Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 44803 

that are available to FDA at the time the 

classification determination is made. 

FDA regularly receives questions from 

medical product sponsors concerning 

the classification of their products. We 

believe that efficient, effective 

regulation would be facilitated by 

providing guidance on this topic. This 

guidance discusses the request for 

designation (RFD) process for obtaining 

a formal determination of a product’s 

classification, and provides general 

concepts regarding FDA’s decision 

process for making classification 

determinations. While issues have 

arisen relating to whether a product 

should be classified as a drug, device, 

biological product, or combination 

product, issues most frequently arise 

regarding whether a product should be 

classified as either a drug or a device. 

Accordingly, this guidance focuses 

particularly on cases in which a product 

may be classified as a drug or device. 

This guidance is organized into two 

substantive sections. Section II provides 

information on the RFD process for 

obtaining a formal determination of 

whether a product is classified as a drug 

or device and on obtaining other 

feedback from FDA on product 

classification questions. Section III 

discusses general concepts and 

definitions relating to FDA’s decisional 

process for making classification 

determinations and addresses issues 

that may arise in determining whether 

products should be classified as drugs 

or devices. 

FDA carefully considered the 

comments received on the two draft 

guidances in preparing this final 

guidance. We have combined the two 

documents into one and made other 

changes for clarity and ease of reference. 

For example, we have revised the 

discussion of the Agency’s 

interpretation and application of the 

term ‘‘chemical action’’ in the definition 

of device at section 201(h) of the FD&C 

Act, to more clearly explain the 

Agency’s approach. With regard to this 

issue and others, we have also included 

additional examples to illustrate the 

application of the Agency’s current 

thinking. 

In light of comments received, we 

have also reconsidered inclusion of 

content on the status of prior Agency 

classification determinations. FDA has 

had limited experience with 

reevaluating classification 

determinations as the issue rarely arises 

for FDA to consider. In addition, it can 

raise a variety of complex scientific and 

regulatory questions. Accordingly, we 

have concluded that it is not 

appropriate to address the topic further 

in guidance at this time. We will 

continue to address the issue on a caseby-case, fact-specific basis as needed, in 

a transparent manner as permitted by, 

and consistent with, applicable legal 

requirements. Any stakeholder who has 

questions regarding the classification of 

a currently marketed product or 

whether that classification should be 

relied upon with respect to a proposed 

product is encouraged to contact the 

Office of Combination Products. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Classification of 

Products as Drugs and Devices & 

Additional Product Classification 

Issues.’’ 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. This guidance is not 

subject to Executive Order 12866. 

III. Paperwork Reduction Act of 1995 

This 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 3 have been approved 

under OMB control number 0910–0523. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.fda.gov/RegulatoryInformation/ 

Guidances/ucm258946.htm. 

Dated: September 21, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20522 Filed 9–25–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5319] 

Devices Proposed for a New Use With 

an Approved, Marketed Drug; Public 

Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public hearing; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing a public hearing on a 

potential approach for device sponsors 

who seek to obtain marketing 

authorization for their products that are 

labeled for a new use with an approved, 

marketed drug when the sponsor for the 

approved drug does not wish to pursue 

or collaborate on the new use. 

DATES: The public hearing will be held 

on November 16, 2017, from 9 a.m. to 

5 p.m. The public hearing may be 

extended or may end early depending 

on the level of public participation. 

Persons seeking to attend or to present 

at the public hearing must register by 

October 26, 2017. Sections II and III 

provides attendance and registration 

information. Electronic or written 

comments will be accepted after the 

public hearing until January 15, 2018. 

Late, untimely filed comments will not 

be considered. 

ADDRESSES: The public hearing will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503, Section A), Silver Spring, 

MD 20993–0002. Entrance for the public 

hearing participants (non-FDA 

employees) is through Building 1, where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/Working

atFDA/BuildingsandFacilities/White

OakCampusInformation/ 

ucm241740.htm. 

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 

44804 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 

1Links to the Federal Register notice for the 

workshop, presentations given, and a full transcript 

of the proceedings are available at: https://

www.fda.gov/combinationproducts/meetings

conferencesworkshops/ucm116623.htm. 

2Although the issues discussed at the meeting 

were described as public health or legal issues, they 

also included scientific and regulatory issues. 

