Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926, 55723-55726 [2018-24321]

Download as PDF Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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 to the Office of Communication, Outreach, and Development, 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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Scott N. Goldie, Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993–0002, 301–796–2055; 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SUPPLEMENTARY INFORMATION: amozie on DSK3GDR082PROD with NOTICES1 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products.’’ Evaluating the safety of drug products, both before approval and after marketing, is a fundamental responsibility of the FDA. This evaluation often requires combining and integrating information from multiple sources, and meta-analysis is a useful tool for this purpose. This draft guidance describes general principles of design, conduct, and reporting that FDA intends to apply to meta-analyses conducted by the Agency, and to use as benchmarks when evaluating meta-analyses conducted by sponsors or third parties. The focus of the draft guidance is on the evaluation of safety. This draft guidance is not intended to be a reference guide on how to conduct a meta-analysis. Rather, this draft guidance document discusses the important principles underlying best practices for safety meta-analyses and the way that FDA intends to factor VerDate Sep<11>2014 17:46 Nov 06, 2018 Jkt 247001 adherence to those principles into its decision-making process. This draft guidance is being issued to fulfill a commitment made under the Prescription Drug User Fee V agreement (section IX.B.3 of the document entitled ‘‘PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017’’) to promote a better understanding and increased consistency among the Agency, industry and other stakeholders regarding metaanalyses and their role in regulatory decision-making. 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 ‘‘Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products.’’ 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft 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 parts 312, 314, and 601 have been approved under OMB control numbers 0910–0014, 0910–0001, and 0910–0338 respectively. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://www.regulations.gov. Dated: November 1, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–24316 Filed 11–6–18; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 55723 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3758] Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 individual patient expanded access applications. DATES: Submit either electronic or written comments on the collection of information by January 7, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 7, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such E:\FR\FM\07NON1.SGM 07NON1 55724 Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices amozie on DSK3GDR082PROD with NOTICES1 as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–N–3758 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not VerDate Sep<11>2014 17:46 Nov 06, 2018 Jkt 247001 in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, 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) PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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. Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926 OMB Control Number 0910–0814— Extension This information collection supports Agency regulations, associated guidance, and Form FDA 3926 concerning individual patient expanded access. Individual patient expanded access allows an individual patient who has a serious or immediately lifethreatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition, the use of an investigational new drug (IND) outside of a clinical investigation, or the use of an approved drug where availability is limited by a risk evaluation and mitigation strategy. When applicable criteria in § 312.305(a) (21 CFR 312.305(a)) (which apply to all types of expanded access) and the criteria in § 312.310(a) (21 CFR 312.310(a)) (which apply specifically to individual patient expanded access, including for emergency use) are met, FDA may permit expanded access. Section 312.305(b) sets forth the submission requirements for all types of expanded access requests. To assist respondents with requirements in § 312.305 we developed Form FDA 3926 (Individual Patient Expanded Access Investigational New Drug Application) and the guidance document entitled, ‘‘Individual Patient Expanded Access Applications: Form FDA 3926.’’ The physician may satisfy some of the submission requirements by referring to information in an existing IND, ordinarily the one held by the investigational drug’s manufacturer, if the physician obtains permission from that IND holder. If permission is obtained, the physician should then provide to FDA a letter of authorization (LOA) from the existing IND holder that permits FDA to reference that IND. One of the requirements under § 312.305(b)(2) is that a ‘‘cover sheet’’ must be included ‘‘meeting the requirements of § 312.23(a).’’ This provision applies to several types of submissions under part 312 (21 CFR part 312), ranging from commercial INDs under § 312.23 that involve large groups of patients enrolled in clinical trials to requests from physicians to use an investigational drug for an individual E:\FR\FM\07NON1.SGM 07NON1 Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices patient. Sponsors currently use Form FDA 1571 for all types of IND submissions to meet the requirements in § 312.23(a). Concerned that physicians requesting expanded access for an individual patient may encounter difficulty in completing Form FDA 1571 and the associated documents because the form is not tailored to requests for individual patient expanded access, we developed Form FDA 3926 to comply with the IND submission requirements in §§ 312.23, 312.305(b), and 312.310(b). Form FDA 3926 provides a streamlined means to request expanded access and is available for licensed physicians. FDA considers a completed Form FDA 3926 with the box in Field 10 checked and the form signed by the physician to be a request in accordance with § 312.10 for a waiver of any additional requirements in part 312 for an IND submission, including additional information currently provided in Form FDA 1571 and Form FDA 1572 (Statement of Investigator, which provides the identity and qualifications of the investigator conducting the clinical investigation). Under § 312.310(d), in an emergency situation that requires the patient to be treated before a written submission can be made, the request to use the investigational drug for individual