Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications; Draft Guidance for Industry; Availability, 49391-49393 [2018-21243]

Download as PDF Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices Estimated Total Annual Burden Hours (Rounded from 523.98): 524. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research, and Evaluation, 330 C Street SW, Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Emily B. Jabbour, ACF/OPRE Certifying Officer. [FR Doc. 2018–21226 Filed 9–28–18; 8:45 am] BILLING CODE 4184–41–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Administration on Intellectual and Developmental Disabilities, President’s Committee for People With Intellectual Disabilities Administration for Community Living, HHS. ACTION: Notice. AGENCY: Thursday, November 8, 2018 from 9:00 a.m. to 4:30 p.m.; and Friday, November 9, 2018 from 9:00 a.m. to 4:30 p.m. These meetings will be open to the general public. ADDRESSES: These meetings will be held at the U.S. Access Board, located at 1331 F Street NW, Suite 800, Washington, DC 20004. Individuals who would like to participate via conference call may do so by dialing toll-free #: 1– 888–949–2790, when prompted enter pass code: 1989852. Individuals whose full participation in the meeting will require special accommodations (e.g., sign language interpreting services, assistive listening devices, materials in alternative format such as large print or Braille) should notify Ms. Allison Cruz, Director, Office of Innovation, via email at Allison.Cruz@acl.hhs.gov, or via amozie on DSK3GDR082PROD with NOTICES DATES: VerDate Sep<11>2014 17:50 Sep 28, 2018 Jkt 247001 telephone at 202–795–7334, no later than Monday, October 19, 2018. The PCPID will attempt to accommodate requests made after this date, but cannot guarantee the ability to grant requests received after the deadline. All meeting sites are barrier free, consistent with the Americans with Disabilities Act (ADA) and the Federal Advisory Committee Act (FACA). FOR FURTHER INFORMATION CONTACT: Ms. Allison Cruz, Director, Office of Innovation, 330 C Street SW, Switzer Building, Room 1114, Washington, DC 20201. Telephone: 202–795–7334. Fax: 202–795–7334. Email: Allison.Cruz@ acl.hhs.gov The PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and support for individuals with intellectual disabilities. The PCPID executive order stipulates that the Committee shall: (1) Provide such advice concerning intellectual disabilities as the President or the Secretary of Health and Human Services may request; and (2) provide advice to the President concerning the following for people with intellectual disabilities: (A) Expanding employment opportunities; (B) connecting people to services; (C) supporting families and caregivers; (D) strengthening the networks; and (E) protecting rights and preventing abuse. Agenda: The Committee Members will discuss preparation of the PCPID 2019 Report to the President, including its content and format, and related data collection and analysis required to complete the writing of the Report. SUPPLEMENTARY INFORMATION: Dated: September 24, 2018. Mary Lazare, Principal Deputy Administrator, Administration for Community Living. [FR Doc. 2018–21319 Filed 9–28–18; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 49391 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to an IND, NDA, BLA, or ANDA.’’ The draft guidance provides recommendations to industry and FDA staff regarding the content and submission procedures for use-related risk analyses, human factors validation study protocols and reports, threshold analyses, and comparative use human factors study protocols and reports. DATES: Submit either electronic or written comments on the draft guidance by November 30, 2018 to ensure that the Agency considers your comments in this review. ADDRESSES: You may submit comments as follows: 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 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 Food and Drug Administration [Docket No. FDA–2018–D–3275] Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice of availability. Frm 00039 Fmt 4703 Sfmt 4703 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 E:\FR\FM\01OCN1.SGM 01OCN1 amozie on DSK3GDR082PROD with NOTICES 49392 Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–D–3275 for ‘‘Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to an IND, NDA, BLA or ANDA.’’ Received comments 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. 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 VerDate Sep<11>2014 17:50 Sep 28, 2018 Jkt 247001 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: Quynh Nhu Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 22, Rm. 4408, Silver Spring, MD 20993, 301–796– 6273, email: quynht.nguyen@ fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Contents of Threshold Analyses and Human Factors Submissions to an IND, NDA, BLA, or ANDA.’’ This document provides guidance to industry on the content and submission procedures for human factors (HF) submissions to promote efficient Agency review. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that drug products submitted for approval under section 505(b) be proven safe and demonstrate substantial evidence of effectiveness for the product’s intended use (21 U.S.C. 355(b)). Under section 351 of the Public Health Service Act (42 U.S. 262), FDA licenses a biological product based on a demonstration that it is safe, pure, and potent, and that it is manufactured in a facility designed to ensure the product continues to be safe, pure, and potent. As part of evaluating drug and biologic products for safety and effectiveness, FDA will evaluate HF data submitted by sponsors in support of the product user interface when submission of such data is warranted. For products that sponsors intend to submit as an abbreviated new drug application (ANDA), the sponsor can rely on the Agency’s previous finding that the listed drug is safe and effective so long as the sponsor can demonstrate certain findings. Certain products, including drug-device combination PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 products, may warrant threshold analyses and additional data, such as data from comparative HF studies. This draft guidance provides recommendations to industry and FDA staff regarding the content and submission procedures for use-related risk analyses, human factors validation study protocols and reports, threshold analyses, and comparative use HF study protocols and reports. This draft guidance applies to submissions for the following types of products: • Human prescription drug products, including biologics, that are the subject of an investigational new drug application (IND), a new drug application (NDA), a biologics license application (BLA), or an abbreviated new drug application (ANDA), and supplements to these applications • Human nonprescription drug products that are the subject of an IND, NDA, or ANDA This draft guidance does not describe when threshold analyses or HF submissions are warranted for any particular application pathway, the processes or procedures associated with their review, or the methods used by the Agency for evaluation. Furthermore, this draft guidance does not describe the methods used to design, conduct, or analyze HF studies. This draft guidance is being issued consistent with FDA’s good guidance practices (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on ‘‘Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to an IND, NDA, BLA or ANDA.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 312 and Form FDA 1571 have been approved under OMB control number 0910–0014. The collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001. The collections of information in 21 CFR part 601 and Form FDA 356h have been approved under OMB control number 0910–0338. E:\FR\FM\01OCN1.SGM 01OCN1 Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices 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: September 25, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–21243 Filed 9–28–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3490] Agency Information Collection Activities; Proposed Collection; Comment Request; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records 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 information collection provisions of the guidance entitled ‘‘Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.’’ DATES: Submit either electronic or written comments on the collection of information by November 30, 2018. 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 November 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. midnight Eastern Time at the end of November amozie on DSK3GDR082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:50 Sep 28, 2018 Jkt 247001 30, 2018. 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 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–3490 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records.’’ 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 49393 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. 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 E:\FR\FM\01OCN1.SGM 01OCN1

