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This draft guidance refers to 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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Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 5759 

8. A preliminary proposed agenda, 

including an estimate of the time needed and 

a designated speaker for each agenda item; 

9. A preliminary list of specific questions, 

grouped by discipline (e.g., chemistry, 

clinical, nonclinical); 

10. A list of all individuals who will attend 

the meeting on behalf of the tobacco product 

manufacturer, importer, researcher, or 

investigator, including titles and 

responsibilities; 

11. The date on which the meeting 

information package will be received by 

FDA; and 

12. Suggested format of the meeting, e.g., 

conference call, in-person meeting at FDA 

offices, video conference, or written 

response, and suggested dates and times for 

the meeting. Meetings are usually scheduled 

for 1 hour. 

This information will be used by the 

Agency to: (1) Determine the utility of 

the meeting, (2) identify Agency staff 

necessary to discuss proposed agenda 

items, and (3) schedule the meeting. 

Meeting Information Packages: An 

individual submitting a meeting 

information package to FDA in advance 

of a meeting should provide summary 

information relevant to the product and 

supplementary information pertaining 

to any issue raised by the individual or 

FDA to be discussed at the meeting. As 

stated in the guidance, FDA 

recommends that meeting information 

packages generally include updates of 

information that was submitted with the 

meeting request and, as applicable: 

1. Product composition and design data 

summary; 

2. Manufacturing and process control data 

summary; 

3. Nonclinical data summary; 

4. Clinical data summary; 

5. Behavioral and product use data 

summary; 

6. User and nonuser perception data 

summary; and 

7. Investigational plans for studies and 

surveillance of the tobacco product, 

including a summary of proposed study 

protocols containing the following 

information (as applicable): 

a. Study objective(s); 

b. Study hypotheses; 

c. Study design; 

d. Study population (inclusion/exclusion 

criteria, comparison group(s); 

e. Human subject protection information, 

including Institutional Review Board 

information; 

f. Primary and secondary endpoints 

(definition and success criteria); 

g. Sample size calculation; 

h. Data collection procedures; 

i. Duration of follow up and baseline and 

follow up assessments, and 

j. Data analysis plan(s). 

The purpose of the information 

package is to provide Agency staff the 

opportunity to adequately prepare for 

the meeting, including the review of 

relevant data concerning the product. In 

the Agency’s experience, reviewing 

such information is critical to achieving 

a productive meeting. For the 

information that was previously 

submitted in the meeting request, the 

information package should provide 

updated information that reflects the 

most current and accurate information 

available. 

Description of Respondents: The 

respondents to this collection of 

information are manufacturers, 

importers, researchers, and investigators 

of tobacco products who seek to meet 

with FDA to discuss their plans 

regarding the development or marketing 

of a tobacco product. 

In the Federal Register of September 

17, 2015 (80 FR 55855), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Meeting Requests 

Combining and Sending Meeting Request Letters for Manufacturers, Importers, and Researchers .......................... 67 1 67 10 670 

Meeting Information Packages 

Combining and Submitting Meeting Information Packages 

for Manufacturers, Importers, and Researchers .............. 67 1 67 18 1,206 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,876 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA’s estimate of the number of 

respondents for meeting requests in 

table 1 of this document is based on the 

number of meeting requests to be 

received over the next 3 years. 

In the next 3 years of this collection, 

FDA estimates that 67 preapplication 

meetings will be requested. The number 

is not expected to change, as the public 

is more experienced in submitting 

applications for substantial equivalence, 

requests for nonsubstantial equivalence, 

etc. 

Thus, FDA estimates the number of 

manufacturers, importers, researchers, 

and investigators who are expected to 

submit meeting requests in table 1 of 

this document to be 67 (50 year-1 

requests + 100 year-2 requests + 50 year3 requests ÷ 3). The hours per response, 

which is the estimated number of hours 

that a respondent would spend 

preparing the information 

recommended by this guidance to be 

submitted with a meeting request, is 

estimated to be approximately 10 hours 

each, and the total burden hours for 

meeting requests are expected to be 670 

hours (10 hours preparation/mailing × 

67 average respondents per year). Based 

on FDA’s experience, the Agency 

expects it will take respondents this 

amount of time to prepare, gather, copy, 

and submit brief statements about the 

product and a description of the 

purpose and details of the meeting. 

FDA’s estimate of the number of 

respondents for compiling meeting 

information packages in table 1 of this 

document is based on 67 respondents 

each preparing copies of their 

information package and submitting 

them to FDA, for a total of 1,206 hours 

annually. The hours per response, 

which is the estimated number of hours 

that a respondent would spend 

preparing the information package as 

recommended by the guidance, is 

estimated to be approximately 18 hours 

per information package. Based on 

FDA’s experience, the Agency expects 

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5760 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 

that it will take respondents 1,206 hours 

of time (67 respondents × 18 hours) to 

gather, copy, and submit brief 

statements about the product, a 

description of the details of the 

anticipated meeting, and data and 

information that generally would 

already have been generated for the 

planned research and/or product 

development. 

The total number of burden hours for 

this collection of information is 1,876 

hours (670 hours to prepare and submit 

meeting requests and 1,206 hours to 

prepare and submit information 

packages). 

Dated: January 29, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02000 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–2016–D–0199] 

Enforcement Policy on National Health 

Related Item Code and National Drug 

Code Numbers Assigned to Devices; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability and Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance for 

industry and FDA staff entitled 

‘‘Enforcement Policy on National Health 

Related Item Code and National Drug 

Code Numbers Assigned to Devices.’’ 

When finalized, this draft document 

will describe the Agency’s intent not to 

enforce, before September 24, 2021, the 

prohibition against providing National 

Health Related Item Code (NHRIC) or 

National Drug Code (NDC) numbers on 

device labels and device packages, with 

respect to certain finished devices 

manufactured and labeled prior to 

September 24, 2018. In addition, when 

finalized, this draft guidance will 

describe the Agency’s intent to continue 

considering requests for continued use 

of FDA labeler codes under a system for 

the issuance of unique device identifiers 

(UDIs) until September 24, 2018. This 

draft guidance is not the final version of 

the guidance 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 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 April 4, 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. 

• 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– 

2016–D–0199 for ‘‘Enforcement Policy 

on National Health Related Item Code 

and National Drug Code Numbers 

Assigned to Devices.’’ 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 draft 

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 ‘‘Enforcement Policy 

on National Health Related Item Code 

and National Drug Code Numbers 

Assigned to Devices’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health (CDRH), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002. 

Alternatively, you may submit written 

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