83 FR 42662 - Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 164 (August 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 164 (August 23, 2018)
| Page Range | 42662-42664 | |
| FR Document | 2018-18214 |
[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)] [Notices] [Pages 42662-42664] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18214] ----------------------------------------------------------------------- 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Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment.'' The purpose of this draft guidance is to assist sponsors who are developing drugs, devices, or biological products to treat the underlying pathophysiology and structural progression of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 This draft guidance does not address improvement of symptoms of OA, such as pain or [[Page 42663]] functional impairment, which will be addressed in future guidances. DATES: Submit either electronic or written comments on the draft guidance by October 22, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.thefederalregister.org/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. [[Page 42664]] 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/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
![42662 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
Dispute Resolution Panel, each panel, more of the following areas: Quality III. Nomination Procedures
according to its specialty area, performs assurance concerning the design, Any interested person may nominate
the following duties: (1) Advises the manufacture, and use of medical one or more qualified individuals for
Commissioner regarding recommended devices. To be eligible for selection as membership on one or more of the
classification or reclassification of a representative of the general public, advisory panels or advisory committees.
devices into one of three regulatory nominees should possess appropriate Self-nominations are also accepted.
categories, (2) advises on any possible qualifications to understand and Nominations must include a current,
risks to health associated with the use contribute to the committee’s work. complete resume or curriculum vitae for
of devices, (3) advises on formulation of Three of the members shall be officers each nominee, including current
product development protocols, (4) or employees of any State or local business address, telephone number,
reviews premarket approval government or of the Federal and email address if available and a
applications for medical devices, (5) Government; two shall be representative signed copy of the Acknowledgement
reviews guidelines and guidance of the interests of the device and Consent form available at the FDA
documents, (6) recommends exemption manufacturing industry; two shall be Advisory Nomination Portal (see
of certain devices from the application representatives of the interests of ADDRESSES). Nominations must also
of portions of the FD&C Act, (7) advises physicians and other health specify the advisory committee(s) for
on the necessity to ban a device, and (8) professionals; and two shall be which the nominee is recommended.
responds to requests from the Agency to representatives of the interests of the Nominations must also acknowledge
review and make recommendations on general public. Almost all non-Federal that the nominee is aware of the
specific issues or problems concerning members of this committee serves as nomination unless self-nominated. FDA
the safety and effectiveness of devices. Special Government Employees. will ask potential candidates to provide
With the exception of the Medical Members are invited to serve for detailed information concerning such
Devices Dispute Resolution Panel, each overlapping terms of 4 years. The matters related to financial holdings,
panel, according to its specialty area, particular needs at this time for this employment, and research grants and/or
may also make appropriate contracts to permit evaluation of
committee are listed in table 2 of this
recommendations to the Commissioner possible sources of conflict of interest.
document.
on issues relating to the design of This notice is issued under the
clinical studies regarding the safety and B. Panels of the Medical Devices Federal Advisory Committee Act (5
effectiveness of marketed and Advisory Committee U.S.C. app. 2) and 21 CFR part 14,
investigational devices. relating to advisory committees.
The Dental Products Panel also The Medical Devices Advisory
functions at times as a dental drug Committee (MDAC) with its 18 panels Dated: August 17, 2018.
panel. The functions of the dental drug shall consist of a maximum of 159 Leslie Kux,
panel are to evaluate and recommend standing members. Members are Associate Commissioner for Policy.
whether various prescription drug selected by the Commissioner or [FR Doc. 2018–18216 Filed 8–22–18; 8:45 am]
products should be changed to over-the- designee from among authorities in BILLING CODE 4164–01–P
counter status and to evaluate data and clinical and administrative medicine,
make recommendations concerning the engineering, biological and physical
approval of new dental drug products sciences, and other related professions. DEPARTMENT OF HEALTH AND
for human use. Almost all non-Federal members of this HUMAN SERVICES
The Medical Devices Dispute committee serve as Special Government
Resolution Panel provides advice to the Employees. A maximum of 122 Food and Drug Administration
Commissioner on complex or contested members shall be standing voting [Docket No. FDA–2018–D–2896]
scientific issues between FDA and members and 37 shall be nonvoting
medical device sponsors, applicants, or members who serve as representatives Osteoarthritis: Structural Endpoints for
manufacturers relating to specific of consumer interests and of industry the Development of Drugs, Devices,
products, marketing applications, interests. FDA is publishing separate and Biological Products for Treatment;
regulatory decisions and actions by documents announcing the Request for Draft Guidance for Industry;
FDA, and Agency guidance and Nominations Notification for Non- Availability
policies. The panel makes Voting Representatives on certain AGENCY: Food and Drug Administration,
recommendations on issues that are panels of the MDAC. Persons nominated HHS.
lacking resolution, are highly complex for membership on the panels should
in nature, or result from challenges to ACTION: Notice of availability.
