81 FR 5764 - Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 22 (February 3, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 22 (February 3, 2016)
| Page Range | 5764-5766 | |
| FR Document | 2016-01888 |
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)] [Notices] [Pages 5764-5766] From the Federal Register Online [www.thefederalregister.org] [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Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.''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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 3, 2016.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 [email protected] 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
![5764 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
information collection is available on DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
the Internet at http://www.reginfo.gov/ HUMAN SERVICES HUMAN SERVICES
public/do/PRAMain.
Food and Drug Administration Food and Drug Administration
Dated: January 28, 2016.
Leslie Kux, [Docket No. FDA–2015–D–4848]
Associate Commissioner for Policy. [Docket No. FDA–2011–N–0915]
Human Factors Studies and Related
[FR Doc. 2016–01883 Filed 2–2–16; 8:45 am]
Agency Information Collection Clinical Study Considerations in
BILLING CODE 4164–01–P Activities; Announcement of Office of Combination Product Design and
Management and Budget Approval; Development; Draft Guidance for
Guidance for Industry on Industry and Food and Drug
DEPARTMENT OF HEALTH AND Administration Staff; Availability
Postmarketing Adverse Event
HUMAN SERVICES
Reporting for Nonprescription Human AGENCY: Food and Drug Administration,
Food and Drug Administration Drug Products Marketed Without an HHS.
Approved Application ACTION: Notice.
[Docket No. FDA–2012–N–0253]
AGENCY: Food and Drug Administration, SUMMARY: The Food and Drug
Agency Information Collection HHS. Administration (FDA or Agency) is
Activities; Announcement of Office of announcing the availability of a draft
ACTION: Notice.
Management and Budget Approval; guidance for industry and FDA staff
Postmarketing Adverse Drug entitled ‘‘Human Factors Studies and
SUMMARY: The Food and Drug Related Clinical Study Considerations
Experience Reporting Administration (FDA) is announcing in Combination Product Design and
that a collection of information entitled Development.’’ This document provides
AGENCY: Food and Drug Administration,
‘‘Guidance for Industry on guidance to industry and FDA staff on
HHS.
Postmarketing Adverse Event Reporting the underlying principles of human
ACTION: Notice. for Nonprescription Human Drug factors (HF) studies during the
Products Marketed Without an development of combination products.
SUMMARY: The Food and Drug Approved Application’’ has been Combination products are comprised of
Administration (FDA) is announcing approved by the Office of Management any combination of a drug and a device;
that a collection of information entitled and Budget (OMB) under the Paperwork a device and a biological product; a
‘‘Postmarketing Adverse Drug Reduction Act of 1995. biological product and a drug; or a drug,
Experience Reporting’’ has been a device, and a biological product.
approved by the Office of Management FOR FURTHER INFORMATION CONTACT: FDA
DATES: Although you can comment on
and Budget (OMB) under the Paperwork PRA Staff, Office of Operations, Food
any guidance at any time (see 21 CFR
Reduction Act of 1995. and Drug Administration, 8455
10.115(g)(5)), to ensure that the Agency
Colesville Rd., COLE–14526, Silver
FOR FURTHER INFORMATION CONTACT: FDA considers your comments on this draft
Spring, MD 20993–0002, PRAStaff@
PRA Staff, Office of Operations, Food guidance before it begins work on the
fda.hhs.gov.
and Drug Administration, 8455 final version of the guidance, submit
Colesville Rd., COLE–14526, Silver SUPPLEMENTARY INFORMATION: On July 2, either electronic or written comments
Spring, MD 20993–0002, PRAStaff@ 2015, the Agency submitted a proposed on the draft guidance by May 3, 2016.
fda.hhs.gov. collection of information entitled ADDRESSES: You may submit comments
‘‘Guidance for Industry on as follows:
SUPPLEMENTARY INFORMATION: On July 1, Postmarketing Adverse Event Reporting
2015, the Agency submitted a proposed Electronic Submissions
for Nonprescription Human Drug
collection of information entitled Submit electronic comments in the
Products Marketed Without an
‘‘Postmarketing Adverse Drug following way:
Approved Application’’ to OMB for • Federal eRulemaking Portal: http://
Experience Reporting’’ to OMB for
review and clearance under 44 U.S.C. www.regulations.gov. Follow the
review and clearance under 44 U.S.C.