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–5319 for ‘‘Devices Referencing 

Drugs; Public Hearing; 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 

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: John 

Barlow Weiner, Associate Director for 

Policy, Office of Combination Products, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

5129, Silver Spring, MD 20933, 301– 

796–8930, combination@fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Medical products are often intended 

and labeled for use in conjunction with 

other medical products marketed by 

different sponsors (as used in this 

document, ‘‘sponsor’’ includes an 

applicant or manufacturer). In some 

cases, the medical products are of 

different types (such as drug and device, 

biological product and device, or drug 

and biological product). Typically, the 

different sponsors collaborate when the 

two products are to be used together for 

a new intended use. In some cases, 

products intended for use with one 

another comprise a ‘‘combination 

product’’ as the term is defined in 21 

CFR 3.2(e). Regardless of whether the 

products meet the definition of a 

combination product, collaboration 

between the sponsors can facilitate 

product development and obtaining 

marketing authorization for the products 

for the combined use, and can, thereby, 

enable access to innovative treatment 

options for patients. Inclusion of the 

combined use in the labeling of both 

products helps ensure user 

understanding, and the collaboration 

can also be important to ensuring the 

ongoing safety and effectiveness of the 

products for the combined use. 

Sometimes, however, sponsors seek 

marketing authorization from FDA for a 

medical product for a new use with the 

approved, marketed medical product of 

another sponsor (i.e., not included in 

the labeling for the approved, marketed 

product), and the sponsor of the 

approved, marketed product does not 

wish to pursue the new use or work 

with the other product sponsor. 

Generally, such proposed products have 

been devices proposing new uses with 

approved, marketed drugs (referred to in 

this notice as devices referencing drugs 

or DRDs), though other scenarios have 

been proposed as well, such as drugs 

proposed for new uses with cleared or 

approved, marketed devices. This notice 

focuses on DRDs. 

In FDA’s experience, DRDs may be 

proposed: (1) To enhance the safety or 

effectiveness of the marketed drug for its 

already approved indication; (2) for use 

with the approved drug for an 

indication for which the drug is not 

approved; or (3) to provide some other 

benefit, such as increasing user comfort 

or convenience. Such new uses have 

generally also involved a change in how 

the drug is used or administered, such 

as a change in dose, route, or rate of 

administration. 

FDA seeks to ensure that safe and 

effective medical products can be 

brought onto the market in a timely 

manner. The Agency encourages 

development of products that advance 

public health, particularly those that 

significantly improve the safety or 

effectiveness of an existing treatment or 

that address an unmet medical need. 

DRDs have the potential to advance the 

public health by offering new uses with 

approved, marketed drugs that might 

not otherwise be developed, because the 

drug sponsor does not wish to pursue 

the new use. At the same time, DRDs 

raise unique public health, scientific, 

regulatory, and legal issues. 

FDA, in cooperation with the Drug 

Information Association, held a public 

meeting in 2005 on combined uses of 

separately distributed products.1 That 

meeting focused on the public health, 

legal, regulatory, and scientific issues 2

that arise when sponsors seek to 

develop or market a product of one type 

(device, drug, or biological product) that 

would be labeled for use with an 

approved product of a different type, 

where the proposed use is not included 

in the labeling for the approved product. 

As reflected in the notice for that 

meeting and the presentations and 

discussions at the meeting, devices 

intended for a new combined use with 

a drug raise unique public health, 

scientific, regulatory and legal issues 

when the sponsors for the two products 

do not work together on the new 

combined use of the two products. 

Since that time, FDA has gained greater 

experience with these issues and 

believes that many of these issues for 

DRDs could be addressed under the 

approach described below. 

FDA wishes to obtain further public 

input through a more focused hearing 

Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 44805 

3FDA has not determined at this time whether 

DRDs may be reviewed through other device 

premarket authorization pathways besides 

premarket approval applications (PMAs), but FDA 

intends to consider this issue and welcomes 

comment on it. 

on the Agency’s potential approach for 

premarket review of proposed DRDs. 

The Agency is seeking this type of 

public engagement because of the 

potential importance of the issue for the 

public health and the need for input 

across the medical product industry and 

among public health stakeholders 

regarding how FDA should proceed. 

