Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 5764-5766 [2016-01888]

Download as PDF 5764 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices information collection is available on the Internet at http://www.reginfo.gov/ public/do/PRAMain. DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: January 28, 2016. Leslie Kux, Associate Commissioner for Policy. Food and Drug Administration Food and Drug Administration [Docket No. FDA–2015–D–4848] [Docket No. FDA–2011–N–0915] [FR Doc. 2016–01883 Filed 2–2–16; 8:45 am] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0253] AGENCY: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Postmarketing Adverse Drug Experience Reporting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Postmarketing Adverse Drug Experience Reporting’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On July 1, 2015, the Agency submitted a proposed collection of information entitled ‘‘Postmarketing Adverse Drug Experience Reporting’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0230. The approval expires on December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/ public/do/PRAMain. On July 2, 2015, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0636. The approval expires on December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/ public/do/PRAMain. Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy. Dated: January 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–01884 Filed 2–2–16; 8:45 am] [FR Doc. 2016–01885 Filed 2–2–16; 8:45 am] BILLING CODE 4164–01–P BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES Food and Drug Administration, HHS. VerDate Sep<11>2014 19:14 Feb 02, 2016 Jkt 238001 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.’’ This document provides guidance to industry and FDA staff on the underlying principles of human factors (HF) studies during the development of combination products. Combination products are comprised of any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 3, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// 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 http://www.regulations.gov. E:\FR\FM\03FEN1.SGM 03FEN1 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES • 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2015–D–4848 for ‘‘Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 VerDate Sep<11>2014 19:14 Feb 02, 2016 Jkt 238001 comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Office of Combination Products, Food and Drug Administration, Bldg. 32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send one selfaddressed 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: Patricia Love, Deputy Director, Office of Combination Products, Office of Special Medical Programs, Office of Medical Products and Tobacco, Office of the Commissioner, Food and Drug Administration, at patricia.love@ fda.hhs.gov or 301–796–8933. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.’’ This document provides guidance to industry and FDA staff on the underlying principles of HF studies during the development of combination products as defined under 21 CFR part 3. This draft guidance describes Agency recommendations regarding HF information in a combination product investigational or marketing application. It clarifies the different types of HF studies, offers recommendations for timing and sequencing of HF studies, and discusses how HF studies contribute to assuring that combination products are safe and effective for the intended users, uses and environments. The draft guidance also addresses process considerations for HF information in investigational or marketing applications to promote development and timely review of safe and effective combination products. In addition, the draft guidance describes PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 5765 how HF studies relate to other clinical studies. This draft guidance refers to two existing guidance documents that provide related information on HF considerations. These are Guidance for Industry and FDA Staff, ‘‘Applying Human Factors and Usability Engineering to Optimize Medical Device Design,’’ accessible at http:// www.fda.gov/downloads/ MedicalDevices/DeviceRegulation andGuidance/GuidanceDocuments/ UCM259760.pdf and Draft Guidance ‘‘Safety Considerations for Product Design to Minimize Medication Errors,’’ accessible at http://www.fda.gov/ downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ UCM331810.pdf. This draft guidance provides examples of the use of HF studies for different types of combination products in different clinical settings. FDA welcomes comments to the docket on other examples of combination products and why they may or may not need HF studies. Additionally FDA seeks comments on what challenges and development risks may arise depending upon whether HF studies are conducted before, in parallel to, or after major clinical studies. II. Significance of Guidance 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 ‘‘Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.’’ 