5756 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 

It is not intended to constitute an 

official interpretation of the complaint 

or proposed order, or to modify in any 

way the proposed order’s terms. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2016–01944 Filed 2–2–16; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

[Docket No. ATSDR–2016–0001] 

Availability of Draft Toxicological 

Profile; Glutaraldehyde 

AGENCY: Agency for Toxic Substances 

and Disease Registry (ATSDR), 

Department of Health and Human 

Services (DHHS). 

ACTION: Notice of availability and 

request for comment. 

SUMMARY: This notice, prepared by the 

Agency for Toxic Substances and 

Disease Registry (ATSDR), announces 

the availability of the Toxicological 

Profile for Glutaraldehyde for review 

and comment. All toxicological profiles 

issued as ‘‘Drafts for Public Comment’’ 

represent ATSDR’s best efforts to 

provide important toxicological 

information on priority hazardous 

substances. We are seeking public 

comments and additional information or 

reports on studies about the health 

effects of glutaraldehyde for review and 

potential inclusion in the profile. 

Comments can include additional 

information or reports on studies about 

the health effects of glutaraldehyde. 

Although ATSDR will consider key 

studies for this substance during the 

profile development process, this 

Federal Register notice solicits any 

relevant, additional studies, particularly 

unpublished data. ATSDR will evaluate 

the quality and relevance of such data 

or studies for possible inclusion into the 

profile. ATSDR is providing a public 

comment period for this document as a 

means to best serve public health and 

our clients. 

DATES: Written comments on this draft 

Toxicological Profile must be received 

on or before May 3, 2016. 

ADDRESSES: You may submit comments, 

identified by docket number ATSDR– 

2016–0001, by any of the following 

methods: 

• Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Division of Toxicology and 

Human Health Sciences, Agency for 

Toxic Substances and Disease Registry, 

1600 Clifton Rd. NE., MS F–57, Atlanta, 

GA, 30329. Attn: Docket No. ATSDR– 

2016–0001. 

Instructions: All submissions received 

must include the agency name and 

docket number for this notice. All 

relevant comments will be posted 

without change. Because all public 

comments regarding ATSDR 

Toxicological Profiles are available for 

public inspection, no confidential 

business information or other 

confidential information should be 

submitted in response to this notice. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Delores Grant, Division of Toxicology 

and Human Health Sciences, Agency for 

Toxic Substances and Disease Registry, 

1600 Clifton Rd. NE., MS F–57, Atlanta, 

GA, 30329. Phone: (800) 232–4636 or 

770–488–3351. 

SUPPLEMENTARY INFORMATION: The 

Superfund Amendments and 

Reauthorization Act of 1986 (SARA) (42 

U.S.C. 9601 et seq.) amended the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act of 1980 (CERCLA or Superfund) (42 

U.S.C. 9601 et seq.) by establishing 

certain requirements for ATSDR and the 

U.S. Environmental Protection Agency 

(U.S. EPA) regarding hazardous 

substances that are most commonly 

found at facilities on the CERCLA 

National Priorities List (NPL). Among 

these statutory requirements is a 

mandate for the Administrator of 

ATSDR to prepare toxicological profiles 

for each substance included on the 

priority list of hazardous substances 

[also called the Substance Priority List 

(SPL)]. This list identifies 275 

hazardous substances that ATSDR (in 

cooperation with EPA) has determined 

pose the most significant potential 

threat to human health. The 2015 SPL 

is available online at 

www.atsdr.cdc.gov/spl. 

In addition, ATSDR has the authority 

to prepare toxicological profiles for 

substances not found at sites on the 

National Priorities List, in an effort to 

‘‘establish and maintain inventory of 

literature, research, and studies on the 

health effects of toxic substances’’ under 

CERCLA Section 104(i)(1)(B), to respond 

to requests for consultation under 

section 104(i)(4), and as otherwise 

necessary to support the site-specific 

response actions conducted by ATSDR. 

The public comments and other data 

submitted in response to the Federal 

Register notices are available for public 

inspection at ATSDR. Comments are 

available for public inspection from 

Monday through Friday, except for legal 

holidays, from 9 a.m. until 5 p.m., 

Eastern Time, at 4770 Buford Hwy NE., 

Atlanta, Georgia 30341. Please call 

ahead to 1–800–232–4636 and ask for a 

representative in the Division of 

Toxicology and Human Health Sciences 

to schedule your visit. 

Availability 

The Glutaraldehyde Toxicological 

Profile is available online at http://

www.atsdr.cdc.gov/toxprofiles/

index.asp and www.regulations.gov, 

Docket No. ATSDR–2016–0001. 

Donna B. Knutson, 

Acting Director, Office of Policy, Planning 

and Evaluation, National Center for 

Environmental Health and Agency for Toxic 

Substances and Disease Registry. 

[FR Doc. 2016–01972 Filed 2–2–16; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–4599] 

List of Highest Priority Devices for 

Human Factors Review; 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 the draft 

guidance entitled ‘‘List of Highest 

Priority Devices for Human Factors 

Review.’’ FDA is issuing this draft 

guidance document in order to inform 

medical device manufacturers which 

device types should have human factors 

data included in premarket 

submissions. FDA believes these device 

types have clear potential for serious 

harm resulting from use error and that 

review of human factors data in 

premarket submissions will help FDA 

evaluate the safety and effectiveness and 

substantial equivalence of these devices. 

This draft guidance is not final nor is it 

in effect at this time. 