II. Purpose and Scope of the Public 

Hearing 

The purpose of the public hearing is 

to obtain comment from stakeholders on 

the potential approach described below, 

for premarket review of DRDs. As 

described above, DRDs, for purposes of 

this document and hearing, are devices 

that are intended for a use with an 

approved, marketed drug that is not in 

the labeling for the approved drug, 

where the drug application is held by a 

different sponsor that does not wish to 

pursue or collaborate on the new use 

with the device sponsor. The approach 

described below might be appropriate, 

for example, for drug delivery systems 

seeking to be labeled for use with an 

approved drug, for an indication for 

which that drug has not been approved 

(e.g., to administer the drug to treat a 

different disease or condition or a new 

patient population). We also welcome 

comment on any public health, 

scientific, regulatory, or legal 

considerations relating to DRDs and 

other medical products seeking to be 

labeled for new uses with approved, 

marketed medical products of a 

different type where the sponsor for the 

approved, marketed product does not 

wish to pursue or collaborate on the 

new use. The comments that FDA 

receives from this public hearing may 

help inform the further development of 

this approach. 

A. A Potential Approach for Premarket 

Review of DRDs 

FDA strongly recommends 

collaboration between sponsors on new 

combined uses of their medical 

products. The Agency is prepared to 

work with sponsors to facilitate such 

collaboration. When sponsors work 

together, they usually have an ongoing 

relationship that enables them to resolve 

many of the public health, scientific, 

regulatory, and legal issues that may 

arise as a result of two products being 

the responsibility of two independent 

sponsors. Such collaboration also can 

provide important information to 

support a regulatory decision (see 

below). Where collaboration between 

sponsors is not feasible, for example, 

because one sponsor does not wish to 

collaborate, FDA believes that the 

following factors could help address 

many of the public health, scientific, 

regulatory, and legal issues associated 

with DRDs. In doing so, these factors 

could allow for a DRD to be reviewed 

and approved via a device premarket 

authorization pathway 3 without 

approval of conforming labeling changes 

for the approved, marketed drug 

through a new drug application (NDA) 

or supplement to an NDA (see Section 

II.B Submission Considerations for 

further discussion). 

B. Factors 

DRD sponsors should be able to 

address the following issues as 

discussed below: 

1. Safety and Effectiveness of the New 

Use of the Drug. The DRD sponsor is 

able to demonstrate the safety and 

effectiveness of the new use of the drug 

that is included in the DRD labeling, by 

providing substantial evidence that the 

drug will have the effect it purports or 

is represented to have under the 

conditions of use described in the 

proposed DRD labeling and showing 

that the drug is safe for use under the 

conditions prescribed, recommended, or 

suggested in the proposed DRD labeling, 

as this is the standard that applies to 

new uses of drugs (see 21 U.S.C. 355(c) 

and (d)). If there are multiple approved 

versions of the approved drug 

product(s) referenced in the DRD 

labeling (including generic versions), 

the DRD sponsor is able to demonstrate 

the generalizability of the new use with 

all such versions of the drug product. 

2. User Confusion and Medication 

Error/Use Error. Given the potential for 

user confusion or medication error/use 

error, for example, due to certain 

differences in the labeling for the DRD 

and the approved drug that it is 

referencing, the DRD sponsor is able to 

demonstrate that the potential for user 

confusion or error has been adequately 

addressed. The DRD labeling must 

provide adequate directions for the new 

use with the approved, marketed drug. 

3. Postmarket Change Management. 

The DRD sponsor is able to demonstrate 

that it is able to address safety or 

effectiveness issues associated with 

changes to the approved, marketed drug, 

for example, by demonstrating: That the 

likelihood of changes to the approved, 

marketed drug is low; changes to the 

drug are unlikely to raise safety or 

effectiveness issues with respect to the 

conditions of use with the drug as 

described in the DRD labeling; and 

periodic testing will be conducted and 

be adequate to assure ongoing safety and 

effectiveness of the combined use. It is 

important that these issues be addressed 

because the DRD sponsor does not have 

a relationship with the sponsor for the 

approved, marketed drug, and, 

therefore, any changes to the two 

products will not be coordinated or 

communicated in advance. 

4. Postmarket Safety. The DRD 

sponsor is able to demonstrate that it 

has a postmarket safety plan to 

adequately address adverse events, 

including medication errors, related to 

the drug when used with the DRD. It is 

important that its postmarket safety plan 

allows the DRD sponsor to adequately 

capture, report, and respond 

appropriately to adverse events 

associated with the new drug use 

described in the DRD labeling, because 

the DRD sponsor does not have a 

relationship with the sponsor(s) of the 

approved, marketed drug and because 

the DRD sponsor will often be uniquely 

positioned to understand and address 

adverse events resulting from the new 

use of the drug described in the DRD 

labeling. 