Agencies

[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49391-49393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21243]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3275]


Contents of a Complete Submission for Threshold Analyses and 
Human Factors Submissions to Drug and Biologic Applications; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Contents 
of a Complete Submission for Threshold Analyses and Human Factors 
Submissions to an IND, NDA, BLA, or ANDA.'' The draft guidance provides 
recommendations to industry and FDA staff regarding the content and 
submission procedures for use-related risk analyses, human factors 
validation study protocols and reports, threshold analyses, and 
comparative use human factors study protocols and reports.

DATES: Submit either electronic or written comments on the draft 
guidance by November 30, 2018 to ensure that the Agency considers your 
comments in this review.

ADDRESSES: You may submit comments as follows:

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

[[Page 49392]]

identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-3275 for ``Contents of a Complete Submission for Threshold 
Analyses and Human Factors Submissions to an IND, NDA, BLA or ANDA.'' 
Received comments 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.
    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: Quynh Nhu Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 22, Rm. 4408, Silver Spring, MD 20993, 301-796-
6273, email: [email protected]; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Contents of Threshold Analyses and Human Factors Submissions 
to an IND, NDA, BLA, or ANDA.'' This document provides guidance to 
industry on the content and submission procedures for human factors 
(HF) submissions to promote efficient Agency review.
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that 
drug products submitted for approval under section 505(b) be proven 
safe and demonstrate substantial evidence of effectiveness for the 
product's intended use (21 U.S.C. 355(b)). Under section 351 of the 
Public Health Service Act (42 U.S. 262), FDA licenses a biological 
product based on a demonstration that it is safe, pure, and potent, and 
that it is manufactured in a facility designed to ensure the product 
continues to be safe, pure, and potent. As part of evaluating drug and 
biologic products for safety and effectiveness, FDA will evaluate HF 
data submitted by sponsors in support of the product user interface 
when submission of such data is warranted. For products that sponsors 
intend to submit as an abbreviated new drug application (ANDA), the 
sponsor can rely on the Agency's previous finding that the listed drug 
is safe and effective so long as the sponsor can demonstrate certain 
findings. Certain products, including drug-device combination products, 
may warrant threshold analyses and additional data, such as data from 
comparative HF studies.
    This draft guidance provides recommendations to industry and FDA 
staff regarding the content and submission procedures for use-related 
risk analyses, human factors validation study protocols and reports, 
threshold analyses, and comparative use HF study protocols and reports. 
This draft guidance applies to submissions for the following types of 
products:
     Human prescription drug products, including biologics, 
that are the subject of an investigational new drug application (IND), 
a new drug application (NDA), a biologics license application (BLA), or 
an abbreviated new drug application (ANDA), and supplements to these 
applications
     Human nonprescription drug products that are the subject 
of an IND, NDA, or ANDA
    This draft guidance does not describe when threshold analyses or HF 
submissions are warranted for any particular application pathway, the 
processes or procedures associated with their review, or the methods 
used by the Agency for evaluation. Furthermore, this draft guidance 
does not describe the methods used to design, conduct, or analyze HF 
studies.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (21 CFR 10.115). The draft guidance, when finalized, 
will represent FDA's current thinking on ``Contents of a Complete 
Submission for Threshold Analyses and Human Factors Submissions to an 
IND, NDA, BLA or ANDA.'' It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 312 and Form FDA 1571 have 
been approved under OMB control number 0910-0014. The collections of 
information in 21 CFR part 314 have been approved under OMB control 
number 0910-0001. The collections of information in 21 CFR part 601 and 
Form FDA 356h have been approved under OMB control number 0910-0338.

[[Page 49393]]

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21243 Filed 9-28-18; 8:45 am]
 BILLING CODE 4164-01-P

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