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. III. Electronic Access Persons with access to the Internet may obtain the document at http://www. fda.gov/RegulatoryInformation/ Guidances/ucm122047.htm, http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or http:// www.regulations.gov. IV. Paperwork Reduction Act of 1995 This draft guidance refers to currently 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 E:\FR\FM\03FEN1.SGM 03FEN1 5766 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 21 CFR part 314 for NDAs and ANDAs have been approved under OMB control number 0910–0001. The collections of information in 21 CFR part 601 for BLAs have been approved under OMB control number 0910–0338. The collections of information in 21 CFR part 814, subparts B and E, for PMAs have been approved under OMB control number 0910–0231. The collections of information in 21 CFR part 814, subpart H, for humanitarian device exemption applications have been approved under OMB control number 0910–0332. The collections of information in 21 CFR part 807, subpart E, for 510(k) notifications have been approved under OMB control number 0901–0120. The collections of information in 21 CFR part 312 for INDs have been approved under OMB control number 0910–0014. The collections of information in 21 CFR part 812 for IDEs have been approved under OMB control number 0910–0078. The collections of information in 21 CFR part 820 for the quality system regulation have been approved under OMB control number 0910–0073. Dated: January 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–01888 Filed 2–2–16; 8:45 am] BILLING CODE 4161–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Meeting of the Presidential Commission for the Study of Bioethical Issues Presidential Commission for the Study of Bioethical Issues, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice of meeting. AGENCY: The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twenty fourth meeting on March 3, 2016. At this teleconference meeting, the Commission will discuss its ongoing development of pedagogical materials to facilitate the integration of bioethics into education in a range of traditional and non-traditional settings. DATES: The teleconference meeting will take place March 3, 2016, from 2 p.m. to approximately 4 p.m. ADDRESSES: The public teleconference will be conducted by telephone only. The agenda and call-in number will be posted at least one week in advance at http://www.bioethics.gov. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:14 Feb 02, 2016 Jkt 238001 Lisa M. Lee, Executive Director, Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue NW., Suite C–100, Washington, DC 20005. Telephone: 202–233–3960. Email: Lisa.Lee@bioethics.gov. Additional information may be obtained at www.bioethics.gov. FOR FURTHER INFORMATION CONTACT: Pursuant to the Federal Advisory Committee Act of 1972, Public Law 92–463, 5 U.S.C. app. 2, notice is hereby given of the twenty fourth meeting of the Commission. The public teleconference will be open to the public with attendance limited to space available. Under authority of Executive Order 13521, dated November 24, 2009, the President established the Commission. The Commission is an expert panel of not more than 13 members who are drawn from the fields of bioethics, science, medicine, technology, engineering, law, philosophy, theology, or other areas of the humanities or social sciences. The Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner. The main agenda for the Commission’s twenty fourth meeting is to discuss its ongoing development of pedagogical materials to facilitate the integration of bioethics into education in a range of traditional and nontraditional settings. The draft meeting agenda, call-in number, and other information about the Commission will be available at www.bioethics.gov. The Commission welcomes input from anyone wishing to provide public comment on any issue before it. Respectful consideration of opposing views and active participation by citizens in public exchange of ideas enhances overall public understanding of the issues at hand and conclusions reached by the Commission. The Commission is particularly interested in receiving comments and questions during the meeting that are responsive to specific sessions. Written comments will be accepted in advance, during, and after the meeting and are especially welcome. Comments will be publicly available, including any personally identifiable or confidential business information that they contain. Trade secrets should not be submitted. Written comments will be accepted by email to info@bioethics.gov, or by mail SUPPLEMENTARY INFORMATION: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 to the following address: Public Commentary, Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue NW., Suite C–100, Washington, DC 20005. To accommodate as many individuals as possible, the time for each question or comment may be limited. If the number of individuals wishing to pose a question or make a comment is greater than can reasonably be accommodated during the scheduled meeting, the Commission may make a random selection. Anyone planning to call into the meeting, who needs special assistance or other reasonable accommodations, should notify Esther Yoo by telephone at (202) 233–3960, or email at Esther.Yoo@bioethics.gov in advance of the meeting. The Commission will make every effort to accommodate persons who need special assistance. Dated: January 20, 2016. Lisa M. Lee, Executive Director, Presidential Commission for the Study of Bioethical Issues. [FR Doc. 2016–01982 Filed 2–2–16; 8:45 am] BILLING CODE 4154–06–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Presidential Advisory Council on HIV/AIDS; Correction Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. AGENCY: ACTION: Notice; correction. The meeting of the Presidential Advisory Council on HIV/ AIDS (PACHA) scheduled for January 28 and 29, 2016, is postponed due to inclement weather. This meeting will be rescheduled at a future date. SUMMARY: FOR FURTHER INFORMATION CONTACT: Caroline Talev, MPA, Committee Manager, Hubert Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. Phone: 202– 205–1178. Fax: 202–401–4005. Email: Caroline.Talev@hhs.gov. Correction In the Federal Register of January 5, 2016, Vol. 81, No. 2, on pages 243–244 a meeting of the Presidential Advisory Council on HIV/AIDS was announced. That meeting has been cancelled due to inclement weather. E:\FR\FM\03FEN1.SGM 03FEN1