3507. An Agency may not conduct or instructions for submitting comments.
3507. An Agency may not conduct or
sponsor, and a person is not required to Comments submitted electronically,
sponsor, and a person is not required to
respond to, a collection of information respond to, a collection of information including attachments, to http://
unless it displays a currently valid OMB unless it displays a currently valid OMB www.regulations.gov will be posted to
control number. OMB has now control number. OMB has now the docket unchanged. Because your
approved the information collection and approved the information collection and comment will be made public, you are
has assigned OMB control number has assigned OMB control number solely responsible for ensuring that your
0910–0230. The approval expires on 0910–0636. The approval expires on comment does not include any
December 31, 2018. A copy of the December 31, 2018. A copy of the confidential information that you or a
supporting statement for this supporting statement for this third party may not wish to be posted,
information collection is available on information collection is available on such as medical information, your or
mstockstill on DSK4VPTVN1PROD with NOTICES
the Internet at http://www.reginfo.gov/ the Internet at http://www.reginfo.gov/ anyone else’s Social Security number, or
public/do/PRAMain. public/do/PRAMain. confidential business information, such
Dated: January 28, 2016. as a manufacturing process. Please note
Dated: January 27, 2016.
that if you include your name, contact
Leslie Kux, Leslie Kux,
information, or other information that
Associate Commissioner for Policy. Associate Commissioner for Policy. identifies you in the body of your
[FR Doc. 2016–01884 Filed 2–2–16; 8:45 am] [FR Doc. 2016–01885 Filed 2–2–16; 8:45 am] comments, that information will be
BILLING CODE 4164–01–P BILLING CODE 4164–01–P posted on http://www.regulations.gov.
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![5766 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
21 CFR part 314 for NDAs and ANDAs FOR FURTHER INFORMATION CONTACT: Lisa to the following address: Public
have been approved under OMB control M. Lee, Executive Director, Presidential Commentary, Presidential Commission
number 0910–0001. The collections of Commission for the Study of Bioethical for the Study of Bioethical Issues, 1425
information in 21 CFR part 601 for BLAs Issues, 1425 New York Avenue NW., New York Avenue NW., Suite C–100,
have been approved under OMB control Suite C–100, Washington, DC 20005. Washington, DC 20005. To
number 0910–0338. The collections of Telephone: 202–233–3960. Email: accommodate as many individuals as
information in 21 CFR part 814, Lisa.Lee@bioethics.gov. Additional possible, the time for each question or
subparts B and E, for PMAs have been information may be obtained at comment may be limited. If the number
approved under OMB control number www.bioethics.gov. of individuals wishing to pose a
0910–0231. The collections of SUPPLEMENTARY INFORMATION: Pursuant question or make a comment is greater
information in 21 CFR part 814, subpart to the Federal Advisory Committee Act than can reasonably be accommodated
H, for humanitarian device exemption of 1972, Public Law 92–463, 5 U.S.C. during the scheduled meeting, the
applications have been approved under app. 2, notice is hereby given of the Commission may make a random
OMB control number 0910–0332. The twenty fourth meeting of the selection.
collections of information in 21 CFR Commission. The public teleconference
part 807, subpart E, for 510(k) Anyone planning to call into the
will be open to the public with
notifications have been approved under meeting, who needs special assistance
attendance limited to space available.
OMB control number 0901–0120. The Under authority of Executive Order or other reasonable accommodations,
collections of information in 21 CFR 13521, dated November 24, 2009, the should notify Esther Yoo by telephone
part 312 for INDs have been approved President established the Commission. at (202) 233–3960, or email at
under OMB control number 0910–0014. The Commission is an expert panel of Esther.Yoo@bioethics.gov in advance of
The collections of information in 21 not more than 13 members who are the meeting. The Commission will make
CFR part 812 for IDEs have been drawn from the fields of bioethics, every effort to accommodate persons
approved under OMB control number science, medicine, technology, who need special assistance.
