Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45597 

Advisory Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ 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.’’ FDA 

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 the 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: 

Lauren D. Tesh, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

AMDAC@fda.hhs.gov, or the FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check 

FDA’s Web site at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The committee will discuss 

new drug application (NDA) 209367, 

ciprofloxacin inhalation powder, 

sponsored by Bayer HealthCare 

Pharmaceuticals, Inc., for the proposed 

indication of reduction of exacerbations 

in non-cystic fibrosis bronchiectasis 

(NCFB) adult patients (≥18 years of age) 

with respiratory bacterial pathogens. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

November 1, 2017, will be provided to 

the committee. Oral presentations from 

the public will be scheduled between 

approximately 1:30 p.m. and 2:30 p.m. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 24, 2017. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

October 25, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require special accommodations 

due to a disability, please contact 

Lauren D. Tesh at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 26, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20949 Filed 9–28–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5608] 

Opioid Policy Steering Committee; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

establishing a public docket to solicit 

suggestions, recommendations, and 

comments from interested parties, 

including patients and patient 

representatives, health care 

professionals, academic institutions, 

regulated industry, and other interested 

organizations, on questions relevant to 

FDA’s newly established Opioid Policy 

Steering Committee (OPSC). Opioid 

addiction and the resulting overdoses 

and deaths have created a national 

crisis, which requires action by federal 

agencies that may in some instances be 

unprecedented in order to address the 

situation and attempt to turn the tide on 

the crisis. As a public health agency 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
45598 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 

responding to the crisis, FDA seek 

public input as it considers how its 

authorities can or should be used to 

address this crisis. This information will 

help the Agency understand areas of 

focus important to the public and 

identify and address opioid product and 

policy issues that need clarification. 

FDA is especially interested in hearing 

from interested parties in three key 

areas: What more can FDA do to ensure 

that the full range of available 

information, including about possible 

public health effects, is considered 

when making opioid-related regulatory 

decisions; what steps can FDA take with 

respect to dispensing and packaging 

(e.g., unit of use) to facilitate 

consistency of and promote appropriate 

prescribing practice; and should FDA 

require some form of mandatory 

education for health care professionals 

who prescribe opioid drug products, 

and if so, how should such a system be 

implemented? 

DATES: Submit either electronic or 

written comments by December 28, 

2017. 

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 December 28, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 28, 2017. 

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–5608 for ‘‘Opioid Policy 

Steering Committee; Establishment of a 

Public Docket; Request for Comments.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://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 

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 

‘‘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: 

Kathleen Davies, Office of Medical 

Products and Tobacco, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 2310, Silver Spring, 

MD 20993, 301–796–2205. 

SUPPLEMENTARY INFORMATION: On April 

19, 2017, the Secretary of Health and 

Human Services announced the HHS 

strategy for fighting the opioid crisis. 

The five point strategy includes: (1) 

Improving access to prevention, 

treatment, and recovery services; (2) 

targeting availability and distribution of 

overdose-reversing drugs; (3) 

strengthening timely public health data 

and reporting; (4) supporting cuttingedge research; and (5) advancing the 

practice of pain management. Following 

that announcement, on May 23, 2017, 

the Commissioner of Food and Drugs 

announced his intention to take more 

forceful steps to combat the opioid 

crisis. An OPSC was established to 

explore and develop additional tools or 

strategies FDA can use to confront this 

crisis. The OPSC has a broad mandate 

to consider steps that FDA can take to 

confront the opioid crisis. FDA is 

seeking suggestions, recommendations, 

and comments from interested parties, 

including patients and patient 

representatives, health care 

professionals, academic institutions, 

regulated industry, and other interested 

organizations, with regard to a number 

of topics related to three overarching 

questions: (1) What more can or should 

FDA do to ensure that the full range of 

available information, including about 

possible public health effects, is 

considered when making opioid-related 

regulatory decisions; (2) what steps can 

or should FDA take with respect to 

dispensing and packaging (e.g., unit of 

use) to facilitate consistency of and 

promote appropriate prescribing 

practice; and (3) should FDA require 

some form of mandatory education for 

health care professionals who prescribe 

opioid drug products, and if so, how 

should such a system be implemented? 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45599 

1FDA acknowledges the Joint Meeting of the Drug 

Safety and Risk Management Advisory Committee 

and the Anesthetic and Analgesic Drug Products 

Advisory Committee Meeting, held May 3–4, 2016, 

discussed mandatory education for health care 

professionals (Docket No. FDA–2016–N–0820). 