5. Data Reliance. The DRD sponsor is 

able to provide all information needed 

to evaluate the safety and effectiveness 

of the new use with the approved drug 

referenced in the DRD labeling, without 

relying on any proprietary information 

for the approved drug (e.g., by instead 

relying on non-product-specific 

published literature, generalizable 

knowledge). The DRD sponsor may also 

be able to include in its application 

safety and effectiveness data and 

information from the marketing 

application for the drug that are 

publicly available, for example, if the 

approved reference listed drug has been 

withdrawn from sale, provided that 

FDA has determined that the approved 

reference listed drug was not withdrawn 

from sale for reasons of safety or 

effectiveness (see 21 U.S.C. 355(l) and 

21 CFR 314.161 and 314.430). 

Generally, a DRD sponsor would not 

have a right of reference to proprietary 

information on the approved drug with 

which the DRD is proposed to be used 

because the DRD sponsor has no 

relationship with the sponsor of the 

approved drug. 

C. Submission Considerations 

At the investigational stage, 

depending on the details of the 

investigational plan, a DRD sponsor may 

seek to submit an investigational new 

drug application (IND) or an 

investigational device exemption 

application (IDE). Either way, the Center 

for Drug Evaluation and Research 

44806 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 

(CDER) and the Center for Devices and 

Radiological Health (CDRH) would 

collaborate on the review. DRD sponsors 

should consult with CDER and CDRH as 

to which application to submit for a 

particular investigation. 

FDA believes that a PMA would 

generally be the appropriate device 

marketing application because, e.g., 

DRDs are expected to represent a new 

intended use or raise different questions 

of safety or effectiveness as compared to 

a legally marketed predicate device. 

Generally, PMAs for DRDs would be 

reviewed by CDRH, and CDRH would 

collaborate with CDER on the review of 

the DRD. CDRH would have the lead on 

device-specific issues, and CDER would 

have the lead on drug-specific issues. 

The Centers would identify any review 

aspects where review considerations 

overlap, to ensure Agency alignment on 

how to address these considerations and 

communicate about them to DRD 

sponsors. 

D. Questions for Commenters To 

Address 

FDA welcomes all feedback on the 

potential approach and on any public 

health, scientific, regulatory, and legal 

issues raised by it. We seek public 

comment on the factors and submission 

considerations described in this notice, 

and propose the following questions in 

an effort to prompt substantive input 

from stakeholders: 

1. Are there public health, scientific, 

regulatory, or legal issues that should be 

considered with respect to this potential 

approach for DRDs? If so, are there ways 

to address those issues? 

2. Is each of the factors and 

submission considerations described 

above appropriate? If not, why not? 

What modifications would you propose 

and why? Are there additional factors or 

submission considerations that the 

Agency should take into account? Please 

provide examples to illustrate your 

view. 

3. Should the approach described in 

this notice be limited to certain 

situations, such as where the combined 

use would potentially address an unmet 

medical need for a serious or lifethreatening condition? If so, please 

provide a detailed analysis in support of 

your view, including its legal 

justification. 

4. With respect to the user confusion 

and medication error/use error factor, 

are there other issues that DRD sponsors 

should address or that FDA should 

consider, to ensure that the DRD 

labeling provides adequate directions 

for the new use with the approved, 

marketed drug, without approval of 

conforming labeling changes for the 

approved, marketed drug? What issues 

should be considered with respect to 

promotional activities by the DRD 

sponsor and/or by any sponsors for the 

drug being referenced? 

5. With regard to the postmarket 

change management factor, what would 

be examples of circumstances in which 

the DRD sponsor would be able to 

adequately address this factor? What 

types of postmarket changes to the drug 

should the DRD sponsor be prepared to 

identify and address? What postmarket 

mechanisms, including specific testing 

or monitoring, would be appropriate to 

ensure ongoing safety and effectiveness 

of the combined use? 

6. When multiple versions of the 

drug, including generics, are marketed, 

what challenges exist in identifying 

which versions of the drug can be used 

with the DRD? How can DRD sponsors 

make this information clear to health 

care providers, pharmacists, and 

patients? 

7. What challenges exist at the 

investigational application stage, and 

how can those challenges be addressed? 

Are there circumstances where an IND 

would be the more appropriate 

investigational application for a clinical 

investigation of a DRD? Are there 

circumstances where an IDE would be 

the more appropriate investigational 

application? 

