44802 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices 

Dated: September 19, 2017. 

Lance Robertson, 

Administrator and Assistant Secretary for 

Aging. 

[FR Doc. 2017–20460 Filed 9–25–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0429] 

Classification of Products as Drugs 

and Devices and Additional Product 

Classification Issues; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry and FDA staff 

entitled ‘‘Classification of Products as 

Drugs and Devices & Additional Product 

Classification Issues.’’ This guidance 

provides the Agency’s current thinking 

on approaches for classifying products 

as drugs and devices, and on certain 

additional product classification issues. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 26, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2011–D–0429 for ‘‘Classification of 

Products as Drugs and Devices & 

Additional Product Classification 

Issues.’’ 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 office 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance document 

entitled ‘‘Classification of Products as 

Drugs and Devices & Additional Product 

Classification Issues’’ to the Office of 

Combination Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5129, Silver Spring, 

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

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

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 20993–0002, 

301–796–8930. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry and FDA staff 

entitled ‘‘Classification of Products as 

Drugs and Devices & Additional Product 

Classification Issues.’’ This guidance 

finalizes two related draft guidance 

documents issued in June 2011, entitled 

‘‘Classification of Products as Drugs and 

Devices & Additional Product 

Classification Issues’’ and 

‘‘Interpretation of the Term ’Chemical 

Action’ in the Definition of Device 

under Section 201(h) of the Federal 

Food, Drug, and Cosmetic Act.’’ 

This guidance is intended to provide 

the Agency’s current thinking on 

approaches for classifying products as 

drugs and devices, and on certain 

additional product classification issues. 

FDA determines whether to classify a 

product as a drug or device based on the 

statutory definitions for these terms set 

forth in section 201(g) and (h) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 321(g) and 

(h)), respectively, as applied to the 

scientific data concerning the products 

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