted. DATES: Submit either electronic or written comments on the collection of information by January 5, 2015. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food SUMMARY: E:\FR\FM\05NON1.SGM 05NON1 65664 Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES Investigational New Drug (IND) Regulations—21 CFR Part 312 (OMB Control Number 0910–0014)—Extension 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. FDA is charged with implementing statutory requirements that drug VerDate Sep<11>2014 17:42 Nov 04, 2014 Jkt 235001 products marketed in the United States be shown to be safe and effective, properly manufactured, and properly labeled for their intended uses. Section 505(a) of the FD&C Act provides that a new drug may not be introduced or delivered for introduction into interstate commerce in the United States unless FDA has previously approved a new drug application (NDA). FDA approves an NDA only if the sponsor of the application first demonstrates that the drug is safe and effective for the conditions prescribed, recommended, or suggested in the product’s labeling. Proof must consist, in part, of adequate and well-controlled studies, including studies in humans, that are conducted by qualified experts. The IND regulations establish reporting requirements that include an initial application as well as amendments to that application, reports on significant revisions of clinical investigation plans, and information on a drug’s safety or effectiveness. In addition, the sponsor is required to give FDA an annual summary of the previous year’s clinical experience. Submissions are reviewed by medical officers and other Agency scientific reviewers assigned responsibility for overseeing the specific study. The IND regulations also contain recordkeeping requirements that pertain to the responsibilities of sponsors and investigators. The detail and complexity of these requirements are dictated by the scientific procedures and human subject safeguards that must be followed in the clinical tests of investigational new drugs. 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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. There are two forms that are required under part 312: 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. Form FDA–1572—‘‘Investigator Statement.’’ Before permitting an investigator to begin participation in an investigation, the sponsor must obtain and record this form. It includes background information on the investigator and the investigation, and a general outline of the planned investigation and the study protocol. FDA is requesting OMB approval for the following reporting and recordkeeping requirements in part 312. I. Reporting Requirements 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 E:\FR\FM\05NON1.SGM 05NON1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices information 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. VerDate Sep<11>2014 17:42 Nov 04, 2014 Jkt 235001 .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 ‘‘PreNDA’’ 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 65665 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. II. Recordkeeping Requirements 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: E:\FR\FM\05NON1.SGM 05NON1 65666 Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1 mstockstill on DSK4VPTVN1PROD with NOTICES 312.2(e), Requests for FDA advice on the applicability of part 312 to a planned clinical investigation .................... 312.8, Requests to charge for an investigational drug ..... 312.10, Requests to waive a requirement in part 312 ...... 312.23(a) through (f), IND content and format (including Form FDA 1571) ............................................................ 312.30(a) through (e), Protocol amendments ................... 312.31(b), Information amendments .................................. 312.32(c) and (d), IND Safety reports ............................... 312.33(a) through (f), IND Annual reports ......................... 312.38(b) and (c), Notifications of withdrawal of an IND .. 312.42, Sponsor requests that a clinical hold be removed, including sponsor submission of a complete response to the issues identified in the clinical hold order 312.44(c) and (d), Sponsor responses to FDA when IND is terminated ................................................................... 312.45(a) and (b), Sponsor requests for or responses to an inactive status determination of an IND by FDA ...... 312.47, Meetings, including ‘‘End-of-Phase 2’’ meetings and ‘‘Pre-NDA’’ meetings ............................................... 312.53(c), Investigator reports submitted to the sponsor, including Form FDA 1572, curriculum vitae, clinical protocol, and financial disclosure. (Third party disclosure) ............................................................................... 312.54(a), Sponsor submissions to FDA concerning investigations involving an exception from informed consent under 21 CFR 50.24 .............................................. 312.54(b), Sponsor notifications to FDA and others concerning an IRB determination that it cannot approve research because it does not meet the criteria in the exception from informed consent in § 50.24(a). (Includes third party disclosure) ..................................................... 