Federal Register / Vol. 82, No. 209 / Tuesday, October 31, 2017 / Notices 50429 

(6) How can CDC support state and 

local health departments, traditional 

healthcare providers, not for profit 

health institutions, and professional 

healthcare partner organizations to 

ensure that evidence-based tobacco 

cessation interventions are integrated 

into primary and behavioral health care 

settings on a consistent and sustainable 

basis? 

(7) How can the public health sector 

most effectively maximize the impact of 

public and private insurance coverage of 

cessation treatments as part of efforts to 

ensure that all tobacco users have 

barrier-free access to these treatments? 

References 

1. U.S. Department of Health and Human 

Services. The Health Consequences of 

Smoking—50 Years of Progress: A Report 

of the Surgeon General. Atlanta: U.S. 

Department of Health and Human 

Services, Centers for Disease Control and 

Prevention, National Center for Chronic 

Disease Prevention and Health 

Promotion, Office on Smoking and 

Health, 2014. 

2. Xu X, Bishop EE, Kennedy SM, Simpson 

SA, Pechacek TF. Annual Healthcare 

Spending Attributable to Cigarette 

Smoking: An Update. American Journal 

of Preventive Medicine 2014;48(3):326– 

33. 

3. Babb S, Malarcher A, Schauer G, Asman 

K, Jamal A. Quitting Smoking Among 

Adults—United States, 2000–2015. 

MMWR Morb Mortal Wkly Rep 

2017;65:1457–1464. 

4. Siu AL; US Preventive Services Task 

Force. Behavioral and pharmacotherapy 

interventions for tobacco smoking 

cessation in adults, including pregnant 

women: U.S. Preventive Services Task 

Force recommendation statement. Ann 

Intern Med 2015;163:622–34. 

5. Fiore MC, Jae ́n CR, Baker TB, et al. 

Treating Tobacco Use and Dependence: 

2008 Update—Clinical Practice 

Guidelines. Rockville (MD): U.S. 

Department of Health and Human 

Services, Public Health Service, Agency 

for Healthcare Research and Quality, 

2008. 

6. Jamal A, King BA, Neff LJ, Whitmill J, 

Babb SD, Graffunder CM. Current 

Cigarette Smoking Among Adults— 

United States, 2005–2015. MMWR Morb 

Mortal Wkly Rep 2016;65:1205–1211. 

7. Institute of Medicine. Ending the Tobacco 

Problem: A Blueprint for the Nation. 

Washington: The National Academies 

Press, 2007. 

8. Jha P, Ramasundarahettige C, Landsman V, 

Rostron B, Thun M, Anderson RN, 

McAfee T, Peto R. 21st-century hazards 

of smoking and benefits of cessation in 

the United States. New England Journal 

of Medicine 2013;368(4):341–50. 

Dated: October 25, 2017. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2017–23669 Filed 10–30–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[CDC–2017–0048; Docket Number NIOSH– 

156–C] 

Final Immediately Dangerous to Life or 

Health (IDLH) Value Profiles 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: NIOSH announces the 

availability of the following four 

Immediately Dangerous to Life or Health 

(IDLH) Value Profile documents: 

Acetonitrile [CAS No. 75–05–8], 

Chloroacetonitrile [CAS No. 107–14–2], 

Methacrylonitrile [CAS No. 126–98–7], 

and Nitrogen dioxide [CAS No. 10102– 

44–0]. 

DATES: The final IDLH Value Profile 

documents were published on 

September 29, 2017. 

ADDRESSES: These documents may be 

obtained at the following link: https://

www.cdc.gov/niosh/idlh/default.html. 

FOR FURTHER INFORMATION CONTACT: R. 

Todd Niemeier, MS, CIH, NIOSH, 

Education and Information Division 

(EID), Robert A. Taft Laboratories, 1090 

Tusculum Ave., MS–C32, Cincinnati, 

OH 45226, phone 513/533–8166 (not a 

toll-free number), email: rbn4@cdc.gov. 