patient expanded access may be made by telephone (or other rapid means of communication) to the appropriate FDA review division. Authorization of the emergency use may be given by an FDA official over the telephone, provided the physician explains how the expanded access use will meet the requirements of §§ 312.305 and 312.310 and agrees to submit an expanded access application within 15 working days of FDA’s initial authorization of the expanded access use (§ 312.310(d)). The physician may choose to use Form FDA 3926 for the expanded access application. As explained in the instructions for Form FDA 3926 and discussed in the guidance document, the following information is submitted to FDA: • Initials for the patient and date of submission. • Type of submission (initial or follow-up submission). • Clinical information, including indication, brief clinical history of the patient (age, gender, weight, allergies, diagnosis, prior therapy, response to prior therapy), and the reason for requesting the proposed treatment, including an explanation of why the patient lacks other therapeutic options. • Treatment information, including the investigational drug’s name and the name of the entity supplying the drug (generally the manufacturer), the applicable FDA review division (if known), and the treatment plan. This should include the planned dose, route and schedule of administration, planned duration of treatment, monitoring procedures, and planned modifications to the treatment plan in the event of toxicity. • LOA, generally obtained from the entity that is the sponsor of the IND (e.g., commercial sponsor/drug manufacturer) being referenced, if applicable. • Physician’s qualification statement. An appropriate statement includes medical school attended, year of graduation, medical specialty, State medical license number, current employment, and job title. Alternatively, the relevant portion of the physician’s curriculum vitae may be attached. • Physician’s contact information, including name, physical address, email address, telephone number, facsimile number, and physician’s IND number, if previously issued by FDA. • Contents of submission (for followup/additional submissions), including the type of submission being made. FDA 55725 accepts Form FDA 3926 for certain follow-up/additional submissions, which include the following: Initial Written IND Safety Report (§ 312.32(c)); Followup to a Written IND Safety Report (§ 312.32(d)); Annual Report (§ 312.33); Summary of Expanded Access Use (treatment completed) (§ 312.310(c)(2)); Change in Treatment Plan (§ 312.30); General Correspondence or Response to FDA Request for Information (§ 312.41); and Response to Clinical Hold (§ 312.42(e)). • Request for authorization to use Form FDA 3926 for individual patient expanded access application. • Signature of the physician certifying that treatment will not begin until 30 days after FDA receives the completed application and all required material unless the submitting physician receives earlier notification from FDA that the treatment may proceed. The physician agrees not to begin or continue clinical investigations covered by the IND if those studies are placed on clinical hold. The physician also certifies that informed consent will be obtained in compliance with Federal requirements (including FDA’s regulations in 21 CFR part 50) and that an institutional review board (IRB) that complies with all Federal requirements (including FDA’s regulations in 21 CFR part 56) will be responsible for initial and continuing review and approval of the expanded access use. The physician also acknowledges that in the case of an emergency request, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment. The physician agrees to conduct the investigation in accordance with all other applicable regulatory requirements. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Guidance on Individual Patient Expanded Access Applications: Form FDA 3926 Number of respondents Expanded access submission elements included in Form FDA 3926. amozie on DSK3GDR082PROD with NOTICES1 1 There Number of responses per respondent 790 Average burden per response Total annual responses 3.03 2,394 0.75 (45 mins.) ...... Total hours 1,795 are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection, we are retaining the currently approved burden estimate. The estimates for ‘‘number of respondents,’’ ‘‘number of responses per respondent,’’ and ‘‘total annual responses’’ were obtained from reports VerDate Sep<11>2014 17:46 Nov 06, 2018 Jkt 247001 and data management systems from the Center for Drug Evaluation and Research (CDER) and from other sources familiar with the number of submissions received for individual patient expanded access use under part 312. The estimates for ‘‘average burden per PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 response’’ were based on information CDER provided and personnel of the U.S. Department of Health and Human Services familiar with preparing and reviewing expanded access submissions by practicing physicians. E:\FR\FM\07NON1.SGM 07NON1 55726 Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices Based on data from the Document Archiving, Reporting and Regulatory Tracking System for the number of submissions to FDA using FDA Form 3926 during fiscal years 2015, 2016, and 2017, we estimate that approximately 790 licensed physicians would use FDA Form 3926 to submit 1.46 requests per physician (respondent) for individual patient expanded access, for a total of 1,153 responses annually. Based on these estimates, FDA calculates the total annual responses to be 2,394 (1,153 requests for individual patient expanded access and 1,241 follow-up submissions) by 790 physicians for an average of 3.03 responses per respondent. FDA estimates the average burden per response to be 45 minutes (0.75 hour). Based on this estimate, FDA calculates the total burden to be 1,795 hours. Dated: October 31, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–24321 Filed 11–6–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–4130] Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 the procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements. amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:46 Nov 06, 2018 Jkt 247001 Submit either electronic or written comments on the collection of information by January 7, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 7, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–N–4130 for ‘‘Agency Information PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55723-55726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24321]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3758]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Individual Patient Expanded Access Applications: Form 
FDA 3926