312.55(a), Investigator brochures submitted by the sponsor to each investigator. (Third party disclosure) .......... 312.55(b), Sponsor reports to investigators on new observations, especially adverse reactions and safe use. (Third party disclosure) .................................................. 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) ..................................................... 312.58(a), Sponsor’s submissions of clinical investigation records to FDA on request during FDA inspections ...... 312.64, Investigator reports to the sponsor, including progress reports, safety reports, final reports, and financial disclosure reports. (Third party disclosure) ....... 312.70, During the disqualification process of a clinical investigator by FDA, the number of investigator responses or requests to FDA following FDA’s notification to an investigator of its failure to comply with investigation requirements ................................................ 312.110(b)(4) and (b)(5), Written certifications and written statements submitted to FDA relating to the export of an investigational drug ................................................... 312.120(b), Submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical studies not conducted under an IND ................................................ 312.120(c), Waiver requests submitted to FDA related to the use of foreign clinical studies not conducted under an IND ............................................................................ 312.130, Requests for disclosable information in an IND and for investigations involving an exception from informed consent under § 50.24 ....................................... VerDate Sep<11>2014 17:42 Nov 04, 2014 Jkt 235001 Number of responses per respondent Number of respondents 21 CFR Section PO 00000 Frm 00052 Average burden per response Total annual responses Total hours 800 56 50 1 1.25 1.76 800 70 88 24 48 24 19,200 3,360 2,112 1,689 3,739 4,537 755 2,877 862 1.57 5.77 3.39 24.28 2.76 1.54 2,648 21,588 15,377 18,332 7,953 1,328 1,600 284 100 32 360 28 4,236,800 6,130,992 1,537,700 586,624 2,863,080 37,184 158 1.30 205 284 58,220 12 16 192 12 1 260 1.73 451 12 5,412 225 1.86 419 160 67,040 1,444 8.38 12,087 80 966,960 7 5 35 48 1,680 7 1 7 48 336 590 3.50 2,067 48 99,216 590 3.50 2,067 48 99,216 3,584 6.52 23,355 80 1,868,400 60 1 60 8 480 1,444 1 1,444 24 34,656 4 1 4 40 160 11 26.28 289 75 21,675 1,414 8.63 12,198 32 390,336 35 2.34 82 24 1,968 3 8 24 3 Fmt 4703 Sfmt 4703 1 E:\FR\FM\05NON1.SGM 05NON1 65667 Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1—Continued 312.310(b) and 312.305(b), Submissions related to expanded access and treatment of an individual patient .. 312.310(d), Submissions related to emergency use of an investigational new drug ................................................. 312.315(c) and 312.305(b), Submissions related to expanded access and treatment of an intermediate-size patient population ........................................................... 312.320(b), Submissions related to a treatment IND or treatment protocol .......................................................... Average burden per response Total annual responses Total hours 228 1.76 401 8 3,208 410 2.19 899 16 14,384 44 7.07 311 120 37,320 12 12.67 152 300 45,600 ........................ Total ............................................................................ 1 There Number of responses per respondent Number of respondents 21 CFR Section .......................... ........................ ........................ 19,134,039 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS1 Number of recordkeepers 21 CFR Section 312.52(a), Sponsor records for the transfer of obligations to a contract research organization. 312.57, Sponsor recordkeeping showing the receipt, shipment, or other disposition of the investigational drug, and any financial interests. 312.62(a), Investigator recordkeeping of the disposition of drugs. 312.62(b), Investigator recordkeeping of case histories of individuals. 312.160(a)(3), Records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests. 312.160(c) Shipper records of alternative disposition of unused drugs. Total ................................................. 1 There Number of records per recordkeeper 335 Average burden per recordkeeping Total annual records 1.50 Total hours 503 2 ....................... 1,006 1,689 1 1,689 100 ................... 168,900 1,444 1 1,444 40 ..................... 57,760 1,444 1 1,444 40 ..................... 57,760 547 1.40 782 0.50 (30 minutes). 391 547 1.40 782 0.50 (30 minutes). 391 .............................. ................................ .............................. ........................... 286,190 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS1 mstockstill on DSK4VPTVN1PROD with NOTICES 312.2(e), Requests for FDA advice on the applicability of part 312 to a planned clinical investigation .................... 312.8, Requests to charge for an investigational drug ..... 312.10, Requests to waive a requirement in part 312 ...... 312.23(a) through (f), IND content and format .................. 312.30(a) through (e), Protocol amendments ................... 