Agencies

[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5764-5766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01888]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4848]


Human Factors Studies and Related Clinical Study Considerations 
in Combination Product Design and Development; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry and FDA staff 
entitled ``Human Factors Studies and Related Clinical Study 
Considerations in Combination Product Design and Development.'' This 
document provides guidance to industry and FDA staff on the underlying 
principles of human factors (HF) studies during the development of 
combination products. Combination products are comprised of any 
combination of a drug and a device; a device and a biological product; 
a biological product and a drug; or a drug, a device, and a biological 
product.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 3, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://www.regulations.gov.

[[Page 5765]]

     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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-D-4848 for ``Human Factors Studies and Related Clinical Study 
Considerations in Combination Product Design and Development.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Combination Products, Food and Drug Administration, Bldg. 
32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. 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: Patricia Love, Deputy Director, Office 
of Combination Products, Office of Special Medical Programs, Office of 
Medical Products and Tobacco, Office of the Commissioner, Food and Drug 
Administration, at patricia.love@fda.hhs.gov or 301-796-8933.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Human Factors Studies and Related Clinical 
Study Considerations in Combination Product Design and Development.'' 
This document provides guidance to industry and FDA staff on the 
underlying principles of HF studies during the development of 
combination products as defined under 21 CFR part 3. This draft 
guidance describes Agency recommendations regarding HF information in a 
combination product investigational or marketing application. It 
clarifies the different types of HF studies, offers recommendations for 
timing and sequencing of HF studies, and discusses how HF studies 
contribute to assuring that combination products are safe and effective 
for the intended users, uses and environments. The draft guidance also 
addresses process considerations for HF information in investigational 
or marketing applications to promote development and timely review of 
safe and effective combination products. In addition, the draft 
guidance describes how HF studies relate to other clinical studies.
    This draft guidance refers to two existing guidance documents that 
provide related information on HF considerations. These are Guidance 
for Industry and FDA Staff, ``Applying Human Factors and Usability 
Engineering to Optimize Medical Device Design,'' accessible at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259760.pdf and Draft Guidance ``Safety 
Considerations for Product Design to Minimize Medication Errors,'' 
accessible at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM331810.pdf.
    This draft guidance provides examples of the use of HF studies for 
different types of combination products in different clinical settings. 
FDA welcomes comments to the docket on other examples of combination 
products and why they may or may not need HF studies. Additionally FDA 
seeks comments on what challenges and development risks may arise 
depending upon whether HF studies are conducted before, in parallel to, 
or after major clinical studies.

II. Significance of Guidance

    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 ``Human 
Factors Studies and Related Clinical Study Considerations in 
Combination Product Design and Development.'' 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm, 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently 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

[[Page 5766]]

21 CFR part 314 for NDAs and ANDAs have been approved under OMB control 
number 0910-0001. The collections of information in 21 CFR part 601 for 
BLAs have been approved under OMB control number 0910-0338. The 
collections of information in 21 CFR part 814, subparts B and E, for 
PMAs have been approved under OMB control number 0910-0231. The 
collections of information in 21 CFR part 814, subpart H, for 
humanitarian device exemption applications have been approved under OMB 
control number 0910-0332. The collections of information in 21 CFR part 
807, subpart E, for 510(k) notifications have been approved under OMB 
control number 0901-0120. The collections of information in 21 CFR part 
312 for INDs have been approved under OMB control number 0910-0014. The 
collections of information in 21 CFR part 812 for IDEs have been 
approved under OMB control number 0910-0078. The collections of 
information in 21 CFR part 820 for the quality system regulation have 
been approved under OMB control number 0910-0073.

    Dated: January 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01888 Filed 2-2-16; 8:45 am]
 BILLING CODE 4161-01-P