I. Assessing Benefit and Risk in the 

Opioids Setting 

In a July 6, 2017, article in the Journal 

of the American Medical Association, 

FDA explained its approach to assessing 

the benefits and risks of drug products, 

describing a structured approach that, in 

the case of opioids, includes extensive 

additional review of the risks related to 

the potential misuse and abuse of these 

products. FDA explained that it is 

working to incorporate the effects of 

decisions on public health into its 

benefit-risk framework in a more 

quantitative manner that can 

supplement and enhance the strong 

qualitative work that the Agency already 

performs (Ref. 1). In addition, in March 

2016, FDA commissioned a study from 

the National Academies of Sciences, 

Engineering, and Medicine to outline 

the state of the science regarding 

prescription opioid abuse and misuse, 

the evolving role that opioid analgesics 

play in pain management, and 

additional actions FDA should consider 

to address the opioid crisis with 

particular emphasis on strengthening its 

benefit-risk framework for opioids. That 

report was issued in July (Ref. 2). While 

FDA considers the report 

recommendations, we would like to 

solicit additional feedback that will 

supplement those recommendations. 

Specific questions on which FDA 

seeks comment relating to this topic are 

as follows: 

1. How should FDA tailor, or 

otherwise amend, its assessment of 

benefit and risk in the context of opioid 

drugs to ensure that the Agency is 

giving adequate consideration to the 

risks associated with the labeled 

indication of these drugs and the risks 

associated with the potential abuse and 

misuse of these products? 

2. Are there specific public health 

considerations other than misuse and 

abuse that FDA should incorporate into 

its current framework for benefit and 

risk assessment as a way to reduce the 

opioid addiction epidemic? That 

framework includes, but is not limited 

to, how FDA makes regulatory decisions 

to approve new opioids, evaluates their 

use in the postmarket setting, or limits 

or influences their prescribing through 

product labeling or other risk 

management measures. 

II. Steps To Promote Proper Prescribing 

and Dispensing 

Proper prescribing and dispensing are 

critical to successfully reducing opioid 

misuse and abuse. A 2016 Centers for 

Disease Control and Prevention (CDC) 

Guideline for Prescribing Opioids for 

Chronic Pain reported that, ‘‘[w]hen 

opioids are used for acute pain, 

clinicians should prescribe the lowest 

effective dose of immediate-release 

opioids and should prescribe no greater 

quantity than needed for the expected 

duration of pain severe enough to 

require opioids. Three days or less will 

often be sufficient; more than seven 

days will rarely be needed.’’ (Ref. 3.) 

And a recent analysis showed that, 

across six studies of patients who had 

undergone a variety of surgical 

procedures, 67 percent to 92 percent of 

patients reported unused opioid 

analgesics. Moreover, ‘‘[r]ates of safe 

storage and/or disposal of unused 

opioids were low,’’ resulting in an 

‘‘important reservoir of unused opioids 

available for nonmedical use . . . .’’ 

(Ref. 4). There are clinical situations 

that may require a supply of opioid 

analgesics that exceeds current CDC 

guidelines and FDA wants to make sure 

that patients have what they need in 

those cases. But FDA believes there are 

situations in which patients are 

prescribed an opioid analgesic when a 

non-opioid pain treatment would be 

adequate or, when an opioid product is 

necessary, treatment with a shorter 

course of therapy would be more 

appropriate, and without specific 

requirements, variance in prescribing 

habits are likely to persist. 