SUPPLEMENTARY INFORMATION: On May 5, 

2017, NIOSH published a request for 

public review in the Federal Register 

[82 FR 21239] on IDLH Value profiles. 

We did not receive public comments, 

but did receive peer and stakeholder 

comments. These comments received 

were reviewed and addressed where 

appropriate. 

Frank Hearl, 

Chief of Staff, National Institute for 

Occupational Safety and Health, Centers for 

Disease Control and Prevention. 

[FR Doc. 2017–23665 Filed 10–30–17; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5897] 

Packaging, Storage, and Disposal 

Options To Enhance Opioid Safety— 

Exploring the Path Forward; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Packaging, Storage, 

and Disposal Options To Enhance 

Opioid Safety—Exploring the Path 

Forward.’’ The purpose of this 2-day 

public workshop is to host a scientific 

discussion with experts and seek input 

from interested stakeholders regarding 

the role of packaging, storage, and 

disposal options within the larger 

landscape of activities aimed at 

addressing abuse, misuse, or 

inappropriate access of prescription 

opioid drug products (opioids); guiding 

principles and considerations for the 

design of packaging, storage, and 

disposal options for opioids; integrating 

packaging, storage, and disposal options 

into existing health care and pharmacy 

systems, including both open and 

closed health care systems (e.g., a closed 

system such as the U.S. Department of 

Veterans Affairs); data needs and how to 

address challenges in assessing the 

impact of packaging, storage, and 

disposal options in both the premarket 

and postmarket settings; and ways in 

which FDA could encourage the 

development and assessment of 

packaging, storage, and disposal options 

for opioids that have the potential to 

enhance opioid safety. 

DATES: The public workshop will be 

held on December 11 and 12, 2017, from 

8:30 a.m. to 5 p.m. Submit either 

electronic or written comments on this 

public workshop by February 12, 2018. 

See the SUPPLEMENTARY INFORMATION

section for registration date and 

information. 

ADDRESSES: The public workshop will 

be held at the Sheraton Silver Spring 

Hotel, 8777 Georgia Ave., Silver Spring, 

MD 20910. The hotel’s phone number is 

301–589–0800. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before February 12, 2018. The 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
50430 Federal Register / Vol. 82, No. 209 / Tuesday, October 31, 2017 / Notices 

1https://healthpolicy.duke.edu/events/exploringpackaging-storage-and-disposal-solutions-enhanceopioid-safety. 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of February 12, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2017–N–5897 for ‘‘Packaging, Storage, 

and Disposal Options To Enhance 

Opioid Safety—Exploring the Path 

Forward.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Irene Z. Chan, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 4420, Silver Spring, 

MD 20993–0002, 301–796–3962, 

Irene.Chan2@fda.hhs.gov; or Michelle 

Eby, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 22, 

Rm. 4422, Silver Spring, MD 20993– 

0002, 301–796–4714, Michelle.Eby@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is deeply concerned about the 

widespread epidemic of opioid abuse, 

dependence, and overdose in the United 

States. FDA believes packaging, storage, 

and disposal options have the potential 

to enhance the safety of legally 

prescribed opioids. The development of 

such options is an important component 

of a multi-pronged approach to 

addressing the current opioid epidemic. 

FDA is exploring a scientific 

framework that supports and encourages 

the development of packaging, storage, 

and disposal options that can reduce or 

deter misuse, abuse, or inappropriate 

access to opioids, while allowing for the 

safe use of opioids by patients who need 

them. FDA will need to define the 

specific problems that packaging, 

storage, and disposal options could 

most effectively address; the guiding 

scientific principles to consider for the 

design and evaluation of these options; 

and the types of data most useful for 

evaluating them. 

The Duke-Margolis Center for Health 

Policy previously convened an expert 

workshop on June 1, 2017, to begin 

examining the potential role of 

packaging, storage, and disposal options 

in enhancing opioid safety and deterring 

misuse, abuse, and inappropriate access. 