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 comment of 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: 

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Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 5757 

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. 

• 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–4599 for ‘‘List of Highest 

Priority Devices for Human Factors 

Review.’’ 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. 

An electronic copy of the guidance 

document is available for download 

from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘List of Highest 

Priority Devices for Human Factors 

Review’’ to the Office of the Center 

Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Hoste, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2531, Silver Spring, 

MD 20993–0002, 240–402–3747, or 

shannon.hoste@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Human factors testing is a valuable 

component of product development for 

medical devices. FDA recommends that 

manufacturers consider human factors 

testing for medical devices as a part of 

a robust design control subsystem. This 

draft guidance, if finalized, will inform 

medical device manufacturers which 

device types should have human factors 

data included in premarket submissions 

(i.e., for premarket approval 510(k)). 

FDA believes these device types have 

clear potential for serious harm 

resulting from use error and that review 

of human factors data in premarket 

submissions will help FDA evaluate the 

safety and effectiveness and substantial 

equivalence of these devices. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of the guidance document, 

‘‘Applying Human Factors and Usability 

Engineering to Medical Devices,’’ to 

assist industry in following appropriate 

human factors and usability engineering 

processes to maximize the likelihood 

that new medical devices will be safe 

and effective for the intended users, 

uses, and use environments. Devices 

that should include human factors data 

in premarket submissions are listed in 

this draft guidance. When and if this 

draft guidance is finalized, FDA 

recommends that for devices identified 

in the draft guidance, manufacturers 

should provide FDA with a report that 

summarizes the human factors or 

usability engineering processes they 

have followed, including any 

preliminary analyses and evaluations 

and human factors validation testing, 

results, and conclusions. 

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 the list of highest priority devices for 

human factors review. 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 interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

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5758 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘List of Highest Priority Devices for 

Human Factors Review’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1500052 to identify 

the guidance you are requesting. 

IV. 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 820 are 

approved under OMB control number 

0910–0073; the collections of 

information in 21 CFR part 812 are 

approved under OMB control number 

0910–0078; the collections of 

information in 21 CFR part 807, subpart 

E are approved under OMB control 

number 0910–0120; the collections of 

information in 21 CFR part 814, 

subparts A through E are approved 

under OMB control number 0910–0231; 

the collections of information in 21 CFR 

part 814, subpart H are approved under 

OMB control number 0910–0332; the 

collections of information in 21 CFR 

parts 801 and 809 are approved under 

OMB control number 0910–0485; and 

the collections of information in the 

guidance document entitled ‘‘Requests 

for Feedback on Medical Device 

Submissions: The Pre-Submission 

Program and Meetings with Food and 

Drug Administration Staff’’ are 

approved under OMB control number 

0910–0756. 

Dated: January 28, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01889 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–D–0429] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance on 

Meetings With Industry and 

Investigators on the Research and 

Development of Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by March 4, 

2016. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0731. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance on Meetings With Industry 

and Investigators on the Research and 

Development of Tobacco Products 

OMB Control Number 0910–0731— 

Extension 

The Family Smoking Prevention and 

Tobacco Control Act (Pub. L. 111–31) 

offers tobacco product manufacturers 

several pathways to obtain an order 

from FDA to authorize the marketing of 

a new tobacco product before it may be 

introduced or delivered into interstate 

commerce. To provide assistance with 

these pathways to market products, FDA 

will meet with tobacco product 

manufacturers, importers, researchers, 

and investigators (or their 

representatives) when appropriate. This 

guidance is intended to assist persons 

who seek meetings with FDA relating to 

their research to inform the regulation of 

tobacco products, or to support the 

development or marketing of tobacco 

products. The guidance has been 

revised to provide clarity. 

In the guidance, the Agency 

discusses, among other things: 

• What information FDA 

recommends persons include in a 

meeting request; 

• How and when to submit a request; 

and 

• What information FDA 

recommends persons submit prior to a 

meeting. 

This guidance describes two 

collections of information: (1) The 

submission of a meeting request 

containing certain information and (2) 

the submission of an information 

package in advance of the meeting. The 

purpose of this proposed information 

collection is to allow FDA to conduct 

meetings with tobacco manufacturers, 

importers, researchers, and investigators 

in an effective and efficient manner. 

FDA issued this guidance as a level 2 

guidance consistent with FDA’s good 

guidance practices regulations (21 CFR 

10.115). 

Meeting Requests: The guidance sets 

forth FDA’s recommendations for 

materials to be included in a request for 

a meeting with FDA to discuss the 

research and development of tobacco 

products. In the guidance, FDA 

recommends that the following 

information be included in the meeting 

request: 

1. Product name and FDA-assigned 

Submission Tracking Number (if applicable); 

2. Product category (e.g., cigarettes, 

smokeless tobacco) (if applicable); 

3. Product use (indicate for consumer use 

or for further manufacturing); 

4. Contact information for the authorized 

point of contact for the company requesting 

the meeting; 

5. The topic of the meeting being requested 

(e.g., a new tobacco product application, an 

application for permission to market an 

MRTP, or investigational use of a new 

tobacco product); 

6. A brief statement of the purpose of the 

meeting, which could include a discussion of 

the types of studies or data to be discussed 

at the meeting, the general nature of the 

primary questions to be asked, and where the 

meeting fits in the overall product 

development plans; 

7. A preliminary list of the specific 

objectives/outcomes expected from the 

meeting; 

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