312.31(b), Information amendments .................................. 312.32(c) and (d), IND Safety reports ............................... 312.33(a) through (f), IND Annual reports ......................... 312.38(b) and (c), Notifications of withdrawal of an IND .. 312.42, Sponsor requests that a clinical hold be removed, including sponsor submission of a complete response to the issues identified in the clinical hold order 312.44(c) and (d), Sponsor responses to FDA when IND is terminated ................................................................... 312.45(a) and (b), Sponsor requests for or responses to an inactive status determination of an IND by FDA ...... 312.47, Meetings, including ‘‘End-of-Phase 2’’ meetings and ‘‘Pre-NDA’’ meetings ............................................... 312.53(c), Investigator reports submitted to the sponsor, including Form FDA–1572, curriculum vitae, clinical protocol, and financial disclosure ................................... VerDate Sep<11>2014 17:42 Nov 04, 2014 Jkt 235001 Number of responses per respondent Number of respondents 21 CFR section PO 00000 Frm 00053 Total annual responses Average burden per response Total hours 217 20 2 335 694 77 161 745 134 1.18 1.50 1 1.35 5.84 2.43 8.83 2.14 1.69 255 30 2 452 4,050 187 1,421 1,595 227 24 48 24 1,600 284 100 32 360 28 6,120 1,440 48 723,200 1,150,200 18,700 45,472 574,200 6,356 67 1.30 87 284 24,708 34 1.15 39 16 624 55 1.38 76 12 912 88 1.75 154 160 24,640 453 6.33 2,869 80 229,520 Fmt 4703 Sfmt 4703 E:\FR\FM\05NON1.SGM 05NON1 65668 Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS1—Continued 312.54(a), Sponsor submissions to FDA concerning investigations involving an exception from informed consent under § 50.24 .......................................................... 312.54(b), Sponsor notifications to FDA and others concerning an IRB determination that it cannot approve research because it does not meet the criteria in the exception from informed consent in § 50.24(a) ................. 312.55(a), Number of investigator brochures submitted by the sponsor to each investigator ............................... 312.55(b), Number of sponsor reports to investigators on new observations, especially adverse reactions and safe use .......................................................................... 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 .................... 312.58(a), Number of sponsor’s submissions of clinical investigation records to FDA on request during FDA inspections ........................................................................ 312.64, Number of investigator reports to the sponsor, including progress reports, safety reports, final reports, and financial disclosure reports ..................................... 312.70, During the disqualification process of a clinical investigator by FDA, the number of investigator responses or requests to FDA following FDA’s notification to an investigator of its failure to comply with investigation requirements ................................................ 312.110(b)(4) and (b)(5), Number of written certifications and written statements submitted to FDA relating to the export of an investigational drug .............................. 312.120(b), Number of submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical studies not conducted under an IND ....................... 312.120(c), Number of waiver requests submitted to FDA related to the use of foreign clinical studies not conducted under an IND ...................................................... 312.130, Number of requests for disclosable information in an IND and for investigations involving an exception from informed consent under § 50.24 ............................ 312.310(b) and 312.305(b), Number of submissions related to expanded access and treatment of an individual patient .................................................................. 312.310(d), Number of submissions related to emergency use of an investigational new drug ..................... 312.315(c) and 312.305(b), Number of submissions related to expanded access and treatment of an intermediate-size patient population ..................................... 312.320(b), Number of submissions related to a treatment IND or treatment protocol ..................................... mstockstill on DSK4VPTVN1PROD with NOTICES Average burden per response Total annual responses Total hours 1 1 1 48 48 1 1 1 48 48 239 1.91 457 48 21,936 243 4.95 1,203 48 57,744 108 2.21 239 80 19,120 7 8 56 10,411 24 249,864 7 1 2,728 3.82 5 1 5 40 200 18 1 18 75 1,350 280 9.82 2,750 32 88,000 7 2.29 16 24 384 350 1.34 470 8 3,760 78 1.08 84 8 672 76 2.76 210 16 3,360 9 1 9 120 1,080 1 Total ............................................................................ 1 There Number of responses per respondent Number of respondents 21 CFR section 1 1 300 300 ........................ ........................ 3,254,062 ........................ .......................... are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS1 Number of recordkeepers 21 CFR Section 312.52(a), Sponsor records for the transfer of obligations to a contract research organization. VerDate Sep<11>2014 17:42 Nov 04, 2014 Jkt 235001 Number of records per recordkeeper 75 PO 00000 Frm 00054 1.40 Fmt 4703 Sfmt 4703 Total annual records 105 E:\FR\FM\05NON1.SGM Average burden per recordkeeping 2 ....................... 