Specific questions on which FDA 

seeks comment relating to this topic are 

as follows: 

1. Should FDA consider adding a 

recommended duration of treatment for 

specific types of patient needs (e.g., for 

specific types of surgical procedures) to 

opioid analgesic product labeling? Or, 

should FDA work with prescriber 

groups that could, in turn, develop 

expert guidelines on proper prescribing 

by indication? 

2. If opioid product labeling 

contained recommended duration of 

treatment for certain common types of 

patient needs, how should this 

information be used by FDA, other state 

and Federal health agencies, providers, 

and other intermediaries, such as health 

plans and pharmacy benefit managers, 

as the basis for making sure that opioid 

drug dispensing more appropriately and 

consistently aligns with the type of 

patient need for which a prescription is 

being written? 

3. Are there steps FDA should take 

with respect to dispensing and 

packaging (e.g., unit of use) to facilitate 

consistency of and promote appropriate 

prescribing practice? 

4. Are there other steps that FDA 

should take to help promote the 

prescribing of treatment durations that 

are appropriately tailored to a clinical 

patient need? 

III. Requirements for Prescriber 

Education 

Recently, the option of mandating 

education or training for health care 

professionals who prescribe opioid 

medications has been more widely 

discussed,1 and some states already are, 

or are considering, mandating such 

prescriber education. For example, as of 

July 1, 2017, health care professionals in 

New York State who are licensed to 

prescribe controlled substances must 

complete, and register their completion 

of, at least 3 hours of course work or 

training in pain management, palliative 

care, and addiction (Ref. 5). 

Specific questions on which FDA 

seeks comment relating to this topic are 

as follows: 

1. Are there circumstances under 

which FDA should require some form of 

mandatory education for health care 

professionals to ensure that prescribing 

professionals are informed about 

appropriate prescribing and pain 

management recommendations, 

understand how to identify the risk of 

abuse in individual patients, know how 

to get patients with a substance use 

disorder into treatment, and know how 

to prescribe treatment for—and properly 

manage—patients with substance use 

disorders, among other educational 

goals? Are there other steps FDA could 

take to educate health care professionals 

to ensure that prescribing professionals 

are informed about appropriate 

prescribing and pain management 

recommendations? 

2. How might FDA operationalize 

such a requirement if it were to pursue 

this policy goal? For example, should 

mandatory education apply to all 

prescribing health care professionals, or 

only a subset of prescribing health care 

professionals? If only a subset, how 

would FDA construct a framework that 

focuses mandatory education on only 

that subset—for example, by requiring 

mandatory education only for those 

writing prescriptions for longer 

durations as opposed to those for very 

short-term use? 

3. What steps should FDA take to 

make implementing such mandatory 

education efficient and more feasible? 

For example, should FDA work 

collaboratively with state public health 

agencies, state licensing boards, 

provider organizations, such as medical 

specialty societies and health plans, or 

with other stakeholders, such as 


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45600 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 

pharmacy benefit managers, to integrate 

or avoid duplicating their educational 

programs or requirements? What other 

steps might FDA consider to make 

implementation less burdensome and 

more effective? 

IV. Additional Matters for 

Consideration 

1. What other steps should FDA take 

to operationalize the above described 

goals? 

2. Are there additional policy steps 

FDA should consider relating to the 

OPSC that are not identified in this 

notice? 

We invite interested parties to review 

these questions and submit comments to 

the docket for the OPSC to consider. In 

addition, we invite interested parties to 

submit additional policy considerations 

or recommendations for actions that 

FDA could or should undertake to help 

the Agency better address the opioid 

addiction crisis. 

V. References 

1. Gottlieb, Scott and J. Woodcock. 

‘‘Marshaling FDA Benefit-Risk Expertise to 

Address the Current Opioid Abuse 

Epidemic.’’ Journal of the American Medical 

Association. 2017;318(5):421–422. 

Doi:10.1001/jama.2017.9205. Available at 

http://jamanetwork.com/journals/jama/ 

fullarticle/2643333. Accessed August 2017. 