have adequately diversified experience
regular advisory panel proceedings or appropriate to the work of the panel in SUMMARY: The Food and Drug
Agency decisions or actions. such fields as clinical and Administration (FDA or Agency) is
II. Criteria for Voting Members administrative medicine, engineering, announcing the availability of a draft
biological and physical sciences, guidance for industry entitled
A. Device Good Manufacturing Practice statistics, and other related professions. ‘‘Osteoarthritis: Structural Endpoints for
Advisory Committee The nature of specialized training and the Development of Drugs, Devices, and
The Committee consists of a core of experience necessary to qualify the Biological Products for Treatment.’’ The
nine members including the Chair. nominee as an expert suitable for purpose of this draft guidance is to
daltland on DSKBBV9HB2PROD with NOTICES
Members and the Chair are selected by appointment may include experience in assist sponsors who are developing
the Secretary of Health and Human medical practice, teaching, and/or drugs, devices, or biological products to
Services. Persons nominated for research relevant to the field of activity treat the underlying pathophysiology
membership as a health professional or of the panel. The particular needs at this and structural progression of
officer or employee of any Federal, time for each panel are listed in table 2. osteoarthritis (OA). This draft guidance
State, or local government should have Members will be invited to serve for does not address improvement of
knowledge of or expertise in any one or terms of up to 4 years. symptoms of OA, such as pain or
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![42664 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
II. Paperwork Reduction Act of 1995 untimely filed comments will not be Submissions,’’ publicly viewable at
This draft guidance refers to considered. Electronic comments must https://www.regulations.gov or at the
previously approved collections of be submitted on or before October 22, Dockets Management Staff between 9
information that are subject to review by 2018. The https://www.regulations.gov a.m. and 4 p.m., Monday through
the Office of Management and Budget electronic filing system will accept Friday.
(OMB) under the Paperwork Reduction comments until midnight Eastern Time • Confidential Submissions—To
at the end of October 22, 2018. submit a comment with confidential
Act of 1995 (44 U.S.C. 3501–3520). The
Comments received by mail/hand information that you do not wish to be
collections of information in 21 CFR
delivery/courier (for written/paper made publicly available, submit your
parts 312 and 314 have been approved
submissions) will be considered timely comments only as a written/paper
under OMB control numbers 0910–0014
if they are postmarked or the delivery submission. You should submit two
and 0910–0001, respectively.
service acceptance receipt is on or copies total. One copy will include the
III. Electronic Access before that date. information you claim to be confidential
Persons with access to the internet with a heading or cover note that states
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
ComplianceRegulatoryInformation/ following way: Agency will review this copy, including
Guidances/default.htm, http:// • Federal eRulemaking Portal: the claimed confidential information, in
www.fda.gov/BiologicsBloodVaccines/ https://www.regulations.gov. Follow the its consideration of comments. The
GuidanceComplianceRegulatory instructions for submitting comments. second copy, which will have the
Information/default.htm, https:// Comments submitted electronically, claimed confidential information
www.fda.gov/MedicalDevices/Device including attachments, to https:// redacted/blacked out, will be available
RegulationandGuidance/ www.regulations.gov will be posted to for public viewing and posted on
GuidanceDocuments/default.htm, or the docket unchanged. Because your https://www.regulations.gov. Submit
https://www.regulations.gov. comment will be made public, you are both copies to the Dockets Management
solely responsible for ensuring that your Staff. If you do not wish your name and
Dated: August 20, 2018. comment does not include any contact information to be made publicly
Leslie Kux, confidential information that you or a available, you can provide this
Associate Commissioner for Policy. third party may not wish to be posted, information on the cover sheet and not
[FR Doc. 2018–18214 Filed 8–22–18; 8:45 am] such as medical information, your or in the body of your comments and you
BILLING CODE 4164–01–P anyone else’s Social Security number, or must identify this information as
confidential business information, such ‘‘confidential.’’ Any information marked
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
DEPARTMENT OF HEALTH AND that if you include your name, contact except in accordance with 21 CFR 10.20
HUMAN SERVICES information, or other information that and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
Food and Drug Administration comments, that information will be of comments to public dockets, see 80
[Docket No. FDA–2013–N–0377] posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
• If you want to submit a comment the information at: https://www.gpo.gov/
Agency Information Collection with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
Activities; Proposed Collection; do not wish to be made available to the 23389.pdf.
Comment Request; Tobacco Health public, submit the comment as a Docket: For access to the docket to
Document Submission written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
HHS. received, go to https://
Written/Paper Submissions www.regulations.gov and insert the
ACTION: Notice. docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
SUMMARY: The Food and Drug
follows: ‘‘Search’’ box and follow the prompts
Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
announcing an opportunity for public and/or go to the Dockets Management
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
comment on the proposed collection of Management Staff (HFA–305), Food and
certain information by the Agency. Rockville, MD 20852.
Drug Administration, 5630 Fishers
Under the Paperwork Reduction Act of FOR FURTHER INFORMATION CONTACT:
Lane, Rm. 1061, Rockville, MD 20852.
1995 (PRA), Federal Agencies are • For written/paper comments Amber Sanford, Office of Operations,
required to publish notice in the submitted to the Dockets Management Food and Drug Administration, Three
Federal Register concerning each Staff, FDA will post your comment, as White Flint North, 10A–12M, 11601
proposed collection of information, well as any attachments, except for Landsdown St., North Bethesda, MD
including each proposed extension of an information submitted, marked and 20852, 301–796–8867, PRAStaff@
existing collection of information, and identified, as confidential, if submitted fda.hhs.gov.
to allow 60 days for public comment in as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the
response to the notice. This notice Instructions: All submissions received PRA (44 U.S.C. 3501–3520), Federal
daltland on DSKBBV9HB2PROD with NOTICES
solicits comments on Tobacco Health must include the Docket No. FDA– Agencies must obtain approval from the
Document Submissions. 2013–N–0377 for ‘‘Tobacco Health Office of Management and Budget
DATES: Submit either electronic or Document Submission.’’ Received (OMB) for each collection of
written comments on the collection of comments, those filed in a timely information they conduct or sponsor.
information by October 22, 2018. manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
ADDRESSES: You may submit comments in the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
as follows. Please note that late, submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
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Document Created: 2018-08-23 00:33:05
Document Modified: 2018-08-23 00:33:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 83 FR 42662 |
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