05NON1 Total hours 210 Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices 65669 TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS1—Continued Number of recordkeepers 21 CFR Section Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 312.57, Sponsor recordkeeping showing the receipt, shipment, or other disposition of the investigational drug, and any financial interests. 312.62(a), Investigator recordkeeping of the disposition of drugs. 312.62(b), Investigator recordkeeping of case histories of individuals. 312.160(a)(3), Records pertaining to the shipment of drugs for investigational use in laboratory research animals or in vitro tests. 312.160(c), Shipper records of alternative disposition of unused drugs. 335 2.70 904 100 ................... 90,400 453 1 453 40 ..................... 18,120 453 1 453 40 ..................... 18,120 111 1.40 155 0.50 (30 minutes). 78 111 1.40 155 0.50 (30 minutes). 78 Total ................................................. .............................. ................................ .............................. 1 There BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1119] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed LowAcid Foods in Hermetically Sealed Containers; Correction Food and Drug Administration, HHS. Notice; correction. The Food and Drug Administration (FDA or we) is correcting a notice that appeared in the Federal Register of August 14, 2014. The notice announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. In this document, we correct some errors that appeared in the notice. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:42 Nov 04, 2014 Jkt 235001 In FR Doc. 2014–19241, appearing on page 47642 in the Federal Register of August 14, 2014 (79 FR 47642), we make the following corrections: 1. On page 47643, in the second column, in the Response to Comment 3, delete the sentence starting with ‘‘The scope of the voluntary submission . . . and the product label.’’ 2. On page 47643, in the second column, in the Response to Comment 3, in the sentence starting with ‘‘Consequently, we have proposed . . .,’’ delete ‘‘institute the voluntary consultation process discussed in this document’’ and replace it with ‘‘provide for the voluntary registration and Form FDA 2541e submission process’’. 3. On page 47643, in the second and third columns, in the Response to Comment 3, delete the sentences starting with ‘‘The ability to submit a voluntary submission . . . of part 114’’ and the remaining sentences in the response and replace them with ‘‘FDA has authority to implement the voluntary submission process under sections 402 and 404 of the FD&C Act.’’ 4. On page 47643, in the third column, in the Response to Comment 4, replace the response with the following: ‘‘A voluntary process filing submission will not result in part 114 applying to products that are not acidified foods as defined in 21 CFR 114.3(b). Further, the voluntary process filing submission process will not result in any changes to part 114.’’ 5. On pages 47643 to 47644, in the third column on page 47643 and in the first column on page 47644, in the Response to Comment 5, replace the response with the following: ‘‘Our inspectors will not expect all SUPPLEMENTARY INFORMATION: [FR Doc. 2014–26304 Filed 11–4–14; 8:45 am] ACTION: 127,006 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 31, 2014. Leslie Kux, Assistant Commissioner for Policy. AGENCY: ........................... PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 manufacturers to submit voluntary submissions.’’ 6. On page 47644, in the first column, in the Response to Comment 7, replace the response with the following: ‘‘As discussed in the response to Comment 4, if a product is not an acidified food, the product is not subject to the good manufacturing practice requirements in part 114 and will not become subject to those regulations as a result of a voluntary submission.’’ 7. On page 47644, in the first and second columns, in the Response to Comment 8, replace the response with the following: ‘‘The draft guidance did address the issue of what constitutes a fermented food. We expect that the acidified foods guidance, when finalized, will provide guidance on what constitutes a fermented food.’’ 8. On page 47644, in the second column, in the Response to Comment 9, replace the response with the following: ‘‘Manufacturers are free to decide whether to make a voluntary submission, and we believe that some manufacturers may choose to do so. For FDA, the voluntary submission results in increased efficiency.’’ 9. On page 47644, in the second and third columns, in the Response to Comment 10, delete the first paragraph of the response and delete the second sentence in the second paragraph of the response. 10. On page 47645, in the first column, in the Response to Comment 13, in the second sentence in the second paragraph of the response, delete ‘‘to prevent the detention of product’’. 11. On page 47645, in the third column, in the Response to Comment 20, in the first sentence of the response, replace ‘‘and provides’’ with ‘‘and, when finalized, will provide’’. E:\FR\FM\05NON1.SGM 05NON1