2. National Academies of Sciences, 

Engineering, and Medicine. ‘‘Pain 

Management and the Opioid Epidemic: 

Balancing Societal and Individual Benefits 

and Risks of Prescription Opioid Use (2017), 

Consensus Study Report.’’ Richard J. Bonnie, 

Morgan A. Ford, and Jonathan K. Phillips 

(eds.). Available at https://www.nap.edu/ 

catalog/24781/pain-management-and-theopioid-epidemic-balancing-societal-andindividual. Accessed August 2017. 

3. Dowell, D., T. M. Haegerich, and R. 

Chou. ‘‘CDC Guideline for Prescribing 

Opioids for Chronic Pain—United States, 

2016.’’ Item 6 in ‘‘Determining When to 

Initiate or Continue Opioids for Chronic 

Pain.’’ Morbidity and Mortality Weekly 

Report Recommendations and Reports 

2016;65(No. RR–1):1–49. DOI: http://

dx.doi.org/10.15585/mmwr.rr6501e1. 

Accessed August 2017. 

4. Bicket, M. C., J. J. Long, P. J. Pronovost, 

et al. ‘‘Prescription Opioid Analgesics 

Commonly Unused After Surgery, A 

Systematic Review.’’ JAMA Surgery. 

Published online August 2, 2017. 

DOI:10.1001/jamasurg.2017.0831. Available 

at http://jamanetwork.com/journals/ 

jamasurgery/fullarticle/2644905. Accessed 

August 2017. 

5. New York State Department of Health, 

Mandatory Prescriber Education. Available at 

https://www.health.ny.gov/professionals/ 

narcotic/mandatory_prescriber_education/. 

Accessed August 2017. 

Dated: September 26, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20905 Filed 9–28–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[HHS–OS–0990–0281–60D] 

Agency Generic Information Collection 

Activities; Proposed Collection; Public 

Comment Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before November 28, 

2017. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0281–60D 

and project title for reference, to the 

Report Clearance Officer, Sherrette 

Funn. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Information Collection Request Title: 

Prevention Communication Formative 

Research—Revision—OMB No. 0990– 

0281. 

Abstract: The Office of Disease 

Prevention and Health Promotion 

(ODPHP) is focused on developing and 

disseminating health information to the 

public. ODPHP faces an increasingly 

urgent interest in finding effective ways 

to communicate health information to 

America’s diverse population. ODPHP 

strives to be responsive to the needs of 

America’s diverse audiences while 

simultaneously serving all Americans 

across a range of channels, from print to 

new communication technologies. To 

carry out prevention information efforts, 

ODPHP is committed to conducting 

formative and usability research to 

provide guidance on the development 

and implementation of their 

communication and education efforts. 

The information collected will be used 

to improve communication, products, 

and services that support key office 

activities including: Healthy People, 

Dietary Guidelines for Americans, 

Physical Activity Guidelines for 

Americans, healthfinder.gov, and 

increasing health care quality and 

patient safety. ODPHP communicates 

through its Web sites 

(www.healthfinder.gov, 

www.HealthyPeople.gov, 

www.health.gov) and through other 

channels including social media, print 

materials, interactive training modules, 

and reports. Data collection will be 

qualitative and quantitative and may 

include in-depth interviews, focus 

groups, web-based surveys, omnibus 

surveys, card sorting, and various forms 

of usability testing of materials and 

interactive tools to assess the public’s 

understanding of disease prevention 

and health promotion content, 

responses to prototype materials, and 

barriers to effective use. 

The program is requesting a 3-year 

clearance. 

Likely Respondents: Respondents are 

likely to be either consumers or health 

professionals. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Data collection task Instrument/form name Number of 

respondents 

Number 

responses/ 

respondent 

Average burden/ 

response 

(in hours) 

Total response 

burden 

(in hours) 

In-depth interviews ............... Screener ............................... 1,500 1 10/60 250 

Interview ............................... 500 1 1.00 500 

Focus groups ........................ Screener ............................... 2,925 1 10/60 487.5 


asabaliauskas on DSKBBXCHB2PROD with NOTICES