0910–0078. The collections of engineering, law, philosophy, theology, Dated: January 20, 2016.
information in 21 CFR part 820 for the or other areas of the humanities or
quality system regulation have been Lisa M. Lee,
social sciences. The Commission
approved under OMB control number Executive Director, Presidential Commission
advises the President on bioethical
0910–0073. for the Study of Bioethical Issues.
issues arising from advances in
[FR Doc. 2016–01982 Filed 2–2–16; 8:45 am]
Dated: January 28, 2016. biomedicine and related areas of science
Leslie Kux, and technology. The Commission seeks BILLING CODE 4154–06–P
Associate Commissioner for Policy. to identify and promote policies and
[FR Doc. 2016–01888 Filed 2–2–16; 8:45 am] practices that ensure scientific research,
health care delivery, and technological DEPARTMENT OF HEALTH AND
BILLING CODE 4161–01–P
innovation are conducted in a socially HUMAN SERVICES
and ethically responsible manner.
The main agenda for the Meeting of the Presidential Advisory
DEPARTMENT OF HEALTH AND Council on HIV/AIDS; Correction
HUMAN SERVICES Commission’s twenty fourth meeting is
to discuss its ongoing development of
pedagogical materials to facilitate the AGENCY: Department of Health and
Public Meeting of the Presidential
Commission for the Study of integration of bioethics into education Human Services, Office of the Secretary,
Bioethical Issues in a range of traditional and non- Office of
traditional settings. The draft meeting the Assistant Secretary for Health.
AGENCY: Presidential Commission for agenda, call-in number, and other
the Study of Bioethical Issues, Office of ACTION: Notice; correction.
information about the Commission will
the Assistant Secretary for Health, be available at www.bioethics.gov.
Office of the Secretary, Department of The Commission welcomes input SUMMARY: The meeting of the
Health and Human Services. from anyone wishing to provide public Presidential Advisory Council on HIV/
ACTION: Notice of meeting. comment on any issue before it. AIDS (PACHA) scheduled for January
Respectful consideration of opposing 28 and 29, 2016, is postponed due to
SUMMARY: The Presidential Commission views and active participation by inclement weather. This meeting will be
for the Study of Bioethical Issues (the citizens in public exchange of ideas rescheduled at a future date.
Commission) will conduct its twenty enhances overall public understanding
fourth meeting on March 3, 2016. At FOR FURTHER INFORMATION CONTACT:
of the issues at hand and conclusions Caroline Talev, MPA, Committee
this teleconference meeting, the reached by the Commission. The
Commission will discuss its ongoing Manager, Hubert Humphrey Building,
Commission is particularly interested in 200 Independence Avenue SW.,
development of pedagogical materials to receiving comments and questions
facilitate the integration of bioethics Washington, DC 20201. Phone: 202–
during the meeting that are responsive
into education in a range of traditional 205–1178. Fax: 202–401–4005. Email:
to specific sessions. Written comments
and non-traditional settings. Caroline.Talev@hhs.gov.
will be accepted in advance, during, and
DATES: The teleconference meeting will
mstockstill on DSK4VPTVN1PROD with NOTICES
after the meeting and are especially Correction
take place March 3, 2016, from 2 p.m. welcome. Comments will be publicly
to approximately 4 p.m. available, including any personally In the Federal Register of January 5,
ADDRESSES: The public teleconference identifiable or confidential business 2016, Vol. 81, No. 2, on pages 243–244
will be conducted by telephone only. information that they contain. Trade a meeting of the Presidential Advisory
The agenda and call-in number will be secrets should not be submitted. Council on HIV/AIDS was announced.
posted at least one week in advance at Written comments will be accepted by That meeting has been cancelled due to
http://www.bioethics.gov. email to info@bioethics.gov, or by mail inclement weather.
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Document Created: 2016-02-03 00:40:02
Document Modified: 2016-02-03 00:40:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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 [email protected] or 301-796-8933. | |
| FR Citation | 81 FR 5764 |
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