Agencies

[Federal Register Volume 79, Number 214 (Wednesday, November 5, 2014)]
[Notices]
[Pages 65663-65669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26304]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1721]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Investigational New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on regulations under which the 
clinical investigation of the safety and effectiveness of unapproved 
new drugs and biological products can be conducted.

DATES: Submit either electronic or written comments on the collection 
of information by January 5, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA 
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food

[[Page 65664]]

and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Investigational New Drug (IND) Regulations--21 CFR Part 312 (OMB 
Control Number 0910-0014)--Extension

    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.
    FDA is charged with implementing statutory requirements that drug 
products marketed in the United States be shown to be safe and 
effective, properly manufactured, and properly labeled for their 
intended uses. Section 505(a) of the FD&C Act provides that a new drug 
may not be introduced or delivered for introduction into interstate 
commerce in the United States unless FDA has previously approved a new 
drug application (NDA). FDA approves an NDA only if the sponsor of the 
application first demonstrates that the drug is safe and effective for 
the conditions prescribed, recommended, or suggested in the product's 
labeling. Proof must consist, in part, of adequate and well-controlled 
studies, including studies in humans, that are conducted by qualified 
experts. The IND regulations establish reporting requirements that 
include an initial application as well as amendments to that 
application, reports on significant revisions of clinical investigation 
plans, and information on a drug's safety or effectiveness. In 
addition, the sponsor is required to give FDA an annual summary of the 
previous year's clinical experience.
    Submissions are reviewed by medical officers and other Agency 
scientific reviewers assigned responsibility for overseeing the 
specific study. The IND regulations also contain recordkeeping 
requirements that pertain to the responsibilities of sponsors and 
investigators. The detail and complexity of these requirements are 
dictated by the scientific procedures and human subject safeguards that 
must be followed in the clinical tests of investigational new drugs.
    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.
    There are two forms that are required under part 312:
    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.
    Form FDA-1572--``Investigator Statement.'' Before permitting an 
investigator to begin participation in an investigation, the sponsor 
must obtain and record this form. It includes background information on 
the investigator and the investigation, and a general outline of the 
planned investigation and the study protocol.
    FDA is requesting OMB approval for the following reporting and 
recordkeeping requirements in part 312.