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (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 individual patient expanded 
access applications.

DATES: Submit either electronic or written comments on the collection 
of information by January 7, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 7, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such

[[Page 55724]]

as a manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-3758 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance for Industry on 
Individual Patient Expanded Access Applications: Form FDA 3926.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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.

Guidance for Industry on Individual Patient Expanded Access 
Applications: Form FDA 3926

OMB Control Number 0910-0814--Extension

    This information collection supports Agency regulations, associated 
guidance, and Form FDA 3926 concerning individual patient expanded 
access. Individual patient expanded access allows an individual patient 
who has a serious or immediately life-threatening disease or condition 
and there is no comparable or satisfactory alternative therapy to 
diagnose, monitor, or treat the disease or condition, the use of an 
investigational new drug (IND) outside of a clinical investigation, or 
the use of an approved drug where availability is limited by a risk 
evaluation and mitigation strategy. When applicable criteria in Sec.  
312.305(a) (21 CFR 312.305(a)) (which apply to all types of expanded 
access) and the criteria in Sec.  312.310(a) (21 CFR 312.310(a)) (which 
apply specifically to individual patient expanded access, including for 
emergency use) are met, FDA may permit expanded access.
    Section 312.305(b) sets forth the submission requirements for all 
types of expanded access requests. To assist respondents with 
requirements in Sec.  312.305 we developed Form FDA 3926 (Individual 
Patient Expanded Access Investigational New Drug Application) and the 
guidance document entitled, ``Individual Patient Expanded Access 
Applications: Form FDA 3926.''
    The physician may satisfy some of the submission requirements by 
referring to information in an existing IND, ordinarily the one held by 
the investigational drug's manufacturer, if the physician obtains 
permission from that IND holder. If permission is obtained, the 
physician should then provide to FDA a letter of authorization (LOA) 
from the existing IND holder that permits FDA to reference that IND.
    One of the requirements under Sec.  312.305(b)(2) is that a ``cover 
sheet'' must be included ``meeting the requirements of Sec.  
312.23(a).'' This provision applies to several types of submissions 
under part 312 (21 CFR part 312), ranging from commercial INDs under 
Sec.  312.23 that involve large groups of patients enrolled in clinical 
trials to requests from physicians to use an investigational drug for 
an individual

[[Page 55725]]