8. How may this approach impact 

future product development? 

9. Would an approach similar to the 

potential approach presented in this 

notice be appropriate for other types of 

combined uses (e.g., drugs referencing 

devices where the device sponsor does 

not wish to collaborate on the new use)? 

If so, how should the factors, 

submission considerations, or both be 

modified for other types of combined 

uses? Are there additional factors that 

should be considered for other types of 

combined uses? 

10. Are there other possible 

approaches that may be used to seek 

marketing authorization for combined 

uses of drugs and devices where 

product sponsors are unable or 

unwilling to collaborate? Please provide 

a detailed analysis in support of your 

proposed approach, including its legal 

justification. 

11. Recognizing that collaboration is 

preferable, what actions can FDA and 

stakeholders take to encourage and 

facilitate collaboration between device 

sponsors and sponsors of approved, 

marketed drugs to develop new 

combined uses of their medical 

products? 

12. Would an approach similar to the 

potential approach presented in this 

notice be appropriate in the case where 

a drug sponsor would like to include in 

the drug labeling the use of one or more 

approved or cleared companion 

diagnostics for its new drug in the same 

class as the drugs for which the 

companion diagnostic is approved or 

cleared but none of the companion 

diagnostic sponsors intend to add the 

new drug to the device labeling? If so, 

how should the factors, submission 

considerations, or both be modified? 

Are there additional factors that should 

be considered? Are there other possible 

approaches that may be used for such 

circumstance? Please provide a detailed 

analysis in support of your proposed 

approach, including its legal 

justification. 

III. Registration 

Registration and Requests for Oral 

Presentations: The FDA Conference 

Center at the White Oak location is a 

Federal facility with security procedures 

and limited seating. Attendance will be 

free and on a first-come, first-served 

basis. If you wish to attend (either in 

person or by webcast (see Streaming 

Webcast of the Public Hearing)) and/or 

present at the hearing, please register for 

the hearing and/or make a request for 

oral presentations or comments at 

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

MeetingsConferencesWorkshops/ 

ucm572528.htm by October 26, 2017 

and provide complete contact 

information for each attendee (i.e., 

name, title, affiliation, address, email 

address, and telephone number). Those 

without email access can register by 

contacting John Barlow Weiner by 

October 26, 2017 (see FOR FURTHER

INFORMATION CONTACT). 

FDA will try to accommodate all 

persons who wish to make a 

presentation. Individuals wishing to 

present should identify the number of 

the question, or questions, they wish to 

address. This will help FDA organize 

the presentations. Individuals and 

organizations with common interests 

should consolidate or coordinate their 

presentations and request time for a 

joint presentation. FDA will notify 

registered presenters of their scheduled 

presentation times. The time allotted for 

each presentation will depend on the 

number of individuals who wish to 

speak. Once FDA notifies registered 

presenters of their scheduled times, they 

are encouraged to submit an electronic 

copy of their presentation to 

combination@fda.gov on or before 

November 2, 2017. Persons registered to 

make an oral presentation are 

encouraged to arrive at the hearing room 

early and check in at the onsite 

registration table to confirm their 

designated presentation time. An 

Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 44807 

agenda for the hearing and any other 

background materials will be made 

available 5 days before the hearing at 

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

MeetingsConferencesWorkshops/ 

ucm572528.htm. 

If you need special accommodations 

because of a disability, please contact 

the Office of Combination Products at 

301–796–8930 or combination@fda.gov 

at least 7 days before the hearing. 

Streaming Webcast of the Public 

Hearing: For those unable to attend in 

person, FDA will provide a live webcast 

of the hearing. To join the hearing via 

the webcast, please go to https://

www.fda.gov/NewsEvents/Meetings

ConferencesWorkshops/ 

ucm572528.htm. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A transcript will also be 

available in either hard copy or on CD– 

ROM, after submission of a Freedom of 

Information request. The Freedom of 

Information office address is available 

on the Agency’s Web site at https://

www.fda.gov. 