I. Reporting Requirements

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 Sec.  
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 Sec.  312.10(a), estimates for the information 
collection in this requirement are included under Sec. Sec.  312.23 and 
312.31. In addition, other waiver requests under Sec.  312.10 are 
estimated in table 1.
21 CFR 312.20(c)--Applications for investigations involving an 
exception from informed consent under Sec.  50.24 (21 CFR 50.24). 
Estimates for the

[[Page 65665]]

information collection in this requirement are included under Sec.  
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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  312.320.
21 CFR 312.85--Sponsors conducting phase 4 studies. Estimates for the 
information collection in this requirement are included under Sec.  
312.23, and under Sec. Sec.  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 Sec.  
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.

II. Recordkeeping Requirements

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 Sec.  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 Sec.  
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:

[[Page 65666]]



                         Table 1--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
----------------------------------------------------------------------------------------------------------------
312.2(e), Requests for FDA                   800            1                800              24          19,200
 advice on the applicability of
 part 312 to a planned clinical
 investigation..................
312.8, Requests to charge for an              56            1.25              70              48           3,360
 investigational drug...........
312.10, Requests to waive a                   50            1.76              88              24           2,112
 requirement in part 312........
312.23(a) through (f), IND                 1,689            1.57           2,648           1,600       4,236,800
 content and format (including
 Form FDA 1571).................
312.30(a) through (e), Protocol            3,739            5.77          21,588             284       6,130,992
 amendments.....................
312.31(b), Information                     4,537            3.39          15,377             100       1,537,700
 amendments.....................
312.32(c) and (d), IND Safety                755           24.28          18,332              32         586,624
 reports........................
312.33(a) through (f), IND                 2,877            2.76           7,953             360       2,863,080
 Annual reports.................
312.38(b) and (c), Notifications             862            1.54           1,328              28          37,184
 of withdrawal of an IND........
312.42, Sponsor requests that a              158            1.30             205             284          58,220
 clinical hold be removed,
 including sponsor submission of
 a complete response to the
 issues identified in the
 clinical hold order............
312.44(c) and (d), Sponsor                    12            1                 12              16             192
 responses to FDA when IND is
 terminated.....................
312.45(a) and (b), Sponsor                   260            1.73             451              12           5,412
 requests for or responses to an
 inactive status determination
 of an IND by FDA...............
312.47, Meetings, including                  225            1.86             419             160          67,040
 ``End-of-Phase 2'' meetings and
 ``Pre-NDA'' meetings...........
312.53(c), Investigator reports            1,444            8.38          12,087              80         966,960
 submitted to the sponsor,
 including Form FDA 1572,
 curriculum vitae, clinical
 protocol, and financial
 disclosure. (Third party
 disclosure)....................
312.54(a), Sponsor submissions                 7            5                 35              48           1,680
 to FDA concerning
 investigations involving an
 exception from informed consent
 under 21 CFR 50.24.............
312.54(b), Sponsor notifications               7            1                  7              48             336
 to FDA and others concerning an
 IRB determination that it
 cannot approve research because
 it does not meet the criteria
 in the exception from informed
 consent in Sec.   50.24(a).
 (Includes third party
 disclosure)....................
312.55(a), Investigator                      590            3.50           2,067              48          99,216
 brochures submitted by the
 sponsor to each investigator.
 (Third party disclosure).......
312.55(b), Sponsor reports to                590            3.50           2,067              48          99,216
 investigators on new
 observations, especially
 adverse reactions and safe use.
 (Third party disclosure).......
312.56(b), (c), and (d), Sponsor           3,584            6.52          23,355              80       1,868,400
 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)....................
312.58(a), Sponsor's submissions              60            1                 60               8             480
 of clinical investigation
 records to FDA on request
 during FDA inspections.........
312.64, Investigator reports to            1,444            1              1,444              24          34,656
 the sponsor, including progress
 reports, safety reports, final
 reports, and financial
 disclosure reports. (Third
 party disclosure)..............
312.70, During the                             4            1                  4              40             160
 disqualification process of a
 clinical investigator by FDA,
 the number of investigator
 responses or requests to FDA
 following FDA's notification to
 an investigator of its failure
 to comply with investigation
 requirements...................
312.110(b)(4) and (b)(5),                     11           26.28             289              75          21,675
 Written certifications and
 written statements submitted to
 FDA relating to the export of
 an investigational drug........
312.120(b), Submissions to FDA             1,414            8.63          12,198              32         390,336
 of ``supporting information''
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.120(c), Waiver requests                   35            2.34              82              24           1,968
 submitted to FDA related to the
 use of foreign clinical studies
 not conducted under an IND.....
312.130, Requests for                          3            1                  3               8              24
 disclosable information in an
 IND and for investigations
 involving an exception from
 informed consent under Sec.
 50.24..........................