patient. Sponsors currently use Form FDA 1571 for all types of IND 
submissions to meet the requirements in Sec.  312.23(a).
    Concerned that physicians requesting expanded access for an 
individual patient may encounter difficulty in completing Form FDA 1571 
and the associated documents because the form is not tailored to 
requests for individual patient expanded access, we developed Form FDA 
3926 to comply with the IND submission requirements in Sec. Sec.  
312.23, 312.305(b), and 312.310(b). Form FDA 3926 provides a 
streamlined means to request expanded access and is available for 
licensed physicians. FDA considers a completed Form FDA 3926 with the 
box in Field 10 checked and the form signed by the physician to be a 
request in accordance with Sec.  312.10 for a waiver of any additional 
requirements in part 312 for an IND submission, including additional 
information currently provided in Form FDA 1571 and Form FDA 1572 
(Statement of Investigator, which provides the identity and 
qualifications of the investigator conducting the clinical 
investigation).
    Under Sec.  312.310(d), in an emergency situation that requires the 
patient to be treated before a written submission can be made, the 
request to use the investigational drug for individual patient expanded 
access may be made by telephone (or other rapid means of communication) 
to the appropriate FDA review division. Authorization of the emergency 
use may be given by an FDA official over the telephone, provided the 
physician explains how the expanded access use will meet the 
requirements of Sec. Sec.  312.305 and 312.310 and agrees to submit an 
expanded access application within 15 working days of FDA's initial 
authorization of the expanded access use (Sec.  312.310(d)). The 
physician may choose to use Form FDA 3926 for the expanded access 
application.
    As explained in the instructions for Form FDA 3926 and discussed in 
the guidance document, the following information is submitted to FDA:
     Initials for the patient and date of submission.
     Type of submission (initial or follow-up submission).
     Clinical information, including indication, brief clinical 
history of the patient (age, gender, weight, allergies, diagnosis, 
prior therapy, response to prior therapy), and the reason for 
requesting the proposed treatment, including an explanation of why the 
patient lacks other therapeutic options.
     Treatment information, including the investigational 
drug's name and the name of the entity supplying the drug (generally 
the manufacturer), the applicable FDA review division (if known), and 
the treatment plan. This should include the planned dose, route and 
schedule of administration, planned duration of treatment, monitoring 
procedures, and planned modifications to the treatment plan in the 
event of toxicity.
     LOA, generally obtained from the entity that is the 
sponsor of the IND (e.g., commercial sponsor/drug manufacturer) being 
referenced, if applicable.
     Physician's qualification statement. An appropriate 
statement includes medical school attended, year of graduation, medical 
specialty, State medical license number, current employment, and job 
title. Alternatively, the relevant portion of the physician's 
curriculum vitae may be attached.
     Physician's contact information, including name, physical 
address, email address, telephone number, facsimile number, and 
physician's IND number, if previously issued by FDA.
     Contents of submission (for follow-up/additional 
submissions), including the type of submission being made. FDA accepts 
Form FDA 3926 for certain follow-up/additional submissions, which 
include the following: Initial Written IND Safety Report (Sec.  
312.32(c)); Followup to a Written IND Safety Report (Sec.  312.32(d)); 
Annual Report (Sec.  312.33); Summary of Expanded Access Use (treatment 
completed) (Sec.  312.310(c)(2)); Change in Treatment Plan (Sec.  
312.30); General Correspondence or Response to FDA Request for 
Information (Sec.  312.41); and Response to Clinical Hold (Sec.  
312.42(e)).
     Request for authorization to use Form FDA 3926 for 
individual patient expanded access application.
     Signature of the physician certifying that treatment will 
not begin until 30 days after FDA receives the completed application 
and all required material unless the submitting physician receives 
earlier notification from FDA that the treatment may proceed. The 
physician agrees not to begin or continue clinical investigations 
covered by the IND if those studies are placed on clinical hold. The 
physician also certifies that informed consent will be obtained in 
compliance with Federal requirements (including FDA's regulations in 21 
CFR part 50) and that an institutional review board (IRB) that complies 
with all Federal requirements (including FDA's regulations in 21 CFR 
part 56) will be responsible for initial and continuing review and 
approval of the expanded access use. The physician also acknowledges 
that in the case of an emergency request, treatment may begin without 
prior IRB approval, provided the IRB is notified of the emergency 
treatment within 5 working days of treatment. The physician agrees to 
conduct the investigation in accordance with all other applicable 
regulatory requirements.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
   Guidance on Individual Patient  Expanded       Number of     responses per   Total annual         Average  burden per  response          Total hours
     Access  Applications: Form FDA 3926         respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expanded access submission elements included              790            3.03           2,394  0.75 (45 mins.)..........................           1,795
 in Form FDA 3926.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection, we are retaining 
the currently approved burden estimate. The estimates for ``number of 
respondents,'' ``number of responses per respondent,'' and ``total 
annual responses'' were obtained from reports and data management 
systems from the Center for Drug Evaluation and Research (CDER) and 
from other sources familiar with the number of submissions received for 
individual patient expanded access use under part 312. The estimates 
for ``average burden per response'' were based on information CDER 
provided and personnel of the U.S. Department of Health and Human 
Services familiar with preparing and reviewing expanded access 
submissions by practicing physicians.

[[Page 55726]]

    Based on data from the Document Archiving, Reporting and Regulatory 
Tracking System for the number of submissions to FDA using FDA Form 
3926 during fiscal years 2015, 2016, and 2017, we estimate that 
approximately 790 licensed physicians would use FDA Form 3926 to submit 
1.46 requests per physician (respondent) for individual patient 
expanded access, for a total of 1,153 responses annually. Based on 
these estimates, FDA calculates the total annual responses to be 2,394 
(1,153 requests for individual patient expanded access and 1,241 
follow-up submissions) by 790 physicians for an average of 3.03 
responses per respondent. FDA estimates the average burden per response 
to be 45 minutes (0.75 hour). Based on this estimate, FDA calculates 
the total burden to be 1,795 hours.

    Dated: October 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24321 Filed 11-6-18; 8:45 am]
 BILLING CODE 4164-01-P