IV. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with 21 CFR 

part 15. The hearing will be conducted 

by a presiding officer, who will be 

accompanied by FDA senior 

management from the Office of the 

Commissioner, the Center for Drug 

Evaluation and Research, the Center for 

Devices and Radiological Health, and 

the Center for Biologics Evaluation and 

Research. Under § 15.30(f), the hearing 

is informal and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may pose questions; they may 

question any person during or at the 

conclusion of each presentation. Public 

hearings under part 15 are subject to 

FDA’s policy and procedures for 

electronic media coverage of FDA’s 

public administrative proceedings (21 

CFR part 10, subpart C). Under § 10.205, 

representatives of the media may be 

permitted, subject to certain limitations, 

to videotape, film, or otherwise record 

FDA’s public administrative 

proceedings, including presentations by 

participants. The hearing will be 

transcribed as stipulated in § 15.30(b) 

(see Transcripts). To the extent that the 

conditions for the hearing, as described 

in this notice, conflict with any 

provisions set out in part 15, this notice 

acts as a waiver of those provisions as 

specified in § 15.30(h). 

Dated: September 19, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20521 Filed 9–25–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

COMPETES Reauthorization Act 

Challenge Competition 

AGENCY: Health Resources and Services 

Administration, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration’s (HRSA’s) 

Maternal and Child Health Bureau 

(MCHB) announces a prize competition 

to support the development and testing 

of low-cost, scalable technology-based 

innovations to meet the needs of 

families and health care providers of 

children with special health care needs 

(CSHCN), particularly children with 

medical complexity (CMC), to improve 

the quality of care, patient 

empowerment, and family experiences 

while saving costs to the health care 

system. 

FOR FURTHER INFORMATION CONTACT: 

James Resnick, Office of the Associate 

Administrator, MCHB, JResnick@

hrsa.gov, (301) 443–3222, or Marie 

Mann, Division of Services for Children 

with Special Health Needs, MCHB, 

MMann@hrsa.gov, (301) 443–4925. 

SUPPLEMENTARY INFORMATION: On 

January 4, 2011, the America 

COMPETES Reauthorization Act of 2010 

was signed into law allowing the use of 

challenges and prize competitions 

increasing agencies’ ability to promote 

and harness innovation. Competitions 

run by the federal government result in 

a number of benefits to the public, 

including the following: 

(a) Increasing the number and 

diversity of the individuals, teams, and 

organizations that are addressing a 

particular problem or challenge of 

national significance; 

(b) Improving the skills of the 

participants in the competition; and 

(c) Directing attention to new market 

opportunities and stimulating private 

sector investment. 

This challenge structured in three 

phases, reach a diverse population of 

innovators and solvers, including 

coders, public health experts, 

individuals affiliated with academic 

institutions, research and development 

communities in the private sector, and 

others. All submissions will be 

evaluated and separate prizes will be 

awarded for each of the three phases 

below. 

Phase 1: Design 

Phase 2: Development and Small Scale 

Testing 

Phase 3: Scaling 

Estimated dates for each phase are as 

follows: 

Phase 1: Effective on January 22, 2018 

Phase 1 Submission Period Ends: April 

20, 2018, 11:59 p.m. ET 

Phase 1 Judging Period: April 21–May 

18, 2018 

Phase 1 Winners Announced: May 25, 

2018 

Phase 2 Begins: May 29, 2018 

Phase 2 Submission Period Ends: 

October 26, 2018 

Phase 2 Judging Period: October 29– 

November 20, 2018 

Phase 2 Winners Announced: December 

4, 2018 

Phase 3 Begins: December 7, 2018 

Phase 3 Submission Period Ends: May 

10, 2019 

Phase 3 Winner Announced: May 30, 

2019 

Subject of Challenge Competition 

MCHB is sponsoring the Making 

Technology Work for Care Planning and 

Coordination for Children with Special 

Health Care Needs Challenge. CSHCN, 

particularly CMC, often rely on multiple 

systems, services, and health 

professionals to maintain health and 

optimize well-being. Care coordination 

and care planning centered on the 

comprehensive needs of the child and 

family can lead to improved quality and 

experience of care, as well as more costeffective care. Even with the presence of 

care coordinators and the development 

of shared care plans, communication 

and collaboration gaps remain because 

care coordinators and the shared care 

plans often are specific to providers 

and/or systems. Families have 

expressed frustration about working 

with the multiple systems and the lack 

of communication and coordination 

between them. They try to address the 

gap by assuming responsibility for their 

children’s 24/7 care and care 

coordination. However, they often 

encounter numerous obstacles and 

barriers to fulfilling this role, including 

difficulty obtaining needed information 

or guidance from health professionals. 

They desire resources like electronic 

and informational tools to allow easy 

aggregation of information and sharing