[[Page 65667]]

 
312.310(b) and 312.305(b),                   228            1.76             401               8           3,208
 Submissions related to expanded
 access and treatment of an
 individual patient.............
312.310(d), Submissions related              410            2.19             899              16          14,384
 to emergency use of an
 investigational new drug.......
312.315(c) and 312.305(b),                    44            7.07             311             120          37,320
 Submissions related to expanded
 access and treatment of an
 intermediate-size patient
 population.....................
312.320(b), Submissions related               12           12.67             152             300          45,600
 to a treatment IND or treatment
 protocol.......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............      19,134,039
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                            Table 2--Estimated Annual Recordkeeping Burden for Human Drugs\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Number of       Number of records     Total annual
              21 CFR Section                 recordkeepers     per recordkeeper        records       Average burden per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
312.52(a), Sponsor records for the                       335                1.50                503  2...............................              1,006
 transfer of obligations to a contract
 research organization.
312.57, Sponsor recordkeeping showing the              1,689                1                 1,689  100.............................            168,900
 receipt, shipment, or other disposition
 of the investigational drug, and any
 financial interests.
312.62(a), Investigator recordkeeping of               1,444                1                 1,444  40..............................             57,760
 the disposition of drugs.
312.62(b), Investigator recordkeeping of               1,444                1                 1,444  40..............................             57,760
 case histories of individuals.
312.160(a)(3), Records pertaining to the                 547                1.40                782  0.50 (30 minutes)...............                391
 shipment of drugs for investigational
 use in laboratory research animals or in
 vitro tests.
312.160(c) Shipper records of alternative                547                1.40                782  0.50 (30 minutes)...............                391
 disposition of unused drugs.
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  .................  ..................  .................  ................................            286,190
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                           Table 3--Estimated Annual Reporting Burden for Biologics\1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
312.2(e), Requests for FDA                   217            1.18             255              24           6,120
 advice on the applicability of
 part 312 to a planned clinical
 investigation..................
312.8, Requests to charge for an              20            1.50              30              48           1,440
 investigational drug...........
312.10, Requests to waive a                    2            1                  2              24              48
 requirement in part 312........
312.23(a) through (f), IND                   335            1.35             452           1,600         723,200
 content and format.............
312.30(a) through (e), Protocol              694            5.84           4,050             284       1,150,200
 amendments.....................
312.31(b), Information                        77            2.43             187             100          18,700
 amendments.....................
312.32(c) and (d), IND Safety                161            8.83           1,421              32          45,472
 reports........................
312.33(a) through (f), IND                   745            2.14           1,595             360         574,200
 Annual reports.................
312.38(b) and (c), Notifications             134            1.69             227              28           6,356
 of withdrawal of an IND........
312.42, Sponsor requests that a               67            1.30              87             284          24,708
 clinical hold be removed,
 including sponsor submission of
 a complete response to the
 issues identified in the
 clinical hold order............
312.44(c) and (d), Sponsor                    34            1.15              39              16             624
 responses to FDA when IND is
 terminated.....................
312.45(a) and (b), Sponsor                    55            1.38              76              12             912
 requests for or responses to an
 inactive status determination
 of an IND by FDA...............
312.47, Meetings, including                   88            1.75             154             160          24,640
 ``End-of-Phase 2'' meetings and
 ``Pre-NDA'' meetings...........
312.53(c), Investigator reports              453            6.33           2,869              80         229,520
 submitted to the sponsor,
 including Form FDA-1572,
 curriculum vitae, clinical
 protocol, and financial
 disclosure.....................

