42662 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 

Dispute Resolution Panel, each panel, 

according to its specialty area, performs 

the following duties: (1) Advises the 

Commissioner regarding recommended 

classification or reclassification of 

devices into one of three regulatory 

categories, (2) advises on any possible 

risks to health associated with the use 

of devices, (3) advises on formulation of 

product development protocols, (4) 

reviews premarket approval 

applications for medical devices, (5) 

reviews guidelines and guidance 

documents, (6) recommends exemption 

of certain devices from the application 

of portions of the FD&C Act, (7) advises 

on the necessity to ban a device, and (8) 

responds to requests from the Agency to 

review and make recommendations on 

specific issues or problems concerning 

the safety and effectiveness of devices. 

With the exception of the Medical 

Devices Dispute Resolution Panel, each 

panel, according to its specialty area, 

may also make appropriate 

recommendations to the Commissioner 

on issues relating to the design of 

clinical studies regarding the safety and 

effectiveness of marketed and 

investigational devices. 

The Dental Products Panel also 

functions at times as a dental drug 

panel. The functions of the dental drug 

panel are to evaluate and recommend 

whether various prescription drug 

products should be changed to over-thecounter status and to evaluate data and 

make recommendations concerning the 

approval of new dental drug products 

for human use. 

The Medical Devices Dispute 

Resolution Panel provides advice to the 

Commissioner on complex or contested 

scientific issues between FDA and 

medical device sponsors, applicants, or 

manufacturers relating to specific 

products, marketing applications, 

regulatory decisions and actions by 

FDA, and Agency guidance and 

policies. The panel makes 

recommendations on issues that are 

lacking resolution, are highly complex 

in nature, or result from challenges to 

regular advisory panel proceedings or 

Agency decisions or actions. 

II. Criteria for Voting Members 

A. Device Good Manufacturing Practice 

Advisory Committee 

The Committee consists of a core of 

nine members including the Chair. 

Members and the Chair are selected by 

the Secretary of Health and Human 

Services. Persons nominated for 

membership as a health professional or 

officer or employee of any Federal, 

State, or local government should have 

knowledge of or expertise in any one or 

more of the following areas: Quality 

assurance concerning the design, 

manufacture, and use of medical 

devices. To be eligible for selection as 

a representative of the general public, 

nominees should possess appropriate 

qualifications to understand and 

contribute to the committee’s work. 

Three of the members shall be officers 

or employees of any State or local 

government or of the Federal 

Government; two shall be representative 

of the interests of the device 

manufacturing industry; two shall be 

representatives of the interests of 

physicians and other health 

professionals; and two shall be 

representatives of the interests of the 

general public. Almost all non-Federal 

members of this committee serves as 

Special Government Employees. 

Members are invited to serve for 

overlapping terms of 4 years. The 

particular needs at this time for this 

committee are listed in table 2 of this 

document. 

B. Panels of the Medical Devices 

Advisory Committee 

The Medical Devices Advisory 

Committee (MDAC) with its 18 panels 

shall consist of a maximum of 159 

standing members. Members are 

selected by the Commissioner or 

designee from among authorities in 

clinical and administrative medicine, 

engineering, biological and physical 

sciences, and other related professions. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. A maximum of 122 

members shall be standing voting 

members and 37 shall be nonvoting 

members who serve as representatives 

of consumer interests and of industry 

interests. FDA is publishing separate 

documents announcing the Request for 

Nominations Notification for NonVoting Representatives on certain 

panels of the MDAC. Persons nominated 

for membership on the panels should 

have adequately diversified experience 

appropriate to the work of the panel in 

such fields as clinical and 

administrative medicine, engineering, 

biological and physical sciences, 

statistics, and other related professions. 

The nature of specialized training and 

experience necessary to qualify the 

nominee as an expert suitable for 

appointment may include experience in 

medical practice, teaching, and/or 

research relevant to the field of activity 

of the panel. The particular needs at this 

time for each panel are listed in table 2. 

Members will be invited to serve for 

terms of up to 4 years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on one or more of the 

advisory panels or advisory committees. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete resume or curriculum vitae for 

each nominee, including current 

business address, telephone number, 

and email address if available and a 

signed copy of the Acknowledgement 

and Consent form available at the FDA 

Advisory Nomination Portal (see 

ADDRESSES). Nominations must also 

specify the advisory committee(s) for 

which the nominee is recommended. 

Nominations must also acknowledge 

that the nominee is aware of the 

nomination unless self-nominated. FDA 

will ask potential candidates to provide 

detailed information concerning such 

matters related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflict of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: August 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18216 Filed 8–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2896] 

Osteoarthritis: Structural Endpoints for 

the Development of Drugs, Devices, 

and Biological Products for Treatment; 

Draft Guidance for Industry; 

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 draft 

guidance for industry entitled 

‘‘Osteoarthritis: Structural Endpoints for 

the Development of Drugs, Devices, and 

Biological Products for Treatment.’’ The 

purpose of this draft guidance is to 

assist sponsors who are developing 

drugs, devices, or biological products to 

treat the underlying pathophysiology 

and structural progression of 

osteoarthritis (OA). This draft guidance 

does not address improvement of 

symptoms of OA, such as pain or 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 42663 

functional impairment, which will be 

addressed in future guidances. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 22, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2018–D–2896 for ‘‘Osteoarthritis: 

Structural Endpoints for the 

Development of Drugs, Devices, and 

Biological Products for Treatment.’’ 

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. 

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 draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002; or 

Office of the Center Director, Guidance 

and Policy Development, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Nikolay Nikolov, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 3202, 

Silver Spring, MD 20993–0002, 301– 

796–5281; Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911; or Sahar Dawisha, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm, 5536, Silver Spring, MD 20993– 

0002, 301–796–6192. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Osteoarthritis: Structural Endpoints for 

the Development of Drugs, Devices, and 

Biological Products for Treatment.’’ The 

purpose of this draft guidance is to 

assist sponsors who are developing 

drugs, devices, or biological products to 

treat the underlying pathophysiology 

and structural progression of OA. This 

guidance does not address improvement 

of symptoms of OA, such as pain or 

functional impairment. FDA recognizes 

the importance of these outcomes, 

which will be addressed in future 

guidances. The previous draft guidance 

for industry entitled ‘‘Clinical 

Development Programs for Drugs, 

Devices, and Biological Products 

Intended for the Treatment of 

Osteoarthritis (OA),’’ published July 15, 

1999, has been withdrawn. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Osteoarthritis: Structural Endpoints 

for the Development of Drugs, Devices, 

and Biological Products for Treatment.’’ 

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. 


daltland on DSKBBV9HB2PROD with NOTICES
42664 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information that 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 

parts 312 and 314 have been approved 

under OMB control numbers 0910–0014 

and 0910–0001, respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, https://

www.fda.gov/MedicalDevices/Device

RegulationandGuidance/ 

GuidanceDocuments/default.htm, or 

https://www.regulations.gov. 

Dated: August 20, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18214 Filed 8–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0377] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Health 

Document Submission 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or 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 Tobacco Health 

Document Submissions. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 22, 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 October 22, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 22, 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– 

2013–N–0377 for ‘‘Tobacco Health 

Document Submission.’’ 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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 


daltland on DSKBBV9HB2PROD with NOTICES