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. 

Dated: January 28, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01883 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0253] 

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. 

SUMMARY: 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. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 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. 

Dated: January 27, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01884 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0915] 

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 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 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 28, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01885 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 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 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 

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 

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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 

AGENCY: 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. 

SUMMARY: 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. 

FOR FURTHER INFORMATION CONTACT: 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. 

SUPPLEMENTARY INFORMATION: 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 

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 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of 

the Assistant Secretary for Health. 

ACTION: Notice; correction. 

SUMMARY: 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. 

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. 

mstockstill on DSK4VPTVN1PROD with NOTICES