[[Page 65668]]

 
312.54(a), Sponsor submissions                 1            1                  1              48              48
 to FDA concerning
 investigations involving an
 exception from informed consent
 under Sec.   50.24.............
312.54(b), Sponsor notifications               1            1                  1              48              48
 to FDA and others concerning an
 IRB determination that it
 cannot approve research because
 it does not meet the criteria
 in the exception from informed
 consent in Sec.   50.24(a).....
312.55(a), Number of                         239            1.91             457              48          21,936
 investigator brochures
 submitted by the sponsor to
 each investigator..............
312.55(b), Number of sponsor                 243            4.95           1,203              48          57,744
 reports to investigators on new
 observations, especially
 adverse reactions and safe use.
312.56(b), (c), and (d), Sponsor             108            2.21             239              80          19,120
 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...
312.58(a), Number of sponsor's                 7            1                  7               8              56
 submissions of clinical
 investigation records to FDA on
 request during FDA inspections.
312.64, Number of investigator             2,728            3.82          10,411              24         249,864
 reports to the sponsor,
 including progress reports,
 safety reports, final reports,
 and financial disclosure
 reports........................
312.70, During the                             5            1                  5              40             200
 disqualification process of a
 clinical investigator by FDA,
 the number of investigator
 responses or requests to FDA
 following FDA's notification to
 an investigator of its failure
 to comply with investigation
 requirements...................
312.110(b)(4) and (b)(5), Number              18            1                 18              75           1,350
 of written certifications and
 written statements submitted to
 FDA relating to the export of
 an investigational drug........
312.120(b), Number of                        280            9.82           2,750              32          88,000
 submissions to FDA of
 ``supporting information''
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.120(c), Number of waiver                   7            2.29              16              24             384
 requests submitted to FDA
 related to the use of foreign
 clinical studies not conducted
 under an IND...................
312.130, Number of requests for              350            1.34             470               8           3,760
 disclosable information in an
 IND and for investigations
 involving an exception from
 informed consent under Sec.
 50.24..........................
312.310(b) and 312.305(b),                    78            1.08              84               8             672
 Number of submissions related
 to expanded access and
 treatment of an individual
 patient........................
312.310(d), Number of                         76            2.76             210              16           3,360
 submissions related to
 emergency use of an
 investigational new drug.......
312.315(c) and 312.305(b),                     9            1                  9             120           1,080
 Number of submissions related
 to expanded access and
 treatment of an intermediate-
 size patient population........
312.320(b), Number of                          1            1                  1             300             300
 submissions related to a
 treatment IND or treatment
 protocol.......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       3,254,062
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                             Table 4--Estimated Annual Recordkeeping Burden for Biologics\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Number of       Number of records     Total annual
              21 CFR Section                 recordkeepers     per recordkeeper        records       Average burden per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
312.52(a), Sponsor records for the                        75                1.40                105  2...............................                210
 transfer of obligations to a contract
 research organization.

[[Page 65669]]

 
312.57, Sponsor recordkeeping showing the                335                2.70                904  100.............................             90,400
 receipt, shipment, or other disposition
 of the investigational drug, and any
 financial interests.
312.62(a), Investigator recordkeeping of                 453                1                   453  40..............................             18,120
 the disposition of drugs.
312.62(b), Investigator recordkeeping of                 453                1                   453  40..............................             18,120
 case histories of individuals.
312.160(a)(3), Records pertaining to the                 111                1.40                155  0.50 (30 minutes)...............                 78
 shipment of drugs for investigational
 use in laboratory research animals or in
 vitro tests.
312.160(c), Shipper records of                           111                1.40                155  0.50 (30 minutes)...............                 78
 alternative disposition of unused drugs.
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  .................  ..................  .................  ................................            127,006
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26304 Filed 11-4-14; 8:45 am]
BILLING CODE 4164-01-P