This workshop provided a forum for 

discussing (1) the role of packaging, 

storage, and disposal options in 

addressing factors that enable opioid 

abuse and misuse or inappropriate 

access; (2) the current range of existing 

packaging, storage, and disposal 

options; (3) approaches to evaluating the 

impact of packaging, storage, and 

disposal options on misuse and abuse or 

inappropriate access of opioids; and (4) 

considerations for integrating the use of 

packaging, storage, and disposal options 

into existing health care and pharmacy 

systems. Following the June 1, 2017, 

Duke-Margolis Center for Health Policy 

expert workshop, an issues paper was 

developed.1 While the expert workshop 

and subsequent issues paper were 

supported through a cooperative 

agreement with FDA, the views 

expressed in the accompanying 

documents are those of the participants 

in attendance of that expert workshop, 

and do not necessarily reflect the 

official positions and policies of the 

Department of Health and Human 

Services, or imply endorsements by the 

U.S. Government or other organizations. 

II. Topics for Discussion at the Public 

Workshop 

In this 2-day public workshop, FDA 

plans to explore the appropriate path 

forward by hosting a scientific 

discussion with experts and seeking 

input from interested stakeholders. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 209 / Tuesday, October 31, 2017 / Notices 50431 

Further discussion is needed regarding 

(1) the role of packaging, storage, and 

disposal options within the larger 

landscape of activities aimed at 

addressing opioid abuse, misuse, or 

inappropriate access; (2) guiding 

principles and considerations for the 

design of packaging, storage, and 

disposal options for opioids; (3) 

integrating packaging, storage, and 

disposal options into existing health 

care and pharmacy systems, including 

both open and closed health care 

systems (e.g., a closed system such as 

the U.S. Department of Veterans 

Affairs); (4) data needs and how to 

address challenges in assessing the 

impact of packaging, storage, and 

disposal options in both the premarket 

and postmarket settings; and (5) ways in 

which FDA could encourage the 

development and assessment of 

packaging, storage, and disposal options 

for opioids that have the potential to 

enhance opioid safety. 

Participants will include individuals 

from a broad set of Federal, State, and 

private and public stakeholders who are 

working on the challenges of improving 

pain management while addressing the 

opioid abuse epidemic. Public 

participation and comment is 

encouraged. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, ‘‘Packaging, Storage, and 

Disposal Options to Enhance Opioid 

Safety—Exploring the Path Forward,’’ 

please visit the following Web site to 

register: https://

nakamotoevents.wufoo.com/forms/ 

pads-task-force-public-meeting/. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop must 

register by December 1, 2017, midnight 

Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. If time and space permit, 

onsite registration on the day of the 

public workshop will be provided 

beginning at 7:30 a.m. We will let 

registrants know if registration closes 

before the day of the public workshop. 

If you need special accommodations 

due to a disability, please contact 

Michelle Eby at Michelle.Eby@

fda.hhs.gov no later than December 4, 

2017. 

Public Participation in Scientific 

Workshop: Time will be provided 

during the discussion of each agenda 

topic for audience participants to 

provide comments if desired. Comments 

should be specific to the discussion 

topic, and the time provided will be at 

the discretion of the session chair. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast. Additional information 

will be made available regarding 

accessing the webcast 2 days prior to the 

public workshop at https://

www.fda.gov/Drugs/NewsEvents/ 

ucm571797.htm. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A link to the transcript will 

also be available on the internet at 

https://www.fda.gov/Drugs/NewsEvents/ 

ucm571797.htm. 

Dated: October 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23535 Filed 10–30–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No FDA–2008–D–0610] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Postmarketing Adverse 

Event Reporting for Medical Products 

and Dietary Supplements During an 

Influenza Pandemic 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection in the guidance on 

‘‘Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 2, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before January 2, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 2, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 


asabaliauskas on DSKBBXCHB2PROD with NOTICES